00-23245. 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-971, must be received on or before October 13, 2000.

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-971 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Ann Sibold, 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 control number PF-971. 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-971 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-971. 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 Comestic 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: August 25, 2000.

Peter Caulkins,

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 petitioner and represents the view of the petitioners. 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.

BASF Agro Research

PP 6F4716

EPA has received a pesticide petition (PP 6F4716) from BASF Agro Research, P.O. Box 400, Princeton, NJ 08543-0400 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1-pyrrole-3-carbonitrile (chlorfenapyr) in or on the raw agricultural commodity (RAC) (fruiting vegetables grown under greenhouse conditions) at (1.5 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 supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The nature of the residues of chlorfenapyr in plants (tomato, citrus, potato, and head lettuce) is adequately understood and the residue of concern consists of the parent molecule.

2. Analytical method. The gas chromatography (GC) analytical method, M 2427, which is proposed as the enforcement method for the residue of chlorfenapyr in tomato and pepper, has a limit of quantitation (LOQ) of 0.05 ppm.

3. Magnitude of residues. Tomato and pepper field trials have been conducted. The residue data were collected from studies having multiple applications (5) of chlorfenapyr with a maximum seasonal rate of up to 0.60 - 1.0 lb active ingredient/Acre to tomato and pepper. The resulting chlorfenapyr residues in the raw agricultural commodity ranged from <0.05 ppm (the LOQ of the method) to 1.2 ppm.

B. Toxicological Profile

1. Acute toxicity. Based on the EPA's toxicity category criteria, the acute toxicity category for chlorfenapyr technical is category II or moderately toxic (signal word WARNING) and the acute toxicity category for the 2SC formulation is category III or slightly toxic (signal word CAUTION). Males appear to be more sensitive to the effects of chlorfenapyr than females. The acute toxicity profile indicates that absorption by the oral route appears to be greater than by the dermal route. The following are the results from the acute toxicity tests conducted on the technical material.

i. Rat oral. LD₅₀ of 441/1152 milligrams/kilogram body weight (mg/kg bwt) modifying factor (MF) toxicology category II.

ii. Rabbit dermal. LD₅₀: >2,000 mg/kg bwt MF toxicology category III.

iii. Acute inhalation. LC₅₀: 0.83/>2.7 mg/L MF toxicology category III.

iv. Eye irritation. Moderately irritating toxicology category III.

v. Dermal irritation. Non-irritating toxicology category IV.

vi. Dermal sensitization. Non-sensitizer non-sensitizer.

vii. Acute neurotoxicity. No observed adverse effect level (NOAEL) 45 mg/kg bwt.— Not an acute neurotoxicant.

2. Genotoxicty. Chlorfenapyr technical (94.5%) was examined in a battery of in vitro and in vivo tests to assess its genotoxicity and its potential for carcinogenicity. These tests are summarized below.

i. Microbial/microsome mutagenicity assay. Non-mutagenic.

ii. Mammalian cell chinese hampster ovary/hypoxanthine guanine phophoribosyl transferase (CHO/HGPRT) mutagenicity assay. Non-mutagenic.

iii. In vivo micronucleus assay. Non-genotoxic.

iv. In vitro chromosome aberration assay in CHO. Non-clastogenic.

v. In vitro aberration assay in CHLC. Non-clastogenic.

vi. Unscheduled DNA synthesis (UDS) assay. Non-genotoxic.

3. Reproductive and developmental toxicity. Chlorfenapyr is neither a reproductive nor developmental toxicant and is not a teratogenic agent in the Sprague Dawley rat or the New Zealand white rabbit. This is demonstrated by the results of the following studies:

i. Rat oral teratology. NOAEL for maternal toxicity 25 mg/kg bwt/day and NOAEL for fetal/developmental toxicity at 225 mg/kg bwt/day.

ii. Rabbit oral teratology. NOAEL for maternal 5 mg/kg bwt/day and NOAEL for fetal/developmental toxicity 30 mg/kg bwt/day

iii. Rat 2-generation reproduction. NOAEL for parental toxicity/growth and offspring development 60 ppm (5 mg/kg bwt/day) and NOAEL for reproductive performance 600 ppm (44 mg/kg bwt/day).

