Flumioxazin; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 18004-18008 [05-6852]
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18004
Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices
0.07 ppm, the anticipated iprovalicarb
residue in tomato paste is only 0.10
ppm. (0.07 ppm x 1.38 = 0.10 ppm).
B. Toxicological Profile
OPPTS Harmonized Guideline
870.1100, Acute oral toxicity, LD50
5,000 milligram/kilogram/body weight
(mg/kg/bwt) is the only entry that did
not appear in Table 1 of the final rule
of August 22, 2002.
1. Acute toxicity. See Table 1 of the
final rule published in the Federal
Register of August 22, 2002 (67 FR
54351) (FRL–7194–3).
2. Genotoxicity. See Table 1 of the
final rule published in the Federal
Register of August 22, 2002 (67 FR
54351).
3. Reproductive and developmental
toxicity. See Table 1 of the final rule
published in the Federal Register of
August 22, 2002 (67 FR 54351).
4. Subchronic toxicity. See Table 1 of
the final rule published in the Federal
Register of August 22, 2002 (67 FR
54351).
5.Chronic toxicity. See Table 1 of the
final rule published in the Federal
Register of August 22, 2002 (67 FR
54351).
6. Animal metabolism. See Table 1 of
the final rule published in the Federal
Register of August 22, 2002 (67 FR
54351).
7. Metabolite toxicology. The toxicity
of p-methyl-phenethylamine, a rat, plant
and soil metabolite, was investigated in
two studies:
i. The acute oral LD50 in Wistar rats
was determined to be in the range of 300
to 500 mg/kg/bwt.
ii. No mutagenic activity was
observed in the Salmonella/microsome
test. p-Methyl-phenethylamine was
found at concentrations of <0.2% and
has been determined to not be
toxicologically significant.
8. Endocrine disruption. No endocrine
disruption potential was observed in the
2–generation reproduction study,
developmental toxicity studies,
subchronic feeding studies, and chronic
feeding studies.
C. Aggregate Exposure
1. Dietary exposure. There are no
registered uses of iprovalicarb in the
United States, and no registrations are
pending. Dietary exposure to
iprovalicarb in the United States is
limited to residues in/on imported grape
commodities and the proposed
imported tomato commodities.
i. Food. Exposure to iprovalicarb
residues in food is limited to imported
grape and tomato commodities. U.S.
consumption of fresh grapes, grape
juice, raisins and wine that is from
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imported sources is estimated to be
35%, 43.3%, 7%, and 15%,
respectively. The percent U.S.
consumption of tomato commodities
potentially treated with iprovalicarb
that is from imported sources is
estimated to be 13.4% for fresh tomatoes
and 2.9% for processed tomatoes.
ii. Drinking water. Iprovalicarb is not
registered for use in the United States.
Therefore, there is no exposure to
iprovalicarb through drinking water in
the United States.
2. Non-dietary exposure. Iprovalicarb
is not registered for use in the United
States. Therefore, there is no nondietary exposure to iprovalicarb in the
United States.
D. Cumulative Effects
Iprovalicarb is a member of a new
class of chemistry and does not have a
mode of action that is common with
other registered pesticides. Therefore,
there are no cumulative effects.
E. Safety Determination
1. U.S. population. Iprovalicarb has
low acute toxicity, so no acute safety
determination is needed. EPA has
previously determined that the chronic
Population Adjusted Dose for
iprovalicarb is 0.026 mg/kg/bwt/day and
the uncertainty factor is 100. Based
upon average residues in/on imported
tomato commodities, and assuming that
100% of the tomato commodities that
are imported from countries in which
iprovalicarb is potentially used have
been treated with iprovalicarb, the
estimated chronic dietary risk based
upon exposure of 50% of the reference
population was estimated using CARES
verison 1.3 to be 0.1% of the cPAD. The
excess lifetime cancer risk was
estimated using CARES version 1.3 to be
1.64 x 10-8.
2. Infants and children. The
population subgroup with the maximum
estimated dietary exposure is children
age 1 to 2 years old. For this subgroup,
and using the same assumptions as
listed for the U.S. population, the
estimated chronic dietary risk is 0.5% of
the cPAD.
F. International Tolerances
Currently, there is no CODEX
maximum residue level (MRL) for
iprovalicarb residues in/on tomatoes.
Italy is the only country for which there
currently is a registration for the use of
iprovalicarb on tomatoes and for which
the additional active ingredient
included in the formulation for
resistance management purposes also
has a U.S. tolerance. Italy has
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established an MRL of 1.0 ppm for
iprovalicarb residues in/on tomatoes.
