02-32988. Prosulfuron; Notice of Filing Pesticide Petitions to Establish Tolerances for a Certain Pesticide Chemical 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 prosulfuron in or on various food commodities.

DATES:

Comments, identified by docket ID number OPP-2002-0343, must be received on or before January 30, 2003.

ADDRESSES:

Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Jim Tompkins, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; 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:

• 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 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 identification (ID) number OPP-2002-0343. 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, 1921 Jefferson Davis Hwy., 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 [phone].

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

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

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at 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-2002-0343. 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 [e-mail], Attention: Docket ID Number OPP-2002-0343. 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-2002-0343.

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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2002-0343. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI To the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Make sure to submit your comments by the deadline in this notice.

7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects

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

Dated: December 20, 2002.

 Debra Edwards,

Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

The petitioner's summary of the pesticide petitions is printed below as required by FFDCA section 408(d)(3). The summary of the petitions was prepared by the petitioner and represents the view of the petitioner. The petitions 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.

EPA has received pesticide petitions (PP 5F4469) and (PP 4F4336), from Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419-8300 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 prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea in or on the raw agricultural commodities, cereal grains group (except rice and wild rice) grain at 0.01 parts per million (ppm), cereal grains group (except rice and wild rice) forage at 0.10 ppm, cereal grains group (except rice and wild rice) fodder at 0.01 ppm, cereal grains group (except rice and wild rice) straw at 0.02 ppm, cereal grains group (except rice and wild rice) hay at 0.20 ppm, milk at 0.01 ppm, meat, fat, kidney, liver, and meat by-products of cattle, goats, hogs, horses, and sheep at 0.05 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 is a revised notice of filing to amend a previous notice of filing published in the Federal Register of August 25, 1999 (FR 64 46382) (FRL-6093-7), to propose permanent tolerances, instead of the current time-limited tolerances for prosulfuron.

A. Residue Chemistry

1. Plant metabolism. The nature of the residue of prosulfuron in corn is adequately understood. Significant pathways involve oxidation of the phenyl ring to give 5-hydroxy prosulfuron, which is followed by sugar conjugation. Hydrolytic cleavage of the sulfonylurea bridge occurs for both prosulfuron and 5-hydroxy prosulfuron, yielding the corresponding sulfonamide and triazine amine moieties. The sulfonamide metabolites are subsequently conjugated with sugars. Demethylation of the triazine amine results in the formation of the corresponding hydroxy triazine, which is further hydrolyzed at the amino group to form the dihydroxy triazine.

2. Analytical method. Adequate analytical methods exist for the detection and measurement of residue levels of prosulfuron in or on raw and processed commodities of cereal grains, and for meat, milk and eggs. The limit of quantitation (LOQ) is 0.01 ppm for crop commodities, processed fractions and milk, and 0.05 ppm for meat and eggs. The method is based on commodity-specific cleanup procedures followed by determination by high performance liquid chromatography with ultraviolet (UV) detection.

3. Magnitude of residues. Complete, full geography residue programs, including processing, have been conducted on corn, wheat and grain sorghum. A three-level dairy animal feeding study to determine the transfer of residues of prosulfuron from animal feed commodities to meat and milk has also been conducted.

B. Toxicological Profile

1. Acute toxicity. EPA has set an acute reference dose of 0.1 milligram/kilogram/day (mg/kg/day) based upon a no observed adverse effect level (NOAEL) of 10 mg/kg/day from the rat acute neurotoxicity study (lowest observed adverse effect level (LOAEL) of 250 mg/kg/day due to reduced motor activity and body temperature in males and impaired righting reflex in females) and a 100-fold uncertainty factor (UF).

2. Genotoxicty. Prosulfuron was negative for mutagenic/genotoxic effects when tested in a bacterial reverse gene mutation assay with and without metabolic activation using different S. typhimurium and E. coli stains; in a mammalian gene mutation study using V79 cells; in an in vitro mammalian cytogenetic test using Chinese hamster ovary (CHO) cells with and without metabolic activation; in a micronucleus test in mice; and in a DNA- repair using freshly isolated rat liver hepatocytes.

