E9-13161. Notice of Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the Agency's receipt of several initial filings of pesticide petitions proposing the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

DATES:

Comments must be received on or before July 10, 2009.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is [phone].

Instructions: Direct your comments to the docket ID number and the pesticide petition number of interest as shown in the body of this document. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

A contact person, with telephone number and e-mail address, is listed at the end of each pesticide petition summary. You may also reach each contact person by mail at: Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed at the end of the pesticide petition summary of interest.

B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, 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 claimed as CBI. In addition to one complete version of the comment that includes 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. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

II. What Action is the Agency Taking?

EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of regulations in 40 CFR part 174 or part 180 for residues of pesticide chemicals in or on various food commodities. EPA has determined that the pesticide petitions described in this notice contain the data or information prescribed 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 pesticide petitions. Additional data may be needed before EPA can make a final determination on these pesticide petitions.

Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that are the subject of this notice, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available on-line at http://www.regulations.gov.

As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.

New Tolerance

1. PP 8E7505. (EPA-HQ-OPP-2009-0307). The Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance in 40 CFR part 180 for the combined residues of the herbicide, clethodim, ((E)-()-2-[1-[[(3-chloro-2-propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one) and its metabolites containing the 5-(2-(ethylthio)propyl]cyclohexen-3-one and the 5-[2-(ethylthio)propyl]-5-hydroxycyclohexen-3-one moieties and their sulfoxides and sulfones, expressed as clethodim, in or on artichoke, globe at 1.3 parts per million (ppm); bushberry subgroup 13-07B at 3.0 ppm; caneberry subgroup 13-07A at 0.30 ppm; and peach at 0.20 ppm. The analytical methods for detecting and measuring levels of clethodim have been developed and validated in/on all appropriate agricultural commodities and respective processing fractions. The limit of quantitation (LOQ) of clethodim in the methods is 0.2 ppm, which allows monitoring of food with residues at the levels proposed for the tolerances. Contact: Sidney Jackson, [phone], [e-mail].

2. PPs 9E7546 and 9F7547. (EPA-HQ-OPP-2009-0273). IR-4, IR-4 Project Headquarters, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance in 40 CFR part 180 for residues of the insecticide novaluron, N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy] phenyl]amino]carbonyl]-2,6-difluorobenzamide in or on berry, low growing, subgroup 13-07G at 0.50 ppm; Swiss chard at 12 ppm; bean, snap, succulent at 0.60 ppm; bean, dry at 0.20 ppm; vegetable, cucurbit, group 9 at 0.25 ppm; and the following food commodities at 1.1 ppm; cocona; eggplant, African; eggplant, pea; eggplant, scarlet; goji berry; huckleberry, garden; martynia; naranjilla; okra; roselle; sunberry; tomato, bush; tomato, currant; tomato, tree; and vegetable, fruiting, group 8.

In addition, EPA received a pesticide petition, PP 9F7547, from Makhteshim-Agan of North America, Inc., 4515 Falls of Neuse Rd., Raleigh, NC 27609, proposing to establish a tolerance for residues of the insecticide novaluron, N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy] phenyl]amino]carbonyl]-2,6-difluorobenzamide in or on sorghum, grain at 3 ppm; sorghum, aspirated grain fractions at 25 ppm; sorghum, forage at 6 ppm, and sorghum, stover at 40 ppm. Makhteshim-Agan of North America, Inc. is the manufacturer and basic registrant of novaluron. Makhteshim-Agan of North America, Inc., prepared and summarized the information in support of the subject pesticide petitions for novaluron.

An adequate analytical method, gas chromatography/electron capture detector (GC/ECD), as published in the Federal Register of April 5, 2006 (71 FR 65) (FRL-7756-8), is available for enforcing tolerances of novaluron residues in or on cucurbits, fruiting vegetables, beans (snap and dry), low-growing berries, Swiss chard and grain sorghum. The method verification trial supports a limit of quantitation (LOQ) of 0.05 ppm, and the limit of detection (LOD) is 0.005 ppm for the different matrices. The LOQ = 0.05 ppm was taken as the lowest level validated by this method. Contacts: for PP 9E7546 - Laura Nollen, [phone], [e-mail]; for PP 9F7547 - Jennifer Gaines, [phone], [e-mail].

