Tebuconazole; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 28527-28534 [05-9590]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 95 (Wednesday, May 18, 2005)]
[Notices]
[Pages 28527-28534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9590]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0097; FRL-7708-5]


Tebuconazole; 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-
2005-0097, must be received on or before June 17, 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: Mary L. Waller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9354; e-mail address: waller.mary@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-2005-0097. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at https://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The 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

[[Page 28528]]

receipt by EPA, identify the appropriate docket ID number in the 
subject line on the first page of your comment. Please ensure that your 
comments are submitted within the specified comment period. Comments 
received after the close of the comment period will be marked ``late.'' 
EPA is not required to consider these late comments. If you wish to 
submit CBI or information that is otherwise protected by statute, 
please follow the instructions in Unit I.D. Do not use EPA Dockets or 
e-mail to submit CBI or information protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at https://www.epa.gov/
edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2005-0097. The system is an `` anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov, 
Attention: Docket ID Number OPP-2005-0097. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0097.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0097. 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: April 29, 2005.
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

[[Page 28529]]

pesticide chemical residues or an explanation of why no such method is 
needed.

Interregional Research Project No. 4 and Bayer CropScience LP

PP 9E6045, 9E6046, 9E6048, 0E6103, 0E6117, 0E6153, 0E6158, 0E6212, 
6F4668, 7F4895, 0F6086, 0E6091, 0F6129, 1F6289, 4E6842, and 4F6854

    EPA has received pesticide petitions 9E6045, 9E6046, 9E6048, 
0E6103, 0E6117, 0E6153, 0E6158, and 0E6212 from Interregional Research 
Project No. 4 (IR4), 681 U.S. Highway 1 South, North 
Brunswick, NJ 08902-3390. EPA has also received pesticide petitions 
6F4668, 7F4895, 0F6086, 0E6091, 0F6129, 1F6289, 4E6842, and 4F6854 from 
Bayer CropScience LP, P.O. Box 12014, 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 
tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol in or on the raw 
agricultural commodities as follows:
    1. PP 6F4668 proposes the establishment of tolerances in or on 
fruit, pome, group 11 at 0.05 parts per million (ppm).
    2. PP 7F4895 proposes the establishment of tolerances in or on nut, 
tree, group 14 at 0.05 ppm; almond, hulls at 5.0 ppm; pistachio at 0.05 
ppm; barley, hay at 6.0 ppm; barley, straw at 1.4 ppm; wheat, forage at 
3.0 ppm; wheat, hay at 6.0 ppm; wheat, straw at 1.4 ppm.
    3. PP 0F6086 proposes the establishment of tolerances in or on 
bean, succulent at 0.1 ppm; bean, dry, seed at 0.1 ppm; cotton, 
undelinted seed at 2.0 ppm; cotton, gin byproducts at 16 ppm.
    4. PP 0E6091 proposes the establishment of import tolerances in or 
on asparagus at 0.01 parts per million (ppm); coffee, green bean, at 
0.1 ppm; coffee, roasted bean, at 0.2 ppm; garlic, dry bulb at 0.1 ppm; 
onion, dry bulb at 0.1 ppm.
    5. PP 0F6129 proposes the establishment of tolerances in or on 
corn, field, grain at 0.01 ppm; corn, field, forage at 3.0 ppm; corn, 
field, stover at 3.0 ppm; corn, pop, grain at 0.01 ppm; corn, pop, 
stover at 3.0 ppm; corn, sweet, kernel plus cob with husks removed at 
0.5 ppm; corn, sweet, forage at 6.0 ppm; corn, sweet, stover at 5.0 
ppm; soybean, seed at 0.01 ppm; soybean, forage at 0.01 ppm; soybean, 
hay at 0.05 ppm.
    6. PP 1F6289 and 0E6117 proposes the establishment of tolerances in 
or on fruit, stone, group 12, except cherry at 1.0 ppm.
    7. PP 9E6045 proposes the establishment of tolerances in or on 
turnip, greens at 8.0 ppm; turnip, roots at 0.4 ppm.
    8. PP 9E6046 and 4E6842 proposes the establishment of tolerances in 
