[Federal Register Volume 67, Number 168 (Thursday, August 29, 2002)]
[Rules and Regulations]
[Pages 55323-55331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22093]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0189; FRL-7193-4]


Imazethapyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for combined residues 
of imazethapyr, its metabolite CL 288511 and its metabolite CL 182704 
in or on rice bran, rice grain, and rice straw. This regulation also 
establishes a tolerance for combined residues of imazethapyr and its 
metabolite CL 288511 in or on crayfish and meat byproducts of cattle, 
goat, hog, horse, and sheep. BASF requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996.

DATES: This regulation is effective August 29, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0189, 
must be received on or before October 28, 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 ID number OPP-2002-0189 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; e-mail address: [email protected].

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/. 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.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0189. 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 September 27, 2000 (65 FR 58074) (FRL-
6744-6), 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

[[Page 55324]]

Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 0F6168) by American Cyanamid, now 
BASF, 26 Davis Drive, Research Triangle Park, NC 27709. This notice 
included a summary of the petition prepared by American Cyanamid, the 
registrant. There were no comments received in response to the notice 
of filing.
    The petition requested that 40 CFR 180.447 be amended by 
establishing a tolerance for combined residues of the herbicide 
imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid as it free acid or 
ammonium salt and its metabolite CL 288511, 2-[4,5-dihydro-4-methyl-4-
(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(1-hydroxyethyl)-3-pyridine 
carboxylic acid both free and conjugated, in or on rice grain at 0.5 
parts per million (ppm), rice straw at 0.3 ppm, and crayfish at 0.1 
ppm.
    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).
    After analysis of submitted residue chemistry data, EPA determined 
that appropriate tolerances for rice and crayfish differ from those 
proposed by the registrant. EPA determined that a tolerance of 1.2 ppm 
is needed for rice bran; no tolerance for rice bran was proposed by the 
registrant. EPA also determined that tolerances should be 0.20 ppm 
instead of 0.5 ppm for rice grain, and 0.15 ppm instead of 0.3 ppm for 
rice straw. Further, EPA determined that the tolerance expression for 
rice commodities should be for imazethapyr and the metabolites CL 
288511 and CL 182704 (5-[1-(beta-D-glucopyranosyloxy)ethyl]-2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-
pyridinecarboxylic acid); the registrant's proposed tolerance 
expression for rice commodities was for imazethapyr as the free acid 
and ammonium salt and CL 288511 both free and conjugated. For crayfish, 
EPA determined that the tolerance expression should be for imazethapyr 
and CL 288511; the registrant's proposed tolerance expression for 
crayfish was for imazethapyr as the free acid and ammonium salt and CL 
288511 both free and conjugated. Finally, EPA determined that 
tolerances of 0.10 ppm for imazethapyr and CL 288511 need to be 
established for meat byproducts of cattle, goat, hog, horse, and sheep; 
the registrant did not propose tolerances for these commodities. EPA 
determined that tolerances are not needed for eggs; milk; meat and fat 
of cattle, goat, hog, horse, and sheep; and poultry commodities because 
there is no reasonable expectation of finite residues based on the 
calculated maximum total dietary burdens and the results of the poultry 
metabolism study.

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 a tolerance for combined residues of imazethapyr and its 
metabolite CL 288511 on crayfish and meat byproducts of cattle, goat, 
hog, horse, and sheep at 0.10 ppm, and for tolerances for combined 
residues of imazethapyr, its metabolite CL 288511, and its metabolite 
CL 182704 on rice bran at 1.2 ppm, rice grain at 0.20 ppm, and rice 
straw at 0.15 ppm. 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 imazethapyr are 
discussed in the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

                            Table 1.--Acute, Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
                                                                    MRID No. (year)/
            Guideline No.                     Study Type          Classification/Doses           Results
----------------------------------------------------------------------------------------------------------------
870.1100                               Acute Oral               00159375 (1985)          LD50 []5,000 mg/kg (male
                                                                5,000 mg/kg............   and female rats)
                                                                                         Toxicity Category IV
----------------------------------------------------------------------------------------------------------------
870.1200                               Acute Dermal             00159375 (1985)          LD50 []2,000 mg/kg(male
                                                                2,000 mg/kg............   and female rabbits)
                                                                                         Toxicity Category III
----------------------------------------------------------------------------------------------------------------
870.1300                                Acute Inhalation        00159378 (1985)          LD50 []3.27 mg/L (male and
                                                                3.27 mg/L..............   female rats)
                                                                                         Toxicity Category III
----------------------------------------------------------------------------------------------------------------
870.2400                               Primary Eye Irritation   00159375 (1985)          Not an irritant
                                                                Acceptable/guideline...  Toxicity Category III
                                                                0.1 mL.................
----------------------------------------------------------------------------------------------------------------

