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Rule

Imazamox; Exemption from the Requirement of a Tolerance

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes an exemption from the requirement of a tolerance for residues of the imazamox on all food commodities when applied/used as a herbicide. The Interregional Research Project Number 4 (IR-4) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996, requesting an exemption from the requirement of a tolerance. After review of the available data, EPA determined that the toxicological profile for imazamox supports an exemption from the requirement of a tolerance; no adverse effects were observed in the submitted toxicological studies regardless of the route of exposure. Since this regulation eliminates the need to establish maximum permissible levels for residues of imazamox, the Agency is also deleting 40 CFR 180.508, which includes previously established maximum permissible levels for residues of imazamox.

DATES:

This regulation is effective February 14, 2003. Objections and requests for hearings, identified by docket ID number OPP-2003-0034, must be received on or before April 15, 2003.

ADDRESSES:

Written objections and hearing requests submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit IX. of the SUPPLEMENTARY INFORMATION.

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FOR FURTHER INFORMATION CONTACT:

Hoyt Jamerson, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9368; e-mail address: jamerson.hoyt@epa.gov.

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SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:-

  • Crop production
  • Animal production
  • Food manufacturing
  • 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 this unit could also be affected. The North American Start Printed Page 7429Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any 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-2003-0034. 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/​. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/​nara/​cfr/​cfrhtml_​00/​Title_​40/​40cfr180_​00.html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm.-

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.

II. Background and Statutory Findings-

In the Federal Register of December 23, 2002 (67 FR 78229) (FRL-7284-5), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 2E6472) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709. This notice included a summary of the petition prepared by BASF Corporation. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of imazamox (2-[4,5-dihydro-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-methoxymethyl-3-pyridinecarboxylic acid) in or on all food commodities.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

III. Toxicological Profile

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by imazamox are discussed in this unit.

Table 1.—Subchronic, Chronic, and Other Toxicity

Guideline No.Study TypeResults
870.310090-Day oral toxicity rodentsNOAEL = 1661 milligram/kilogram/day (mg/kg/day), highest dose tested (HDT)
There were no treatment-related effects observed in this study.
870.315090-Day oral toxicity in nonrodentsNOAEL = 1.3 gram/kilogram/day (g/kg/day) (HDT)
There were no treatment-related effects observed in this study.
870.320021/28-Day dermal toxicityNOAEL = 1000 mg/kg/day (HDT)
There were no observed toxic effects at any dose level.
870.3700aPrenatal developmental in rodents (rat)Maternal NOAEL = > 1000 mg/kg/day (limit dose)
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No maternal toxicity or clinical signs of toxicity were observed. Mean body weight gain was reduced during the early dosing periods (days 6-12) at the 1000 mg/kg/day dose compared to the control group. Body weights were comparable between the treated and the control groups for the remainder of the dosage period (days 12-16) and the post dosage period (days 16 to 20). Slightly reduced mean body weight gain observed during early dosing period (days 6-12) was not considered biologically relevant.
Developmental NOAEL = equal to or greater than 1000 mg/kg/day.
No treatment-related fetal gross external, visceral or skeletal malformations or variations were seen at any dose level.
870.3700bPrenatal developmental in nonrodents (rabbit)Maternal NOAEL = 900 mg/kg/day (HDT)
Marginally reduced body weights and slightly decreased food consumption in F1 males and females were observed in in test animals at the 900 mg/kg/day dose level, but were not considered biologically significant.
Developmental NOAEL = equal to or greater than 900 mg/kg/day (HDT)
There were no treatment-related developmental effects observed at any of the administered dose levels.
870.3800Reproduction and fertility effectsParental/Systemic NOAEL = 1469 mg/kg/day in males/ 1705 mg/kg/day in females (HDT)
There were no treatment-related systemic or reproductive toxicity observed at any of the administered dose levels.
870.4100bChronic toxicity dogsNOAEL = 1,165 mg/kg/day (HDT)
There were no treatment-related effects observed at any of the administered dose levels.
870.4200Carcino-genicity ratsNOAEL = 1,068 mg/kg/day in males/1,284 mg/kg/day in females (HDT)
There were no treatment-related effects observed in this study.
There was no evidence of carcinogenicity in rats treated with imazamox in the diet for 24 months. The highest dose tested (1,068/1,284 mg/kg/day) is considered an adequate upper limit for this study.
870.4300Carcino-genicity miceNOAEL = 1,053 mg/kg/day for males (HDT)/1,348 mg/kg/day for females (HDT)
There were no treatment-related effects observed in this study.
There was no evidence of carcinogenicity in mice treated with imazamox in the diet for 24 months. The highest dose tested (1,053/1,348 mg/kg/day) is considered an adequate upper limit for this study.
870.5100Gene MutationNegative
870.5375CytogeneticsNegative
870.5385Other EffectsNegative
870.7485Metabolism and pharmacokinetics[14]CImazamox was readily absorbed by male and female rats following intravenous or oral dosing. Imazamox was rapidly excreted as the unchanged parent compound, primarily in the urine following intravenous administration and in the urine and feces following oral administration.