or on hop, dried cones at 30.0 ppm.
    9. PP 9E6048 proposes the establishment of tolerances in or on 
vegetable, cucurbit, group 9 at 0.1 ppm.
    10. PP 0E6103 proposes the establishment of tolerances in or on 
mango at 0.2 ppm.
    11. PP 0E6153 proposes the establishment of tolerances in or on 
sunflower, seed at 0.05 ppm; sunflower, oil at 0.2 ppm; sunflower, meal 
at 0.2 ppm.
    12. PP 0E6158 proposes the establishment of tolerances in or on 
okra at 1.0 ppm.
    13. PP 0E6212 proposes the establishment of tolerances in or on 
lychee at 1.5 ppm.
    14. PP 4F6854 proposes the establishment of tolerances in or on 
soybean, seed at 0.06ppm; soybean, forage at 17 ppm; soybean, hay at 45 
ppm; soybean, hulls at 0.06 ppm and grain, aspirated fractions at 15 
ppm.
    15. Bayer CropScience proposes to add a post-harvest use on 
cherries at the current 0-day pre-harvest tolerance level of 4.0 ppm.
    EPA has determined that the petitions contain 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. The nature of the residue in plants and 
animals is adequately understood. The residue of concern is the parent 
compound only, as specified in 40 CFR 180.474.
    2. Analytical method. An enforcement method for plant commodities 
has been validated on various commodities. It has undergone successful 
EPA validation and has been submitted for inclusion in PAM II. The 
animal method has also been approved as an adequate enforcement method.
    3. Magnitude of residues--i. Almond. Six residue crop field trial 
studies were conducted in EPA's Region 10 to evaluate the quantity of 
tebuconazole residue in almond nutmeat and almond hulls following 
treatment with Elite 45 DF. Tebuconazole residues were quantitated by 
gas chromatography using a thermionic specific detector. The LOQ for 
tebuconazole was 0.05 ppm for almond nutmeat and 0.1 ppm for almond 
hulls. Residues in all nutmeat samples were less than or equal to the 
LOQ. The highest average field trial residue value for almond hulls was 
4.13 ppm. Therefore, tolerances of 0.05 and 5.0 ppm are being proposed 
for almond nutmeat and hulls, respectively.
    ii . Asparagus. Three field trials were conducted in Peru to 
evaluate the quantity of tebuconazole residue in or on asparagus spears 
following four foliar applications of Folicur 3.6 F to asparagus ferns. 
Tebuconazole residues were quantitated by gas chromatography using a 
nitrogen phosphorus detector. The limit of quantitation (LOQ) for 
tebuconazole was 0.01 ppm. Since the residue of tebuconazole was < 0.01 
ppm in all treated asparagus samples, a tolerance on 0.01 ppm is being 
proposed.
    iii. Bean (succulent). Studies were conducted to evaluate the 
quantity of tebuconazole residue on fresh bean pods and dry bean seed 
following treatments with Folicur 3.6 F. Twelve field trials were 
conducted on fresh beans, and fourteen field trials were conducted on 
dry beans. Tebuconazole residues were quantitated by gas chromatography 
using a thermionic specific detector. The limit of quantitation (LOQ) 
for tebuconazole was 0.05 ppm. The highest residue of tebuconazole was 
0.06 ppm in fresh beans. The highest residue in dry beans was 0.08 ppm. 
Therefore, tolerances are being proposed at 0.1 ppm for both succulent 
and seed beans.
    iv. Coffee. Four field trials were conducted in Brazil and four 
field trials were conducted in Guatemala to evaluate the quantity of 
tebuconazole residue in or on dried green coffee beans following 
applications of Folicur 3.6 F to coffee trees. Tebuconazole residues 
were quantitated by gas chromatography. The LOQ was 0.01 ppm. The 
maximum residue value was 0.07 with the majority of the residue values 
being below the LOQ. Therefore, a tolerance of 0.1 ppm is being 
requested for green beans.
    A processing study was conducted on dried green coffee beans from a 
field trial in Guatemala. Tebuconazole residues in dried green coffee 
beans, roasted coffee beans, and instant coffee were quantitated by gas 
chromatography. The LOQ for tebuconazole was 0.01 in green coffee 
beans, 0.8 ppm in roasted coffee beans and 0.04 ppm in instant coffee. 
The highest average residue found in this study was 0.04 ppm in dried 
green coffee beans, 0.08 ppm in roasted coffee