3. PP 9E7548. (EPA-HQ-OPP-2009-0302). IR-4, IR-4 Project Headquarters, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance in 40 CFR part 180 for residues of the insecticide diazinon in or on mushrooms at 0.75 ppm. Adequate analytical methodology is available for data collection and enforcing tolerances of diazinon. The enforcement method (AG-550 and its modifications) is a gas chromatography/flame photometric detector (GC/FPD) method that can be used for determination of residues of diazinon, diazoxon and hydroxyl diazinon in plant and animal matrices. There is also a confirmatory method that uses gas chromatography/mass spectrometry (GC/MS). The FDA PESTDATA database dated 1/94 (PAM Vol. 1, Appendix I) indicates diazinon is completely recovered using FDA Multi-residue Protocols D and E (PAM, Vol. 1 Sections 232.4 and 311.1/212.2). Diazoxon and hydroxyl diazinon are also completely recovered using protocol D. Contact: Susan Stanton, [phone], [e-mail].

4. PP 8F7500. (EPA-HQ-OPP-2009-0139). Bayer CropScience, P. O. Box 12014, 2 T. W. Alexander Dr., Research Triangle Park, NC 27709, proposes to establish a tolerance in 40 CFR part 180 for residues of the insecticide spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate) in or on avocado and the tropical fruit subgroup which can be surrogated with avocado data, i.e. black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star apple at 1.3 ppm. Adequate analytical methodology using liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) detection is available. Contact: Rita Kumar, [phone], [e-mail].

5. PP 9F7537. (EPA-HQ-OPP-2009-0263). Bayer CropScience LLC, 2 T. W. Alexander Dr., Research Triangle Park, NC 27709, proposes to establish a tolerance in 40 CFR part 180 for residues of the insecticide spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate]) and its metabolites BYI 08330-enol (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one), BYI 08330-ketohydroxy (cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-2,4-dione), BYI08330-enol-Glc (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside), and BYI 08330-mono-hydroxy (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one), calculated as spirotetramat equivalents in or on pistachio at 0.25 ppm; cotton, undelinted seed at 0.4 ppm; acerola, atemoya, avocado, birida, black sapote, canistel, cherimoya, custard apple, feijoa, jaboticaba, guava, ilama, longan, mamey sapote, mango, passionfruit, persimmon, pulasan, rambutan, sapodilla, soursop, spanish lime, star apple, starfruit, sugar apple, wax jambu, and white sapote at 1.5 ppm; okra at 2.5 ppm; soybean at 3 ppm, vegetables, legume, group 06 (except soybean) at 4 ppm; plum, prune, dried at 4.5 ppm; vegetables, foliage of legume, except soybean, subgroup 07A at 5 ppm; cotton, gin byproducts at 7 ppm; soybean, forage at 9 ppm; soybean, aspirated grain fractions at 10 ppm; lychee at 12 ppm; and soybean, hay at 16 ppm. Spirotetramat residues are quantified in raw agricultural commodities by high pressure LC/MS/MS using the stable isotopically labeled analytes as internal standards. The LOQ for each analyte was 0.01 ppm for all commodities. Contact: Rita Kumar, [phone], [e-mail].

Amended Tolerance

PP 9F7547. (EPA-HQ-OPP-2009-0273). Makhteshim-Agan of North America, Inc., 4515 Falls of Neuse Rd., Raleigh, NC 27609, proposes to amend the tolerances in 40 CFR 180.598 by requesting to increase the established livestock tolerances for residues of the insecticide novaluron, N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy] phenyl]amino]carbonyl]-2,6-difluorobenzamide in or on poultry, fat from 0.40 ppm to 7.0 ppm; poultry, meat from 0.03 ppm to 0.40 ppm; poultry, meat byproducts from 0.04 ppm to 0.80 ppm; hog, fat from 0.05 ppm to 1.5 ppm; hog, meat from 0.01 ppm to 0.07 ppm; hog, meat byproducts from 0.01 ppm to 0.15 ppm; and eggs from 0.05 ppm to 1.5 ppm. Makhteshim-Agan of North America, Inc. is the manufacturer and basic registrant of novaluron. An adequate analytical method, GC/ECD, as published in the Federal Register of April 5, 2006 (71 FR 65) (FRL-7756-8), is available for enforcing tolerances of novaluron residues in or on cucurbits, fruiting vegetables, beans (snap and dry), low-growing berries, Swiss chard and grain sorghum. The method verification trial supports a LOQ of 0.05 ppm, and the LOD is 0.005 ppm for the different matrices. The LOQ = 0.05 ppm was taken as the lowest level validated by this method. Contact: Jennifer Gaines, [phone], [e-mail].

List of Subjects

• Environmental protection
• Agricultural commodities
• Feed additives
• Food additives
• Pesticides and pests
• Reporting and recordkeeping requirements

Dated: May 22, 2009.

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office of Pesticide Programs.