02-13814. 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.

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 control number OPP-2002-0078, must be received on or before July 3, 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 OPP-2002-0078 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Shaja Brothers, Registration Support Branch, 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,” “Regulations and Proposed Rules,” 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 OPP-2002-0078 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 OPP-2002-0078 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 OPP-2002-0078. 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 identified 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 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 section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects

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

Dated: May 17,2002.

Robert Forrest,

Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the Interregional Research Project Number 4, and represents the view of the Interreional Research Project. EPA is publishing the petition summary verbatim without editing it in any way. 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.

PP 1E6322

EPA has received a pesticide petition (1E6322) from the Interregional Research Project Number 4, 681 U.S. Highway 1 South, North Brunswick, New Jersey 08902-3390] proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.479 by establishing a tolerance for residues of the herbicide [halosulfuron, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl) amino]carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate] in or on the raw agricultural commodities (RAC) dry bean and succulent snap bean at 0.05 parts per million (ppm). 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. This notice includes a summary of the petition prepared by Gowan Company, Yuma, Arizona 85366.

A. Residue Chemistry

1. Plant metabolism. The metabolism of halosulfuron-methyl as well as the nature of the residues in plants is adequately understood for purposes of this tolerance.

2. Analytical method. A practical analytical method, gas chromatography with a nitrogen specific detector (TSD) which detects and measures residues of halosulfuron-methyl, is available for enforcement purposes with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances. This enforcement method has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual (PAM II). It has undergone independent laboratory validation and validation at the Beltsville laboratory.

3. Magnitude of residues. In snap and dry bean residue studies, there were no quantifiable residues found in the RAC using an analytical method with limit of quantitation (LOQ) of 0.05 ppm.

B. Toxicological Profile

The nature of the toxic effects caused by halosulfuron-methyl is discussed in unit II.B of the Federal Register on April 31, 2001 (66 FR 45993) (FRL-6796-1).

C. Aggregate Exposure

1. Dietary exposure. Tolerances have been established (40 CFR 180.479) for residues of halosulfuron-methyl in or on a variety of plant and animal RACs.

i. Food— a. Acute exposure. For purposes of assessing the potential dietary exposure from food under existing and proposed tolerances, the aggregate exposure is based on the Theoretical Maximum Residue Contribution (TMRC) which is an estimate of the level of residues consumed daily if each food item contained pesticide residues equal to the tolerance.

The calculated TMRC value using the 99.9^th percentile consumption data was 0.006 milligrams/kilograms bodyweight day (mg/kg bwt day) or 1.2% acute Reference Dose (aRfD) for the general U.S. population. TMRC is obtained by multiplying the tolerance levels for each commodity by the daily consumption of the food forms of that commodity eaten by the U.S. population and various population subgroups.

In conducting this exposure assessment, conservative assumptions were made resulting in a large overestimate of human exposure. Thus, the dietary exposures to halosulfuron-methyl are less 3.0% aRfD for all sub-populations. Food consumption data from DEEM software were used in the calculation.

b. Chronic exposure. The chronic Reference Dose (cRfD) is 0.1 mg/kg/day. For all established and proposed tolerances of halosulfuron-methyl, the calculated TMRC value for the U.S. population is 0.00049 mg/kg/day or 0.5% RfD.

ii. Drinking water. The estimated environmental concentrations (EECs) in ground water (acute and chronic) is 0.008 μg/L. The estimated EECs (acute and chronic) for surface water are 4.3 μg/L and 1.1 μg/L, respectively. These estimates are based on a maximum application rate of 0.063 lbs. active per acre, which may be applied twice per season. There is no Maximum Contaminant Level (MCL) established for residues of halosulfuron-methyl.

2. Non-dietary exposure. The non-dietary exposure assessment for halosulfuron-methyl is discussed in unit II.C of the Federal Register on April 31, 2001 (66 FR 45993) (FRL-6796-1).