[[Page 28530]]

and 0.03 ppm in instant coffee. The data show that there is no 
concentration of residues as a result of processing into instant coffee 
and a slight concentration from dry beans (0.04 ppm) to roasted beans 
(0.08) ppm. A 0.2 ppm tolerance is being proposed for roasted coffee 
beans.
    v. Corn. Field trials were conducted on field corn and sweet corn 
to support establishing tolerances for field, sweet, and popcorn. Based 
on these data, tolerances are being requested for grain, forage and 
stove of field corn; grain and stover of popcorn; K + CWHR, stove, and 
forage of sweet corn.
    vi. Cotton. Studies were conducted to evaluate the quantity of 
tebuconazole residue in undelinted cotton seed and cotton gin 
byproducts (gin trash) following treatment of cotton plants with 
Folicur 3.6 F. Tebuconazole residues in undelinted cotton seed were 
quantitated by gas chromatography. The limit of LOQ was 0.05 ppm in 
undelinted cotton seed and 0.2 ppm in gin trash. The highest measured 
residue in undelinted cotton seed was 1.89 ppm and 15.2 ppm in cotton 
gin trash at a 29-day PHI. Therefore, tolerances are being proposed at 
2.0 ppm for undelinted cotton seed and 16.0 ppm for cotton gin trash.
    A cotton processing study was conducted with Folicur 3.6 F at 5 
times the maximum season proposed label use rate. Processing was 
performed using procedures which simulate commercial processing 
practices. The undelinted seed, meal, hull, and refined oil were 
evaluated for the residue of tebuconazole by gas chromatography. The 
LOQ in undelinted seed was 0.02 ppm. The LOQ in the processed products 
of meal, hull and refined oil was 0.04 ppm. Residue of tebuconazole in 
cotton undelinted seed was 0.04 ppm, while residue in the processed 
commodities were < 0.04 ppm. Therefore, no tolerances are being 
requested for processed products.
    vii. Cucurbit. Data from summer squash, cucumber and cantaloupe 
residue crop field trials were used to evaluate the quantity of 
tebuconazole residue in cucurbits. Data on summer squash were collected 
from California, Florida, Georgia, New York and Ohio. Data on cucumbers 
were collected from Florida, Georgia, Michigan, North Carolina, Ohio 
and Texas. Cantaloupe trials were conducted in California, Georgia, 
Ohio and Texas. Residue levels from all cucurbits ranged from 0.02 to 
0.076 ppm. A tolerance of 0.1 ppm is being proposed by Interregional 
Research Project No. 4.
    viii. Garlic. Three field trials were conducted in Mexico to 
evaluate the quantity of tebuconazole residue in or on garlic bulbs 
after a seed (clove) treatment of Folicur 3.6 F. Tebuconazole residues 
were quantitated by gas chromatography. The limit of quantitation for 
tebuconazole was 0.10 ppm. Since all average validated tebuconazole 
residues were at or below the LOQ, a tolerance of 0.1 ppm is being 
proposed.
    ix. Hops. Three field trials were conducted by IR-4 in Oregon and 
Washington and eight field trials were conducted in Germany during 1998 
and 1999 in order to provide information on the magnitude of 
tebuconazole residues on hops. Based on these data and the 30 mg/kg MRL 
1 established by Germany on hops, a tolerance of 30 ppm is requested.
    x. Mango. Three trials were conducted at a tropical fruit packing 
facility in order to provide information on the magnitude of 
tebuconazole residues on mango (post-harvest). Tebuconazole residues 
were quantitated by gas chromatography. All residue values were < 0.05. 
A tolerance of 0.2 ppm is being proposed by Interregional Research 
Project No. 4.
    xi. Onion. Three field trials were conducted in Mexico to evaluate 
the quantity of tebuconazole residue in or on onion bulbs following 
foliar applications of Folicur 3.6 F. Tebuconazole residues were 
quantitated by gas chromatography. The limit of quantitation for 
tebuconazole was 0.10 ppm. Since the highest average field trial (HAFT) 
was below the LOQ, a tolerance of 0.1 ppm is being proposed.
    xii. Pecan. Five residue crop field trial studies were conducted to 
evaluate the quantity of tebuconazole residue in pecan nutmeat 
following treatment of pecan trees with Folicur 3.6 F. These five 
trials were conducted in Regions II, IV, VI and VIII as required in 
EPA's June 1994 guidance on number and location of trials. Residues of 
tebuconazole were quantitated using gas chromatography. Residues in all 
nutmeat samples were less than or equal to the LOQ of 0.05 ppm. 
Therefore, a tolerance of 0.05 ppm is being proposed.
    xiii. Plum. Residue data from pre-harvest applications plus IR-4's 
pre-harvest plus post-harvest trials provide information on the 
magnitude of tebuconazole residues on plums. The highest tebuconazole 
residue detected in plums was 0.5 ppm. These data along with data on 
peaches previously submitted by Bayer support a tolerance of 1.0 ppm on 
stone fruit except cherries.
    xiv. Pome fruit. Data from apple field and a processing trial and 
pear field trials were conducted to evaluate the quantity of 
tebuconazole residue from foliar applications to pome fruit. These data 
support a tolerance of 0.05 ppm on pome fruit.
    xv. Soybean (rotational crop). Field trials were conducted in 20 
locations to evaluate the quantity of tebuconazole residue in 
rotational soybeans following treatment of winter wheat with FOLICUR 
3.6F. At 30 days following the application of FOLICUR 3.6F, the wheat 
crop was destroyed, and soybeans were planted-back into the same plots, 
except for a single field trial in which the plant-back interval was 
increased to 45-days due to weather conditions. Tebuconazole residue 
was quantitated by liquid chromatography-tandem mass spectrometry (lc-
ms/ms). The limits of quantitation (LOQ's) for tebuconazole were 0.01 
ppm in soybean forage and seed and 0.02 ppm in soybean hay. 
Tebuconazole residue in soybean forage and seed was < 0.01 ppm in all 
samples. The highest average field trial (HAFT) tebuconazole residue in 
soybean hay was 0.03 ppm.
    A total of 20 field trials (18 harvest and two decline) were 
conducted to measure the magnitude of tebuconazole residue in/on 
soybean forage, hay, and seed following three foliar spray applications 
of FOLICUR 3.6 F at a target rate of 0.1125 lb ai/acre/application. The 
residue of tebuconazole was quantitated in soybean forage, hay, and 
seed by liquid chromatography/mass spectrometry-mass spectrometry (lc/
ms-ms). The limit of quantitation (LOQ) was 0.01 ppm in soybean forage 
and seed and 0.05 ppm in soybean hay. The highest average field trial 
(HAFT) tebuconazole residue found in forage, seed, and hay were 14.5 
ppm, 0.05 ppm, and 42.1 ppm, respectively.
    A processing study was conducted to evaluate the quantity of 
tebuconazole residue in soybean aspirated grain fractions and soybean 
processed commodities from the rotational crop of soybeans following 
treatment of winter wheat with FOLICUR 3.6F. A single foliar spray 
application of FOLICUR 3.6F was made to winter wheat at a rate of 0.589 
Ib ai/acre (5X the maximum recommended label use rate. At a 30-day 
plant-back interval following the application of FOLICUR 3.6F, the 
wheat was destroyed, and soybeans were planted back into the same test 
plots. Soybean seed was collected from the field trial at the earliest 
dry harvest, and processed to produce processed commodities of hulls, 
meal, and refined-bleached-deodorized oil. Tebuconazole residue was 
quantitated by liquid chromatography-tandem mass spectrometry (lc-ms/
ms). The limit of

