[Federal Register: September 1, 2004 (Volume 69, Number 169)]
[Notices]
[Page 53436-53440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se04-72]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0282; FRL-7676-4]
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.
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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-
2004-0282, must be received on or before October 1, 2004.
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 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.
[[Page 53437]]
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-2004-0282. 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 South Bell St., Arlington, VA. This
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The docket telephone number is (703)
305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B. EPA intends to work towards
providing electronic access to all of the publicly available docket
materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0282. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2004-0282. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0282.
3. By hand delivery or courier. Deliver your comments to: Public
Information
[[Page 53438]]
and Records Integrity Branch (PIRIB), Office of Pesticide Programs
(OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 South Bell St., Arlington, VA, Attention: Docket ID
Number OPP-2004-0282. 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 pesticide petitions 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 these petitions contain 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 supports granting of the petitions.
Additional data may be needed before EPA rules on the petitions.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: August 25, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petitions
The petitioner summary of the pesticide petitions is printed below
as required by FFDCA section 408(d)(3). The summary of the petitions
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)
Pesticide Petitions (PP) 3E6700 and 3E6638
EPA has received pesticide petitions (PP 3E6700 and 3E6638) from
the IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-
3390, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C.
346a(d), to amend 40 CFR part 180.532 by establishing tolerances for
residues of cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-
pyrimidinamine, in or on the following raw agricultural commodities
(RACs):
PP 3E6700 proposes a tolerance for bean, dry and bean,
succulent, at 0.6 parts per million (ppm).
PP 3E6638 proposes a tolerance for leafy greens subgroup
4A, except spinach, at 30 ppm.
Additional data may be needed before EPA rules on the petitions.
Syngenta Crop Protection, Inc., Greensboro, NC 27409 is the
manufacturer of the chemical pesticide, cyprodinil. Syngenta 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.
A. Residue Chemistry
1. Plant metabolism. The metabolism of cyprodinil is adequately
understood for the purpose of the proposed tolerances.
2. Analytical method. Syngenta 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. Residue data to support the requested
tolerances for crops in this submission have been submitted. The
requested tolerances are adequately supported.
B. Toxicological Profile
An assessment of toxic effects caused by cyprodinil is discussed in
detail in Unit III.A. and Unit III.B. in the Federal Register of
September 19, 2003 (68 FR 54808) (FRL-7326-4). It is a final rule
establishing tolerances for residues of cyprodinil in or on several raw
agricultural commodities. Interested parties are referred to that
document for an in depth discussion of toxicological findings.
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. This conclusion is conditional on submission and review
[[Page 53439]]
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, they 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. Tier III acute and chronic dietary exposure
evaluations were 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 peeled lychees (0.01X) were used in
these assessments. The apple juice processing factor was used as a
surrogate for pear juice. All other processing factors used the
DEEM\TM\ defaults. All consumption data for these assessments were
taken from the United States Department of Agriculture's (USDA's)
Continuing Survey of Food Intake by individuals (CSFII) with the 1994-
1996 consumption database and the Supplemental CSFII children's survey
(1998) consumption database. These exposure assessments included all
registered uses and pending uses on bean, dry and bean, succulent and
the leafy greens subgroup 4A, except spinach. Secondary residues in
animal commodities were estimated.
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.
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 mg/kg-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
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 aRfD 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 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 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
(%cRfD). Chronic exposure to the most sensitive subpopulation (children
1 and 2 years old) resulted in a MOE of 1,074 (8.4% of the cRfD 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 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.
iv. 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 1,550 to 2,030 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 uses the Screening
Concentrations in Groundwater (SCI-GROW) model to determine acute and
chronic estimated environmental concentrations in groundwater, and the
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) to determine acute and chronic estimated environmental
concentrations in surface water. Based on the model outputs, the EECs
for cyprodinil (plus the CGA-249287 metabolite) are 0.16 parts per
billion (ppb) for acute and chronic exposure to groundwater 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 Drinking
Water Levels of Comparison (DWLOC) 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.
2. 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.
3. Acute and chronic aggregate exposure. Based on the completeness
and reliability of the toxicity data supporting these petitions, and
the results of the above exposure calculations, Syngenta 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
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether
[[Page 53440]]
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,
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 cRfD of 0.03mg/kg-bw/day for the most sensitive subpopulation,
children 1 and 2 years old. Estimated concentrations of cyprodinil
residues in surface and groundwater are below the calculated acute
DWLOC. The children 1 and 2 years old subpopulation has the lowest
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 aRfD of 1.5 mg/kg-bw/day. Acute
DWLOC were calculated based on an aPAD of 1.5 mg/kg/day. The females
(13-49 years) subpopulation generated an acute DWLOC of approximately
44,500 ppb. The acute EEC of 33 ppb is considerably less than 44,500
ppb. Therefore, Syngenta concludes that the chronic and aggregate risk
from cyprodinil residues in food and drinking water would not be
expected to exceed EPA's level of concern.
Syngenta 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 cRfD 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. 04-19823 Filed 8-31-04; 8:45 am]
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