[Federal Register: December 8, 2004 (Volume 69, Number 235)]
[Notices]
[Page 71045-71049]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de04-78]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0398; FRL-7689-1]
Flumioxazin; Notice of Filing a Pesticide Petition to Establish
aTolerance 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 apesticide
petition proposing the establishment of regulations for residuesof a
certain pesticide chemical in or on various foodcommodities.
DATES: Comments, identified by docket identification(ID) number OPP-
2004-0398, must be received on or before January 7, 2005.
ADDRESSES: Comments may be submitted electronically, bymail, or
through hand delivery/courier. Follow the detailed instructionsas
provided in Unit I. of the SUPPLEMENTARYINFORMATION.
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller,Registration
Division (7505C), Office of Pesticide Programs, EnvironmentalProtection
Agency, 1200 Pennsylvania Ave., NW.,Washington, DC20460-0001; telephone
number: (703) 305-6224; e-mail address:miller.joanne@epamail.epa.gov.
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:
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
providesa guide for readers regarding entities likely to be affected by
thisaction. Other types of entities not listed in this unit could also
beaffected. The North American Industrial Classification System (NAICS)
codeshave been provided to assist you and others in determining whether
thisaction might apply to certain entities. If you have any questions
regardingthe applicability of this action to a particular entity,
consult the personlisted under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other RelatedInformation?
1. Docket. EPA has established an official publicdocket for this
action under docket ID number OPP-2004-0398.The official public docket
consists of the documents specificallyreferenced in this action, any
public comments received, and otherinformation related to this action.
Although, a part of the officialdocket, the public docket does not
include Confidential BusinessInformation (CBI) or other information
whose disclosure is restricted bystatute. The official public docket is
the collection of materials that isavailable for public viewing at the
Public Information and RecordsIntegrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. BellSt., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m.,Monday through Friday,
excluding legal holidays. The docket telephonenumber 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
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be available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B. EPA intends to work towards providing electronic access to
all of the publicly available docket materials through EPA's electronic
public docket.
For public commenters, it is important to note that EPA's policy
is that public comments, whether submitted electronically or on paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also, include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0398. 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-2004-0398. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0398.
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-2004-0398. 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.
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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: November 24, 2004.
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 Valent U.S.A. Corporation 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.
Valent U.S.A. Corportion
PP 4F6829
EPA has received a pesticide petition (4F6829) from Valent U.S.A.
Corporation, 1600 Riviera Ave., Suite 200, Walnut Creek, CA 94596,
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 the herbicide chemical
flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or
on the following raw agricultural commodities: Fruit, pome (Crop Group
11) at 0.02 parts per million (ppm) and fruit, stone (Crop Group 12) at
0.02 ppm. EPA has determined that the petition contains data or
information regarding the elements set forth in section 408(d)(2) of
the FFDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
petition. Additional data may be needed before EPA rules on the
petition.
A. Residue Chemistry
1. Plant metabolism. The metabolism of flumioxazin is adequately
understood for the purpose of the proposed tolerances.
2. Analytical method. Practical analytical methods for detecting
and measuring levels of flumioxazin have been developed and validated
in or on all appropriate agricultural commodities and respective
processing fractions. The limit of quantitation (LOQ) of flumioxazin in
the methods is 0.02 ppm which will allow monitoring of food with
residues at the levels proposed for the tolerances.
3. Magnitude of residues. Residue data on apples, pears, plums,
peaches, and cherries (sweet and tart) have been submitted which
adequately support the requested tolerances. Processing studies were
conducted with apples and plums. No residues of flumioxazin were
detected in any of the raw agricultural commodities or processing
commodities collected from these studies even when orchards were
treated at an exaggerated (2x) rate. No tolerances are proposed for
apple or plum processing commodities.
B. Toxicological Profile
The toxicological profile for flumioxazin which supports this
petition for tolerances was previously published in the Federal
Register of April 18, 2001 (66 FR 19870) (FRL-6778-5).