[[Page 28531]]

quantitation (LOQ) for tebuconazole in soybean seed was 0.01 ppm. 
Tebuconazole residue in the treated soybean seed was < 0.01 ppm. No 
tebuconazole residue above the limit of quantitation was measured in 
the soybean seed from the 5X exaggerated rate.
    A processing study was conducted to measure the magnitude of 
tebuconazole residue in/on soybean seed, aspirated grain fractions, 
hulls, meal, refined oil, defatted flour, full fat flour, and protein 
isolate following three foliar spray applications of FOLICUR 3.6 F at a 
five-fold (5X) exaggerated rate. Processing was performed using batch 
procedures that simulated commercial processing practices. The residues 
of tebuconazole were quantitated by high-pressure liquid 
chromatography/triple stage quadrupole mass spectrometry (lc/ms-ms). 
The limit of quantitation (LOQ) for tebuconazole in all matrices was 
0.01 ppm. Concentration of tebuconazole residues were only seen in the 
soybean aspirated grain fractions (concentration factor = 276X) and 
soybean hulls (concentration factor = 1.1X).
    xvi. Soybean. Field trials were conducted in 20 locations to 
evaluate the quantity of tebuconazole residue in rotational soybeans 
following treatment of winter wheat with FOLICUR 3.6F. At 30 days 
following the application of FOLICUR 3.6F, the wheat crop was 
destroyed, and soybeans were planted-back into the same plots, except 
for a single field trial in which the plant-back interval was increased 
to 45-days due to weather conditions. Tebuconazole residue was 
quantitated by liquid chromatography-tandem mass spectrometry (lc-ms/
ms). The limits of quantitation (LOQ's) for tebuconazole were 0.01 ppm 
in soybean forage and seed and 0.02 ppm in soybean hay. Tebuconazole 
residue in soybean forage and seed was < 0.01 ppm in all samples. The 
highest average field trial (HAFT) tebuconazole residue in soybean hay 
was 0.03 ppm.
    A total of 20 field trials (18 harvest and two decline) were 
conducted to measure the magnitude of tebuconazole residue in/on 
soybean forage, hay, and seed following three foliar spray applications 
of FOLICUR 3.6 F at a target rate of 0.1125 lb ai/acre/application. The 
residue of tebuconazole was quantitated in soybean forage, hay, and 
seed by liquid chromatography/mass spectrometry-mass spectrometry (lc/
ms-ms). The limit of quantitation (LOQ) was 0.01 ppm in soybean forage 
and seed and 0.05 ppm in soybean hay. The highest average field trial 
(HAFT) tebuconazole residue found in forage, seed, and hay were 14.5 
ppm, 0.05 ppm, and 42.1 ppm, respectively.
    A processing study was conducted to evaluate the quantity of 
tebuconazole residue in soybean aspirated grain fractions and soybean 
processed commodities from the rotational crop of soybeans following 
treatment of winter wheat with FOLICUR 3.6F. A single foliar spray 
application of FOLICUR 3.6F was made to winter wheat at a rate of 0.589 
Ib ai/acre (5X the maximum recommended label use rate. At a 30-day 
plant-back interval following the application of FOLICUR 3.6F, the 
wheat was destroyed, and soybeans were planted back into the same test 
plots. Soybean seed was collected from the field trial at the earliest 
dry harvest, and processed to produce processed commodities of hulls, 
meal, and refined-bleached-deodorized oil. Tebuconazole residue was 
quantitated by liquid chromatography-tandem mass spectrometry (lc-ms/
ms). The limit of quantitation (LOQ) for tebuconazole in soybean seed 
was 0.01 ppm. Tebuconazole residue in the treated soybean seed was < 
0.01 ppm. No tebuconazole residue above the limit of quantitation was 
measured in the soybean seed from the 5X exaggerated rate.
    A processing study was conducted to measure the magnitude of 
tebuconazole residue in/on soybean seed, aspirated grain fractions, 
hulls, meal, refined oil, defatted flour, full fat flour, and protein 
isolate following three foliar spray applications of FOLICUR 3.6 F at a 
five-fold (5X) exaggerated rate. Processing was performed using batch 
procedures that simulated commercial processing practices. The residues 
of tebuconazole were quantitated by high-pressure liquid 
chromatography/ triple stage quadrupole mass spectrometry (lc/ms-ms). 
The limit of quantitation (LOQ) for tebuconazole in all matrices was 
0.01 ppm. Concentration of tebuconazole residues were only seen in the 
soybean aspirated grain fractions (concentration factor = 276X) and 
soybean hulls (concentration factor = 1.1X).
    xvii. Sunflower. IR-4 received requests from Kansas and North 
Dakota for the use of tebuconazole on sunflowers. To support these 
requests, magnitude of residue data were collected from seven field 
trials located in EPA region 5. Three of the trials were conducted in 
Kansas; the remaining four trials were located in North Dakota. Since 
all residues in the 1X field trails are less than the LOQ of 0.04 ppm, 
a tolerance of 0.05 ppm is being proposed for sunflower seed. Based on 
a processing study on peanuts completed by Bayer Corporation, a 
processing study was deemed not necessary and tolerances of 0.2 ppm are 
being requested for sunflower oil and sunflower meal.
    xviii. Turnip. Five field trials were conducted in order to provide 
information on the magnitude of tebuconazole residues on turnip tops 
and roots following foliar applications of Folicur 3.6 F. Trials were 
conducted in Georgia, New Jersey, Ohio, Tennessee and Texas. Residue 
levels ranged from 0.75 ppm to 5.62 ppm for turnip tops and < 0.05 ppm 
to 0.234 ppm for turnip roots. A tolerance of 8.0 ppm for turnip tops 
and 0.4 ppm for turnip roots is being proposed by Interregional 
Research Project No. 4.
    xvix. Wheat. Nineteen residue crop field trial studies were 
conducted to evaluate the quantity of tebuconazole residue in wheat 
following a foliar application of Folicur 3.6 F. These trials were 
conducted in EPA Regions II, IV, V, VI, VII, VIII and XI. Residues of 
tebuconazole were quantitated by gas chromatography using a thermionic 
specific detector. The limit of quantitation (LOQ) for green forage, 
hay, and straw was 0.1 ppm. The LOQ for grain was 0.05 ppm. The highest 
average field trial (HAFT) was 2.51 ppm for green forage, 5.31 ppm for 
wheat hay, and 1.27 ppm for wheat straw. The residues of tebuconazole 
in wheat grain were less than the LOQ of 0.05 ppm. Data from a 5x 
processing study also showed residues of tebuconazole in wheat grain 
less than the LOQ of 0.05 ppm.
    xx. Cherry (post-harvest). IR-4 conducted four field trials in 
Michigan, California, and Washington (2 trials) to support the use of 
tebuconazole as a post-harvest fresh market use on cherries. Each trial 
received 6 pre-harvest foliar applications at 0.225 lb ai/A with a 0 or 
1 day PHI plus a post-harvest treatment at 0.225 to 0.450 lab ai/100 
gal. Neither the rate nor type of post-harvest use appeared to 
correspond strongly to residue levels observed. Data support the 
presently established tolerance of 4 ppm for pre-harvest applications 
to cherries.