[FR Doc. 05–7042 Filed 4–7–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0089; FRL–7706–8]
Flumioxazin; Notice of Filing a
Pesticide Petition to Establish a
Tolerance for a Certain Pesticide
Chemical in or on Food
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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–
0089, must be received on or before May
9, 2005.
ADDRESSES: Comments may be
submitted electronically, by mail, or
through hand delivery/courier. Follow
the detailed instructions as provided in
Unit I. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT:
Joanne I. Miller, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW.,Washington,
DC 20460–0001; 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 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
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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–
0089. The official public docket consists
of the documents specifically referenced
in this action, any public comments
received, and other information related
to this action. Although, a part of the
official docket, the public docket does
not include Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
The official public docket is the
collection of materials that is available
for public viewing at the Public
Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1801 S. Bell St., Arlington, VA. This
docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays. The docket
telephone number is (703) 305–5805.
2. Electronic access. You may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/.
An electronic version of the public
docket is available through EPA’s
electronic public docket and comment
system, EPA Dockets. You may use EPA
Dockets at https://www.epa.gov/edocket/
to submit or view public comments,
access the index listing of the contents
of the official public docket, and to
access those documents in the public
docket that are available electronically.
Although, not all docket materials may
be available electronically, you may still
access any of the publicly available
docket materials through the docket
facility identified in Unit I.B.1. Once in
the system, select ‘‘search,’’ then key in
the appropriate docket ID number.
Certain types of information will not
be placed in the EPA Dockets.
Information claimed as CBI and other
information whose disclosure is
restricted by statute, which is not
included in the official public docket,
will not be available for public viewing
in EPA’s electronic public docket. EPA’s
policy is that copyrighted material will
not be placed in EPA’s electronic public
docket but will be available only in
printed, paper form in the official public
docket. To the extent feasible, publicly
available docket materials will be made
available in EPA’s electronic public
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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 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
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your name, mailing address, and an email address or other contact
information in the body of your
comment. Also, include this contact
information on the outside of any disk
or CD ROM you submit, and in any
cover letter accompanying the disk or
CD ROM. This ensures that you can be
identified as the submitter of the
comment and allows EPA to contact you
in case EPA cannot read your comment
due to technical difficulties or needs
further information on the substance of
your comment. EPA’s policy is that EPA
will not edit your comment, and any
identifying or contact information
provided in the body of a comment will
be included as part of the comment that
is placed in the official public docket,
and made available in EPA’s electronic
public docket. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment.
i. EPA Dockets. Your use of EPA’s
electronic public docket to submit
comments to EPA electronically is
EPA’s preferred method for receiving
comments. Go directly to EPA Dockets
at https://www.epa.gov/edocket/, and
follow the online instructions for
submitting comments. Once in the
system, select ‘‘search,’’ and then key in
docket ID number OPP–2005–0089. The
system is an ‘‘anonymous access’’
system, which means EPA will not
know your identity, e-mail address, or
other contact information unless you
provide it in the body of your comment.
ii. E-mail. Comments may be sent by
e-mail to opp-docket@epa.gov,
Attention: Docket ID number OPP–
2005–0089. 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),
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Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001, Attention: Docket ID
number OPP–2005–0089.
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–2005–0089. 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.
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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: March 22, 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 Interregional Research
Project Number 4 (IR–4), 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.
Interregional Research Project Number
4 (IR–4)
PP 4E6845
EPA has received a pesticide petition
(4E6845) from Interregional Research
Project Number 4 (IR–4), Rutgers, State
University of New Jersey, 681 U.S.
Highway No. 1 S. North New
Brunswick, NJ 08902, 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
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residues of the herbicide chemical
flumioxazin, 2-[7-fluoro-3,4-dihydro-3oxo-4-(2-propynyl)-2H-1,4-benzoxazin6-yl]-4,5,6,7-tetrahydro-1H-isoindole1,3(2H)-dione, in or on strawberry at
0.10 parts per million (ppm). EPA has
determined that the petitions contain
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/on all
appropriate agricultural commodities
and respective processing fractions. The
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 strawberry have been submitted
which adequately support the requested
tolerance.
B. Toxicological Profile
The toxicological profile for
flumioxazin which supports this
petition for tolerances was published in
the Federal Register on March 31, 2004
(69 FR 16823)(FRL–7351–2).