C. Aggregate Exposure
1. Dietary exposure. Acute and chronic dietary analyses were
conducted to estimate exposure to potential flumioxazin residues in or
on the following crops: Peanuts and soybeans (existing tolerances);
cotton, grapes, almond, pistachio, and sugarcane, vegetable, tuberous
and corm (Subgroup 1C), onion, dry bulb and mint (tolerances pending);
nut, tree (Group 14), (tolerances to be proposed in the future); and
fruit, pome (Group 11) and fruit, stone (Group 12) (tolerances proposed
in the current petition). The Cumulative and Aggregate Risk Evaluation
System (CARES) Version 1.1 was used to conduct this assessment.
Proposed tolerances and conservative estimates for percentages of the
percent crop treated were used in these assessments. No adjustments
were made for common washing, cooking, or preparation practices.
Exposure estimates for water were made based upon modeling Generic
Expected Environmental Concentration (GENEEC 1.2).
i. Food--a. Acute. The acute dietary exposure estimate of
flumioxazin residues in food at the 99.9th percentile was
calculated to be, at most, 26.3% of the acute reference dose (aRfD)
with a margin of exposure (MOE) of 3,797. The population subgroup with
the highest exposure was children 1-2 years old. The aRfD was defined
as the no observed adverse effect level (NOAEL) from an oral
developmental study in rats and includes an uncertainty factor of 100
to account for intraspecies and interspecies variation and an
additional 10-fold uncertainty factor for FQPA (NOAEL = 3 milligrams/
kilogram body weight (mg/kg bwt/day), aRfD = 0.003 mg/kg/day).
b. Chronic. The chronic dietary exposure estimate of flumioxazin
residues in food at the 100th percentile was calculated to
be, at most, 2.5% of the chronic reference dose (cRfD) with a MOE of
40,000. The population subgroup with the highest exposure was the
general U.S. population. The cRfD was defined as the NOAEL from a rat
2-year chronic/oncogenicity study and includes an uncertainty factor of
100 to account for intraspecies and interspecies variation and an
additional 10-fold uncertainty factor for Food Quality Protection Act
(FQPA) (NOAEL = 2 mg/kg bwt/day, cRfD = 0.002 mg/kg/day).
ii. Drinking water. Since flumioxazin is applied outdoors to
growing agricultural crops, the potential exists for the parent or its
metabolites to reach ground water or surface water that may be used for
drinking water. Because of the physical properties of flumioxazin, it
is unlikely that flumioxazin or its metabolites can leach to potable
ground water. To quantify potential exposure from drinking water,
surface water concentrations for flumioxazin were estimated using
GENEEC 1.2. Because KOC could not be measured directly in adsorption-
desorption studies because of chemical stability, GENEEC values
representative of a range of KOC values were modeled. The simulation
that was selected for these exposure estimates used an average KOC of
385, indicating high mobility. The peak GENEEC concentration predicted
in the simulated pond water was 9.8 parts per billion (ppb). Using
standard assumptions about body weight and water consumption, the acute
exposure from this drinking water would be 0.00028 and 0.00098 mg/kg/
day for
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adults and children, respectively. The 56-day GENEEC concentration
predicted in the simulated pond water was 0.34 ppb. Chronic exposure
from this drinking water would be 0.0000097 and 0.000034 mg/kg/day for
adults and children, respectively; 1.7% of the chronic population
adjusted dose (cPAD) of 0.002 mg/kg/day for children. Based on this
worse case analysis, the contribution of drinking water to the dietary
exposure is comparable to that from food, but the risk is still
negligible.
2. Non-dietary exposure. Flumioxazin is proposed only for
agricultural uses and no homeowner or turf uses. Thus, no non-dietary
risk assessment is needed.
D. Cumulative Effects
Section 408(b)(2)(D)(v) 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
include not only toxicity, chemistry, and exposure data, but also
scientific policies and methodologies for understanding common
mechanisms of toxicity and conducting cumulative risk assessments.
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 the methodologies to resolve the complex scientific
issues concerning common mechanism of toxicity in a meaningful way for
most registered pesticides.