B. Toxicological Profile

    1. Acute toxicity. Tebuconazole exhibits moderate toxicity. The rat 
acute oral LD50 = 3,933 milligram/kilogram (mg/kg) (category 
III); the rabbit acute dermal LD50 > 5,000 mg/kg (category 
IV); and the rat acute inhalation LC50 > 0.371 milligram/ 
Liter (mg/L) (category II). Technical tebuconazole was slightly 
irritating to the eye (category III) and was not a skin irritant 
(category IV) in rabbits. Tebuconazole was not a dermal sensitizer.

[[Page 28532]]

    2. Genotoxicity. An Ames test with Salmonella sp., a mouse 
micronucleus assay, a sister chromatid exchange assay with Chinese 
hamster ovary cells, and an unscheduled DNA synthesis assay with rat 
hepatocytes provided no evidence of mutagenicity.
    3.Reproductive and developmental toxicity.--i. In a developmental 
toxicity study, pregnant female rats were gavaged with technical 
tebuconazole at levels of 0, 30, 60, or 120 mg/kg/day between days 6 
and 15 of gestation. The maternal NOAEL was 30 mg/kg/day and the 
maternal LOAEL was 60 mg/kg/day based on increased absolute and 
relative liver weights. The developmental NOAEL was 30 mg/kg/day and 
the developmental LOAEL was 60 mg/kg/day based on delayed ossification 
of thoracic, cervical and sacral vertebrae, sternum and limbs plus an 
increase in supernumerary ribs.
    ii. In a developmental toxicity study, pregnant female rabbits were 
gavaged with technical tebuconazole at levels of 0, 10, 30, or 100 mg/
kg/day between days 6 and 18 of gestation. The maternal NOAEL was 30 
mg/kg/day and the maternal LOAEL was 100 mg/kg/day based on minimal 
depression of body weight gains and food consumption. The developmental 
NOAEL was 30 mg/kg/day and the developmental LOAEL was 100 mg/kg/day 
based on increased postimplantation losses, malformations in 8 fetuses 
out of 5 litters (including peromelia in 5 fetuses/4 litters; 
palatoschisis in 1 fetus/1 litter), hydrocephalus and delayed 
ossification.
    iii. In a developmental toxicity study, pregnant female mice were 
gavaged with technical tebuconazole at levels of 0, 10, 30, or 100 mg/
kg/day between days 6 and 15 of gestation (part 1 of study) or at 
levels of 0, 10, 20, 30, or 100 mg/kg/day between days 6 and 15 of 
gestation (part 2 of study). The maternal NOAEL was 10 mg/kg/day and 
the maternal LOAEL was 20 mg/kg/day. Maternal toxicity (hepatocellular 
vacuolation and elevations in AST, ALP and alkaline phosphatase) 
occurred at all dose levels but was minimal at 10 mg/kg/day. Reduction 
in mean corpuscular volume in parallel with reduced hematocrit occurred 
at doses greater than or equal to 20 mg/kg/day. The liver was the 
target organ. The developmental NOAEL was 10 mg/kg/day and the 
developmental LOAEL was 30 mg/kg/day based on an increase in the number 
of runts.
    iv. In a developmental toxicity study, pregnant female mice were 
administered dermal doses of technical tebuconazole applied at levels 
of 0, 100, 300, or 1,000 mg/kg/day between days 6 and 15 of gestation. 
Equivocal maternal toxicity was observed 1,000 mg/kg/day. The maternal 
NOAEL was nearly-eq 1,000 mg/kg/day. The developmental NOAEL was 1,000 
mg/kg/day.
    v. In a 2-generation reproduction study, rats were fed technical 
tebuconazole at levels of 0, 100, 300, or 1,000 ppm, (0, 5, 15, or 50 
mg/kg/day, males and females). The parental maternal NOAEL was 15 mg/
kg/day and the parental LOAEL was 50 mg/kg/day based on depressed body 
weights, increased spleen hemosiderosis and decreased liver and kidney 
weights. The reproductive NOAEL was 15 mg/kg/day and the reproductive 
LOAEL of 50 mg/kg/day based on decreased pup body weights from birth 
through 3-4 weeks.
    vi. In a developmental neurotoxicity study, pregnant female rats 
were fed a nominal concentration of 0, 100, 300 or 1,000 ppm of 
tebuconazole in the diet. The NOAEL for maternal toxicity in this study 
was 300 ppm (based on mortality, body weight and feed consumption 
