01-13420. 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 PF-1024, must be received on or before June 29, 2001.

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-1024 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Akiva Abramovitch, Insecticide Rodenticide 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” “Regulation 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 PF-1024. 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-1024 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-1024. 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 16, 2001.

James Jones,

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 petitioner and represents the view of the petitioner. 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.

Aventis CropScience (formerly, Rhone-Poulenc Ag Company)

PP 0F06082

EPA has received a pesticide petition (0F06082) from Aventis CropScience (formerly, Rhone-Poulenc Ag Company), P.O. Box 12014, #2 T.W. Alexander Drive, Research Triangle Park, NC 27709 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180, by establishing tolerances for residues of acetamiprid in or on the raw agricultural commodity brassica (cole crops) at 1.2 parts per million (ppm); canola seed and mustard seed at 1.2 ppm; citrus at 0.5 ppm; cottonseed at 0.06 ppm; fruiting vegetables at 0.2 ppm; grapes at 0.2 ppm; leafy vegetables at 3.0 ppm; and pome fruits at 0.70 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.

A. Residue Chemistry

1. Plant metabolism. The metabolism of acetamiprid in plants is well understood, having been investigated in eggplant, apples, cabbage, carrots, and cotton. Metabolism in plants primarily involves demethylation of the N-methyl group with subsequent hydrolysis of the acetamidine function to give the N-acetyl compound. This compound is then hydrolyzed to the corresponding amine followed by oxidation to the alcohol and acid. Conjugation of the alcohol with glucose is also significant. Degradation of the side chain without loss of the N-methyl group is seen in carrots since this is the major metabolic route in soil.

2. Analytical method. Based upon the metabolism of acetamiprid in plants and the toxicology of the parent and metabolites, quantification of the parent acetamiprid is sufficient to determine toxic residues. As a result a method has been developed which involves extraction of acetamiprid from crops with methanol, filtration, partitioning and cleanup, and analysis by gas chromatography/electron capture detector (GC/ECD) methods. The limit of quantification for the method is 0.01 ppm and the method detection limit (MDL) is 0.0005 ppm.

3. Magnitude of residues. Magnitude of residue studies were conducted in pome fruit (apples and pears); brassica (cole crops including broccoli, cabbage and mustard greens); leafy vegetables (leaf lettuce, head lettuce, celery, and spinach); fruiting vegetables (tomatoes, eggplant, and peppers); citrus (oranges, grapefruit, and lemon); grapes; canola seed; mustard seed; and cotton. Trials were conducted in all of the major use areas for each of the crops as specified in the Residue Chemistry Guidelines OPPTS 860.1500 with applications at the maximum label use rate for each crop. (Trials for mustard seed were conducted in Canada.). As a result of the field trials, the following tolerances are proposed for each of the crop group, crops or matrices: pome fruit at 0.70 ppm; brassica (cole crops) at 1.2 ppm; leafy vegetables at 3.0 ppm; fruiting vegetables at 0.2 ppm; grapes at 0.2 ppm; citrus at 0.5 ppm; canola seed at 0.01 ppm; mustard seed at 0.01 ppm; cottonseed at 0.06 ppm; and cotton gin trash at 20 ppm. Processing studies were also conducted with apples, citrus, cottonseed, grapes, and tomatoes. Maximum processed commodity residues exceeded 1.2x the RAC tolerance only with citrus dry pulp (2.22x) and tomato paste (1.65x). Therefore, tolerances are proposed for these processed commodities as follows: citrus dry pulp at 1.2 ppm and tomato paste at 0.4 ppm. Tolerances are also proposed for milk, liver, kidney, muscle and fat at 0.05 ppm.

B. Toxicological Profile

1. Acute toxicity. The acute oral LD₅₀ for acetamiprid was 146 milligrams/kilogram (mg/kg) for female Sprague-Dawley rats and 217 mg/kg for male rats. The acute dermal LD₅₀ for acetamiprid was greater than 2,000 mg/kg in rats. The acute 4-hour inhalation LC₅₀ for acetamiprid was greater than 1.15 milligrams/Liter (mg/L), the highest attainable concentration. Acetamiprid was not irritating to the eyes, or skin and was not considered to be a sensitizing agent. The no observed adverse effect level (NOAEL) for acute neurotoxicity was 10 mg/kg and no evidence of neuropathy was noted.