4. Subchronic toxicity. The following are the results of the subchronic toxicity test that have been conducted with chlorfenapyr.

i. 28-day rabbit dermal. NOAEL 100 mg/kg bwt/day

ii. 28-day rat feeding. NOAEL >600 ppm (<71.6 mg/kg bwt/day).

iii. 28-day mouse feeding. NOAEL >160 ppm (<32 mg/kg bwt/day).

iv. 13-week rat dietary. NOAEL 150 ppm (11.7 mg/kg bwt/day).

v. 13-week mouse dietary. NOAEL 40 ppm (8.2 mg/kg bwt/day).

vi. 13-week dog dietary. NOAEL 120 ppm (4.2 mg/kg bwt/day).

5. Chronic toxicity. Chlorfenapyr is not oncogenic in either Sprague Dawley rats or CD-1 mice and is not likely to be carcinogenic in humans. The following are the results of the chronic toxicity tests that have been conducted with chlorfenapyr:

i. 1-year neurotoxicity in rats. NOAEL 60 ppm (2.6/3.4 mg/kg bwt/day MF).

ii. 1-year dog dietary. NOAEL 120 ppm (4.0/4.5 mg/kg bwt/day MF).

iii. 24-month rat dietary. NOAEL for chronic effects 60 ppm (2.9/3.6 mg/kg bwt/day MF, and NOAEL for oncogenic effects 600 ppm (31/37 mg/kg bwt/day).

iv. MF 18-month mouse dietary. NOAEL for chronic effects 20 ppm (2.8/3.7 mg/kg bwt/day MF, and NOAEL for oncogenic effects 240 ppm (34.5/44.5 mg/kg bwt/day MF).

6. Animal metabolism. A metabolism study was conducted in Sprague Dawley rats at approximately 20 and 200 mg/kg bwt using radio labeled chlorfenapyr. Approximately 65% of the administered dose was eliminated during the first 24 hours (62% in feces and 3% in urine) and by 48 hours following dosing, approximately 85% of the dose had been excreted (80% in feces and 5% in urine.) The absorbed chlorfenapyr-related residues were distributed throughout the body and detected in tissues and organs of all treatment groups. The principal route of elimination was via feces, mainly as unchanged parent plus minor N-dealkylated, debrominated, and hydroxylated oxidation products. The metabolic pathway of chlorfenapyr in the laying hen and the lactating goat was also similar to that in laboratory rats.

7. Metabolite toxicology. The parent molecule is the only moiety of toxicological significance which needs regulation in plant and animal commodities.

8. Endocrine disruption. Collective organ weights and histopathological findings from the 2-generation rat reproduction study, as well as from the subchronic and chronic toxicity studies in two or more animal species, demonstrate no apparent estrogenic effects or effects on the endocrine system. There is no information available which suggests that chlorfenapyr would be associated with endocrine effects.

C. Aggregate Exposure

1. Dietary exposure. There is a reasonable certainty that no harm will result from dietary exposure to chlorfenapyr, because dietary exposure to residues on food will use only a fraction of the reference dose (RfD) (including exposure of sensitive subpopulations), and exposure through drinking water is expected to be insignificant.