reductions, and prolonged gestation in the1000 ppm dosage group). The 
1,000 ppm dose level was considered to be excessively toxic for the F1 
offspring, based on mortality, marked reductions in pup body weight and 
body weight gain, reduction in pup absolute brain weight (at postpartum 
day (PD) 12 and adult), a developmental delay in vaginal patency, and 
decreased cerebellar thickness. The effects on brain weight and 
morphology are considered to represent incomplete compensation for the 
marked decrease in body weight gain during development. By 
approximately day 80 postpartum, the body weight had completely 
recovered in the females but was still reduced (89% of the control 
group value) in the males. The brain weights had shown an incomplete 
recovery (90% to 93% of the control group values) in both sexes. The 
EPA has determined that the LOAEL for offspring toxicity in this study 
is 100 ppm. Technical grade tebuconazole did not cause any specific 
neurobehavioral effects in the offspring when administered to the dams 
during gestation and lactation at dietary concentrations up to and 
including 1,000 ppm.
    4. Subchronic toxicity.--i. In a 90-day oral feeding study, rats 
were administered technical tebuconazole at levels of 0, 100, 400, or 
1,600 ppm (0, 8, 34.8, or 171.7 mg/kg/day for males or 0, 10.8, 46.5, 
or 235.2 mg/kg/day for females). In males, the no observed adverse 
effect level (NOAEL) was 34.8 mg/kg/day and the lowest observed adverse 
effect level (LOAEL) was 171.7 mg/kg/day based on decreased body weight 
and decreased body weight gain, adrenal vacuolation and spleen 
hemosiderosis. In females, the NOAEL was 10.8 mg/kg/day and the LOAEL 
of 46.5 mg/kg/day was based on adrenal vacuolation.
    ii. In a 90-day oral feeding study, Beagle dogs were administered 
technical tebuconazole at levels of 0, 200, 1,000, or 5,000 ppm (0, 74, 
368, or 1,749 mg/kg/day for males or 0, 73, 352, or 1,725 mg/kg/day for 
females). In females, the NOAEL was 73 mg/kg/day and the LOAEL was 352 
mg/kg/day based on decreased body weight and decreased body weight 
gain, decreased food consumption and increased liver N-demethylase 
activity. At the highest dose tested (HDT), lens opacity was seen in 
all males and in one female and cataracts were seen in three females.
    iii. In a 21-day dermal toxicity study, rabbits were exposed 
dermally to technical tebuconazole 5 days a week at doses of 0, 50, 
250, or 1,000 mg/kg/day. No significant systemic effects were seen. The 
systemic NOAEL >1,000 mg/kg/day.
    iv. In a 21-day inhalation toxicity study, rats were exposed to 
technical tebuconazole (15 exposures -6 hours/day for 3 weeks) at 
airborne concentrations of 0, 0.0012, 0.0106, or 0.1558 mg/L/day. The 
NOAEL was 0.0106 mg/L/day and the LOAEL was 0.1558 mg/L/day based on 
piloerection and induction of liver N-demethylase.
    5.Chronic toxicity.--i. In a 2-year combined chronic feeding/
carcinogenicity study, rats were administered technical tebuconazole at 
levels of 0, 100, 300, or 1,000 ppm (0, 5.3, 15.9, or 55 mg/kg/day for 
males or 0, 7.4, 22.8, or 86.3 mg/kg/day for females). In males, the 
NOAEL was 5.3 mg/kg/day and the LOAEL was 15.9 mg/kg/day based on C-
cell hyperplasia in the thyroid gland. In females, the NOAEL was 7.4 
mg/kg/day and the LOAEL was 22.8 mg/kg/day based on body weight 
depression, decreased hemoglobin, hematocrit, mean corpuscular volume 
and mean corpuscular hemoglobin concentration and increased liver 
microsomal enzymes. No evidence of carcinogenicity was found at the 
levels tested.
    ii. In a 1-year chronic feeding study, Beagle dogs were 
administered technical tebuconazole at levels of 0, 40, 200, or 1,000 
(weeks 1-39) and 2,000 ppm (weeks 40-52) (0, 1, 5 or 25/50 mg/kg/day 
for males and females). The NOAEL was 1 mg/kg/day and the LOAEL was 5 
mg/kg/day based on ocular lesions (lenticular and corneal opacity) and 
hepatic toxicity (changes in the appearance of the liver and increased 
siderosis).

