Cyprodinil; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 1435-1439 [05-343]
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Federal Register / Vol. 70, No. 5 / Friday, January 7, 2005 / Notices
ERP No. F–AFS–J65422–MT West
Side Reservoir Post-Fire Project,
Proposed Implementation of Timber
Salvage and Access Management
Treatments, Flathead National Forest,
Hungry Horse and Spotted Bear Ranger
Districts, Flathead County, MT.
Summary: EPA supports less
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ERP No. F–AFS–L65456–AK
Resurrection Creek Stream and Riparian
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ERP No. F–AFS–L65457–OR Crooked
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Dated: January 4, 2005.
Robert W. Hargrove,
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[FR Doc. 05–345 Filed 1–6–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0002; FRL–7694–3]
Cyprodinil; 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–
0002, must be received on or before
February 7, 2005.
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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:
Sidney C. Jackson, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7610; e-mail address:
jackson.sidney@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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)
• 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–
0002. 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,
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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 in paper,
will be made available for public
viewing in EPA’s electronic public
docket as EPA receives them and
without change, unless the comment
contains copyrighted material, CBI, or
other information whose disclosure is
restricted by statute. When EPA
identifies a comment containing
copyrighted material, EPA will provide
a reference to that material in the
version of the comment that is placed in
EPA’s electronic public docket. The
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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 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
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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–2005–0002. 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–
2005–0002. In contrast to EPA’s
electronic public docket, EPA’s e-mail
system is not an ‘‘anonymous access’’
system. If you send an e-mail comment
directly to the docket without going
through EPA’s electronic public docket,
EPA’s e-mail system automatically
captures your e-mail address. E-mail
addresses that are automatically
captured by EPA’s e-mail system are
included as part of the comment that is
placed in the official public docket, and
made available in EPA’s electronic
public docket.
iii. Disk or CD ROM. You may submit
comments on a disk or CD ROM that
you mail to the mailing address
identified in Unit I.C.2. These electronic
submissions will be accepted in
WordPerfect or ASCII file format. Avoid
the use of special characters and any
form of encryption.
2. By mail. Send your comments to:
Public Information and Records
Integrity Branch (PIRIB) (7502C), Office
of Pesticide Programs (OPP),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001, Attention: Docket ID
Number OPP–2005–0002.
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–2005–0002. 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
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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.
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List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 22, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office
of Pesticide Programs.
Summary of Petition
The petitioner summary of the
pesticide petition is printed below as
required by FFDCA section 408(d)(3).
The summary of the petition was
prepared by the petitioner and
represents the view of the petitioner.
The petition summary announces the
availability of a description of the
analytical methods available to EPA for
the detection and measurement of the
pesticide chemical residues or an
explanation of why no such method is
needed.
Interregional Research Project Number
4 (IR-4)
PP 8E5012
EPA has received a pesticide petition,
PP 8E5012, from the IR 4, 681 U.S.
Highway #1 South, North Brunswick, NJ
08902 proposing, pursuant to section
408(d) of the FFDCA, 21 U.S.C. 346a(d),
to amend 40 CFR 180.532 by extending
the time-limited tolerances to December
31, 2007, for residues of the fungicide,
cyprodinil, 4-cyclopropyl-6-methyl-Nphenyl-2-pyrimidinamine in or on the
raw agricultural commodities onion, dry
bulb at 0.60 part per million (ppm);
onion, green at 4.0 ppm; and strawberry
at 5.0 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. Syngenta Crop Protection, Inc.,
Greensboro, NC 27409 is the
manufacturer of the chemical pesticide,
cyprodinil. Syngenta Crop Protection,
Inc., prepared and submitted the
following summary of information, data,
and arguments in support of the
pesticide petitions. This summary does
not necessarily reflect the findings of
EPA.
EPA issued a final rule under section
408(d) of the FFDCA, 21 U.S.C. 346a(d),
on June 22, 2001, (FRL–6778–7),
announcing the establishment of timelimited pesticide tolerances in
conjunction to the original pesticide
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petition (PP 8E5012) which expired
December 31, 2003. These tolerances
were time-limited because the Agency
lacked residue data on onion, dry bulb,
onion, green and strawberry. IR-4
requested an extension of these time
limited tolerances to allow extra time to
generate the field residue data. In the
Federal Register of December 31, 2003,
(68 FR 75438); OPP–2003–0394; (FRL–
7337–5) these time-limited tolerances
were extended with an expiration date
of December 31, 2004. All residue data
have been submitted by IR-4. Further
the Agency concluded field
accumulation in rotational crops study
for the CGA-249287, NO-422054, CGA263208, and CGA-232449 metabolites;
and confirmatory data from an acute
oral toxicity study and Ames assay for
the CGA-249287 and NO-422054
metabolites were required; all these data
have been submitted by Syngenta Crop
Protection. EPA has been unable to
complete the reviews of these data prior
to the December 31, 2004 expiration
date. This time-limited tolerance
extension will permit the Agency to
complete the review of these data.