E. Safety Determination
1. U.S. population--i. Acute risk. The potential acute exposure
from food to the U.S. population and various non-child/infant
population subgroups will utilize at most 14.2% of the aRfD. Addition
of the worse case, dietary exposure from water (0.00028 mg/kg/day)
increases this exposure at the 99.9th percentile to 23.7% of
the aRfD. The Agency has no cause for concern if total acute residue
contribution is less than 100% of the aRfD, because the RfD represents
the level at or below which daily aggregate exposure over a lifetime
will not pose appreciable risk to human health. Therefore, it can be
concluded that there is a reasonable certainty that no harm will result
to the overall U.S. population from aggregate, acute exposure to
flumioxazin residues.
ii. Chronic risk. The potential chronic exposure from food to the
U.S. population and various non-child/infant population subgroups will
utilize at most 2.5% of the cRfD. Addition of the worse case, dietary
exposure from water (0.0000097 mg/kg/day) increases this exposure at
the 100th percentile to 3.0% of the cRfD. The Agency has no
cause for concern if total chronic residue contribution is less than
100% of the cRfD, because the RfD represents the level at or below
which daily aggregate exposure over a lifetime will not pose
appreciable risk to human health. Therefore, it can be concluded that
there is a reasonable certainty that no harm will result to the overall
U.S. population from aggregate, chronic exposure to flumioxazin
residues.
2. Infants and children--i. Safety factor for infants and children.
The FQPA safety factor (as required by the Food Quality Protection Act
of August 3, 1996) has been retained at 10x in assessing the risk posed
by flumioxazin. The reasons for retaining the 10x safety factor are as
follows. First, there is evidence of increased susceptibility of rat
fetuses to in utero exposure to flumioxazin by the oral and dermal
route in the prenatal developmental toxicity studies in rats. In
addition, there is evidence of increased susceptibility of young
animals exposed to flumioxazin in the 2-generation reproduction
toxicity study in rats. Finally, there is concern for the severity of
the effects observed in fetuses and young animals when compared to
those observed in the maternal and parental animals. Since the
additional 10x safety factor has been retained to account for the
apparent increased susceptibility from prenatal or postnatal exposures
to flumioxazin, it would be appropriate to apply the extra 10x safety
factor to only selected subpopulations, e.g., infants and children < 6
years old and females >13 years old. For these assessments, however,
the 10x safety factor has been applied to all population subgroups for
all exposure durations (acute and chronic), thus making these
assessments additionally conservative.
ii. Acute risk. The potential acute exposure from food to children
1-2 years old (the most highly exposed child/infant subgroup) will
utilize at most 26.3% of the aRfD. Addition of the worse case, dietary
exposure from water (0.00098 mg/kg/day) increases this exposure at the
99.9th percentile to 59% of the aRfD. Therefore, it can be
concluded that, there is a reasonable certainty that no harm will
result to infants and children from aggregate, acute exposure to
flumioxazin residues.
iii. Chronic risk. The potential chronic exposure from food to
children 1-2 years old (the most highly exposed child/infant subgroup)
will utilize at most 2.4% of the cRfD. Addition of the worse case,
dietary exposure from water (0.000034 mg/kg/day) increases this
exposure at the 100th percentile to 4.2% of the cRfD.
Therefore, it can be concluded that there is a reasonable certainty
that no harm will result to infants and children from aggregate,
chronic exposure to flumioxazin residues.
F. International Tolerances.
Flumioxazin has not been evaluated by the joint meeting on
pesticide residues (JMPR) and there are no codex Maximum Residue Limits
(MRL) for flumioxazin. MRL values have been established to allow the
following uses of flumioxazin in the following countries.
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Country Crop MRL (ppm)
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Argentina Soybean 0.015
Sunflower............. 0.02
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Brazil Soybean 0.05
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France Grape 0.05
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Paraguay Soybean 0.015
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South Africa Soybean 0.02
Groundnut............. 0.02
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Spain Soybean 0.05
Peanut................ 0.05
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[FR Doc. 04-26819 Filed 12-7-04; 8:45 am]
BILLING CODE 6560-50-S