[[Page 28533]]

    iii. In a 1-year chronic feeding study, Beagle dogs were 
administered technical tebuconazole at levels of 0, 100, or 150 ppm (0, 
3.0, or 4.4 mg/kg/day for males or 0, 3.0 or 4.5 mg/kg/day for 
females). The NOAEL was 3.0 mg/kg/day and the LOAEL was 4.4 mg/kg/day 
based on adrenal affects in both sexes. In males there was hypertrophy 
of adrenal zona fasciculata cells amounting to 4/4 at 150 ppm and to 0/
4 at 100 ppm and in controls. Other adrenal findings in males included 
fatty changes in the zona glomerulosa (3/4) and lipid hyperplasia in 
the cortex (2/4) at 150 ppm vs. (1/4) for both effects at 100 ppm and 
control dogs. In females there was hypertrophy of zona fasciculata 
cells of the adrenal amounting to 4/4 at 150 ppm and to 0/4 at 100 ppm 
and 1/4 in controls. Fatty changes in the zona glomerulosa of the 
female adrenal amounted to 2/4 at 150 ppm and to 1/4 at 100 ppm and in 
controls.
    iv. In a 91-week carcinogenicity study, mice were administered 
technical tebuconazole at levels of 0, 500, or 1,500 ppm (0, 84.9, or 
279 mg/kg/day for males or 0, 103.1, or 365.5 mg/kg/day for females). 
Neoplastic histopathology consisted of statistically significant 
increased incidences of hepatocellular neoplasms; adenomas (35.4%) and 
carcinomas (20.8%) at 1,500 ppm in males and carcinomas (26.1%) at 
1,500 ppm in females. Statistically significant decreased body weights 
and increased food consumption were reported that were consistent with 
decreased food efficiency at 500 and 1,500 ppm in males and at 1,500 
ppm in females. Clinical chemistry values (dose-dependent increases in 
plasma GOT, GPT and Alkaline Phosphatase) for both sexes were 
consistent with hepatotoxic effects at both 500 and 1,500 ppm. Relative 
liver weight increases reached statistical significance at both 500 and 
1,500 ppm in males and at 1,500 ppm in females. Non-neoplastic 
histopathology included dose-dependent increases in hepatic pancinar 
fine fatty vacuolation, statistically significant at 500 and 1,500 ppm 
in males and at 1,500 ppm in females. Other histopathology included 
significant oval cell proliferation in both sexes and dose-dependent 
ovarian atrophy that was statistically significant at 500 and 1,500 
ppm. The Maximum Tolerated Dose (MTD) was achieved at or around 500 
ppm.
    6. Animal metabolism. Rats were gavaged with 1 or 20 mg/kg radio-
labeled technical tebuconazole. 98.1 % of the oral dose was absorbed. 
Within 72 hours of dosing, over 87% of the dose was excreted in urine 
and feces. At sacrifice (72 hours post dosing), total residue (-GI 
tract) amounted to 0.63% of the dose. A total of 10 compounds were 
identified in the excreta. A large fraction of the identified 
metabolites corresponded to successive oxidations steps of a methyl 
group of the test material. At 20 mg/kg, changes in detoxication 
patterns may be occurring.
    7. Endocrine disruption. No special studies investigating potential 
estrogenic or endocrine effects of tebuconazole have been conducted. 
However, the standard battery of required studies has been completed. 
These studies include an evaluation of the potential effects on 
reproduction and development, and an evaluation of the pathology of the 
endocrine organs following repeated or long-term exposure. These 
studies are generally considered to be sufficient to detect any 
endocrine effects but no such effects were noted in any of the studies 
with either tebuconazole or its metabolites.