C. Aggregate Exposure
1. Dietary exposure. Acute and
chronic dietary analyses were
conducted to estimate exposure to
potential flumioxazin residues in/on the
following crops: Peanuts, soybeans, and
cottonseed oil (existing tolerances);
grapes, almond, pistachio, and
sugarcane, vegetable, tuberous and corm
(Subgroup 1C), mint, and fruit, pome
(Group 11) and fruit, stone (Group 12)
(tolerances pending); asparagus,
vegetable, bulb (Group 3), leaf petioles
(Subgroup 4B), dried shelled peas and
beans Subgroup 6C), vegetables, fruiting
(Group 8), vegetables, cucurbit (Group
9), berries (Group 13), and nut, tree
(Group 14)(tolerances to be proposed in
the future); and strawberry (tolerances
proposed in the current petition). The
Cumulative and Aggregate Risk
Evaluation System (CARES) Version 2.0
was used to conduct these assessments.
These Tier I assessments used issued
and proposed tolerances, default
processing factors, and the assumption
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of 100% crop treated. No adjustments
were made for common washing,
cooking or preparation practices.
Exposure estimates for water were made
based upon modeling (GENEEC 1.2).
i. Food—a. Acute. The acute dietary
exposure estimate of flumioxazin
residues in food at the 99.9th percentile
for females 13–49 years old was
calculated to be, at most, 21.9% of the
acute population adjusted dose (a-PAD)
with a margin of exposure (MOE) of 450.
This is the only population subgroup
with an identified acute toxicity
endpoint. The a-PAD was defined as the
NOEL from an oral developmental study
in rats and includes an uncertainty
factor of 100 to account for intra-species
and inter-species variation (NOEL = 3
milligrams/kilogram body weight/day
(mg/kg bwt/day), a-PAD = 0.03 mg/kg/
day).
b. Chronic dietary exposure. The
chronic dietary exposure estimate of
flumioxazin residues in food at the 100th
percentile was calculated to be, at most,
18.1% of the chronic population
adjusted dose (c-PAD) with a MOE of
550. The population subgroup with the
highest exposure was children 3–5 years
old. The c-PAD was defined as the no
observed effect level (NOEL) from a rat
2–year chronic/oncogenicity study and
includes an uncertainty factor of 100 to
account for intra-species inter-species
variation (NOEL = 2 mg/kg bwt/day, cPAD = 0.02 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 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; 0.17% of the cPAD of 0.02 mg/kg/day for children.
Based on this worse case analysis, the
contribution of drinking water is
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
females 13–49 years old will utilize at
most 21.9% of the a-PAD. This is the
only population subgroup with an
identified acute toxicity endpoint.
Addition of the worse case, dietary
exposure from water (0.00028 mg/kg/
day) increases this exposure at the 99.9th
percentile to 22.8% of the a-PAD. The
Agency has no cause for concern if total
acute residue contribution is less than
100% of the a-PAD, because the PAD
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.
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18007
population and various non-child/infant
population subgroups will utilize at
most 8.0% of the c-PAD. Addition of the
worse case, dietary exposure from water
(0.0000097 mg/kg/day) has no effect on
this exposure. The Agency has no cause
for concern if total chronic residue
contribution is less than 100% of the cPAD, because the PAD 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. EPA has
determined that the special 10x SF to
protect infants and children should be
removed as published in the Federal
Register of March 31, 2004 (69 FR
16823) (FRL–7351–2). The FQPA factor
has been removed because
developmental toxicity and offspring
toxicity no observed adverse effect
levels/lowest adverse effect levels
(NOAELs/LOAELs) are well
characterized; there is a well-defined
dose-response curve for the
cardiovascular effects; and the
endpoints of concern used for overall
risk assessments are appropriate for the
route of exposure and population
subgroups.
ii. Acute risk. No acute endpoint has
been identified for infants and children.
Therefore, no assessment of acute
exposure from food to this subgroup is
required.
iii. Chronic risk. The potential chronic
exposure from food to children 3–5
years old (the most highly exposed
child/infant subgroup) will utilize at
most 18.1% of the c-PAD. Addition of
the worse case, dietary exposure from
water (0.000034 mg/kg/day) increases
this exposure at the 100th percentile to
18.3% of the c-PAD. 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 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.
E:\FR\FM\08APN1.SGM
08APN1
18008
Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices
Country
Crop
MRL (ppm)
Argentina
Soybean Sunflower
Brazil
Soybean
0.05
France
Grape
0.05
Paraguay
Soybean
South Africa
Soybean Groundnut
0.02 0.02
Spain
Soybean Peanut
0.05 0.05
[FR Doc. 05–6852 Filed 4–7–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0016; FRL–7703–7]
Metconazole; Notice of Filing a
Pesticide Petition to Establish a
Tolerance for a Certain Pesticide
Chemical in or on Food
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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–
0016, must be received on or before May
9, 2005.
