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Notice

Tebuconazole; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

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Information about this document as published in the Federal Register.

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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.

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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.

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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 http://www.epa.gov/​fedrgstr/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper Start Printed Page 28528receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/​edocket/​, and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in docket ID number OPP-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.

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List of Subjects

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Dated: April 29, 2005.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.

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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 Start Printed Page 28529pesticide 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 Start Printed Page 28530and 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 Start Printed Page 28531quantitation (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.

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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).

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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 Start Printed Page 28534mixer/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.

End Supplemental Information

[FR Doc. 05-9590 Filed 5-17-05; 8:45 am]

BILLING CODE 6560-50-S