[Federal Register Volume 69, Number 115 (Wednesday, June 16, 2004)]
[Notices]
[Pages 33635-33638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13411]



[[Page 33635]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0087; FRL-7350-6]


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-
2004-0087, must be received on or before July 16, 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:  Stephanie Nguyen, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 605-0702; e-mail address: 
[email protected].

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-2004-0087. 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 
areavailable 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 EPA's 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 EPAidentifies 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

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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-2004-0087. 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 [email protected], 
Attention: Docket ID Number OPP-2004-0087. 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-2004-0087.
    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-2004-0087. 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: May 27, 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.

Bayer CropScience

PP 3F6792

    EPA has received a pesticide petition (3F6792) from Bayer 
CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709 
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 sorghum, grain at 0.01 part per million (ppm); 
sorghum, forage at 0.01 ppm; and sorghum, stover at 0.01 ppm, 
respectively. EPA has determined that the petition contains data or 
information regarding the elements set forth in

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section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
support granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. 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, thiazolyl-guanidine (TZG), thiazolyl-urea (TZU), and 
(ATMG-Pyr) aminothiazolyl methylguanidine-pyridine 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/mass 
molecular size (MS/MS) detection. In an extraction efficiency testing, 
the plant residues method has also demonstrated the ability to extract 
aged clothianidin residue.
    Although the plant residues lethal dose (LC)-MS/MS method is highly 
suitable for 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 in sorghum. A total of 12 field trials was 
conducted to evaluate the quantity of clothianidin in sorghum forage, 
stover, and grain. Sorghum seed was treated with TI-435 600 fecal 
streptococci (FS) at a rate of 250 grams active ingredient/100 
kilograms (kg) seed. The highest average field trial was less than 0.01 
ppm in sorghum forage, stover, and grain when collected at normal 
harvest of 97 to 167 days after planting of treated seed. In a sorghum 
processing study sorghum seed was treated at a 2X rate of 500 grams 
active ingredient/100 kg seed. No residues at or above the limit of 
quantitation (LOQ) of 0.01 ppm were found in the sorghum grain. 
Therefore, a sorghum processing study was not conducted.

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 LC50 was 5.538 
miligrams/Liters (mg/L) for male and female rats. Clothianidin was not 
irritating to rabbit skin and only slightly irritating to the eyes and 
did not cause skin sensitization in guinea pigs.
    2. Genotoxicity. 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, rats were administered dietary levels of 0, 150, 
500, and 2,500 ppm. The no observed effect level (NOAEL) for 
reproductive parameters was 500 ppm (31.2/36.8 mg/kg/day; for male and 
female), while the NOAEL for developmental effects was 150 ppm (9.8/
11.5 mg/kg/day; for male and female. The parental systemic NOAEL was 
500 ppm (31.2/36.8 mg/kg/day; for male and female).
    A developmental toxicity study was conducted in rats with 
clothianidin 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 study was conducted with rabbits treated orally 
by gavage at 0, 10, 25, 75, and 100 mg/kg/bwt. The NOAEL for maternal 
toxicity was 25 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. A 90-day feeding study was 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 (27.9/34.0 mg/kg/day; 
for the male and female rat, and 650 ppm (19.3 mg/kg/day) for the male 
dog, and 1,500 ppm (42.1 mg/kg/day) for the female 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 NOAEL of 500 ppm (27.9/34.0 mg/kg/day) 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 a NOAEL of 350 ppm (47.2/65.1 mg/kg/day; for males and females 
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 a NOAEL of 
2,000 ppm (46.4 mg/kg/day) for the male dog and 1,500 ppm (40.1 mg/kg/
day) for the female dog.
    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 toxicological profile showed no endocrine related toxicity 
or tumorgenicity. No effects on triiodothyronine (T3), throxine (T4), 
or thyroid stimulating hormone (TSH) were observed in the subchronic 
rat study. In a 2-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. There are no residential uses for 
clothianidin, therefore aggregate exposure consists of dietary (food 
and drinking water) exposures. The acute population adjusted dose (PAD) 
of 0.025 mg/kg bwt/day based on an acute NOAEL of 25 with an 
uncertainty factor (UF) of 1,000 was used to assess acute dietary 
exposure. The chronic (PAD) of 0.0098 mg/kg/bwt/day based on a chronic 
NOAEL of 9.8 with an UF of 1,000 was used to assess chronic exposure.
    i. Food. In the clothianidin pesticide tolerance action for corn 
and canola, the