ADDRESSES: Comments may be
submitted electronically, by mail, or
through hand delivery/courier. Follow
the detailed instructions as provided in
Unit I. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT:
Mary Waller, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9354; e-mail address:
waller.mary@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are 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)
VerDate jul<14>2003
19:00 Apr 07, 2005
Jkt 205001
0.015 0.02
0.015
• 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–
0016. The official public docket consists
of the documents specifically referenced
in this action, any public comments
received, and other information related
to this action. Although a part of the
official docket, the public docket does
not include Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
The official public docket is the
collection of materials that is available
for public viewing at the Public
Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1801 S. Bell St., Arlington, VA. This
docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays. The docket
telephone number is (703) 305–5805.
2. Electronic access. You may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/.
An electronic version of the public
docket is available through EPA’s
electronic public docket and comment
system, EPA Dockets. You may use EPA
Dockets at https://www.epa.gov/edocket/
to submit or view public comments,
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
access the index listing of the contents
of the official public docket, and to
access those documents in the public
docket that are available electronically.
Although not all docket materials may
be available electronically, you may still
access any of the publicly available
docket materials through the docket
facility identified in Unit I.B.1. Once in
the system, select ‘‘search,’’ then key in
the appropriate docket ID number.
Certain types of information will not
be placed in the EPA Dockets.
Information claimed as CBI and other
information whose disclosure is
restricted by statute, which is not
included in the official public docket,
will not be available for public viewing
in EPA’s electronic public docket. EPA’s
policy is that copyrighted material will
not be placed in EPA’s electronic public
docket but will be available only in
printed, paper form in the official public
docket. To the extent feasible, publicly
available docket materials will be made
available in EPA’s electronic public
docket. When a document is selected
from the index list in EPA Dockets, the
system will identify whether the
document is available for viewing in
EPA’s electronic public docket.
Although not all docket materials may
be available electronically, you may still
access any of the publicly available
docket materials through the docket
facility identified in Unit I.B.1. EPA
intends to work towards providing
electronic access to all of the publicly
available docket materials through
EPA’s electronic public docket.
For public commenters, it is
important to note that EPA’s policy is
that public comments, whether
submitted electronically or in paper,
will be made available for public
viewing in EPA’s electronic public
docket as EPA receives them and
without change, unless the comment
contains copyrighted material, CBI, or
other information whose disclosure is
restricted by statute. When EPA
identifies a comment containing
copyrighted material, EPA will provide
a reference to that material in the
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 18004-18008]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6852]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0089; FRL-7706-8]
Flumioxazin; 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.
-----------------------------------------------------------------------
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-
2005-0089, must be received on or before May 9, 2005.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
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 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
[[Page 18005]]
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-2005-0089. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although, a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at https://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although, not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA
Dockets. Information claimed as CBI and other information whose
disclosure is restricted by statute, which is not included in the
official public docket, will not be available for public viewing in
EPA's electronic public docket. EPA's policy is that copyrighted
material will not be placed in EPA's electronic public docket but will
be available only in printed, paper form in the official public docket.
To the extent feasible, publicly available docket materials will be
made available in EPA's electronic public docket. When a document is
selected from the index list in EPA Dockets, the system will identify
whether the document is available for viewing in EPA's electronic
public docket. Although, not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit I.B.
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 https://www.epa.gov/
edocket/, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2005-0089. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID number OPP-2005-0089. 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),
[[Page 18006]]
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID number OPP-2005-0089.
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-2005-0089. 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: March 22, 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 Interregional Research Project Number 4 (IR-
4), 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.
Interregional Research Project Number 4 (IR-4)
PP 4E6845
EPA has received a pesticide petition (4E6845) from Interregional
Research Project Number 4 (IR-4), Rutgers, State University of New
Jersey, 681 U.S. Highway No. 1 S. North New Brunswick, NJ 08902,
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 strawberry at 0.10 parts per million (ppm). EPA has determined that
the petitions contain 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/on all appropriate agricultural commodities and respective
processing fractions. The 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 strawberry have been
submitted which adequately support the requested tolerance.
B. Toxicological Profile
The toxicological profile for flumioxazin which supports this
petition for tolerances was published in the Federal Register on March
31, 2004 (69 FR 16823)(FRL-7351-2).