Previously EPA evaluated the available
cyprodinil data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. The nature of the
toxic effects caused by cyprodinil are
adequately understood and support the
proposed extension of these timelimited tolerances.
A. Residue Chemistry
1. Plant metabolism. The metabolism
of cyprodinil is adequately understood
for the purpose of the proposed
tolerances.
2. Analytical method. Syngenta Crop
Protection has developed and validated
analytical methodology for enforcement
purposes. This method (Syngenta Crop
Protection Method AG-631B) has passed
an Agency petition method validation
for several commodities and is currently
the enforcement method for cyprodinil.
An extensive database of method
validation data using this method on
various crop commodities is available.
3. Magnitude of residues. Complete
residue data to support the requested
tolerances for strawberry; onion, dry
bulb; and onion, green have been
submitted. The requested tolerances are
adequately supported.
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B. Toxicological Profile
An assessment of toxic effects caused
by cyprodinil is discussed in Unit III.A.
and Unit III.B. of the Federal Register
dated June 22, 2001 (66 FR 33478)
(FRL–6778–7).
1. Animal metabolism. The
metabolism of cyprodinil in rats is
adequately understood.
2. Metabolite toxicology. The residues
of concern for tolerance setting purposes
is the parent compound. Based on
structural similarities to genotoxic
nucleotide analogs, there was concern
that the pryimidine metabolites (CGA249287, NOA-422054) may be more
toxic than the parent compound.
However, EPA’s review indicates
similar results in an acute oral and
mutagenicity studies with both the
parent compound and the CGA-249287
metabolite. EPA concluded that the
toxicity of the CGA-249287 and NOA422054 metabolites is no greater than
that of the parent, conditional on
submission and review of confirmatory
data of an acute oral toxicity study and
bacterial reverse mutation assay for the
NOA-422054 metabolite. Although the
metabolites CGA-232449 and CGA263208 were determined to be of
potential toxicological concern, there
are not expected to be more toxic than
cyprodinil per se.
3. Endocrine disruption. Cyprodinil
does not belong to a class of chemicals
known or suspected of having adverse
effects on the endocrine system.
Developmental toxicity studies in rats
and rabbits and a reproduction study in
rats gave no indication that cyprodinil
might have any effects on endocrine
function related to development and
reproduction. The chronic studies also
showed no evidence of a long-term
effect related to the endocrine system.
C. Aggregate Exposure
1. Dietary exposure. A Tier III acute
and chronic dietary exposure evaluation
was made using the Dietary Exposure
Evaluation Model (DEEMTM), version
7.87 from Exponent. Empirically
derived processing studies for apple
juice (0.39X), apple pomace (5.22X),
grape juice (0.29X), dried prunes (2.05X)
and lychee fruit peeling factor (0.0092X)
were used in these assessments. The
apple juice processing factor was used
as a surrogate for pear juice and all other
processing factors used DEEMTM
defaults. All consumption data for these
assessments were taken from the
USDA’s Continuing Survey of Food
Intake by individuals (CSFII) with the
1994–96 consumption database and the
Supplemental CSFII children’s survey
(1998) consumption database. These
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exposure assessments include all
registered uses. Secondary residues in
animal commodities were estimated
based on theoretical worst-case, yet
nutritionally adequate animal diets and
transfer information from feeding
studies.
i. Food. For the purposes of assessing
the potential dietary exposure under the
proposed tolerances, Syngenta Crop
Protection has estimated aggregate
exposure from all crops for which
tolerances are established or proposed.
