[Federal Register Volume 68, Number 31 (Friday, February 14, 2003)]
[Rules and Regulations]
[Pages 7428-7433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3699]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0034; FRL-7291-3]


Imazamox; Exemption from the Requirement of a Tolerance

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.

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: [email protected].

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:-
    [sbull] Crop production
    [sbull] Animal production
    [sbull] Food manufacturing
    [sbull] 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

[[Page 7429]]

Industrial 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 Type            Results
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = 1661
                                   toxicity rodents    milligram/
                                                       kilogram/day (mg/
                                                       kg/day), highest
                                                       dose tested (HDT)
                                                      There were no
                                                       treatment-related
                                                       effects observed
                                                       in this study.
------------------------------------------------------------------------
870.3150                          90-Day oral         NOAEL = 1.3 gram/
                                   toxicity in         kilogram/day (g/
                                   nonrodents          kg/day) (HDT)
                                                      There were no
                                                       treatment-related
                                                       effects observed
                                                       in this study.
------------------------------------------------------------------------
870.3200                          21/28-Day dermal    NOAEL = 1000 mg/kg/
                                   toxicity            day (HDT)
                                                      There were no
                                                       observed toxic
                                                       effects at any
                                                       dose level.
------------------------------------------------------------------------
870.3700a                         Prenatal            Maternal NOAEL = >
                                   developmental in    1000 mg/kg/day
                                   rodents (rat)       (limit dose)

[[Page 7430]]

 
                                                      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.
------------------------------------------------------------------------
870.3700b                         Prenatal            Maternal NOAEL =
                                   developmental in    900 mg/kg/day
                                   nonrodents          (HDT)
                                   (rabbit)
                                                      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.
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects   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.
------------------------------------------------------------------------
870.4100b                         Chronic toxicity    NOAEL = 1,165 mg/
                                   dogs                kg/day (HDT)
                                                      There were no
                                                       treatment-related
                                                       effects observed
                                                       at any of the
                                                       administered dose
                                                       levels.
------------------------------------------------------------------------
870.4200                          Carcino-genicity    NOAEL = 1,068 mg/
                                   rats                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.
------------------------------------------------------------------------
870.4300                          Carcino-genicity    NOAEL = 1,053 mg/
                                   mice                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.
------------------------------------------------------------------------
870.5100                          Gene Mutation       Negative
------------------------------------------------------------------------
870.5375                          Cytogenetics        Negative
------------------------------------------------------------------------
870.5385                          Other Effects       Negative
------------------------------------------------------------------------
870.7485                          Metabolism and      [\14\]CImazamox
                                   pharmacokinetics    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.

[[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,

[[Page 7432]]

EPA 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 [email protected], 
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: [email protected]. 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

[[Page 7433]]

requirement 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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: February 4, 2003.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.-

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


Sec.  180.508  [Removed]

    2. Section 180.508 is removed.

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


Sec.  180.1223  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.

[FR Doc. 03-3699 Filed 2-13-03; 8:45 am]
BILLING CODE 6560-50-S