02-6158. Notice of Filing Pesticide Petitions to Establish a Tolerance for Certain Pesticide Chemicals in or on Food

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of certain pesticide chemicals in or on various food commodities.

DATES:

Comments, identified by docket control number PF-1074, must be received on or before April 15, 2002.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1074 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Shaja Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number [phone]; and e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

Categories	NAICS codes	Examples of potentially affected entities
Industry	111	Crop production
	112	Animal production
	311	Food manufacturing
	32532	Pesticide manufacturing

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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an official record for this action under docket control number PF-1074. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1074 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number PF-1074. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as 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 version of the official record. Information not marked confidential will be included in the public version of the official record 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 control 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 pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals in or on various food commodities under section 408 of the FFDCA, 21 U.S.C. 346a. EPA has determined that these petitions contain data or information regarding the elements set forth in 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: February 28, 2002.

Peter Caulkins,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

Petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of the petitions were prepared by the petitioner and represent the views of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

1. Interregional Research Project Number 4

PP 6E4636

EPA has received pesticide petition (6E4636) from the Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180.142 by establishing a tolerance for residues of the herbicide, plant regulator, and fungicide 2,4-D (2,4-dichlorophenoxyacetic) in or on the raw agricultural commodity wild rice at 0.1 parts per million (ppm). This notice includes a summary of the petition prepared by Rhone-Poulenc Ag Company, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. EPA has determined that the petition contains 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 support 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 of 2,4-D is adequately understood. The regulable residue is 2,4-D per se, as established in 40 CFR 180.142. No livestock feed issues are raised by this action.

2. Analytical method. EN-CAS Method ENC gas liquid chromatograhy/electron capture detector (GLC/ECD), which has underdone successful independent laboratory validation is available for enforcement.

3. Magnitude of residues. One field trial (Minnesota) with 2 treatment rates was conducted. 2,4-D was applied by hand-held sprayer at 0X, 1X, and 2X the proposed label rate. The preharvest interval (PHI) was 53-64 days. Samples of grain and hulls were analyzed with 22½ months of harvest. No detectable residues (<0.05 ppm) of 2,4-D were reported.

B. Toxicological Profile

The nature of the toxic effects caused by 2,4-D are discussed in Unit II.B. of the Federal Register of October 24, 2001, (66 FR 53791) (FRL-6802-5).

C. Aggregate Exposure

The aggregate exposure (food, drinking water, and residential) assessment for 2,4-D is discussed in Unit II.C. of the Federal Register of October 24, 2001. The dietary exposure assessment includes a time-limited tolerance for wild rice at 0.1 ppm which was established in support of a section 18 emergency exemption.

D. Cumulative Effects

The potential for cumulative effects for 2,4-D and other substances with a common mechanism of toxicity is discussed in Unit II.D. of the Federal Register of October 24, 2001.

E. Safety Determination

The safety determination for the U.S. population, infants, and children for 2,4-D is discussed in Unit II.E. of the Federal Register of October 24, 2001.

F. International Tolerances

There are no Codex, Canadian, or Mexican maximum residue limits for use of 2,4-D on wild rice. Therefore, international harmonization is not an issue for this commodity.

2. Interregional Research Project Number 4

PP 1E6325

EPA has received pesticide petition (1E6325) from the Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180.448 by establishing a tolerance for residues of the miticide, hexythiazox, trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites containing the (4-chlorophenyl-4-methyl-2-oxo-3-thiazolidine moiety in or on the raw agricultural commodity date at 1.0 ppm. This notice includes a summary of the petition prepared by Gowan Company, P.O. Box 5569, Yuma, AZ 85366-5569. EPA has determined that the petition contains 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 support granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism of hexythiazox as well as the nature of the residues in plants is adequately understood for purposes of this tolerance. The residue of concern is hexythiazox and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety as specified in 40 CFR 180.448.

2. Analytical method. Adequate methods to enforce the tolerance expression have been submitted for publication in Pesticide Analytical Manual (PAM) II. The approved method is designated as AMR 985-87 which has been used in a variety of commodities. The method involves separation by high performance liquid chromotography (HPLC) followed by ultraviolet (UV) detection at 225 nm.

3. Magnitude of residues. Three field trials (06957.99-CA82, CA83, and CA84) were conducted in Coachella, California. No detectable residues of hexythiazox were found in the untreated date samples. The treated samples from trial CA82 had residues of 0.07 ppm and 0.26 ppm. The treated samples from trial CA83 had residues of 0.09 ppm and 0.11 ppm. The treated samples from trial CA84 had residues of 0.30 ppm and 0.63 ppm. Based on available data, the proposed use, one application of hexythiazox at the rate of 6 oz. (0.1875 lb active) per acre, minimum 90 day PHI should be reported.

B. Toxicological Profile

The nature of the toxic effects caused by hexythiazox are discussed in Unit II.B. of the Federal Register of December 28, 2000 (65 FR 82349) (FRL-6761-6).

C. Aggregate Exposure

The aggregate exposure (food, drinking water, and residential) assessment for hexythiazox is discussed in Unit II.C. of the Federal Register of December 28, 2000. Dates were included in this risk assessment in connection with a section 18 emergency exemption. A time-limited tolerance has been established at 1.0 ppm and is currently set to expire on October 31, 2002.

D. Cumulative Effects

The potential for cumulative effects caused by hexythiazox and other substances with a common mechanism of toxicity is discussed in Unit II.D. of the Federal Register of December 28, 2000.

E. Safety Determination

The safety determination for hexythiazox is discussed in Unit II.E. of the Federal Register of December 28, 2000.

F. International Tolerances

There are no CODEX, Canadian, or Mexican maximum residue limits for hexythiazox on dates.