These assessments utilized residue data
from field trials where cyprodinil was
applied at the maximum intended use
rate and samples were harvested at the
minimum pre-harvest interval (PHI) to
obtain maximum residues. Percent of
crop treated values were estimated
based upon economic, pest and
competitive pressures. The values used
in these assessments were: (Almond,
pome fruit, stone fruit and grape),
100%; onion, 9%, strawberry, 42%,
watercress, 95%; berries, 13%,
(pistachio and herbs), 80%; (crop group
5A and 5B; carrot; turnip, greens;
lychee; longan; and Spanish lime), 10%.
ii. Acute exposure. The acute dietary
risk assessment was performed for the
females 13–49 years old population
subgroup only, since no toxicological
endpoint of concern was identified for
the other population subgroups. An
acute reference dose (aRfD) of 1.5
milligrams/kilograms (mg/kg)-body
weight (bw)/day for the females 13–49
years subpopulation only was based on
a no observable adverse effect level
(NOAEL) of 150 mg/kg-bw/day based on
a rabbit developmental study and an
uncertainty factor of 100X. No
additional FQPA safety factor was
applied. For the purpose of the
aggregate risk assessment, the exposure
value was expressed in terms of a
margin of exposure (MOE), which was
calculated by dividing the NOAEL by
the exposure. In addition, exposure was
expressed as a percent of the acute
reference dose (%aRfD). Acute exposure
to the females 13–49 years
subpopulation resulted in a MOE of 899
(1.1% of the acute RfD of 1.5 mg/kg-bw/
day). Since the benchmark MOE for this
assessment was 100 and since EPA
generally has no concern for exposures
above the benchmark MOE, Syngenta
Crop Protection believes that there is a
reasonable certainty that no harm will
result from the acute dietary (food)
exposures arising from the current and
proposed uses for cyprodinil.
iii. Chronic exposure. The chronic
reference dose (cRfD) for cyprodinil is
0.03 mg/kg-bw/day and is based on a
chronic rat study with a NOAEL of 2.7
mg/kg-bw/day and an uncertainly factor
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of 100X. No additional FQPA safety
factor was applied. The cyprodinil Tier
III chronic dietary exposure assessment
was based upon residue field trial
results. For the purpose of the aggregate
risk assessment, the exposure values
were expressed in terms of margin of
exposure (MOE), which was calculated
by dividing the NOAEL by the exposure
for each population subgroup. In
addition, exposure was expressed as a
percent of the chronic reference dose
(%RfD). Chronic exposure to the most
sensitive sub-population (children 1 and
2 years old) resulted in a MOE of 1,074
(8.4% of the chronic RfD of 0.03 mg/kgbw/day). Since the benchmark MOE for
this assessment was 100 and since EPA
generally has no concern for exposures
resulting in an MOE above the
benchmark MOE, Syngenta Crop
Protection believes that there is a
reasonable certainty that no harm will
result from the chronic dietary (food)
exposures arising from the current and
proposed uses for cyprodinil.
2. Drinking water. Another potential
source of exposure of the general
population to residues of cyprodinil are
residues in drinking water. The
degradation of cyprodinil is microbially
mediated with an aerobic soil
metabolism half-life of less than 46
days. Cyprodinil Kocs vary from 1550 to
2030 and cyprodinil exhibits a strong
binding affinity for soil. Cyprodinil is
stable to hydrolysis but degrades rapidly
under photolytic conditions. Estimated
Environmental Concentrations (EECs) of
cyprodinil in drinking water were
determined by EPA. The EPA ground
water model, Screening Concentrations
in Groundwater (SCI-GROW) was used
to determine acute and chronic
estimated environmental concentrations
in ground water and the Agency’s
surface water model, Pesticide Root
Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS), was
used to determine acute and chronic
estimated environmental concentrations
in surface water. Based on the model
outputs, the estimated environmental
concentrations (EECs) for cyprodinil
(plus the CGA-249287 metabolite) are
0.16 parts per billion (ppb) for acute and
chronic exposure to ground water and
32.9 ppb and 8.1 ppb for acute and
chronic exposure, respectively, to
surface water. The Acute Drinking
Water Level of Comparison (DWLOC)
was calculated based on an acute
Population Adjusted Dose (aPAD) of 1.5
mg/kg/day. For the acute assessment,
the females (13–49 years) subpopulation
generated an acute DWLOC of 44,500
ppb. The acute DWLOC of 44,500 ppb
is considerably higher than the acute
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EEC of 32.9 ppb. Chronic DWLOCs were
calculated based on a chronic
Population Adjusted Dose (cPAD) of
0.03 mg/kg/day. The children 1–2 years
old subpopulation generated the lowest
chronic DWLOC of 275 ppb. Thus, the
chronic DWLOC of 275 ppb is
considerably higher than the chronic
EEC of 8.1 ppb.
