[Federal Register: December 8, 2004 (Volume 69, Number 235)]
[Notices]
[Page 71036-71040]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de04-75]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0377; FRL-7687-4]
Clothianidin; 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-
2004-0377 must be received on or before January 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: Dan Kenny, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7546; e-mail address: Kenny.Dan@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
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-2004-0377. 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
[[Page 71037]]
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-2004-0377. 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-2004-0377. 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-2004-0377.
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 South Bell St., Arlington, VA, Attention: Docket ID
Number OPP-2004-0377. 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 record keeping
requirements.
[[Page 71038]]
Dated: November 30, 2004.
Lois Rossi,
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.
Arvesta Corporation
PP 4F6869
EPA has received a pesticide petition (4F6869) from Arvesta
Corporation, 100 First Street, Suite 1700, San Francisco, CA 94105
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 clothianidin in or on the raw
agricultural commodities grapes at 0.5 parts per million (ppm), raisins
at 1.0 ppm, and potatoes at 0.1 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
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. In plants, the metabolism of clothianidin is
adequately understood for the purposes of establishing these proposed
tolerances. Unchanged, parent clothianidin was the predominant residue
in all crop matrices (14.4 to 64.5% in corn, 66.1 to 96.6% in tomatoes,
4.3 to 24.4% in sugar beets and 24.3 to 63.3% in apples), with the
exception of sugar beet leaves. In sugar beet leaves, the main
components were the methylguanidine and thiazolylmethylguanidine (TMG)
metabolites, accounting for 28.6 and 27.7% respectively. All
metabolites found in plants were also found in the animal metabolism
studies. In animals, parent clothianidin was the major component in
liver, muscle and fat. Based on the available metabolism data, parent
clothianidin, TZG, TZU, and ATMG-Pyr are proposed to be considered as
the residues of concern in livestock matrices.
2. Analytical method. In plants and plant products, the residue of
concern, parent clothianidin, can be determined using high performance
liquid chromatography (HPLC) with electrospray mass spectroscopy (MS/
MS) detection. In an extraction efficiency testing, the plant residues
method has also demonstrated the ability to extract aged clothianidin
residue.
In animal matrices, the residues parent clothianidin, TZG, TZU, and
ATMG-Pyr can also be determined using HPLC with electrospray MS/MS
detection. In an extraction efficiency testing, the animal residues
method can also extract aged clothianidin, TZG, TZU, and ATMG-Pyr
residues.
Although for the plant and animal residues this HPLC-MS/MS method
is highly suitable as an enforcement method, an LC-ultraviolet (UV)
method has also been developed which is suitable for enforcement
(monitoring) purposes in all relevant matrices.
3. Magnitude of residues-- i. Potatoes. Fifteen residue trials were
conducted in key potato producing regions of the United States. At each
trial, two different application regimes, foliar and in-furrow, were
studied in separate plots. Samples were analyzed for residues of
clothianidin.
Three foliar applications of 0.0661 pounds (lb) per active
ingredient/acre (ai/A) were made with the 50 WDG formulation at 28, 21
and 14 days prior to harvest. Clothianidin residues ranged from ND to
0.0205 ppm for this treatment.
One in-furrow application of 0.198 lb ai/A was made with the 16 WSG
formulation. Clothianidin residues ranged from less than the limit of
detection (LOD) (0.007 ppm) to 0.0332 ppm for this treatment.
At one of the trial sites, two additional plots were treated at 5X
the normal application rate for the processing phase of the study.
Spray volumes range from 13.3 to 31.2 gallons per acre (GPA). The
processing portions analyzed were whole tubers, granules, chips, and
wet peel.
The foliar application of 50WDG was made at the 5X rate of 0.331 lb
ai/A for the processing phase of the study. All of the clothianidin
mean residues were less than limit of quantitation (LOQ) except for
granules, which had mean clothianidin residues of 0.0316 ppm. The
concentration factor (CF) for granules was calculated as 3.2. It was
not possible to calculate a reliable CF in commodities other than
granules. A residue decline study indicated that residues do not
increase with longer preharvest intervals (PHI).