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Federal Register notice of May 30, 2003 (68 FR 32390) (FRL-7306-8), EPA 
conducted Tier I acute and chronic dietary assessments for 
clothianidin. These assessments included residues of clothianidin that 
arise from the uses of thiamethoxam which has clothianidin as a common 
metabolite. Based on these assessments, a tolerance of 0.01 ppm for 
sorghum use for clothianidin was added to the analysis. No significant 
contribution was seen from this use. The U.S. population utilized 8.4% 
(0.00211 mg/kg/bwt/day, 95\th\ percentile) of the acute PAD and 6.5% 
(0.000635 mg/kg/bwt/day) of the chronic PAD. The most highly exposed 
subpopulation is children 1 to 2 at 19.1% (0.004772 mg/kg/bwt/day, 
95\th\ percentile) of the acute PAD and 19.1% (0.001874 mg/kg/bwt/day) 
of the chronic PAD.
    ii. Drinking water. EPA's Standard Operating Procedure (SOP) for 
drinking water exposure and risk assessments was used to perform the 
drinking water assessment. This SOP uses a variety of tools to conduct 
drinking water assessment. These tools include water models such as 
Screening Concentration in Groundwater (SCI-GROW), FQPA Index Reservoir 
Screening Tool (FIRST), EPA's Pesticide Root Zone Model/Exposure 
Analysis Modeling System (PRZM/EXAMS), and monitoring data. If 
monitoring data are not available then the models are used to predict 
potential residues in surface water and ground water and the highest is 
assumed to be the drinking water residue. In the case of clothianidin, 
monitoring data do not exist therefore SCI-GROW and FIRST were used to 
estimate a water residue. The calculated drinking water levels of 
comparison (DWLOC) for acute chronic exposure for all adults and 
children exceed the drinking water estimated concentrations (DWEC) from 
the models. The chronic DWLOC for adults is 321 parts per billion (ppb) 
and the acute DWLOC is 801 ppb. The chronic DWLOC for children 1 to 2 
is 79 ppb and the acute DWLOC is 202 ppb. The DWEC for the worst case 
chronic scenario is 2.14 ppb FIRST and the acute DWEC FIRST is 3.97 
ppb. The DWLOC are based on conservative dietary (food) exposures and 
are expected to be much higher in real world situations.
    2. Non-dietary exposure. Clothianidin products are not labeled for 
residential uses (food or non-food), thereby eliminating the potential 
for residential exposure or non-occupational exposure.

D. Cumulative Effects

    Clothianidin is a metabolite of thiamethoxam. Therefore, residues 
of clothianidin resulting from use of thiamethoxam were included in the 
above risk assessment. There are no data 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 aggregate exposure to residues of clothianidin 
present a reasonable certainty of no harm. Exposure from residues in 
crops utilize 8.4% of the acute PAD and 6.5% of the chronic PAD. EPA 
generally has no concerns for exposures below 100% of the PAD. DWLOC 
are well above the estimated drinking water concentrations as 
calculated by conservative models. There are no residential uses so 
aggregate exposure consists of food and drinking water exposures. The 
conservative Tier I assessments demonstrate a reasonable certainty of 
no harm will result from uses of clothianidin for the U.S. population.
    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 2-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 UF 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. Therefore, no additional safety 
or UF is justified.

F. International Tolerances

    No CODEX maximum residue levels have been established for residues 
of clothianidin on any crops at this time.
[FR Doc. 04-13411 Filed 6-15-04; 8:45 am]
BILLING CODE 6560-50-S