3. Non-dietary exposure. There is a
potential residential post-application
exposure to adults and children entering
residential areas treated with
cyprodinil. Since the Agency did not
select a short-term endpoint for dermal
exposure, only intermediate dermal
exposures were considered. Based on
the residential use pattern, no long-term
post-application residential exposure is
expected.
4. Chronic aggregate exposure. Based
on the completeness and reliability of
the toxicity data supporting these
petitions, Syngenta Crop Protection
believes that there is a reasonable
certainty that no harm will result from
aggregate exposure to residues arising
from all current and proposed
cyprodinil uses, including anticipated
dietary exposure from food, water, and
all other types of non-occupational
exposures.
D. Cumulative Effects
Cumulative exposure to substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) requires that,
when considering whether to establish,
modify, or revoke a tolerance, the
Agency consider ‘‘available
information’’ concerning the cumulative
effects of a particular pesticide’s
residues and ‘‘other substances that
have a common mechanism of toxicity.’’
EPA does not have, at this time,
available data to determine whether
cyprodinil has a common mechanism of
toxicity with other substances or how to
include this pesticide in a cumulative
risk assessment. For the purposes of this
tolerance action, the EPA has not
assumed that cyprodinil has a common
mechanism of toxicity with other
substances.
E. Safety Determination
The chronic dietary exposure analysis
(food only) indicated that exposure from
all established and proposed cyprodinil
uses is 8.4% of the chronic RfD of 0.03
mg/kg-bw/day for the most sensitive
subpopulation, children 1 and 2 years
old. Estimated concentrations of
cyprodinil residues in surface and
ground water are below the calculated
acute DWLOC. The children 1 and 2
years old subpopulation has the lowest
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07JAN1
Federal Register / Vol. 70, No. 5 / Friday, January 7, 2005 / Notices
chronic DWLOC of approximately 275
ppb, which is considerably higher than
the chronic EEC of 8 ppb.
The acute dietary exposure analysis
(food only) showed that for female 13–
49 years old, exposure from all
established and proposed cyprodinil
uses would be 1.1% of the acute RfD of
1.5 mg/kg-bw/day. Acute DWLOCs were
calculated based on an acute Populated
Adjusted Dose (aPAD) of 1.5 mg/kg/day.
The females (13–49 years old)
subpopulation generated an acute
DWLOC of approximately 44,500 ppb.
The acute EEC of 33 ppb is considerably
less than 44,500 ppb. Therefore, the
chronic and aggregate risk from
cyprodinil residues in food and
drinking water would not be expected to
exceed the EPA’s level of concern.
Syngenta Crop Protection has
considered the potential aggregate
exposure from food, water and nonoccupational exposure routes and
concluded that aggregate exposure is not
expected to exceed 100% of the chronic
reference dose and that there is a
reasonable certainty that no harm will
result to infants and children from the
aggregate exposure to cyprodinil.
F. International Tolerances
There are no Codex maximum residue
levels established for cyprodinil.
[FR Doc. 05–343 Filed 1–6–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–7858–4]
Air Quality Criteria Document for Lead;
Draft Project Work Plan
Environmental Protection
Agency.
ACTION: Notice of public comment
period.
AGENCY:
SUMMARY: The U.S. Environmental
Protection Agency (EPA) Office of
Research and Development’s National
Center for Environmental Assessment
(NCEA) is reviewing and, as
appropriate, revising the EPA
document, Air Quality Criteria for Lead,
EPA–600/8–83/028aF–dF, published in
June 1986, and the associated
supplement (EPA–600/8–89/049F)
published in 1990. Interested parties are
invited to comment on a draft of EPA’s
Project Work Plan for updating the lead
document.
DATES: The 30-day period for
submission of public comments on the
draft Project Work Plan begins January
7, 2005, and ends February 7, 2005.
VerDate jul<14>2003
18:03 Jan 06, 2005
Jkt 205001
The draft plan will be
available from NCEA by January 7,
2005. Internet users will be able to
download a copy of the draft plan from
the NCEA home page. The URL is
https://www.epa.gov/ncea/. Contact Ms.
Diane Ray by phone (919) 541–3637, fax
(919) 541–1818, or e-mail
(ray.diane@epa.gov) to request hard
copies of this plan. Please provide the
document’s title, Project Work Plan for
Air Quality Criteria for Lead, as well as
your name and address, to facilitate
processing of your request. Public
comments on the draft plan may be
submitted electronically, by mail, by
facsimile, or by hand delivery/courier.