3. Reproductive and developmental toxicity. The data base on prosulfuron relative to prenatal and postnatal effects for children is considered to be essentially complete with no data gaps. The developmental and reproductive toxicity data do not indicate increase susceptibility of rats or rabbits to in utero and/or postnatal exposure to prosulfuron. In a rat teratology study, evidence of maternal toxicity (decreased body weight gain and reduced food consumption) and developmental toxicity (increased incidence of skeletal variations that was not significantly different from the historical control) was found at the maximum tolerated dose of 400 mg/kg. There was no evidence of teratogenicity at any dose, and the maternal and developmental NOAELs were established at 200 mg/kg. In a rabbit teratology study, maternal toxicity (decreased body weight gain and reduced food consumption) was observed in the 100 mg/kg dose group. There was no evidence of teratogenicity at any dose. Since a range-finding rabbit teratology study had seen additional clinical findings and fetotoxicity at maternally toxic doses (≥150 mg/kg) but not in the definitive study at up to 100 mg/kg, a second rabbit teratology study was conducted at doses of 0, 20, 100, and 200 mg/kg/day. Maternal toxicity was observed at 200 mg/kg. The developmental NOAEL was 100 mg/kg and the maternal NOAEL was 20 mg/kg in this study. There was no evidence of teratogenicity at any dose. A rat multigenerational reproduction study indicated reproductive and systemic NOAELs of 13.3 mg/kg/day based on decreased mean body weights and body weight gain observed at 136 mg/kg/day for both pups and parental animals. No treatment-related effects on reproductive performance (i.e., to produce, deliver or raise litters), litter sizes, viability of pups, and necropsy findings in parental animals and offspring were noted up to the highest dose level.

4. Subchronic toxicity. The liver was identified as a target organ at high doses in the rat, mouse, and dog as indicated by slightly increased liver enzymes and liver weights. No histomorphologic correlates of liver damage was noted in the 90-day studies except in the mouse study where centrilobular hypertrophy was found in males at feeding levels ≥1,750 ppm and in females at levels ≥3,500 ppm. In general, NOAELs for target organ effects were established at doses that were much higher than overall study NOAELs, which were based on other indicators of toxicity such body weight gain.

5. Chronic toxicity. In the 1-year dog chronic dosing study, the NOAEL was 1.84 mg/kg/day based on hematologic and clinical chemistry effects and incidence of lipofuscin accumulation in the liver at 18.6 mg/kg/day. In the 18-month mouse carcinogenicity study, there was no evidence of carcinogenic effects up to the highest dose tested (HDT) of 1,062 mg/kg/day. The NOAEL was 1.71 mg/kg/day in males, and 100 mg/kg/day in females based on increased incidence/severity of centrilobular hepatocellular hypertrophy. A 2-year chronic feeding/carcinogenicity study in rats indicated systemic NOAEL of 7.9 mg/kg/day was based on decreased body weight and body weight gain, hematopoietic effects (males), and possibly increased serum GGT and decreased liver, kidney, and adrenal weights (females) at 79.9 mg/kg/ day. There was uncertain evidence of carcinogenicity with slight increases in the incidence of mammary gland adenocarcinomas in females at 95.7 and 205.8 mg/kg/day, slight increase in incidence of benign testicular interstitial cell tumors at 79.9 and 160.9 mg/kg/day (significant trend only). Considering the weight of the evidence, the EPA Reference Dose Committee previously concluded that the chemical should be classified as a Group D carcinogen (inadequate evidence), not classifiable as to human carcinogenicity. The HIARC (meeting December 2, 1999) accepted the previous conclusions and updated the cancer classification to the new classification: “data are inadeqate,” with no new studies required. EPA has set a chronic reference dose of 0.02 mg/kg based on a NOAEL of 1.84 mg/kg in a dog feeding study and a 100-fold UF.

6. Animal metabolism. The metabolic pathways in the rat, goat, and hen are similar and are adequately understood. Prosulfuron is rapidly absorbed from the gastrointestinal (GI) tract of rats and is rapidly excreted. Approximately 90% of the administered dose is excreted during the first 48 hours, predominately via urine. Tissue residues are low. Prosulfuron is metabolized primarily via hydroxylation at side chain and phenyl ring positions and O-demethylation of the triazyl methoxy group. Minor pathways include unsaturation of the trifluoropropyl side chain, hydrolysis of the phenylsulfonylurea bridge and oxidative/hydrolytic cleavage of the triazine ring system. In the goat, the orally administered prosulfuron is quickly eliminated primarily via the urine as prosulfuron. The metabolism of prosulfuron in the goat follows a similar pathway as observed in the rat although not as extensive. The majority of the residues were accounted for as prosulfuron, the triazine amine, which results from bridge hydrolysis (CGA-150829) and the triazinyl hydroxymethyl metabolite (CGA-273437). In the hen, metabolism is similar to that observed in the rat and goat. The major residues found in edible tissues and eggs were prosulfuron, the triazine amine (CGA-150829), and the sulfonamide (CGA-159902) which results from hydrolysis of the sulfonylurea bridge.

7. Metabolite toxicology. Metabolic pathways of prosulfuron in plants and animals are comparable and no detectable residues are found in or on crops. All relevant plant metabolites are observed in the animals and are thus toxicologically covered. The remaining plant metabolites are toxicologically insignificant. Therefore, parent prosulfuron is the appropriate compound for the tolerance expression and analytical monitoring.

8. Endocrine disruption. Prosulfuron does not belong to a class of chemicals known for having significant adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and reproduction study in rats gave no indication that prosulfuron might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of a long-term effect related to the endocrine system.

C. Aggregate Exposure

1. Dietary exposure. Acute and chronic dietary exposure assessments were conducted for prosulfuron using tolerance values published in 40 CFR 180.481. In both assessments it was assumed that 100% of all corn and cereal grains were treated with prosulfuron (100% market share). The exposure analyses was conducted using food consumption data from USDA's 1994-1996 Continuing Survey of Intake by Individuals (CSFII) and Novigen Sciences, Inc. Dietary Exposure Evaluation Model (DEEM).

i. Food. Chronic exposure was compared to a RfD of 0.02 mg/kg based on a NOAEL of 1.84 mg/kg in a dog feeding study and a 100-fold UF. This exposure analysis showed that the U.S. population had an exposure of less than 1% of the chronic RfD. The most sensitive subpopulation was children (1-6 years old) with a chronic exposure of 2.4%. Acute exposure was compared to an acute RfD of 0.1 mg/kg, which was based on a NOAEL of 10 mg/kg from an acute neurotoxicity study in the rat and a 100-fold UF. The most sensitive subpopulation was all infants with an exposure of 2.2% of the acute RfD. The U.S. population showed an exposure of 1.5% of the RfD. These results show that there is more than a reasonable certainty of no harm, through exposure to prosulfuron residues in the diet.

ii. Drinking water. For estimated surface water concentrations using generic expected environmental concentration (GENEEC), the peak day-0 estimate, 1.86 parts per billion (ppb), was used in the acute exposure analysis and the corrected 56-day drinking water concentration of 0.4667 ppb was used in the chronic exposure analysis. The SCI-GROW estimated ground water concentration for the prosulfuron uses of 0.406585 ppb contributed little to the overall exposure. The acute drinking water levels of concern (DWLOC) for prosulfuron were based on the acute RfD, a margin of exposure (MOE), the 99.9^th percentile of the acute dietary exposure for U.S. population subgroups and the body weight - daily water consumption of each respective subgroup. The calculated acute DWLOC values for the population subgroups ranged from 978-3447 ppb. The estimated ground water concentration (0.406585 ppb) and the peak day-0 surface water concentration (1.86 ppb) of prosulfuron did not exceed the acute DWLOC values. The chronic (non-cancer) DWLOC for prosulfuron were based on the chronic RfD, any estimated residential exposure, the chronic dietary exposure for select U.S. population subgroups and the body weight - daily water consumption of each respective subgroup. The calculated chronic DWLOC values for the population subgroups ranged from 197-694. The estimated ground water concentration (0.406585 ppb) and the corrected average 56-day surface water concentration (0.4667 ppb) of prosulfuron did not exceed the chronic DWLOC values. Therefore, there is reasonable certainty that the residues of prosulfuron in the drinking water would not result in unacceptable levels of acute or chronic aggregate human health risk, and that such exposure would not exceed the exposure allowable by the risk cup.

Nondietary exposure. Nondietary exposure to prosulfuron is considered negligible as the chemical is registered for agricultural use only. For workers handling this chemical, acceptable MOE (in the range of thousands) have been obtained for both acute and chronic scenarios.

D. Cumulative Effects

Consideration of a common mechanism of toxicity is not appropriate at this time since there is no information to indicate that toxic effects produced by prosulfuron would be cumulative with those of any other types of chemicals.

E. Safety Determination

1. U.S. population. The calculation shows that less than 1% of the RfD will be utilized for the U.S. population based on chronic toxicity endpoints. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. It is concluded that there is a reasonable certainty that no harm will result from aggregate exposure to prosulfuron residue.

2. Infants and children. The calculated percent of the RfD that will be utilized by aggregate exposure to residues of prosulfuron is only 2.4% for children (1 to 6 years old), the most impacted subpopulation. There were no adverse reproductive or developmental effects indicated in the prosulfuron toxicity data base, which is considered to be essentially complete with no data gaps. It is concluded that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to prosulfuron residues.

F. International Tolerances

No codex MRLs have been established for residues of prosulfuron.