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Notice

Imazamox; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

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Information about this document as published in the Federal Register.

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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-2002-0342, must be received on or before January 22, 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.

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FOR FURTHER INFORMATION CONTACT:

Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-3194; e-mail address: brothers.shaja@epa.gov.

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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 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 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-2002-0342. 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 (703) 305-5805.

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 roviding 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 Start Printed Page 78230objects 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-2002-0342 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 opp-docket@epa.gov, Attention: Docket ID Number OPP-2002-0342. 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-2002-0342.

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-2002-0342. 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.

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List of Subjects

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Start Printed Page 78231

Dated: December 12, 2002.

 Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.

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Summary of Petition

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

PP 2E6472

EPA has received a pesticide petition (2E6472) from 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 Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180. Subpart D by establishing an exemption from the requirement of a tolerance for imazamox,(~)-2-4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl-5-(methoxymethyl)-3-pyridinecarboxylic acid in or on all raw and processed agricultural commodities. 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 notice includes a summary of the petition prepared by BASF Corporation, Research Triangle Park, 27709.

A. Residue Chemistry

1. Plant metabolism. EPA has concluded that the nature of the residue is adequately understood and the residues of concern are the parent imazamox only.

2. Analytical method. Since imazamox and its metabolic degradates are not of toxicological concern, analytical methods are not applicable.

3. Magnitude of residues. Since imazamox and its metabolic degradates are not of toxicological concern, and this petition is a request for an exemption from a tolerance, the magnitude of residues is not applicable.

B. Toxicological Profile

1. Acute toxicity. Imazamox technical is considered to be nontoxic (toxicity category IV) to the rat by the oral route of exposure. In the acute oral toxicity study in rats, the lethal dose LD50 value of imazamox technical was greater than 5,000 milligram/kilogram body weight (mg/kg bwt) for males and females. The results from the acute dermal toxicity study in rabbits indicate that imazamox is slightly toxic (toxicity category III) to rabbits by the dermal exposure. The dermal LD50 value of imazamox technical was greater than 4,000 mg/kg bwt for both male and female rabbits. Imazamox technical is considered to be nontoxic (toxicity category IV) to the rat by the respiratory route of exposure. The 4-hour lethal concentration LC50 value was greater than 6.3 milligrams/Liter (mg/L) (analytical) for both males and females. Imazamox technical was shown to be non-irritating to slightly irritating to rabbit skin (toxicity category IV). Based on the results of a dermal sensitization study (Buehler), imazamox technical is not considered a sensitizer in guinea pigs.

2. Genotoxicity. Imazamox technical was tested in the following four assays measuring several different endpoints of potential genotoxicity. Collective results from these studies indicate that imazamox does not pose a mutagenic or genotoxic risk.

i. Bacterial mutagenicity assay - negative.

ii. In vitro structural chromosomal aberration assay - negative.

iii. In vitro chinese hampster ovary/hypoxanthine guanine phophoribosyl transferase (CHO/HGPRT) assay - negative.

iv. In vivo micronucleus aberration assay - negative.

3. Reproductive and developmental toxicity. The development toxicity study in rats conducted with imazamox technical showed no evidence of teratogenic effects in fetuses and no evidence of developmental toxicity. Thus, imazamox is neither a developmental toxicant nor a teratogen in the rat. The results from this study supported a no observed adverse effect level (NOAEL) for developmental toxicity of 1,000 mg/kg bwt/day, the highest dose tested (HDT) and limit dose. The NOAEL for maternal toxicity was 500 mg/kg bwt/day, based on reduced mean body weights, weight gains and food consumption at 1,000 mg/kg bwt/day. Results from a developmental toxicity study in rabbits conducted with imazamox technical also indicated no evidence of teratogenicity or developmental toxicity. Thus, imazamox technical is neither a developmental toxicant nor a teratogen in the rabbit. In the rabbit developmental toxicity study, the NOAEL for maternal toxicity was 300 mg/kg bwt/day, based on decreased food consumption at 600 mg/kg bwt/day, the next HDT. The NOAEL for developmental toxicity was 900 mg/kg bwt/day, the HDT. The results from the 2-generation reproduction toxicity study in rats with imazamox technical support a NOAEL for parental and reproductive toxicity of 20,000 parts per million (ppm) (or approximately 1,639 mg/kg bwt/day, calculated from the food consumption data), the highest concentration tested (HCT). The NOAEL for growth and development of offspring is also 20,000 ppm (or approximately 1,639 mg/kg bwt/day).

Results from the reproduction study and the developmental toxicity studies conducted with imazamox technical show no increased sensitivity to developing offspring as compared to parental animals, because the NOAELs for growth and development of offspring were equal to or greater than the NOAELs for parental or maternal toxicity.

4. Subchronic toxicity. No treatment-related adverse effects were noted in subchronic toxicity studies at the HDT. A short-term (28-day) dermal study in rabbits was conducted with imazamox technical. No dermal irritation or systemic toxicity was observed at dose levels up to and including 1,000 mg/kg bwt/day HDT, supporting a NOAEL of 1,000 mg/kg bwt/day. In a subchronic (13-week) dietary toxicity study in rats with imazamox technical, no signs of systemic toxicity were noted, supporting a NOAEL of 20,000 ppm (or approximately 1,661 mg/kg bwt/day, calculated from food consumption data), the HCT. In a subchronic (90-day) dietary toxicity study in dogs with imazamox technical, no signs of systemic toxicity were noted, supporting a NOAEL of 40,000 ppm (or approximately 1,368 mg/kg bwt/day, calculated from the food consumption data), the HCT.