Please follow the detailed instructions
as provided in the section of this notice
entitled SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: For
details on the period for submission of
public comments, contact the Office of
Environmental Information Docket;
telephone: (202) 566–1752; facsimile:
(202) 566–1753; or e-mail:
ORD.Docket@epa.gov.
For technical information, contact
Robert Elias, Ph.D., NCEA, facsimile:
(919) 541–1818 or e-mail:
elias.robert@epa.gov.
SUPPLEMENTARY INFORMATION: Section
108(a) of the Clean Air Act directs the
Administrator to identify certain
pollutants which ‘‘may reasonably be
anticipated to endanger public health
and welfare’’ and to issue air quality
criteria for them. These air quality
criteria are to ‘‘accurately reflect the
latest scientific knowledge useful in
indicating the kind and extent of all
identifiable effects on public health or
welfare which may be expected from the
presence of [a] pollutant in the ambient
air * * *.’’ Under section 109 of the
Act, EPA is then to establish National
Ambient Air Quality Standards
(NAAQS) for each pollutant for which
EPA has issued criteria. Section 109(d)
of the Act subsequently requires
periodic review and, if appropriate,
revision of existing air quality criteria to
reflect advances in scientific knowledge
on the effects of the pollutant on public
health and welfare. EPA is also to revise
the NAAQS, if appropriate, based on the
revised criteria.
Lead is one of six ‘‘criteria’’ pollutants
for which EPA has established air
quality criteria and NAAQS. On
November 9, 2004 (69 FR 64926), EPA
formally initiated its current review of
the criteria and NAAQS for lead,
requesting the submission of recent
scientific information on specified
topics. One of the next steps in this
process is to prepare a project work plan
for the review and, if appropriate,
ADDRESSES:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
1439
revision of the existing Air Quality
Criteria Document (AQCD) for lead and
provide for public review of a draft of
the plan.
Accordingly, this notice announces
the availability of a draft of EPA’s
Project Work Plan for Revised Air
Quality Criteria for Lead, NCEA–R–
1465, prepared by NCEA. The purpose
of the Project Work Plan is to describe
the managerial procedures for reviewing
and, as appropriate, revising EPA’s Air
Quality Criteria for Lead, EPA–600/8–
83/028aF–dF, published in June 1986,
and the associated supplement (EPA–
600/8–89/049F) published in 1990. The
draft plan will also be reviewed by the
Clean Air Scientific Advisory
Committee (CASAC) of EPA’s Science
Advisory Board and will be revised in
light of CASAC’s review and comments
received from the general public.
Information on the date and location of
the CASAC public review meeting will
be published in a future Federal
Register notice. The plan may be
modified and amended from time to
time, as necessary, to reflect actual
project requirements and progress.
Accordingly, any proposed schedules
and outlines, or any lists of technical
coordinator assignments, authors, or
reviewers are subject to change. As
indicated above, the draft plan will be
available by January 7, 2005.
EPA has established an official public
docket for information pertaining to the
revision of the Lead AQCD, Docket ID
No. ORD–2004–0018. The official public
docket is the collection of materials,
excluding Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute,
that is available for public viewing at
the Office of Environmental Information
(OEI) Docket in the Headquarters EPA
Docket Center, EPA West Building,
Room B102, 1301 Constitution Ave.,
NW., Washington, DC. The EPA Docket
Center Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OEI
Docket is (202) 566–1752; facsimile:
(202) 566–1753; or e-mail:
ORD.Docket@epa.gov.
An electronic version of the official
public docket is available through EPA’s
electronic public docket and comment
system, E-Docket. You may use EDocket at https://www.epa.gov/edocket/
to submit or view public comments, to
access the index listing of the contents
of the official public docket, and to view
those documents in the public docket
that are available electronically. Once in
the system, select ‘‘search,’’ then key in
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[Federal Register Volume 70, Number 5 (Friday, January 7, 2005)]
[Notices]
[Pages 1435-1439]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-343]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0002; FRL-7694-3]
Cyprodinil; 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-
2005-0002, must be received on or before February 7, 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: Sidney C. Jackson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-7610; e-mail address:
jackson.sidney@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)
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-2005-0002. 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 in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The
[[Page 1436]]
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-2005-0002. 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-2005-0002. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0002.