The acute oral LD₅₀ for Acetamiprid 70WP was 944 mg/kg for female Sprague-Dawley rats and 1,107 mg/kg for male rats. The acute dermal LD₅₀ for formulated acetamiprid was greater than 2,000 mg/kg in rats. The acute inhalation LC₅₀ (4-hour) for Acetamiprid 70WP was determined to be greater than 2.88 mg/L, the highest attainable concentration. Acetamiprid 70WP was concluded to be a mild eye irritant and slight skin irritant. There were no indications of skin sensitization for the formulated product.

2. Genotoxicty. Based on the weight of the evidence provided by a complete test battery, acetamiprid is neither mutagenic nor genotoxic. The compound was found to be devoid of mutagenic activity (with and without metabolic activation) in Salmonella typhimurium and Escherichia coli (Ames assay). Acetamiprid was also not mutagenic in an in vitro mammalian cell gene mutation assay on Chinese hamster ovary (CHO) cells (Hypoxanthine guanine phophoribosyl transferase (HGPRT) locus, with and without metabolic activation). Acetamiprid did not induce unscheduled DNA synthesis unscheduled DNA synthesis (UDS) in either rat liver primary cell cultures or in mammalian liver cells in vivo. In an in vitro chromosomal aberration study using CHO cells, acetamiprid was positive when tested under metabolic activation at cytotoxic dose levels; no effect was detected without metabolic activation. Acetamiprid was non-clastogenic in an in vivo chromosomal aberration study in rat bone marrow. It also was negative in an in vivo mouse bone marrow micronucleus assay.

3. Reproductive and developmental toxicity. In the multi-generation rat reproduction study, a NOAEL of 100 ppm was established based on decreased body weight gains and a reproduction NOAEL of 800 ppm (highest dose tested) was established for reproductive performance and fertility. In the rat teratology study, the developmental NOAEL was 50 mg/kg/day (maternal NOAEL of 16 mg/kg/day based on decreased body weight and food consumption) and in the rabbit teratology study, the developmental NOAEL was 30 mg/kg/day (maternal NOAEL of 15 mg/kg/day based on decreased body weight and food consumption). In both the rat and rabbit there were no fetotoxic or teratogenic findings.

4. Subchronic toxicity. In the 3-month dog feeding study, a NOAEL of 800 ppm (32 mg/kg/day for both males and females) was established based on growth retardation and decreased food consumption.

In the 3-month rat feeding study, a NOAEL of 200 ppm (12.4 and 14.6 mg/kg/day respectively for male and female rats) was established based on liver cell hypertrophy at a dose of 800 ppm.

In the 3-month mouse feeding study, a NOAEL of 400 ppm (53.2 and 64.6 mg/kg/day respectively for male and female rats) was established based on increased liver/body weight ratio and decreased cholesterol in females at 800 ppm.

A 13-week dietary neurotoxicity study, for acetamiprid established a NOAEL of 200 ppm (14.8 and 16.3 mg/kg/day for male and female rats) based on reduced body weight and food consumption decreases at 800 ppm. There was no evidence of neurotoxicity.

A 21-day dermal study, in rabbits at dose levels up to 1,000 mg/kg/day caused no systemic toxicity, dermal irritation or histomorphological lesions in either sex tested.

5. Chronic toxicity. In the 1-year dog study, the NOAEL was established at 600 ppm (20.5 and 21 mg/kg/day for male and female dogs) based on growth retardation and decrease of food consumption at a dose of 1,500 ppm.

In the 18-month mouse study, the NOAEL was established at 130 ppm (20.3 and 25.2 mg/kg/day for male and female mice) based on growth retardation and hepatic toxicity at 400 ppm.

In the 2-year rat study, the NOAEL was 160 ppm (7.1 and 8.8 mg/kg/day for male and female rats) based on growth retardation and hepatic toxicity. There were no indications of carcinogenicity in either the rat or mouse chronic studies.

6. Animal metabolism. The metabolism of acetamiprid is well understood and the primary animal metabolite is IM-2-1.

7. Metabolite toxicology. Testing of IM-2-1 demonstrated that it is significantly less toxic than the parent acetamiprid and it is not being considered as part of the total toxic residue, therefore no tolerance is being requested by the registrant. The acute oral LD₅₀ of IM-2-1 is 2,543 mg/kg for male rats and 1,762 mg/kg for female rats.

8. Endocrine disruption. Acetamiprid does not belong to a class of chemicals known or suspected of having adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and a reproductive study in rats gave no indication that acetamiprid has any effects on endocrine function. The chronic feeding studies also did not show any long-term effects related to endocrine systems.

