02-10633. 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 OPP-2002-0029, must be received on or before May 31, 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-2002-0029 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Sidney Jackson, 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” 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-2002-0029. 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 OPP-2002-0029 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-2002-0029. 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 Federal Food, Drug, and Cosmetic Act (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 a additives
• Pesticides and pests
• Reporting and recordkeeping requirements

Dated: April 17, 2002.

 Debra Edwards,

Acting 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 petitioners and represent the views of the petitioners. EPA is publishing the petition summaries verbatim without editing them 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 4 (IR-4)

2E6356, 2E6372, 2E6375, and 2E6376

EPA has received pesticide petitions numbers 2E6356, 2E6372, 2E6375, and 2E6376, 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 180.507 by establishing and/or amending tolerances for the combined residues of azoxystrobin: (methyl (E)-2-2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl-3-methoxyacrylate) and the Z isomer of azoxystrobin, (methyl (Z)-2-2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl-3-methoxyacrylate) in or on the agricultural commodities:

1. PP# 2E6356 proposes to establish a tolerance for caneberry subgroup at 5.0 parts per million (ppm).

2. PP# 2E6372 proposes to increase the existing tolerance for pistachio from 0.02 ppm to 1.0 ppm.

3. PP# 2E6375 proposes to establish a tolerance for asparagus at 0.02 ppm.

4. PP# 2E6376 proposes to establish a tolerance for cranberry at 0.5 ppm.

Additional data may be needed before EPA rules on the petition. Syngenta Crop Protection, Inc. (Syngenta), Greenboro, North Carolina 27409, is the manufacturer of the chemical pesticide, azoxystrobin. Syngenta prepared and submitted the following summary of information, data, and arguments in support of the pesticide petitions. This summary does not necessarily reflect the findings of EPA.

A. Residue Chemistry

1. Plant metabolism. The metabolism of azoxystrobin as well as the nature of the residues is adequately understood for purposes of the proposed tolerances. Plant metabolism has been evaluated in four diverse crops, cotton, grapes, wheat, and peanuts which should serve to define the similar metabolism of azoxystrobin in a wide range of crops. Parent azoxystrobin is the major component found in crops. Azoxystrobin does not accumulate in crop seeds or fruits. Metabolism of azoxystrobin in plants is complex with more than 15 metabolites identified. These metabolites are present at low levels, typically much less than 5% of the total radioactive residue (TRR).

2. Analytical method. An adequate analytical method, gas chromatography with nitrogen-phosphorus detection (GC-NPD) or in mobile phase by high performance liquid chromatography with ultra-violet detection (HPLC-UV), is available for enforcement purposes with a limit of detection (LOD) that allows monitoring of food with residues at or above the levels set in these tolerances. The analytical chemistry section of EPA concluded that the method(s) are adequate for enforcement. Analytical methods are also available for analyzing meat, milk, poultry, and eggs which also underwent successful independent laboratory validations.

3. Magnitude of residues. Complete residue data for azoxystrobin on caneberries, cranberries, pistachios, head and stem brassica, and asparagus have been submitted. The requested tolerances are adequately supported.

B. Toxicological Profile

An assessment of toxic effects caused by azoxystrobin is discussed in Unit III. A. and Unit III. B. of the Federal Register dated September 21, 2001 (66 FR 48585).

1. Metabolite toxicology. There are no metabolites of concern based on a differential metabolism between plants and animals.

2. Endocrine disruption. There is no evidence that azoxystrobin is an endocrine disrupter.

C. Aggregate Exposure

1. Dietary exposure from food and feed uses. Permanent tolerances have been established (40 CFR 180.507(a)) for the combined residues of azoxystrobin and its Z isomer, in or on a variety of raw agricultural commodities at levels ranging from 0.02 ppm on tree nuts to 50 ppm on leaves of root and tuber vegetables. Included in these tolerances are the numerous ones for animal commodities which were established in conjunction with tolerances for animal feed.

i. Food. For the purposes of assessing the potential acute and chronic dietary exposure, Syngenta has estimated acute and chronic exposure for all registered crops (EPA) pending uses, and newly proposed uses. Novigen Sciences Inc. dietary exposure evaluation model (DEEM), which is licensed to Syngenta, was used to estimate the chronic and acute dietary exposure.

a. Acute. The DEEM model was used for analysis of individual food consumption as reported by the United States Department of Agriculture (USDA) (1994-1996 data with supplemental continuing survey of food intake by individuals (CSFII) children's survey) using the Tier I analysis. The Tier I analysis used tolerance values as anticipated residues. Syngenta's acute dietary exposure assessment estimated percent of the acute population adjusted dose (aPAD) and corresponding margins of exposure (MOE) for the overall U.S. population, and infants/children, as presented in Table 1.