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-2005-0002. 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.
[[Page 1437]]
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: December 22, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner and represents the view of the petitioner.
The petition summary announces the availability of a description of the
analytical methods available to EPA for the detection and measurement
of the pesticide chemical residues or an explanation of why no such
method is needed.
Interregional Research Project Number 4 (IR-4)
PP 8E5012
EPA has received a pesticide petition, PP 8E5012, from the IR 4,
681 U.S. Highway 1 South, North Brunswick, NJ 08902 proposing,
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40
CFR 180.532 by extending the time-limited tolerances to December 31,
2007, for residues of the fungicide, cyprodinil, 4-cyclopropyl-6-
methyl-N-phenyl-2-pyrimidinamine in or on the raw agricultural
commodities onion, dry bulb at 0.60 part per million (ppm); onion,
green at 4.0 ppm; and strawberry at 5.0 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. Syngenta Crop Protection,
Inc., Greensboro, NC 27409 is the manufacturer of the chemical
pesticide, cyprodinil. Syngenta Crop Protection, Inc., prepared and
submitted the following summary of information, data, and arguments in
support of the pesticide petitions. This summary does not necessarily
reflect the findings of EPA.
EPA issued a final rule under section 408(d) of the FFDCA, 21
U.S.C. 346a(d), on June 22, 2001, (FRL-6778-7), announcing the
establishment of time-limited pesticide tolerances in conjunction to
the original pesticide petition (PP 8E5012) which expired December 31,
2003. These tolerances were time-limited because the Agency lacked
residue data on onion, dry bulb, onion, green and strawberry. IR-4
requested an extension of these time limited tolerances to allow extra
time to generate the field residue data. In the Federal Register of
December 31, 2003, (68 FR 75438); OPP-2003-0394; (FRL-7337-5) these
time-limited tolerances were extended with an expiration date of
December 31, 2004. All residue data have been submitted by IR-4.
Further the Agency concluded field accumulation in rotational crops
study for the CGA-249287, NO-422054, CGA-263208, and CGA-232449
metabolites; and confirmatory data from an acute oral toxicity study
and Ames assay for the CGA-249287 and NO-422054 metabolites were
required; all these data have been submitted by Syngenta Crop
Protection. EPA has been unable to complete the reviews of these data
prior to the December 31, 2004 expiration date. This time-limited
tolerance extension will permit the Agency to complete the review of
these data. Previously EPA evaluated the available cyprodinil data and
considered their validity, completeness, and reliability as well as the
relationship of the results of the studies to human risk. EPA also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by
cyprodinil are adequately understood and support the proposed extension
of these time-limited tolerances.
A. Residue Chemistry
1. Plant metabolism. The metabolism of cyprodinil is adequately
understood for the purpose of the proposed tolerances.
2. Analytical method. Syngenta Crop Protection has developed and
validated analytical methodology for enforcement purposes. This method
(Syngenta Crop Protection Method AG-631B) has passed an Agency petition
method validation for several commodities and is currently the
enforcement method for cyprodinil. An extensive database of method
validation data using this method on various crop commodities is
available.
3. Magnitude of residues. Complete residue data to support the
requested tolerances for strawberry; onion, dry bulb; and onion, green
have been submitted. The requested tolerances are adequately supported.
B. Toxicological Profile
An assessment of toxic effects caused by cyprodinil is discussed in
Unit III.A. and Unit III.B. of the Federal Register dated June 22, 2001
(66 FR 33478) (FRL-6778-7).
1. Animal metabolism. The metabolism of cyprodinil in rats is
adequately understood.
2. Metabolite toxicology. The residues of concern for tolerance
setting purposes is the parent compound. Based on structural
similarities to genotoxic nucleotide analogs, there was concern that
the pryimidine metabolites (CGA-249287, NOA-422054) may be more toxic
than the parent compound. However, EPA's review indicates similar
results in an acute oral and mutagenicity studies with both the parent
compound and the CGA-249287 metabolite. EPA concluded that the toxicity
of the CGA-249287 and NOA-422054 metabolites is no greater than that of
the parent, conditional on submission and review of confirmatory data
of an acute oral toxicity study and bacterial reverse mutation assay
for the NOA-422054 metabolite. Although the metabolites CGA-232449 and
CGA-263208 were determined to be of potential toxicological concern,
there are not expected to be more toxic than cyprodinil per se.
