[Federal Register: December 31, 2003 (Volume 68, Number 250)]
[Notices]
[Page 75504-75507]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31de03-70]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0366; FRL-7334-2]
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 ID number OPP-2003-0366, must be
received on or before January 30, 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: Daniel 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 are an
agricultural producer, food manufacturer or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Crop production (NAICS code 111)
[sbull] Animal production (NAICS code 112)
[sbull] Food manufacturing (NAICS code 311)
[sbull] Pesticide manufacturing (NAICS code 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-2003-0366. 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, 1921 Jefferson Davis Hwy., 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 on paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your
[[Page 75505]]
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-2003-0366. 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-2003-0366. 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-2003-0366.
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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID number OPP-2003-0366. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed
additives, Food additives, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 5, 2003.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed
below as required by FFDCA section 408(d)(3). The summary of the
petition was prepared by Arvesta Corporation and represents the view of
the petitioner. The petition summary announces the availability of a
description of the analytical methods available to EPA for the
detection and measurement of the pesticide chemical residues or an
explanation of why no such method is needed.
Arvesta Corporation
PP 1F6342
EPA has received a pesticide petition (1F6342) 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 commodity apples and pears at 1.0 parts per million (ppm).
EPA has determined that the petition contains data or information
regarding the elements set forth in section
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408(d)(2) of the FFDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
support granting of the petition. Additional data may be needed before
EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. 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
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 chromotography (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 has also demonstrated the ability to extract aged clothianidin,
TZG, TZU, and ATMG-Pyr residues.
Although, the plant and animal residues LC-MS/MS method is highly
suitable for enforcement method, an LC-UV method has also been
developed which is suitable for enforcement (monitoring) purposes in
all relevant matrices.
3. Magnitude of residues. For apples, a total of 13 field trials
were conducted to evaluate the magnitude of the residues of
clothianidin in apples. Apple trees were treated with clothianidin at a
rate of 0.2 lb active ingredient (a.i./acre). The highest average field
trial residue found was 0.174 ppm in apple at 7 days pre-harvest
interval (PHI). The apple processing study conducted at the exaggerated
rate of 3X rate indicated no concentration in any processed commodities
including apple juice and wet pomace. A residue decline study was
conducted, and an estimated half-life value was obtained at 5.9 days.
For pears, a total of seven field trials were conducted to
determine the residue level in pear following one single treatment with
clothianidin at a rate of 0.2 lb a.i./acre. The highest average field
trial clothianidin residue was 0.163 ppm in pears. A residue decline
study was conducted, and an estimated half-life value was obtained at
11.5 days for pears.
B. Toxicological Profile
1. Acute toxicity. The acute oral lethal dose (LD)50 was
>5,000 milligrams/kilogram body weight (mg/kg bwt) for both male and
female rats. The acute dermal LD50 was greater than 2,000
mg/kg bwt in rats. The 4-hour inhalation liquid chromatography
(LC)50 6.14 milligrams per liter (mg/L) for male and female
rats. Clothianidin was not irritating to rabbit skin or eyes and did
not cause skin sensitization 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 two-generation
reproduction study, rats were administered dietary levels of 0, 150,
500 and 2,500 ppm. The no observed adverse effect level (NOAEL) for
reproductive parameters was 2,500 ppm. The NOAEL for developmental
effects was 500 ppm based on decreased pup weights and the parental
NOAEL and 150 ppm based on the decreased body weights.
A developmental toxicity study was conducted in rats with
clothanidin using dose levels of 0, 10, 50 and 125 mg/kg bwt by gavage.
The NOAEL for maternal toxicity was established at 10 mg/kg bwt and for
developmental effects it was >125 mg/kg bwt. Additionally, a
developmental toxicity was conducted with rabbits treated orally by
gavage at 0, 10, 25, 75 and 100 mg/kg bwt. The NOAEL for maternal
toxicity was 10 mg/kg bwt and for developmental toxicity it was 75 mg/
kg bwt.
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 NOAELs were established at 500 ppm for rat and 650 ppm
for the dog.
5. Chronic toxicity. A two-year combined rat chronic/oncogenicity
conducted at dietary levels of 0, 150, 500, 1,500 and 3,000 ppm
demonstrated a NOAEL 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, and
1,800 ppm for males and females, respectively, revealed NOAEL of 350
ppm based on reduced body weight gains and increased incidence of
hypercellular hypertrophy. No evidence of oncogenicity was seen in the
rat 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 on overall
NOAEL of 325 ppm based on 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 lethal dose (LD)50 values
range from <500 to >2,000 mg/kg, showing low to moderate toxicity.
8. Endocrine disruption. All guideline studies conducted to
characterize toxicological profile showed no endocrine related toxicity
or tumorgenicity. No effects on T3, T4, TSH were
observed in the subchronic rat study. In a two-generation reproduction
study in rat; and rat and rabbit teratology studies, clothianidin did
not show reproductive or teratogenic effects. The extensive data base
shows that clothianidin has no endocrine properties.