[[Page 55325]]

 
870.2500                               Primary Skin Irritation  00159375 (1985)          Not an irritant
                                                                Acceptable/guideline...  Toxicity Category IV
                                                                0.5 mL.................
----------------------------------------------------------------------------------------------------------------
870.2600                               Dermal Sensitization     00159379 (1985)          Not a skin sensitizer
                                                                Acceptable/guideline...  (Toxicity Category Not
                                                                0.4 mL.................   Applicable)
----------------------------------------------------------------------------------------------------------------
870.3100                               90-Day oral toxicity     00159381 (1986)          NOAEL = 500 mg/kg/day
                                        rodents-rat             Acceptable/guideline...   (HDT).
                                                                0, 1,000, 5,000, or      LOAEL = Not observed.
                                                                 10,000 ppm 0, 50, 250,
                                                                 or 500 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.3150                               90-Day oral toxicity     00159382 (1985)          NOAEL = 250 mg/kg/day
                                        nonrodents-dog          Acceptable/guideline...   (HDT).
                                                                0, 1,000, 5,000 or       LOAEL = Not observed.
                                                                 10,000 ppm 0, 25, 125
                                                                 or 250 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.3200                               21-Day dermal toxicity-  00159383 (1985)          NOAEL = 1,096 mg/kg/day
                                        rabbit                  Acceptable/guideline...   (HDT).
                                                                0, 50, 200, or 1,000 mg/ LOAEL = Not observed.
                                                                 kg/day 0, 54.8, 219.3,
                                                                 or 1,096.5 mg/kg/day
                                                                 (adjusted for purity).
----------------------------------------------------------------------------------------------------------------
870.3700                               Prenatal developmental   40429417 (1985)          Maternal: NOAEL = 375
                                        in rodents-rat          Acceptable/guideline...   mg/kg/day
                                                                0, 125, 375, or 1,125    LOAEL = 1,125 mg/kg/day
                                                                 mg/kg/day.               based on increased
                                                                                          incidences of clinical
                                                                                          signs during the
                                                                                          gestation
                                                                                         Developmental: NOAEL =
                                                                                          1,125 mg/kg/day
                                                                                         LOAEL =Not observed
----------------------------------------------------------------------------------------------------------------
870.3700                               Prenatal developmental   00159384 (1986)          Maternal: NOAEL = 300
                                        in nonrodents-rabbit    Acceptable/guideline...   mg/kg/day
                                                                0, 100, 300, or 1,000    LOAEL = 1,000 mg/kg/day
                                                                 mg/kg/day.               based on an increased
                                                                                          incidence of clinical
                                                                                          signs during
                                                                                          gestation, ulcerations
                                                                                          in the mucosal layer
                                                                                          of the stomach and
                                                                                          gall bladder,
                                                                                          increased abortions,
                                                                                          and maternal deaths.
                                                                                         Developmental: NOAEL =
                                                                                          1,000 mg/kg/day (HDT)
                                                                                         LOAEL = Not observed
----------------------------------------------------------------------------------------------------------------
870.3800                               Reproduction and         40429418 (1987)          Parental/Systemic NOAEL
                                        fertility effects-rat   Acceptable/guideline...   = 500 mg/kg/day (HDT).
                                                                0, 1,000, 5,000 or       LOAEL = Not observed.
                                                                 10,000 ppm 0, 50, 250   Reproductive NOAEL =
                                                                 or 500 mg/kg/day.        500 mg/kg/day (HDT).
                                                                                         LOAEL = Not observed.
                                                                                         Offspring NOAEL = 500
                                                                                          mg/kg/day (HDT).
                                                                                         LOAEL = Not observed.
----------------------------------------------------------------------------------------------------------------
870.4100                               Chronic toxicity-dog...  40429416 (1987)          NOAEL = 250 mg/kg/day
                                                                Acceptable/guideline...   (HDT).
                                                                0, 1,000, 5,000 or       LOAEL = Not observed.
                                                                 10,000 ppm 0, 25, 125,
                                                                 or 250 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.4300                               Chronic/                 40429414 (1987)          NOAEL = 500 mg/kg/day
                                        Carcinogenicity-rat.    Acceptable/guideline...   (HDT).
                                                                0, 1,000, 5,000, or      LOAEL = Not observed.
                                                                 10,000 ppm 0, 50, 250,  No evidence of
                                                                 or 500 mg/kg/day.        carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.4300                               Carcinogenicity-mouse..  40429415 (1987)          NOAEL = 750 mg/kg/day
                                                                Acceptable/guideline...  LOAEL = 1,500 mg/kg/day
                                                                0, 1,000, 5,000, or       (HDT) based on the
                                                                 10,000 ppm 0, 150,       decrement in body
                                                                 750, or 1,500 mg/kg/     weight gain
                                                                 day.                    No evidence of
                                                                                          carcinogenicity at
                                                                                          doses tested.
----------------------------------------------------------------------------------------------------------------
870.5100                               Gene Mutation            00159719 (1986)          Non-mutagenic when
                                                                Acceptable/guideline...   tested up to 5,000
                                                                0, 50, 158, 500, 1,000,   [mu]g/plate, in
                                                                 1581, 3162 or 5,000      presence and absence
                                                                 [mu]g/plate.             of metabolic
                                                                                          activation, in S.
                                                                                          typhimurium strains
                                                                                          TA98, TA100, TA1535,
                                                                                          TA1537, and TA 1538
                                                                                          and E.coli strain
                                                                                          WP2uvra.
----------------------------------------------------------------------------------------------------------------
870.5300                               Gene Mutation            40429419 (1986)          Negative for induction
                                                                Acceptable/guideline...   of forward mutation at
                                                                up to 3333 [mu]g/mL       the HPRT locus in
                                                                 (limit of solubility)    Chinese hamster ovary
                                                                 and 4000 [mu]g/mL        cells, in the presence
                                                                 (beyond limit of         or absence of S9-
                                                                 solubility).             activation at doses up
                                                                                          to limit of solubility
                                                                                          (3,333 [mu]g/mL) and
                                                                                          beyond (4,000 [mu]g/
                                                                                          mL).
----------------------------------------------------------------------------------------------------------------
870.5375                               Chromosome aberration    40438201 (1986)          Did not induce
                                                                Acceptable/guideline...   structural chromosome
                                                                0, 1.14, 1.71, 1.82,      aberration in Chinese
                                                                 2.05, and 2.28 mg/ml     hamster lung (V79)
                                                                 with and without S9      cell cultures in the
                                                                 activation.              presence and absence
                                                                                          of activation up to
                                                                                          cytotoxic
                                                                                          concentrations.
----------------------------------------------------------------------------------------------------------------
870.5450                               Dominant Lethal Assay    00159720 (1985)          Negative for dominant
                                                                Unacceptable/guideline.   lethal effects
                                                                0, 200, 1,000 or 2,000    (chromosomal damage)
                                                                 mg/kg.                   at doses up to 2,000
                                                                                          mg/kg.
----------------------------------------------------------------------------------------------------------------