3. Endocrine disruption. Cyprodinil does not belong to a class of
chemicals known or suspected of having adverse effects on the endocrine
system. Developmental toxicity studies in rats and rabbits and a
reproduction study in rats gave no indication that cyprodinil might
have any effects on endocrine function related to development and
reproduction. The chronic studies also showed no evidence of a long-
term effect related to the endocrine system.
C. Aggregate Exposure
1. Dietary exposure. A Tier III acute and chronic dietary exposure
evaluation was made using the Dietary Exposure Evaluation Model
(DEEM\TM\), version 7.87 from Exponent. Empirically derived processing
studies for apple juice (0.39X), apple pomace (5.22X), grape juice
(0.29X), dried prunes (2.05X) and lychee fruit peeling factor (0.0092X)
were used in these assessments. The apple juice processing factor was
used as a surrogate for pear juice and all other processing factors
used DEEM\TM\ defaults. All consumption data for these assessments were
taken from the USDA's Continuing Survey of Food Intake by individuals
(CSFII) with the 1994-96 consumption database and the Supplemental
CSFII children's survey (1998) consumption database. These
[[Page 1438]]
exposure assessments include all registered uses. Secondary residues in
animal commodities were estimated based on theoretical worst-case, yet
nutritionally adequate animal diets and transfer information from
feeding studies.
i. Food. For the purposes of assessing the potential dietary
exposure under the proposed tolerances, Syngenta Crop Protection has
estimated aggregate exposure from all crops for which tolerances are
established or proposed. These assessments utilized residue data from
field trials where cyprodinil was applied at the maximum intended use
rate and samples were harvested at the minimum pre-harvest interval
(PHI) to obtain maximum residues. Percent of crop treated values were
estimated based upon economic, pest and competitive pressures. The
values used in these assessments were: (Almond, pome fruit, stone fruit
and grape), 100%; onion, 9%, strawberry, 42%, watercress, 95%; berries,
13%, (pistachio and herbs), 80%; (crop group 5A and 5B; carrot; turnip,
greens; lychee; longan; and Spanish lime), 10%.
ii. Acute exposure. The acute dietary risk assessment was performed
for the females 13-49 years old population subgroup only, since no
toxicological endpoint of concern was identified for the other
population subgroups. An acute reference dose (aRfD) of 1.5 milligrams/
kilograms (mg/kg)-body weight (bw)/day for the females 13-49 years
subpopulation only was based on a no observable adverse effect level
(NOAEL) of 150 mg/kg-bw/day based on a rabbit developmental study and
an uncertainty factor of 100X. No additional FQPA safety factor was
applied. For the purpose of the aggregate risk assessment, the exposure
value was expressed in terms of a margin of exposure (MOE), which was
calculated by dividing the NOAEL by the exposure. In addition, exposure
was expressed as a percent of the acute reference dose (%aRfD). Acute
exposure to the females 13-49 years subpopulation resulted in a MOE of
899 (1.1% of the acute RfD of 1.5 mg/kg-bw/day). Since the benchmark
MOE for this assessment was 100 and since EPA generally has no concern
for exposures above the benchmark MOE, Syngenta Crop Protection
believes that there is a reasonable certainty that no harm will result
from the acute dietary (food) exposures arising from the current and
proposed uses for cyprodinil.
iii. Chronic exposure. The chronic reference dose (cRfD) for
cyprodinil is 0.03 mg/kg-bw/day and is based on a chronic rat study
with a NOAEL of 2.7 mg/kg-bw/day and an uncertainly factor of 100X. No
additional FQPA safety factor was applied. The cyprodinil Tier III
chronic dietary exposure assessment was based upon residue field trial
results. For the purpose of the aggregate risk assessment, the exposure
values were expressed in terms of margin of exposure (MOE), which was
calculated by dividing the NOAEL by the exposure for each population
subgroup. In addition, exposure was expressed as a percent of the
chronic reference dose (%RfD). Chronic exposure to the most sensitive
sub-population (children 1 and 2 years old) resulted in a MOE of 1,074
(8.4% of the chronic RfD of 0.03 mg/kg-bw/day). Since the benchmark MOE
for this assessment was 100 and since EPA generally has no concern for
exposures resulting in an MOE above the benchmark MOE, Syngenta Crop
Protection believes that there is a reasonable certainty that no harm
will result from the chronic dietary (food) exposures arising from the
current and proposed uses for cyprodinil.