D. Cumulative Effects

The potential for cumulative effects for halosulfuron-methyl is discussed in unit II.D of the Federal Register on April 31, 2001 (66 FR 45993) (FRL-6796-1).

E. Safety Determination

1. U.S. population. Aggregate chronic exposure to halosulfuron-methyl from “food only” utilizes less than 1% of the chronic populated adjusted dose (cPAD) for the most sensitive subgroup, children (1-6 years). The lowest drinking water level of concern (DWLOC) calculated was 1,000 μg/L for infants and children which is significantly higher than the EEC for chronic ground water (0.008 μg/L) and surface water (1.1 μg/L). As a result, the aggregate risk from chronic exposure to halosulfuron-methyl residues from all anticipated dietary exposures does not pose appreciable risks to human health.

Short-term risk—short-term aggregate exposure takes into account chronic dietary food and water plus short-term residential exposure. For halosulfuron-methyl, the EPA has determined that it is appropriate to aggregate exposure via oral exposure route (food and water) with those via oral and dermal exposure routes from residential uses. The MOEs for “food only” and residential exposure routes are 113, 600, and 330 for females 13+ years. Short-term DWLOC for females 13+ is 10,000 μg/L which is substantially higher than the EECs for acute surface water (4.3 μg/L). The food only and residential (oral and dermal) MOEs are well above the acceptable short-term aggregate MOE of 100. Therefore, exposure to halosulfuron-methyl residues resulting from current and proposed uses does not pose a short-term aggregate risk.

Intermediate-term risk—intermediate-term aggregate exposure takes into account chronic dietary food and water plus intermediate-term residential exposure. The MOEs for “food only” and residential exposure routes are 22,800 and 120 for adult males, and 23,000 and 100 for females 13+ years. The intermediate-term DWLOCs are 590 μg/L and 57 μg/L, respectively, for adult males and females 13+. Intermediate-term DWLOCs are substantially higher than the EEC for chronic surface water (1.1 μg/L). The food only and residential (dermal) MOEs are above the acceptable short-term aggregate MOE of 100. Therefore, exposure to halosulfuron-methyl residues resulting from current and proposed uses does not pose a intermediate-term aggregate risk.

Halosulfuron-methyl has been classified as a Group E chemical based upon the lack of evidence of carcinogenicity in mice and rats, and has been classified as not likely to be a human carcinogen.

Therefore based upon this risk assessment, there is reasonable certainty that no harm will result from aggregate exposure to halosulfuron-methyl residues resulting from current and proposed uses.

2. Infants and children. FFDCA section 408 provides that EPA may apply an additional safety factor (up to 10) in the case of threshold effects for infants and children to account for pre-natal and post-natal toxicity and the completeness of the data base. Except for the pending request for a developmental neurotoxicity study, the toxicity data base is complete for halosulfuron-methyl.

The chronic RfD was determined to be 0.1 mg/kg/day based upon the chronic dog study. The percent of RfD occupied is 0.9% for the most sensitive population subgroup, children (1-6 years old). The DWLOC for chronic exposure for infants and children is 1,000 μg/L and is significantly greater than the maximum concentration of halosulfuron-methyl in drinking water (0.008 μg/L in ground water and 1.1 μg/L in surface water).

Based upon reliable toxicity data, the use of an additional 10X safety factor is not warranted. Dietary assessments do not indicate a level of concern for potential risks to infants and children based upon the low use rates of halosulfuron-methyl, and the results of field and animal RAC studies conclude that detectable residues are not expected in human foods.

Therefore, based on complete and reliable toxicity data and the conservative exposure assessment, it is concluded that there is reasonable certainty that no harm will result to infants and children from aggregate exposure to halosulfuron-methyl residues with respect to the proposed new uses on dry and succulent snap beans.

F. International Tolerances

Maximum residue levels have not been established for residues of halosulfuron-methyl on any food or feed crop by the Codex Alimentarius Commission.