Table 1.—Aggregate Risk Assessment for Acute Exposure to Azoxystrobin

Population Sub-group1	aPAD Milligram/Kilogram/day (mg/kg/day)	Percent aPAD (Food)	Surface Water Estimated Environmental Concentration (EEC) Parts Per Billion (ppb)	Ground Water EEC (ppb)	Acute Drinking Water Levels of Concern (DWLOC) (ppb)
U.S. population	0.67	12	170	0.06	21,000
Children (1 to 6 years old)	0.67	19	170	0.06	5,300
1 Within each of these categories, the subgroup with the highest food exposure was selected.

b. Chronic. The DEEM model was used for analysis of individual food consumption as reported by the USDA (1994-1996 data with supplemental CSFII children's survey) using the Tier I analysis. The Tier I analysis used tolerance values as anticipated residues. Syngenta's chronic dietary exposure assessment estimated percent of the cPAD and corresponding margins of exposure MOE for the overall U.S. population, and infants/children, as presented in Table 2.

Table 2.—Aggregate Risk Assessment for Acute Exposure to Azoxystrobin

Population Sub-group1	cPAD (mg/kg/day)	Percent cPAD (Food)	Surface Water EEC (ppb)	Ground Water EEC (ppb)	Acute DWLOC (ppb)
U.S. population	0.18	14	33	0.06	5,600
Children (1 to 6 years old)	0.18	24	33	0.06	1,300
1 Within each of these categories, the subgroup with the highest food exposure was selected.

ii. From drinking water. There is no established maximum concentration level (MCL) for residues of azoxystrobin in drinking water. No health advisory levels for azoxystrobin in drinking water have been established. The concentration of azoxystrobin in surface water based on generic estimated environmental concentration (GENEEC) modeling and in ground water based on screening concentration in ground water (SCI-GROW) modeling.

2. From non-dietary uses. Azoxystrobin is registered for residential use on ornamentals and turf. The Agency evaluated the existing toxicological data base for azoxystrobin and assessed appropriate toxicological endpoints and dose levels of concern that should be assessed for risk assessment purposes. Dermal absorption data indicate that absorption is less than or equal to 4%. Syngenta agrees with previous EPA short-term and intermediate-term risk assessments for residential exposure which show an aggregate MOE >450 for short-term exposure and MOE of >550 for intermediate-term exposure.

D. Cumulative Effects

Azoxystrobin is related to the naturally occurring strobilurins. Syngenta concluded that further consideration of a common mechanism of toxicity is not appropriate at this time since there are no data to establish whether a common mechanism exists with any other substance.

E. Safety Determination

1. U.S. population. The acute dietary exposure analysis showed that exposure from the proposed new tolerances the general U.S. population would be 12% of the aPAD.

2. Infants and children. The acute dietary exposure analysis showed that exposure from the proposed new tolerances for children 1 to 6 years old (the subgroup with the highest exposure) would be 19% of the aPAD.

The chronic dietary exposure analysis showed that exposure from the proposed new tolerances for children 1 to 6 years old (the subgroup with the highest exposure) would be 24% of the cPAD.

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. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In either case, EPA generally defines the level of appreciable risk as exposure that is greater than 1/100 of the no observed effect level in the animal study appropriate to the particular risk assessment. This hundred-fold uncertainty (safety) factor/margin of exposure (safety) is designed to account for combined interspecies and intraspecies variability. EPA believes that reliable data support using the standard hundred-fold margin/factor not the additional ten-fold margin/factor when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of the standard margin/factor. The Agency ad hoc Food Quality Protection Act (FQPA) safety factor committee removed the additional 10x safety factor to account for sensitivity of infants and children.

Syngenta has considered the potential aggregate exposure from food, water and non-occupational exposure routes and conclude that aggregate exposure is not expected to exceed 100% of the aPAD or cPAD and there is a reasonable certainty that no harm will result to infants and children from the aggregate exposure to azoxystrobin residues.

F. International Tolerances

There are no Codex MRLs established for azoxystrobin.