2. Drinking water. Another potential source of exposure of the
general population to residues of cyprodinil are residues in drinking
water. The degradation of cyprodinil is microbially mediated with an
aerobic soil metabolism half-life of less than 46 days. Cyprodinil Kocs
vary from 1550 to 2030 and cyprodinil exhibits a strong binding
affinity for soil. Cyprodinil is stable to hydrolysis but degrades
rapidly under photolytic conditions. Estimated Environmental
Concentrations (EECs) of cyprodinil in drinking water were determined
by EPA. The EPA ground water model, Screening Concentrations in
Groundwater (SCI-GROW) was used to determine acute and chronic
estimated environmental concentrations in ground water and the Agency's
surface water model, Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS), was used to determine acute and chronic
estimated environmental concentrations in surface water. Based on the
model outputs, the estimated environmental concentrations (EECs) for
cyprodinil (plus the CGA-249287 metabolite) are 0.16 parts per billion
(ppb) for acute and chronic exposure to ground water and 32.9 ppb and
8.1 ppb for acute and chronic exposure, respectively, to surface water.
The Acute Drinking Water Level of Comparison (DWLOC) was calculated
based on an acute Population Adjusted Dose (aPAD) of 1.5 mg/kg/day. For
the acute assessment, the females (13-49 years) subpopulation generated
an acute DWLOC of 44,500 ppb. The acute DWLOC of 44,500 ppb is
considerably higher than the acute EEC of 32.9 ppb. Chronic DWLOCs were
calculated based on a chronic Population Adjusted Dose (cPAD) of 0.03
mg/kg/day. The children 1-2 years old subpopulation generated the
lowest chronic DWLOC of 275 ppb. Thus, the chronic DWLOC of 275 ppb is
considerably higher than the chronic EEC of 8.1 ppb.
3. Non-dietary exposure. There is a potential residential post-
application exposure to adults and children entering residential areas
treated with cyprodinil. Since the Agency did not select a short-term
endpoint for dermal exposure, only intermediate dermal exposures were
considered. Based on the residential use pattern, no long-term post-
application residential exposure is expected.
4. Chronic aggregate exposure. Based on the completeness and
reliability of the toxicity data supporting these petitions, Syngenta
Crop Protection believes that there is a reasonable certainty that no
harm will result from aggregate exposure to residues arising from all
current and proposed cyprodinil uses, including anticipated dietary
exposure from food, water, and all other types of non-occupational
exposures.
D. Cumulative Effects
Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' EPA does not have, at this time,
available data to determine whether cyprodinil has a common mechanism
of toxicity with other substances or how to include this pesticide in a
cumulative risk assessment. For the purposes of this tolerance action,
the EPA has not assumed that cyprodinil has a common mechanism of
toxicity with other substances.
E. Safety Determination
The chronic dietary exposure analysis (food only) indicated that
exposure from all established and proposed cyprodinil uses is 8.4% of
the chronic RfD of 0.03 mg/kg-bw/day for the most sensitive
subpopulation, children 1 and 2 years old. Estimated concentrations of
cyprodinil residues in surface and ground water are below the
calculated acute DWLOC. The children 1 and 2 years old subpopulation
has the lowest
[[Page 1439]]
chronic DWLOC of approximately 275 ppb, which is considerably higher
than the chronic EEC of 8 ppb.
The acute dietary exposure analysis (food only) showed that for
female 13-49 years old, exposure from all established and proposed
cyprodinil uses would be 1.1% of the acute RfD of 1.5 mg/kg-bw/day.
Acute DWLOCs were calculated based on an acute Populated Adjusted Dose
(aPAD) of 1.5 mg/kg/day. The females (13-49 years old) subpopulation
generated an acute DWLOC of approximately 44,500 ppb. The acute EEC of
33 ppb is considerably less than 44,500 ppb. Therefore, the chronic and
aggregate risk from cyprodinil residues in food and drinking water
would not be expected to exceed the EPA's level of concern.
Syngenta Crop Protection has considered the potential aggregate
exposure from food, water and non-occupational exposure routes and
concluded that aggregate exposure is not expected to exceed 100% of the
chronic reference dose and that there is a reasonable certainty that no
harm will result to infants and children from the aggregate exposure to
cyprodinil.
F. International Tolerances
There are no Codex maximum residue levels established for
cyprodinil.
[FR Doc. 05-343 Filed 1-6-05; 8:45 am]
BILLING CODE 6560-50-S