[[Page 55326]]

 
870.5550                               Other Genotoxicity       00159721 (1985)          No evidence that
                                                                Acceptable/guideline...   unscheduled DNA
                                                                0, 0.13, 0.4, 1.3, 4.0,   synthesis was induced
                                                                 13, 40, 133, 400,        by imazethapyr, as
                                                                 1,333, or 4,000 [mu]g/   determined by
                                                                 mL.                      radioactive tracer
                                                                                          procedures [nuclear
                                                                                          silver grain counts].
----------------------------------------------------------------------------------------------------------------
870.7485                               Metabolism and           40429420 and 41467703    In a rat metabolism
                                        pharmacokinetics - rat   (1987)                   study, almost 100% of
                                                                Acceptable/guideline...   the administered
                                                                5.7 mg/kg single dose;    radiolabeled test
                                                                 1,000 mg/kg single       material was recovered
                                                                 dose and 3 daily doses   in the excreta within
                                                                 of 250 mg/kg followed    96 hours (89-95% in
                                                                 by a single dose of      the urine and 6-11% in
                                                                 1000 mg/kg; 1,000 mg/    the feces). Greater
                                                                 kg/day single and        than 95% of the oral
                                                                 repeated dose.           dose was excreted in
                                                                                          the first 31 hours.
                                                                                          The major residue in
                                                                                          both urine and feces
                                                                                          was the parent
                                                                                          compound.
                                                                                          Approximately 2% of
                                                                                          the oral dose was
                                                                                          metabolized and
                                                                                          excreted as CL 288511
                                                                                          (1-hydroxy ethyl
                                                                                          derivative of AC
                                                                                          263,499, parent).
                                                                                         A high percentage of
                                                                                          the administered
                                                                                          material was excreted
                                                                                          in the urine as the
                                                                                          unmodified parent
                                                                                          compound (> 97%) and a
                                                                                          very small amount as
                                                                                          the CL 288511. In the
                                                                                          high dose group, the
                                                                                          unmodified parent
                                                                                          compound was the major
                                                                                          fecal component in
                                                                                          both sexes,
                                                                                          particularly at 12
                                                                                          hours or less. The CL
                                                                                          288511 was the major
                                                                                          metabolite. One
                                                                                          unknown was also found
                                                                                          in significant
                                                                                          quantities. In the low
                                                                                          dose group, six
                                                                                          components were found
                                                                                          in the feces: parent
                                                                                          compound, the CL
                                                                                          288511, the unknown
                                                                                          previously mentioned
                                                                                          and several minor
                                                                                          unknowns.
----------------------------------------------------------------------------------------------------------------