IV. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. Based on a review of the available data, EPA concluded that imazamox showed no toxicological endpoints of concern and, therefore, no dietary, occupational, residential, or aggregate risk assessments are needed.Start Printed Page 7431

V. Aggregate Exposures

In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

A. Dietary Exposure

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.508) for residues of imazamox, per se, in or on canola and the legume vegetable group; imazamox and its metabolite AC263284 in or on wheat (bran, germ, grain, forage, hay, shorts, and straw); and imazamox and its metabolites AC26284 and AC312622 in or on alfalfa (seed, forage and hay). Time-limited tolerances for section 18 emergency exemptions are established for dry bean and canola. Section 180.508, which lists the maximum permissible levels for imazamox, will be removed since this regulation eliminates the need to establish maximum permissible levels for residues of the pesticide.

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. EPA concluded that no acute toxicological endpoint was identified from the toxicological studies submitted for imazamox, including oral developmental toxicity studies in rats and rabbits. Therefore, an acute dietary risk assessment was not conducted.

ii. Chronic exposure. EPA concluded that a chronic dietary risk assessment is not needed since no toxicity was observed at doses exceeding the Limit-Dose (1,000 mg/kg/day and higher) in chronic and subchronic studies in mice, rats, and dogs. A dose of 1,000 mg/kg/day is equivalent to a human diet in which the pesticide comprises approximately 7 percent of dietary consumption.

iii. Cancer. Imazamox is classified as a “not likely human carcinogen” based on the lack of evidence of carcinogenicity in mice and rats. Therefore a cancer risk assessment was not performed.

2. Drinking water exposure. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for imazamox in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of imazamox.

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow groundwater. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Based on the FIRST and SCI-GROW models the estimated environmental concentrations (EECs) for imazamox for acute exposures are estimated to be 5.7 parts per billion (ppb) for surface water and 1.0 ppb for ground water. The EECs for chronic exposures are estimated to be 0.61 ppb for surface water and 1.0 ppb for ground water.

B. Other Non-Occupational Exposure

The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Imazamox is not registered or proposed for use on any sites that would result in residential exposure.-

VI. Cumulative Effects-

Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether imazamox 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, imazamox does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that imazamox has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

VII. Determination of Safety for U.S. Population, Infants and Children

1. U.S. Population. The toxicological profile for imazamox supports a tolerance exemption since no adverse effects were observed in the submitted toxicological studies regardless of the route of exposure. EPA does not expect imazamox to pose a dietary risk under reasonable foreseeable circumstances and, thus, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to imazamox residues. Accordingly, EPA finds that exempting imazamox from the requirement of a tolerance will be safe.

2. Infants and children. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold 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 on toxicity and exposure 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 MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

EPA concludes there is a complete toxicity data base for imazamox and there is no evidence of pre-natal or post-natal toxicity to rat or rabbit fetuses following in utero exposure in the developmental studies or to young rats in the reproduction study. Due to the lack of toxicity in the animal studies, Start Printed Page 7432EPA did not use a margin of exposure (safety) approach to assess the safety of imazamox. For this same reason, an additional margin of safety is not needed for infants and children. The Agency concludes that an exemption from the requirement of a tolerance for imazamox will be safe for infants and children.

VIII. Other Considerations

A. Analytical Method(s)

An analytical method for enforcement purposes is not required, this action eliminates the need for maximum permissible levels for residues of imazamox in or on food commodities.

B. Existing Tolerances

Tolerances are established (40 CFR 180.508) for residues of imazamox, per se, in or on canola and the legume vegetable group; imazamox and its metabolite AC263284 in or on wheat (bran, germ, grain, forage, hay, shorts, and straw); and imazamox and its metabolites AC26284 and AC312622 in or on alfalfa (seed, forage and hay). Time-limited tolerances for section 18 emergency exemptions are established for dry bean and canola. Section 180.508 will be removed since this regulation eliminates the need for maximum permissible levels for residues of the pesticide.

C. International Tolerances

There are no established or proposed Codex Maximum Residue Limits (MRLs) for imazamox.

IX. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0034 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 15, 2003.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential 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. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. -

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0034, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

X. Statutory and Executive Order Reviews

This final rule establishes an exemption from the tolerance Start Printed Page 7433requirement under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

XI. Submission to Congress and the Comptroller General -

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

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List of Subjects in 40 CFR Part 180

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Dated: February 4, 2003.

Debra Edwards,

Acting Director, Registration Division, Office of Pesticide Programs.

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Therefore, 40 CFR chapter I is amended as follows:

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PART 180—[AMENDED]

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1. The authority citation for part 180 continues to read as follows:

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Authority: 21 U.S.C. 321(q), 346(a) and 371.

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[Removed]
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2. Section 180.508 is removed.

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3. Section 180.1223 is added to subpart D to read as follows:

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Imazamox; exemption from the requirement of a tolerance.-

The herbicide imazamox, (±) 2, -[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(methoxymethyl)-3-pyridinecarboxylic acid, is exempt from the requirement of a tolerance on all food commodities when applied as a herbicide in accordance with good agricultural practices.

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[FR Doc. 03-3699 Filed 2-13-03; 8:45 am]

BILLING CODE 6560-50-S