C. Aggregate Exposure

1. Dietary exposure. Acute and chronic dietary analyses were conducted to estimate exposure to potential acetamiprid residues in/on the following crops: cole crop group, citrus crop group, fruiting vegetable crop group, pome fruit crop group, grapes leafy vegetables, canola oil, mustard and cotton using the Dietary Exposure Evaluation Model (DEEM) software. Exposure estimates to water were made based upon modeling.

i. Food. The acute dietary exposure estimates at the 99.9th percentile of for the U.S. Population was calculated to be 3.2% of the acute Reference Dose (RfD). The population subgroup with the highest exposure was children 1-6 at 6% of the acute RFD. The acute RfD was based on the NOAEL of 10 mg/kg/day in the acute neurotoxicity study. Chronic dietary exposure estimates from residues of acetamiprid for the U.S. population was 0.1% of the chronic RfD. The subpopulation with the highest exposure was non-nursing infants with 0.5% of the RfD used. These values are based on projected percentages for percent of crop treated and field trial residues at maximum label rates and minimum pre-harvest intervals (PHI) with no reduction factors for common washing, cooking, or preparation practices. These can be considered conservative values. The chronic RfD was based on the NOAEL of 7 mg/kg/day in the chronic study.

ii. Drinking water. EPA's Standard Operating Procedure (SOP) for Drinking Water Exposure and Risk Assessments was used to perform the drinking water analysis for acetamiprid. This SOP utilizes a variety of tools to conduct drinking water assessment. These tools include water models such as Screening Concentration in Ground Water (SCI-GROW), Generic Expected Environmental Concentration (GENEEC), EPA's Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), and monitoring data. If monitoring data are not available then the models are used to predict potential residues in surface water and ground water. In the case of acetamiprid, monitoring data do not exist, therefore, GENEEC and SCI-GROW models were used to estimate a water residue. The calculated drinking water levels of comparison (DWLOC) for acute and chronic exposures for all adults and children greatly exceed the modeled acetamiprid water residues, drinking water estimated concentrations (DWEC). The acute DWLOC values are 3,360 ppb for adults and 940 ppb for children. The worst case DWEC for acute scenarios is calculated to be 13.27 ppb using the GENEEC surface water model. The chronic DWLOC values are 2,450 ppb for adults and 700 ppb for children. The DWEC for the worst case chronic scenario is 1.59 ppb GENEEC.

2. Non-dietary exposure. A Ready to Use, dilute formulation of acetamiprid will be registered for insect control on outdoor ornamentals, vegetable and fruit trees. Based on surrogate exposure data obtained from a carbaryl study, the homeowner margin of exposure (MOE) was calculated to exceed 10 million. Post-application exposure resulting from contact with acetamiprid treated foliage resulted in an MOE in excess of 500,000.

D. Cumulative Effects

EPA and ILSI are developing the methodologies to resolve the complex scientific issues concerning common mechanism of toxicity and how to cumulate pesticides in a quantitative manner. A determination has not been made that acetamiprid has a common mechanism of toxicity with other substances. Acetamiprid does not appear to produce a common toxic metabolite with other substances. A cumulative risk assessment was therefore not performed for this analysis.

E. Safety Determination

1. U.S. population. Using the conservative assumptions described above, based on the completeness and reliability of the toxicity data, it is concluded that aggregate exposure to the proposed uses of acetamiprid will utilize at most 3.9% of the acute RfD for the U.S. population, and is likely to be much less, as more realistic data and models are developed. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate exposure over a lifetime will not pose appreciable risks to human health. Therefore, there is a reasonable certainty that no harm will occur to the U.S. population from aggregate exposure to acetamiprid.

2. Infants and children. In multi-generation reproduction and teratology studies, NOAEL on reproduction were observed in either rats or rabbits. In the long-term, feeding studies in rats and mice there was no evidence of carcinogenicity. Acetamiprid was not mutagenic under the conditions of testing. Using the conservative exposure assumptions described in the exposure section above, the percent of the RfD that will be used for short-term aggregate exposure to residues of acetamiprid will be 6% for children 1-6 (the most highly exposed sub-group). This value is based on dietary exposure alone as only children over 7 are expected to have residential post-application exposure for the proposed acetamiprid uses. The aggregate exposure for children 7-12 (based on dietary and residential exposure) results in a value of 4.0% of the RfD being used. As in the adult situation, drinking water levels of comparison are much higher than the worst case drinking water estimated concentrations. Therefore, there is a reasonable certainty that no harm will occur to infants and children from aggregate exposure to residues of acetamiprid.

F. International Tolerances

Acetamiprid is registered for use in Chile, Brazil, Mexico and Japan for use on certain food crops for domestic consumption only. Imported commodities containing residues of acetamiprid should not be encountered in the United States at this time.