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Imazamox - Pesticide Tolerance 12/01

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301205; FRL-6817-9]
RIN 2070-AB78

Imazamox; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for residues of
imazamox in or on the raw agricultural commodities: alfalfa forage,
seed and hay, canola seed, vegetable, legume, group wheat forage,
grain, bran, germ, shorts, hay and straw. BASF Corporation, formerly
American Cyanamid Company, requested this tolerance under the Federal
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection
Act of 1996.

DATES: This regulation is effective December 27, 2001. Objections and
requests for hearings, identified by docket control number OPP-301205,
must be received by EPA on or before February 25, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301205 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5697; and e-mail address:
tompkins.jim@epa.gov.

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:

------------------------------------------------------------------------
                                                  Examples of Potentially
              Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                     111  Crop production
                                             112  Animal production
                                             311  Food manufacturing
                                           32532  Pesticide manufacturing
------------------------------------------------------------------------

     This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

     1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations", "Regulations and Proposed Rules," and then look up the
entry for this document under the "Federal Register--Environmental
Documents." You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
A frequently updated
electronic version of 40 CFR part 180 is available at http://
www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a
beta site currently under development.
     2. In person. The Agency has established an official record for
this action under docket control number OPP-301205. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

     In the Federal Register of March 29, 2000 (65 FR 16594) (FRL-6498-
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 of 1996 (FQPA) (Public Law 104-170) announcing
the filing of a pesticide petition (PP) for tolerance by American
Cyanamid Company, P.O. Box 400, Princeton, NJ 08543-0400. This notice
included a summary of the petition prepared by American Cyanamid
Company, the registrant. There were no comments received in response to
the notice of filing. The petition was subsequently transferred to BASF
Corporation, P.O. Box 400, Princeton, NJ 08543-0400.
     The petition requested that 40 CFR 180.508 be amended by
establishing a tolerance for residues of the herbicide imazamox,
()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-(methoxymethyl)-3-pyridinecarboxylic acid, in or on
the raw agricultural commodities: vegetable, legume, group at 0.05 ppm;
canola, seed at 0.05 ppm. Tolerances are established for the combined
residues of the herbicide imazamox, and its metabolite, AC263284
()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-(hydroxymethyl)-3-pyridinecarboxylic acid in or on the
following raw agricultural commodities wheat, grain, forage and hay at
0.3 ppm, wheat, straw at 0.2 ppm, wheat, bran at 1.0 ppm, wheat, shorts
at 0.8 ppm, and wheat, germ at 0.6 ppm. Tolerances are established for
the combined residues of the herbicide imazamox, and its metabolite,
AC263284 (free and conjugated), and AC312622, ()-2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3,5-
pyridinecarboxylic acid in or on the following raw agricultural
commodities: alfalfa, seed at 0.4 ppm, alfalfa, forage at 2.0 ppm and
alfalfa, hay at 4.0 ppm respectively.
     Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish 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. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

     Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of the herbicide imazamox,
()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-(methoxymethyl)-3-pyridinecarboxylic acid, in or on
the raw agricultural commodities: vegetable, legume, group at 0.05 ppm;
canola, seed at 0.05 ppm. Tolerances are established for the combined
residues of the herbicide imazamox, and its metabolite, AC263284
()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-(hydroxymethyl)-3-pyridinecarboxylic acid in or on the
following raw agricultural commodities wheat, grain, forage and hay at
0.3 ppm, wheat, straw at 0.2 ppm, wheat, bran at 1.0 ppm, wheat, shorts
at 0.8 ppm, and wheat, germ at 0.6 ppm. Tolerances are established for
the combined residues of the herbicide imazamox, and its metabolite,
AC263284 (free and conjugated), and AC312622, ()-2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3,5-
pyridinecarboxylic acid in or on the following raw agricultural
commodities: alfalfa, seed at 0.4 ppm, alfalfa, forage at 2.0 ppm and
alfalfa, hay at 4.0 ppm respectively. EPA's assessment of exposures and
risks associated with establishing the tolerance follows.

A. Toxicological Profile

     EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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 the following Table 1 as well as the no observed adverse
effect level (NOAEL). There was no lowest observed adverse effect level
(LOAEL) in any of the subchronic or chronic toxicity studies reviewed.

             Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.              Study Type            Results
------------------------------------------------------------------------
870.1100......................  Acute Oral.......  LD50 > 5,000 mg/kg
                                                     (limit dose),
                                                     toxicity category IV
------------------------------------------------------------------------
870.1200......................  Acute Dermal.....  LD50 > 4,000 mg/kg

                                                     (twice the limit
                                                     dose), toxicity
                                                     category III
------------------------------------------------------------------------

870.1300......................  Acute Inhalation.  LC50 > 6.3 mg/L,
                                                     toxicity category IV
------------------------------------------------------------------------
870.2400......................  Primary Eye        moderately
                                  Irritation.        irritating, toxicity

                                                     category III
------------------------------------------------------------------------
870.2500......................  Primary Skin       Non-irritating,
                                  Irritation.        toxicity category IV
------------------------------------------------------------------------
870.2600......................  Dermal             Non sensitizer
                                  Sensitization.
------------------------------------------------------------------------
870.3100......................  90-Day oral        NOAEL = 1,661 mg/kg/
                                  toxicity rodents.  day, Highest Dose
                                                     Tested (HDT)
------------------------------------------------------------------------
870.3150......................  90-Day oral        NOAEL = 1,333 mg/kg/
                                  toxicity in        day, HDT
                                  nonrodents.
------------------------------------------------------------------------
870.3200......................  21/28-Day dermal   NOAEL = 1,000 mg/kg/
                                  toxicity.          day, HDT
------------------------------------------------------------------------
870.3700......................  Prenatal           Maternal and
                                  developmental in   Developmental NOAEL
                                  rodents.           = 1,000 mg/kg/day,
                                                     HDT
------------------------------------------------------------------------
870.3700......................  Prenatal           Maternal and
                                  developmental in   Developmental NOAEL
                                  nonrodents.        = 900 mg/kg/day, HDT
------------------------------------------------------------------------
870.3800......................  Reproduction and   Parental/Systemic,
                                  fertility          Reproductive and
                                  effects.           Offspring NOAEL =
                                                     1469 mg/kg/day, HDT
------------------------------------------------------------------------
870.4100......................  Chronic toxicity   NOAEL = 1,068 mg/kg/
870.4200......................   and                day, HDT; no
                                  Carcinogenicity    evidence of
                                  rodents.           carcinogenicity
------------------------------------------------------------------------
870.4100......................  Chronic toxicity   NOAEL = 1,165 mg/kg/
                                  dogs.              day, HDT
------------------------------------------------------------------------
870.4300......................  Carcinogenicity    NOAEL = 1,053 mg/kg/
                                  mice.              day, HDT; no
                                                     evidence of
                                                     carcinogenicity
------------------------------------------------------------------------
870.5100......................  Gene Mutation....  Negative
------------------------------------------------------------------------
870.5375......................  Cytogenetics.....  Negative
------------------------------------------------------------------------
870.5385......................  Other Effects....  Negative
------------------------------------------------------------------------
870.7485......................  Metabolism and     Rapidly excreted
                                  pharmacokinetics.  primarily in the
                                                     urine following
                                                     intravenous
                                                     administration, and
                                                     in the urine and
                                                     feces following oral
                                                     administration,
                                                     mainly as unchanged
                                                     parent.
------------------------------------------------------------------------

C. Exposure Assessment

     1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.508) for the residues of imazamox, in or on the
raw agricultural commodity soybeans. Due to low toxicity, it was
determined that a dietary risk assessment of imazamox in food is not
needed and, therefore, none was conducted.
     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. No appropriate endpoint attributable to a single
exposure (dose) was identified in the imazamox toxicity database
including oral developmental toxicity studies in rats and rabbits.
     ii. Chronic exposure. There were no observed adverse effects at the
highest dose tested (1,000 mg/kg/day or higher) in any of the
subchronic or chronic toxicity tests conducted and the August 1998
OPPTS Series 870 Harmonized Test Guidelines for health effects
recommend for subchronic and chronic testing the highest dose tested
should not exceed 1,000 mg/kg/day using the procedures described for
these studies, unless potential human exposure data indicate the need
for higher doses. When imazamox was tested up to or above the limit
dose, no significant adverse effects were observed. Therefore, it was
determined that a chronic dietary risk assessment of imazamox in food
is not needed and, therefore, none was conducted.
     2. Dietary exposure from drinking water. 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 screening
concentration in ground water (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) of imazamox for acute exposures are estimated to
be 32 parts per billion (ppb) for surface water and 0.62 ppb for ground
water. The EECs for chronic exposures are estimated to be 3.4 ppb for
surface water and 0.62 ppb for ground water. These concentrations were
compared to the lowest high dose tested in the toxicity studies (900
mg/kg) divided by an uncertainty factor of 100, i.e., 9 mg/kg. For
chronic exposure in surface water, the EEC of 3.4 ppb is 5/10,000% of 9
mg/kg. For acute exposure in surface water, the EEC of 32 ppb is 4/
1,000% of 9 mg/kg. For chronic and acute exposure in ground water, the
EEC of 0.62 ppb is 7/10,000% of 9 mg/kg. Because the concentration of
imazamox in drinking water are much smaller than 9 mg/kg, the
contribution of consumption of imazamox via drinking water to total
dietary consumption of imazamox (food plus water) is not significant.
     3. From non-dietary 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 for use on any sites that would result in residential
exposure.
     4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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).

D. Safety Factor for Infants and Children

     1. In general. FFDCA section 408 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 database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children.
     2. Prenatal and postnatal sensitivity. No significant toxicity or
pre- or post-natal toxicity was seen in any of the studies conducted
with imazamox.
     3. Conclusion. Due to its low toxicity a risk assessment using a
safety factor approach was not conducted for imazamox. For similar
reasons, it would not be appropriate to use an additional 10x safety
factor to protect infants and children.

E. Aggregate Risks and Determination of Safety

     1. Acute risk. Since the acute toxicity is low (toxicity categories
III and IV) for all tests conducted, the occurrence of an effect of
concern as a result of a one day or single exposure is highly unlikely.
It was determined that contribution of additional dietary risk due to
drinking water consumption is insignificant as described in section C.
2. above.
     2. Chronic risk. There were no observed adverse effects at the
highest dose tested (1,000 mg/kg/day or higher) in any of the
subchronic or chronic toxicity tests conducted and the August 1998
OPPTS Series 870 Harmonized Test Guidelines for health effects
recommend for subchronic and chronic testing the highest dose tested
should not exceed 1000 mg/kg/day using the procedures described for
these studies, unless potential human exposure data indicate the need
for higher doses. When imazamox was tested up to or above the limit
dose, no significant adverse effects were observed. Therefore, it was
determined that a chronic dietary risk assessment of imazamox in food
is not needed and, therefore, none was conducted.
     3. Determination of safety. Based on the low toxicity of imazamox
and the rationales described above, EPA concludes that there is a
reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
imazamox residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

     The method may be requested from Francis Griffith, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort
George G. Mead, Maryland, 20755-5350; telephone number: (410) 305-2905;
e-mail address: griffith.francis@epa.gov.

B. International Residue Limits

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

V. Conclusion

     Therefore, tolerances are established for residues of the herbicide
imazamox, ()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-
oxo-1H-imidazol-2-yl]-5-(methoxymethyl)-3-pyridinecarboxylic acid, in
or on the raw agricultural commodities: vegetable, legume, group at
0.05 ppm; canola, seed at 0.05 ppm. Tolerances are established for the
combined residues of the herbicide imazamox, and its metabolite,
AC263284 ()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-
oxo-1H-imidazol-2-yl]-5-(hydroxymethyl)-3-pyridinecarboxylic acid in or
on the following raw agricultural commodities wheat, grain, forage and
hay at 0.3 ppm, wheat, straw at 0.2 ppm, wheat, bran at 1.0 ppm, wheat,
shorts at 0.8 ppm, and wheat, germ at 0.6 ppm. Tolerances are
established for the combined residues of the herbicide imazamox, and
its metabolite, AC263284 (free and conjugated), and AC312622,
()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-3,5-pyridinecarboxylic acid in or on the following raw
agricultural commodities: alfalfa, seed at 0.4 ppm, alfalfa, forage at
2.0 ppm and alfalfa, hay at 4.0 ppm respectively

VI. 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 control number OPP-301205 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 February
25, 2002.
     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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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 (202) 260-4865.
     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.
     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.
     3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.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.2. Mail your
copies, identified by docket control number OPP-301205, 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.
In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. 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).

VII. Regulatory Assessment Requirements

     This final rule establishes a tolerance 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 tolerance 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.

VIII. 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: December 18, 2001.
Peter Caulkins,
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.

     2. Section 180.508 is amended by revising paragraph (a) to read as
follows:

Sec. 180.508  Imazamox; tolerances for residues.

     (a) General. (1) Tolerances are established for residues of the
herbicide imazamox, ()2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(methoxymethyl)-3-
pyridinecarboxylic acid in or on the raw agricultural commodities:
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Canola, seed............................................            0.05
Vegetable, legume, group................................            0.05
------------------------------------------------------------------------

     (2) Tolerances are established for the combined residues of the
herbicide imazamox, and its metabolite AC263284 [()2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
(hydroxymethyl)-3-pyridinecarboxylic acid in or on the raw agricultural
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Wheat, grain............................................            0.30
Wheat, forage...........................................            0.30
Wheat, hay..............................................            0.30
Wheat, straw............................................            0.20
Wheat, bran.............................................             1.0
Wheat, shorts...........................................            0.80
Wheat, germ.............................................            0.60
------------------------------------------------------------------------

     (3) Tolerances are established for the combined residues of the
herbicide imazamox, and its metabolite AC263284 (free and conjugated),
and AC312622, [()-2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-3,5-pyridinecarboxylic acid in or
on the raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, seed...........................................            0.40
Alfalfa, forage.........................................             2.0
Alfalfa, hay............................................             4.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-31799 Filed 12-26-01; 8:45 am]