The in-furrow application of 16WSG was made at the 5X rate of 0.99
lb ai/A for the processing phase of the study. Clothianidin mean
residues in whole tubers, granules, chips, and wet peel were 0.0258,
0.0546, 0.04 (< LOQ), and 0.007 (< LOQ) ppm, respectively. The CF for
granules, chips, and wet peel were 2.1, 1.6, and < 1, respectively.
ii. Grapes. Twelve residue trials were conducted in key grape
producing regions of the United States. At each trial two different
application regimes, foliar and drip irrigation, were studied in
separate plots. Samples were analyzed for residues of clothianidin.
Two foliar applications of 0.0992 lb ai/A/application were made
with the 50 WDG formulation at 14 and 0 days prior to normal harvest.
Clothianidin residues ranged from 0.0398 to 0.410 ppm for this
treatment.
At all of the trial sites except two in New York, a plot was
established with one drip application of the 16 WSG formulation at
0.1984 lb ai/A at 30 days prior to harvest. Clothianidin residues
ranged from ND to 0.01 ppm (< LOQ) for this treatment.
At two of the trial sites, plots received two drip applications of
16 WSG at the 0.5X rate of 0.0992 lb ai/A. Clothianidin residues were
all less than the LOD, ranging from 0.0005 to 0.006 ppm.
At one of the trial sites, two additional plots were treated at 5X
the normal application rate for the processing phase of the study. The
processing portions analyzed were whole fruit, raisins, and juice.
Two foliar applications of 50WDG were made at the 5X rate of 0.496
lb ai/A/application for the processing phase of the study. Clothianidin
mean residues in whole fruit, raisins, and juice were 0.621, 1.02, and
0.707 ppm, respectively. The concentration factor (CF) was 1.64 for
raisins and 1.14 for juice. A residue decline study indicated that
residues do not increase with longer preharvest intervals (PHI).
The drip irrigation application of 16WSG was made at the 5X rate of
0.992 lb ai/A for the processing phase of the study. Clothianidin mean
residues in whole fruit, raisins, and juice were 0.006, 0.009, and
0.004 ppm, respectively. Since the mean residues in whole fruit and
processed commodities were < LOD, it was not possible to calculate a
reliable CF for either processed commodity.
B. Toxicological Profile
1. Acute toxicity. The acute oral lethal dose (LD)50 was
>5,000 milligram/kilogram (mg/kg) for both male and
[[Page 71039]]
female rats and the acute dermal LD50 was >2,000 mg/kg in
rats. The four-hour inhalation LC 50 was 6.14 mg/L for male
and female rats. Clothianidin was not a dermal or eye irritant in
rabbits and was not a skin sensitizer in guinea pigs.
2. Genotoxicty. Extensive mutagenicity studies were conducted with
clothianidin. Based on the weight of evidence, clothianidin was
considered negative for genotoxicity.
3. Reproductive and developmental toxicity. In a 2-generation
reproduction study with clothianidin, rats were administered dietary
levels of 0, 150, 500 and 2,500 ppm. The no observed effect level
(NOEL) for reproductive parameters was 2,500 ppm. The NOEL for
developmental effects was 500 ppm based on decreased pup weights and
the parental NOEL was 150 ppm based on decreased body weights (bw).
A developmental toxicity study was conducted in rats with
clothianidin using dose levels of 0, 10, 50 and 125 mg/kg/day by
gavage. The NOEL for maternal toxicity was established at 10 mg/kg and
for developmental effects it was >125 mg/kg. Additionally, a
developmental toxicity study was conducted with rabbits treated orally
by gavage at 0, 10, 25, 75 and 100 mg/kg/day. The NOEL for maternal
toxicity was 10 mg/kg and for developmental toxicity, it was 75 mg/kg.
Developmental toxicity studies showed no primary developmental
toxicity and no teratogenic potential was evident.