C. Aggregate Exposure
1. Dietary exposure. Acute and chronic dietary analyses were
conducted to estimate exposure to potential flumioxazin residues in/on
the following crops: Peanuts, soybeans, and cottonseed oil (existing
tolerances); grapes, almond, pistachio, and sugarcane, vegetable,
tuberous and corm (Subgroup 1C), mint, and fruit, pome (Group 11) and
fruit, stone (Group 12) (tolerances pending); asparagus, vegetable,
bulb (Group 3), leaf petioles (Subgroup 4B), dried shelled peas and
beans Subgroup 6C), vegetables, fruiting (Group 8), vegetables,
cucurbit (Group 9), berries (Group 13), and nut, tree (Group
14)(tolerances to be proposed in the future); and strawberry
(tolerances proposed in the current petition). The Cumulative and
Aggregate Risk Evaluation System (CARES) Version 2.0 was used to
conduct these assessments. These Tier I assessments used issued and
proposed tolerances, default processing factors, and the assumption
[[Page 18007]]
of 100% crop treated. No adjustments were made for common washing,
cooking or preparation practices. Exposure estimates for water were
made based upon modeling (GENEEC 1.2).
i. Food--a. Acute. The acute dietary exposure estimate of
flumioxazin residues in food at the 99.9th percentile for
females 13-49 years old was calculated to be, at most, 21.9% of the
acute population adjusted dose (a-PAD) with a margin of exposure (MOE)
of 450. This is the only population subgroup with an identified acute
toxicity endpoint. The a-PAD was defined as the NOEL from an oral
developmental study in rats and includes an uncertainty factor of 100
to account for intra-species and inter-species variation (NOEL = 3
milligrams/kilogram body weight/day (mg/kg bwt/day), a-PAD = 0.03 mg/
kg/day).
b. Chronic dietary exposure. The chronic dietary exposure estimate
of flumioxazin residues in food at the 100th percentile was
calculated to be, at most, 18.1% of the chronic population adjusted
dose (c-PAD) with a MOE of 550. The population subgroup with the
highest exposure was children 3-5 years old. The c-PAD was defined as
the no observed effect level (NOEL) from a rat 2-year chronic/
oncogenicity study and includes an uncertainty factor of 100 to account
for intra-species inter-species variation (NOEL = 2 mg/kg bwt/day, c-
PAD = 0.02 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 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 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; 0.17% of the
c-PAD of 0.02 mg/kg/day for children. Based on this worse case
analysis, the contribution of drinking water is 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 females 13-49 years old will utilize at most 21.9% of the
a-PAD. This is the only population subgroup with an identified acute
toxicity endpoint. Addition of the worse case, dietary exposure from
water (0.00028 mg/kg/day) increases this exposure at the
99.9th percentile to 22.8% of the a-PAD. The Agency has no
cause for concern if total acute residue contribution is less than 100%
of the a-PAD, because the PAD 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 8.0% of the c-PAD. Addition of the worse case, dietary
exposure from water (0.0000097 mg/kg/day) has no effect on this
exposure. The Agency has no cause for concern if total chronic residue
contribution is less than 100% of the c-PAD, because the PAD 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.
EPA has determined that the special 10x SF to protect infants and
children should be removed as published in the Federal Register of
March 31, 2004 (69 FR 16823) (FRL-7351-2). The FQPA factor has been
removed because developmental toxicity and offspring toxicity no
observed adverse effect levels/lowest adverse effect levels (NOAELs/
LOAELs) are well characterized; there is a well-defined dose-response
curve for the cardiovascular effects; and the endpoints of concern used
for overall risk assessments are appropriate for the route of exposure
and population subgroups.
ii. Acute risk. No acute endpoint has been identified for infants
and children. Therefore, no assessment of acute exposure from food to
this subgroup is required.
iii. Chronic risk. The potential chronic exposure from food to
children 3-5 years old (the most highly exposed child/infant subgroup)
will utilize at most 18.1% of the c-PAD. Addition of the worse case,
dietary exposure from water (0.000034 mg/kg/day) increases this
exposure at the 100th percentile to 18.3% of the c-PAD.
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 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.
[[Page 18008]]
----------------------------------------------------------------------------------------------------------------
Country Crop MRL (ppm)
----------------------------------------------------------------------------------------------------------------
Argentina Soybean Sunflower 0.015 0.02
----------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Paraguay Soybean 0.015
----------------------------------------------------------------------------------------------------------------
South Africa Soybean Groundnut 0.02 0.02
----------------------------------------------------------------------------------------------------------------
Spain Soybean Peanut 0.05 0.05
----------------------------------------------------------------------------------------------------------------
[FR Doc. 05-6852 Filed 4-7-05; 8:45 am]
BILLING CODE 6560-50-S