i. Food. For purposes of assessing the potential dietary exposure, a theoretical maximum residue contribution (TMRC) has been calculated from the tolerance of chlorfenapyr in/on fruiting vegetables at 1.5 ppm. This exposure assessment is based on very conservative assumptions, namely 100% of all fruiting vegetables are treated with chlorfenapyr and that the residues of chlorfenapyr in fruiting vegetables are at the tolerance level. Although there are no other established U.S. permanent tolerances for chlorfenapyr, a petition for a permanent tolerance at 0.5 ppm for imported citrus is pending at the Agency. Therefore, the dietary exposures to residues of chlorfenapyr in or on food will be limited to residues in fruiting vegetables, imported citrus and food and feed items derived from them. The contribution of the fruiting vegetables tolerance alone to the daily consumption uses only <1.0% of the RfD for the overall U.S. population and non-nursing infants (<1-year old) and <5% for children (1 to 6 years old).

ii. Drinking water. There is no available information about chlorfenapyr exposures via levels in drinking water. There is no concern for exposure to residues of chlorfenapyr in drinking water because of its extremely low water solubility (120 parts per billion (ppb) at 25 °C). Chlorfenapyr is also immobile in soil and does not leach because it is strongly adsorbed to all common soil types. In addition, the label explicitly prohibits applications near aquatic areas.

2. Non-dietary exposure. There is no available information quantifying non-dietary exposure to chlorfenapyr. However, based on the physical and chemical characteristics of the compound, the proposed use pattern and available information concerning its environmental fate, non-dietary exposure is expected to be negligible. The vapor pressure of chlorfenapyr is less than 1 x 10^-7 mm of mercury (Hg); therefore, the potential for non-occupational exposure by inhalation is insignificant. Chlorfenapyr is currently not registered for use in residential indoor or outdoor uses.

D. Cumulative Effects

The pyrrole insecticides represent a new class of chemistry with a unique mechanism of action. The parent molecule, AC 303,630 is a pro-insecticide which is converted to the active form, CL 303,268, via rapid metabolism by mixed function oxidases (MFOs). The active form uncouples oxidative phosphorylation in the insect mitochondria by disrupting the proton gradient across the mitochondrial membrane. The production of adenosine triphosphate (ATP) is inhibited resulting in the cessation of all cellular functions. Because of this unique mechanism of action, it is highly unlikely that toxic effects produced by chlorfenapyr would be cumulative with those of any other pesticide chemical.

In mammals, there is a lower titer of MFOs, and chlorfenapyr is metabolized by different pathways (including dehalogenation, oxidation and ring hydroxylation) to other polar metabolites without any significant accumulation of the potent uncoupler, CL 303,268. In the rat, approximately 85% of the administered dose is excreted in the feces within 48 hours, thereby reducing the levels of AC 303,630 and CL 303,268 that are capable of reaching the mitochondria. This differential metabolism of AC 303,630 to CL 303,268 in insects versus to other polar metabolites in mammals is responsible for the selective insect toxicity of the pyrroles.

E. Safety Determination

1. U.S. population. The RfD of 0.03 mg/kg bwt/day for the residues of chlorfenapyr in fruiting vegetables is calculated by applying a 100-fold safety factor to the overall NOAEL of 3 mg/kg bwt/day. This NOAEL is based on the results of the chronic feeding studies in the rat and mouse and the 2-generation reproduction study in the rat (see Item 2). Assuming a 10-fold safety factor, pending a developmental neurotoxicity study, the contribution of the fruiting vegetables tolerance alone to the daily consumption uses <5.0% of the reference dose (RfD) for the overall U.S. population and non-nursing infants (<1-year old), and children (1 to 6 years old).

2. Infants and children. The contribution of the fruiting vegetables tolerance alone to the daily consumption uses only <1.0% of the reference dose RfD for the overall U.S. population and non-nursing infants (<1-year old) and <5% for children (1 to 6 years old).

F. International Tolerances

Section 408 (b)(4) of the amended FFDCA requires EPA to determine whether a maximum residue level has been established for the pesticide chemical by the Codex Alimentarius Commission.

There is neither a Codex proposal, nor Canadian or Mexican tolerances/limits for residues of chlorfenapyr in/on fruiting vegetables. Therefore, a compatibility issue is not relevant to the proposed tolerance.