B. 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. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a 
million). Under certain specific circumstances, MOE calculations will 
be used for the carcinogenic risk assessment. In this non-linear 
approach, a ``point of departure'' is identified below which 
carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer = point of departure/exposures) is calculated. A 
summary of the toxicological endpoints for imazethapyr used for human 
risk assessment is shown in the following Table 2:

     Table 2.--Summary of Toxicological Dose and Endpoints for Imazethapyr for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                           Assessment, UF*           Assessment\1\               Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary for general population   None                     N/A                      No hazard has been
 and females 13-50                                                                        identified.
                                                                                          Quantitation of acute
                                                                                          dietary risk is not
                                                                                          required for both
                                                                                          general population and
                                                                                          female 13-50 years old
                                                                                          population sub group.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 250 mg/kg/day    FQPA SF= 1               Chronic Oral Toxicity
                                       UF = 100...............  cPAD = 2.5 mg/kg/day...   [diet] - dog
                                       cRfD = 2.5 mg/kg/day...                           No toxicity was seen at
                                                                                          the HDT of 250 mg/kg/
                                                                                          day.
----------------------------------------------------------------------------------------------------------------

[[Page 55327]]

 
Incidental Oral Short-Term (1-30       Oral NOAEL= 300 mg/kg/   FQPA SF= 1               Developmental Toxicity
 days) and Intermediate-Term (30 days-  day                     LOC for MOE = 100         Study - rabbit
 6 months)                                                       (residential).          Based on ulcerations in
                                                                                          the mucosal layer of
                                                                                          the stomach and the
                                                                                          gall bladder seen at
                                                                                          1000 mg/kg/day
                                                                                          (LOAEL).
----------------------------------------------------------------------------------------------------------------
Dermal Short-Term (1-30 days),         None                     N/A                      No hazard has been
 Intermediate-Term (30 days-6                                                             identified.
 months), and Long-Term (6 months-                                                        Quantitation of short-
 life time)                                                                               , intermediate- and
                                                                                          long-term dermal
                                                                                          exposure risk
                                                                                          assessment is not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
Inhalation, Short-Term (1-30 days)     Oral NOAEL= 300 mg/kg/   LOC* for MOE = 100       Developmental Toxicity
 and Intermediate-Term (30 days-6       day                      (residential and         Study - rabbit
 months)                               inhalation absorption     occupational)           Based on ulcerations in
                                        factor 100%.                                      the mucosal layer of
                                                                                          the stomach and the
                                                                                          gall bladder,
                                                                                          increased incidence of
                                                                                          clinical signs during
                                                                                          gestation, increased
                                                                                          abortions, and
                                                                                          maternal deaths seen
                                                                                          at 1,000 mg/kg/day
                                                                                          (LOAEL).
----------------------------------------------------------------------------------------------------------------
Inhalation, Long-Term (6 months-life   Oral NOAEL= 250 mg/kg/   LOC for MOE = 100        Chronic Oral Toxicity
 time)                                  day                      (residential and         [diet] - dog
                                       inhalation absorption     occupational)           No toxicity was seen at
                                        factor 100%.                                      the HDT of 250 mg/kg/
                                                                                          day.
----------------------------------------------------------------------------------------------------------------
* UF = uncertainty factor, SF = