02-17688. 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 ID number OPP-2002-0130; must be received on or before August 16, 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 ID number OPP-2002-0130; in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Shaja R. Brothers, Registration Support Branch, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 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:

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 ID number OPP-2002-0130. 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 ID number OPP-2002-0130 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 ID number OPP-2002-0130. 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 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 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: July 2, 2002.

Debra Edwards,

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 IR-4 Project, Centre for Minor Crop Pest Management and represents the view of the Centre for Minor Crop Pest Management. 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.

Interregional Research Project Number 4

PP 0E6219

EPA has received a pesticide petition 0E6219 from the IR-4 Project, Centre for Minor Crop Pest Management, Rutgers, The State University of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 8920-3390 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 180.414 by establishing a tolerance for residues of the insecticide, cyromazine, (N-cyclopropyl-1,3,5-triazine-2,4,6-triamine) in or on the raw agricultural commodity dry bean at 3.0 parts per million (ppm). This notice includes a summary of the petition prepared by Novartis Crop Protection Inc., Greensboro, NC 27419. 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 cyromazine in plants is adequately understood for the purposes of these tolerances.

2. Analytical method. Methods AG-408 and AG-417 as listed in the Food and Drug Administration's Pesticide Analytical Manual (PAM), Vol-II are adequate to enforce the proposed tolerance.

3. Magnitude of residues. A total of nine residue field tests were conducted in typical growing regions for dry beans. The data collected support the proposed tolerance of 3.0 ppm.

B. Toxicological Profile

1. Acute toxicity. A rat acute oral toxicity study with a lethal dose (LD)₅₀ of approximately 3,387 milligrams/kilogram (mg/kg) (toxicity category III; moderately toxic). A rat acute dermal toxicity study with a LD₅₀ greater than 3,100 mg/kg (toxicity category III; moderately toxic). A rat acute inhalation study with a lethal concentration (LC)₅₀ greater than 2.9 mg/kg (toxicity category IV; slightly toxic). A primary eye irritation study in the rabbit that showed no eye irritation. A primary dermal irritation study in the rabbit that showed mild irritation (toxicity category; IV). A dermal sensitization study in the guinea pig that showed no sensitization.

2. Genotoxicity. Studies on gene mutation and other genotoxic effects showed no evidence of point mutation in an Ames test; no indication of mutagenic effects in a dominant lethal test; and no evidence of mutagenic effects in a nucleus anomaly test in Chinese hamsters.

3. Reproductive and developmental toxicity. In a rat developmental toxicity study, the maternal NOAEL was 100 mg/kg/day. The maternal LOAEL was 300 mg/kg based on decreased body weight gain and clinical observations. The developmental NOAEL was 300 ppm. The developmental LOAEL was 600 mg/kg based upon an increase of minor skeletal variations.

In a rabbit developmental toxicity study, the maternal NOAEL was 10 mg/kg. The maternal LOAEL was 30 mg/kg based upon decreased body weight gain and food consumption. The developmental NOAEL/LOAEL was greater than or equal to 60 mg/kg.

In a multi-generation study in rats, the systemic NOAEL was 30 ppm (1.5 mg/kg). The systemic LOAEL was 1,000 ppm (50 mg/kg) based upon decreased body weights associated with decreased food consumption. The developmental/offspring systemic NOAEL was 1,000 ppm. The developmental/offspring systemic LOAEL was 3,000 ppm (150 mg/kg) based upon decreased body weight at birth through weaning. There were no effects on reproductive parameters at the highest dose tested (3,000 ppm).

4. Subchronic toxicity. In a 6-month feeding study in dogs, the NOAEL was 30 ppm (0.75 mg/kg). The LOAEL was 300 ppm (7.5 mg/kg) based upon decreased hematocrit and decreased hemoglobin. Groups of male and female beagle dogs (4/sex/dose) were fed diets containing cyromazine at 0, 30, 300, or 3,000 ppm (0, 0.75, 7.5, or 75 mg/kg/day, respectively) for 6-months. No treatment-related effects were observed in survival, clinical signs or body weight parameters. Pronounced effects on hematologic parameters, were manifested as decreases in hematocrit and hemoglobin levels at 300 and 3,000 ppm.

5. Chronic toxicity. In a 24-month feeding study in rats the NOAEL for the study was 30 ppm (1.5 mg/kg/day). The LOAEL was 300 ppm (15.0 mg/kg) based on decreased body weight. In a 24-month mouse chronic feeding carcinogenicity study the NOAEL was 50 ppm (7.5 mg/kg/day). The LOAEL was 1,000 ppm (150.0 mg/kg) based upon decreased body weight. There was no evidence of carcinogenicity at 3,000 ppm (450 mg/kg). In a 24-month rat chronic feeding carcinogenicity study the NOAEL was greater than 3,000 ppm (150 mg/kg) (highest dose tested). There was no evidence of carcinogenicity at 3,000 ppm.

6. Animal metabolism. The metabolism of cyromazine has been adequately characterized in the rat, goat and chicken.

7. Metabolite toxicology. EPA has removed melamine, a metabolite of cyromazine, from the tolerance expression as a residue of toxicological concern. For more information on melamine, see the Federal Register of September 15, 1999 (64 FR 50043) (FRL-6098-7).

8. Endocrine disruption. Cyromazine does not belong to a class of chemicals proven to have adverse effects on the endocrine system. There is no evidence that cyromazine has any effect on endocrine function in developmental or reproduction studies.

C. Aggregate Exposure

1. Dietary exposure. EPA has conducted risk assessments to assess dietary exposures from cyromazine. Details of these assessments are in the Federal Register of September 15, 1999 (64 FR 50043).

i. Food—a. Acute risk. A food-use pesticide is presumed to pose an acute risk if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. There were no toxicological effects attributed to a single exposure (dose) observed in oral toxicity studies including the developmental toxicity studies in rats and rabbits. Therefore, there is a reasonable certainty of no harm from acute dietary exposure.

b. Chronic. The chronic reference dose (RfD) used for the chronic dietary analysis is 0.0075 milligram/kilogram body weight/day (mg/kg bwt/day). The following assumptions were used in the dietary risk assessment: (i) PCT estimates were utilized for cucurbit vegetables, leafy vegetables (except Brassica), onions, peppers and tomatoes. All other crops 100% crop-treated was assumed; (ii) anticipated residue estimates were used for milk, meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep; and (iii) all other commodities tolerance level residues were assumed.

ii. Drinking water exposure—a. Acute. Because no acute dietary endpoint was determined, cyromazine does not pose an acute risk through drinking water.

b. Chronic. EPA has calculated drinking water level of concern (DWLOC) values for chronic (non-cancer) exposure to cyromazine in surface water and ground water. A human health DWLOC is the concentration of a pesticide in drinking water that would result in an acceptable aggregate risk after having factored in all food exposures and other non-occupational exposures for which EPA has reliable data. To calculate the DWLOCs for chronic (non-cancer) exposure relative to a chronic toxicity endpoint, the chronic dietary food exposure was subtracted from the RfD to obtain the acceptable chronic (non-cancer) exposure to cyromazine in drinking water. DWLOCs were then calculated using default body weights and drinking water consumption figures. The modeling conducted was based on the environmental profile and the maximum seasonal application rate proposed for cyromazine (6 applications at 0.125 lb/acre).

2. Non-dietary exposure. Cyromazine is currently registered for commercial outdoor use on landscape ornamentals and commercial interiorscapes. There are no lawn or indoor residential uses and significant residential exposure is not expected.

D. Cumulative Effects

Novartis does not have, at this time, available data to determine whether cyromazine has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, cyromazine does not appear to produce a toxic metabolite produced by other substances.

E. Safety Determination

1. U.S. population. The aggregate exposure to cyromazine from food will utilize 17% of the chronic population dose (cPAD) for the U.S. population. The major identifiable subgroup with the highest aggregate exposure is 34% for children (1-6 years old). Other subgroups include non-nursing infants, (1 year old) utilizing 13% of cPAD, and children (7-12 years old) utilizing 26% of the cPAD. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health.

Based on the chronic dietary (food only) exposures and using default body weights and water consumption figures, chronic DWLOCs for drinking water were calculated. For chronic exposure, based on an adult body weight of 70 kg and 2 liter (2L) consumption of water per day, the DWLOC from chronic dietary exposure in drinking water is 220 ppb. For children (10 kg and consuming 1 liter water/day) the DWLOC is 50 parts per billion (ppb). The estimated chronic drinking water exposure for cyromazine is 28.9 ppb (surface water) and 1.6 ppb (ground water). Thus, the potential residues in drinking water are not greater than the DWLOCs. Therefore, the combined exposure of chronic dietary food and drinking water exposure to cyromazine would be no greater than 100% of the cPAD for children or the general U.S. population.

Due to the nature of the non-dietary use, the commercial use of cyromazine on landscape ornamentals will not result in any significant residential exposure. Therefore, the chronic risk is the sum of food and water and there is reasonable certainty that no harm will result from aggregate exposure to cyromazine residues.

The Cancer Peer Review Committee determined that there is no evidence of carcinogenicity in studies in either the mouse or rat. Based upon this determination it can be concluded that cyromazine does not pose a cancer risk.

Therefore, based on these risk assessments there is a reasonable certainty that no harm will result from aggregate exposure to cyromazine residues.

2. Infants and children. The safety factor for infants and children under FFDCA section 408 provides that EPA shall apply an additional ten-fold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different margin of safety will be safe for infants and children. EPA determined that reliable data support using the standard MOE and uncertainty factor (100 for combined interspecies and intraspecies variability) and that an additional safety factor of 10 is not necessary to be protective of infants and children.

Using the conservative exposure assumptions described above, the aggregate exposure to cyromazine from food will utilize a maximum 34% of the cPAD for children 1-6 years old. EPA generally has no concern for exposures below 100% of the cPAD, because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. As noted above, potential exposure from drinking water is at a level below the DWLOCs. Therefore, based on these risk assessments there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to cyromazine residues.

F. International Tolerances

There are currently no codex, Canadian or Mexican limits for residues of cyromazine on dry beans.