5. Chronic toxicity. The low order of mammalian toxicity of imazamox technical is also evident from the chronic dietary toxicity studies. These studies showed no increased mortalities or clinical signs of toxicity attributed to imazamox treatment. Moreover, there were no treatment-related effects on food consumption, body weights, organ weights, or hematology, clinical chemistry, urinalysis or ophthalmologic parameters. There was no gross or microscopic evidence of treatment-related lesions or carcinogenicity in the Start Printed Page 78232three chronic studies conducted in dogs, mice or rats. A 1-year dietary study was conducted with imazamox technical in dogs at dietary concentrations of 0, 1,000, 10,000, and 40,000 ppm. The NOAEL for this study was 40,000 ppm (or approximately 1,165 mg/kg bwt/day, based on food consumption), the HCT.

A chronic feeding/carcinogenicity study was conducted with imazamox technical in male and female rats at dietary concentrations of 0, 1,000, 10,000, and 20,000 ppm. The NOAEL for systemic toxicity and carcinogenicity was 20,000 ppm (or approximately 1,167 mg/kg bwt/day, based on food consumption) the HCT. A chronic feeding/ carcinogenicity study was conducted with imazamox technical in male and female mice at dietary concentration of 500, 3,500, and 7,000 ppm. The NOAEL for systemic toxicity and carcinogenicity was 7,000 ppm (or approximately 1,201 mg/kg bwt/day, based on food consumption), the HCT.

6. Animal metabolism. The qualitative nature of the residues of imazamox and its metabolites CL 263284 and CL 263284's carboxylate AC 312622 in animals is adequately understood. Based on metabolism studies with goats, hens and rats, there is no reasonable expectation that measurable imazamox-related residues will occur in meat, milk, poultry or eggs from the proposed use.

7. Metabolite toxicology. No toxicologically significant metabolites were detected in plant or animal metabolism studies for soybeans or the rest of the crops in the legume vegetable crop grouping (6) or canola. Therefore, no metabolites need to be regulated in these crops. The plant metabolism study in wheat indicated very low residues of concern. A very small amount of the metabolite CL 263284 was found in the wheat grain. The plant metabolism in alfalfa indicated very low residues in the alfalfa seed. However, the parent imazamox underwent metabolism to the metabolite CL 263284 (the same metabolite seen in wheat). This metabolite was captured by a glucose molecule to form the glucose conjugate CL 189215 and the hydroxymethyl AC 263284 was also further oxidized to the carboxylate metabolite CL 312622. Both metabolites, CL 263284 and CL 312622 were present in the rat metabolism study. No additional toxicologically significant metabolites were detected in any plant or animal studies.

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

C. Aggregate Exposure

1. Dietary exposure—i. Food. Residues of imazamox and its metabolic degradates are not of toxicological concern. Therefore, dietary exposure through he food is not a concern.

ii. Drinking water. Residues of imazamox and its metabolic degradates are not of toxicological concern. Therefore, dietary exposure through water is not a concern.

2. Non-dietary exposure. There is no available information quantifying non-dietary exposure to imazamox. 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 not expected.

D. Cumulative Effects

Because of the low toxicity of imazamox and its metabolic degradates, there is no concern regarding the potential for cumulative effects of imazamox and its degradates with other substances with a common mode of action. Imazamox belongs to the imidazolinone class of chemistry. The herbicidal activity of the imidazolinones is due to the inhibition of acetohydroxy acid synthase (AHAS), an enzyme only found in plants. AHAS is part of the biosynthetic pathway leading to the formation of branched-chain amino acids. Animals lack AHAS and this biosynthetic pathway. This lack of AHAS contributes to the low toxicity of imazamox in mammals. We are aware of no information to indicate or suggest that imazamox has any toxic effects on mammals that would be cumulative with those of any other chemical. Since imazamox is relatively non-toxic, cumulative effects of residues of imazamox and other chemicals are not anticipated. Therefore, for the purposes of this tolerance petition, no assumption has been made with regard to cumulative exposure with other chemicals having a common mode of herbicidal action.

E. Safety Determination

1. U.S. population. Because imazamox and its degradates are not of toxicological concern and there is low exposure to imazamox and its degradates, this exemption from the requirement of a tolerance in or on all raw agricultural commodities will not pose a dietary risk under reasonably foreseeable circumstances.

2. Infants and children. Likewise, because imazamox and its degradates are not of toxicological concern and there is low exposure to imazamox and its degradates, this exemption from the requirement of a tolerance in or on all raw agricultural commodities will not pose a dietary risk under reasonably foreseeable circumstances to the U.S. population sub-group of infants and children.

F. International Tolerances

There is no Codex maximum residue level established for residues of imazamox on any crops.

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FR Doc. 02-32260 Filed 12-20-02; 8:45 a.m.]

BILLING CODE 6560-50-S