4. Subchronic toxicity.90-day feeding studies were conducted in
rats and dogs. The rat study was conducted at dietary levels of 0, 150,
500 and 3,000 ppm and the dog study was conducted at 0, 325, 650 and
1,500 ppm. The NOELs were established at 500 ppm for rat and 650 ppm
for the dog.
5. Chronic toxicity. A 2-year combined rat chronic/oncogenicity
study conducted at dietary levels of 0, 150, 500, 1,500 and 3,000 ppm
demonstrated a NOEL of 150 ppm based on reduced weight gains and non-
neoplastic histomorphological changes. A 78-week mouse oncogenicity
study conducted at dose levels of 0, 100, 350, 1,250, and 2,000/1,800
ppm for males and females, respectively, revealed a NOEL of 350 ppm
based on reduced bw gains and increased incidence of hypercellular
hypertrophy. No evidence of oncogenicity was seen in the rats or the
mice. A 52-week chronic toxicity study in dogs conducted at dietary
levels of 0, 325, 650, 1,500 and 2,000 ppm revealed an overall NOEL of
325 ppm and no observed adverse effect level (NOAEL) of 650 ppm based
on a slight decrease in ALT.
6. Animal metabolism. The nature of the clothianidin residue in
livestock is adequately understood. In animals, parent clothianidin was
the major component in liver, muscle and fat. Based on the available
metabolism data, parent clothianidin, TZG, TZU, and ATMG-Pyr are
proposed to be considered as the residues of concern in livestock
matrices.
7. Metabolite toxicology. Eight in vivo metabolites of clothianidin
identified in the rat were investigated for acute oral endpoint
mutagenic activity. None of the metabolites were mutagenic either with
or without activation and the LD50 values range from <500 to
>2,000 mg/kg, showing low to moderate toxicity.
8. Endocrine disruption. All guideline studies conducted to
characterize the toxicological profile showed no endocrine related
toxicity or tumorgenicity. No effects on T3, T4, or TSH were observed
in the subchronic rat study. In a 2-generation reproduction study in
the rat, and rat and rabbit teratology studies, clothianidin did not
show reproductive or teratogenic effects. The extensive database shows
that clothianidin has no endocrine properties.
C. Aggregate Exposure
1. Dietary exposure. Tolerances are proposed for residues of
clothianidin on grapes, raisins, and potatoes. For the purposes of
assessing the potential dietary exposure for these proposed tolerances,
an exposure assessment was conducted using Dietary Exposure Evaluation
Model (DEEM\TM\) software, consumption data derived from the 1994-1998
USDA Continuing Surveys of Food Intake by Individuals (CSFII), and
residue levels at proposed tolerance levels.
i. Food -- a. Acute dietary exposure. The acute population adjusted
dose (aPAD) of 0.25 mg/kg bw/day (acute NOAEL with a 100-fold
uncertainty factor) was used to assess dietary exposure. Arvesta
Corporation has conducted an acute dietary exposure Tier 1 analysis
with DEEM\TM\ using the proposed tolerances for grapes, raisins, and
potatoes of 0.5, 1.0, and 0.1 ppm, respectively, 100% crop treated and
default processing factors for the overall US population and the
following subpopulations: All infants (< 1 year), children (1-2 years),
females (13-49 years), and adults (50+). Arvesta has conducted an acute
Tier 1 analysis from the uses on grapes and potatoes. This analysis
also includes the anticipated exposure to clothianidin resulting from
both Bayer's seed treatment uses and uses of thiamethoxam, of which
clothianidin is a major metabolite. The results of this Tier 1 analysis
indicate that the highest exposure never exceeds 18.00% of the aPAD at
the 95th percentile of exposure.
b. Chronic dietary exposure. The chronic population adjusted dose
(cPAD) of 0.098 mg/kg bw/day (chronic NOEL with a 100-fold uncertainty
factor) was used to assess chronic dietary exposure. Arvesta has
conducted a chronic Tier 1 analysis, including the anticipated exposure
to clothianidin resulting from Bayer's seed treatment uses and uses of
thiamethoxam, and the results indicate that the highest exposure never
exceeds 13.41% of the cPAD.