C. Aggregate Exposure
1. Dietary exposure. The acute reference dose (aRfD) of 0.6 mg/kg
bwt/day (acute NOAEL with a 100-fold uncertainty factor) was used to
assess acute dietary exposure.
Seed treatment use. Bayer has conducted an acute dietary exposure
Tier 2 assessment estimating the percent of the aRfD and corresponding
margins
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of exposure (MOE) for the overall U.S. population (all seasons) and the
following subpopulations: all infants (<1 year), non-nursing infants
(<1 year), children (1-6 years), children (7-12 years), females (13-19
years), females (13-50 years), males (13-19 years), males (>20 years),
and seniors (>55 years). In this refined Tier 2 analysis, all evaluated
population subgroups had an exposure equal to 0% of the aRfD with a
corresponding MOE of >1 million at the 95th percentile.
Foliar application use (pome fruit). Tomen has conducted an acute
dietary exposure Tier 1 analysis with Dietary Exposure Evaluation Model
(DEEM) using proposed tolerance of 1 ppm, 100% crop treated and no
adjustment of processing factor for the overall U.S. populations and
the following subpopulations: all infants, nursing infants (<1 year),
non-nursing infants (<1 year), children (1-6 years), children (7-12
years), and females (13-50 years). The results of Tier 1 analysis from
foliar use of pome fruit indicated that the highest exposure never
exceeds 5.42% of the aRfD at the 95th percentile.
The chronic reference dose (cRfD) of 0.097 mg/kg bwt/day (chronic
NOAEL with a 100-fold uncertainty factor) was used to assess chronic
dietary exposure.
Seed treatment use. Bayer's chronic dietary analysis estimated the
percent of the cRfD and corresponding MOE for the overall U.S.
population (all seasons) and the following subpopulations: all infants
(<1 year), non-nursing infants (<1 year), children (1-6 years),
children (7-12 years), females (13-19 years), females (13-50 years),
males (13-19 years), males (>20 years), and seniors (>55 years). In
this analysis, all evaluated population subgroups had an exposure equal
to 0% of the cRfD. The corresponding MOE was >1 million.
Foliar application use. Tomen has conducted a chronic Tier 1
analysis and the results indicated that the highest exposure never
exceeds 8.7% of the cRfD at the 95th percentile.
i. Food. See above discussion.
ii. Drinking water. For drinking water, the models SCI-GROW (ground
water), and generic expected environmental concentration (GENEEC)
(surface water), were selected to calculate the potential exposure of
TM-444 in drinking water. Both short-term (acute) and long-term
(chronic) exposures were estimated with respect to foliar uses on
apples and pears. The predicted ground water concentrations for foliar
application of apples and pears were 1.17 and 1.30 [mu]/L,
respectively. The highest estimated acute and chronic exposures from
surface water were 9.10 and 3.07 [mu]/L, respectively. Based on the
standard exposure scenarios for drinking water (70kg adult- 2L/day; 10
kg child- 1L/day), the potential human exposure and risk can be
estimated. Using the acute (0.60 mg/kg/day) and chronic (0.097 mg/kg/
day) reference doses (RfD), the human risk from exposure to TM-444 in
drinking water is estimated. The risk to adults and children from
ground water exposure ranged from 0.006 to 0.019% of the acute RfD and
from 0.038 to 0.134% of the chronic RfD; from surface water, the
estimated risk ranged from 0.039% to 0.152% of the acute RfD and 0.081
to 0.316% of the chronic RfD respectively.
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 aggregate exposure to clothianidin from all
proposed uses will be less than 9% of the RfD for the overall U.S.
population. All evaluated population subgroups had an exposure less
than 9% of the RfD. EPA generally has no concerns for exposures below
100% of the RfD, because the RfD represents the level at or below which
daily aggregate exposure over a lifetime will not pose appreciable
risks to human health. Thus, Arvesta believes that 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
two-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 data base. Based
on the current toxicological data requirements the toxicology data base
for clothianidin relative to prenatal and postnatal development is
complete, including the developmental neurotoxicity study. None of the
studies indicated the offsprings to be more sensitive. All effects were
secondary to severe maternal toxicity. The RfD for clothianidin was
calculated using the NOAEL of 9.7 mg/kg bw/day from the two-year
chronic/oncogenicity study. This NOAEL is lower than the NOAEL from the
two-generation reproduction study, the developmental studies, and the
developmental neurotoxicity study. Moreover, using a toxicologically
justified UF of 100, the RfD for a non-oncogenic clothianidin was
established at a level 0.097 mg/kg/day, a value that offers a measure
of safety that is the highest among the other alternative compounds for
control of apple and pear pests.
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. 03-32205 Filed 12-30-03; 8:45 am]
BILLING CODE 6560-50-S