C. Aggregate Exposure

    1. Dietary exposure. An aggregate risk assessment was conducted for 
residues of tebuconazole using Exponent Inc.'s Dietary Exposure 
Evaluation Model (DEEMTM) software. Crops included in this 
risk assessment are all registered uses for tebuconazole, Section 18 
uses, and all pending uses which include barley, wheat, tree nut crop 
group, pistachio, beans, cotton, pome fruit, asparagus, coffee, garlic, 
onion, corn, soybean, stone fruit, turnips, hops, cucurbits crop group, 
mango, sunflower, okra, and lychee. For the acute assessment, the LOAEL 
of 8.8 mg/kg/day from Bayer's rat developmental neurotoxicity study was 
used. The populations adjusted dose for acute dietary (aPAD) was 
determined by dividing the LOAEL by an uncertainty factor of 1,000 (10X 
for interspecies differences, 10X for intraspecies variability, and 10X 
for an FQPA safety factor): aPAD = 8.8/1000 =0.0088 mg/kg bw/day. For 
the chronic risk assessment, Bayer used the NOAEL of 3.0 mg/kg/day from 
a 1-year dog feeding study. The population adjusted dose for chronic 
dietary (cPAD) was determined by dividing the NOAEL by an uncertainty 
factor of 100 (10x for interspecies differences and 10X for 
intraspecies variability): cPAD = 3/100-0.03 mg/kg bw/day.
    i. Food. In acute and chronic, Tier 3 dietary (food) risk 
assessments were conducted using data from field trials and data from 
PDP where appropriate. The acute analysis indicated that the most 
highly exposed population subgroup was Children (1-2 yrs) with an 
exposure equal to 27.6% of the aPAD. The U.S. total population had an 
exposure equal to 17.5% of the aPAD. The chronic analysis also showed 
that the most highly exposed population subgroup was children (1-2 yrs) 
with an exposure equal to 0.3% of the cPAD. The total U.S. population 
had a chronic exposure equal to 0.1% of the cPAD. These exposure 
estimates are below EPA's level of concern.
    ii. Drinking water. No monitoring data are available for residues 
of tebuconazole in drinking water and EPA has established no health 
advisory levels or maximum contaminant levels for residues of 
tebuconazole in drinking water. The potential concentrations of 
tebuconazole in drinking water were determined using the TIER II PRZM/
EXAMS model for surface water and the SCI-GROW model for groundwater. 
Since the estimated groundwater concentrations were considerably lower 
than the surface water concentrations, the more conservative surface 
water estimates were used to calculate the Drinking Water Estimated 
Concentration (DWEC). The PRZM/EXAMS model estimated an acute DWEC of 
33.8 ppb and a chronic DWEC of 19.2 ppm.
    Bayer has calculated an acute Drinking Water Level of Comparison 
(aDWLOC) for the total U.S. population at 254 ppb and an aDWLOC for the 
most highly exposed population subgroup (children (1-2 yrs)) at 64 ppb. 
Chronic DWLOCs for the U.S. total population and children (1-2 yrs) 
were calculated to be 1,049 and 299, respectively. Since these DWLOCs 
are greater than their respective DWECs determined by the PRZM/EXAMS 
model, tebuconazole exposure from drinking water is below EPA's level 
of concern.
    2. Non-dietary exposure. Tebuconazole is currently registered for 
use on the following residential non-food sites: Residential 
application to roses, flowers, trees and shrubs; the formulation of 
wood-based composite products; wood products for in-ground contact; 
plastics; exterior paints, glues and adhesives. Residential exposure to 
homeowners who mix, load and apply tebuconazole to roses, flowers, 
trees and shrubs as well as post-application exposure of adults and 
youth (age 10-12) to tebuconazole residues from this use was assessed. 
(Based on the US EPA residential exposure SOPs, the use pattern 
precludes likely post-application exposure to younger age groups.) 
Short-term and intermediate-term margins of exposure for homeowners 
mixing, loading and applying tebuconazole using pump sprayers and hose-
end sprayers were 3,040 and 218, respectively. Chronic margins-of-
exposure for the homeowner

[[Page 28534]]

mixer/loader/applicator using the same equipment were 14,900 and 1,070 
ppm, respectively. Short-term and intermediate-term margins of post-
application exposure for adults ranged from 408 - 2,120. The margins-of 
exposure for youth ranged from 712 to 3,700. Chronic margins of post-
application exposure exceeded 4,930 for adults and youth.
    For the remaining uses (wood treatment, plastics, paints, glues and 
adhesives) EPA has determined that exposure via incidental ingestion 
(by children) and inhalation is not a concern for these products which 
are used outdoors. A non-dietary assessment of exposure to tebuconazole 
from the copper tebuconazole-treated wood showed all tebuconazole MOEs 
exceeding 10,000. Therefore, there is no unacceptable risk associated 
with this use for tebuconazole.

D. Cumulative Effects

    Tebuconazole is a member of the triazole class of systemic 
fungicides. At this time, the EPA has not made a determination that 
tebuconazole and other substances that may have a common mechanism of 
toxicity would have cumulative effects. Therefore, for this tolerance 
petition, it is assumed that tebuconazole does not have a common 
mechanism of toxicity with other substances and only the potential 
risks of tebuconazole in its aggregate exposure are considered. The 
cumulative effects of the primary common metabolites (1,2,4-triazole 
and its TA and TAA conjugates are being addressed by the US Triazole 
Task Force.

E. Safety Determination

    1. U.S. population. Based on the exposure assessments described in 
C under aggregate exposure and on the completeness and reliability of 
the toxicity data, it can be concluded that aggregate exposure 
estimates from all label and pending uses of tebuconazole are 17.5% of 
the aPAD and 0.1% percent of the cPAD for dietary exposures. Exposure 
estimates calculated from tebuconazole in drinking water are below the 
EPA's level on concern. In addition, no unacceptable risks were 
determined for non-dietary exposure.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of tebuconazole, data 
from developmental toxicity studies in mice, rats, rabbits and a 2-
generation reproduction study in the rat are considered. The 
developmental toxicity studies are designed to evaluate adverse effects 
on the developing organism resulting from maternal pesticide exposure 
during gestation. Reproduction studies provide information relating to 
effects from exposure to the pesticide on the reproductive capability 
of mating animals and data on systemic toxicity.
    Using the conservative exposure assumptions described above under 
Aggregate Exposure, it can be concluded that the aggregate dietary 
exposure estimates from the proposed uses of tebuconazole would not 
exceed 27.6% of the aPAD and 0.3% of the cPAD for the most sensitive 
population subgroup children (1-2 years). Exposure estimates calculated 
from tebuconazole in drinking water are below the EPA's level on 
concern. In addition, no unacceptable risks were determined for non-
dietary exposure.

F. International Tolerances

    For tebuconazole uses pending with the EPA, CODEX MRLs have been 
established for barley at 0.2 mg/kg; barley straw and fodder, dry at 10 
mg/kg; cucumber at 0.2 mg/kg; pome fruits at 0.5 mg/kg; summer squash 
at 0.02 mg/kg; wheat at 0.05 mg/kg and wheat straw and fodder, dry at 
10 mg/kg.
[FR Doc. 05-9590 Filed 5-17-05; 8:45 am]
BILLING CODE 6560-50-S