ii. Drinking water. For drinking water, the models screening
concentration in ground water (SCI-GROW) (ground water) and the Food
Quality Protection Act (FQPA) index reservoir screening tool (FIRST)
(surface water), were selected to calculate the potential exposure of
clothianidin in drinking water. Both short-term (acute) and long-term
(chronic) exposures were estimated with respect to foliar and drip-
irrigation uses for grapes and foliar and in-furrow uses for potatoes.
The worst case drinking water estimated concentrations (DWEC) for these
applications to grapes and potatoes were 15.1 parts per billion (ppb)
for the acute and 0.5 ppb for the chronic using the FIRST model. The
acute and chronic drinking water levels of comparison (DWLOC) were
calculated for each of the population subgroups. The acute DWLOC for
the most sensitive population subgroup, children 1-2 years, was
calculated to be 2,050 ppb and the chronic DWLOC for this population
subgroup is 849 ppb. The acute DWLOC for the U.S. population is 8,417
ppb and the chronic DWLOC is 3,350 ppb. The calculated acute and
chronic DWLOCs for the U.S. population and children 1-2 years exceed
the DWECs from the models.
2. Non-dietary exposure. Clothianidin is currently not registered
for use on any residential non-food site. Therefore, residential
exposure to clothianidin residues will be through dietary exposure
only.
D. Cumulative Effects
There is no information available to indicate that toxic effects
produced by clothianidin are cumulative with those of any other
compound.
E. Safety Determination
1. U.S. population. Using the conservative exposure assumptions
described above and based on the completeness of the toxicity data, it
can be concluded that total food-only exposure to clothianidin from all
[[Page 71040]]
proposed crop uses will be less than 3.8% of the aPAD and less than
2.34% of the cPAD for the overall U.S. population. All evaluated
population subgroups had an exposure of less than 18.00% of the aPAD
and less than 13.41% of the cPAD. EPA generally has no concerns for
exposures below 100% of the PAD, because the PAD represents the level
at or below which daily aggregate exposure over a lifetime will not
pose appreciable risks to human health. The DWLOCs exceed the DWECs as
calculated by conservative models. There are no residential uses of
clothianidin; therefore, aggregate exposure consists of food and
drinking water exposures. Thus, it can be concluded that there is a
reasonable certainty that no harm will result from aggregate exposure
to clothianidin residues.
2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of clothianidin, the
data from developmental toxicity studies in both the rat and rabbit, a
2-generation reproduction study in rats and a developmental
neurotoxicity study in rats have been considered.
The developmental toxicity studies evaluate potential adverse
effects on the developing animal resulting from pesticide exposure of
the mother during prenatal development. The reproduction study
evaluates effects from exposure to the pesticide on the reproductive
capability of mating animals through two generations, as well as any
observed systemic toxicity.
The developmental neurotoxicity studies evaluate the
neurobehavioral and neurotoxic effects on the developing animal
resulting from the exposure of the mother. FFDCA section 408 provides
that EPA may apply an additional uncertainty factor for infants and
children based on the threshold effects to account for prenatal and
postnatal effects and the completeness of the toxicity database. Based
on the current toxicological data requirements, the toxicology database
for clothianidin relative to prenatal and postnatal development is
complete, including the developmental neurotoxicity study. None of the
studies indicated the offspring to be more sensitive. All effects were
secondary to severe maternal toxicity. The cPAD for clothianidin was
calculated using the NOAEL of 9.8 mg/kg bw/day from the 2-generation
rat reproduction study.
F. International Tolerances
No CODEX maximum residue levels (MRL's) have been established for
residues of clothianidin on any crops at this time.
[FR Doc. 04-27004 Filed 12-7-04; 8:45 am]
BILLING CODE 6560-50-S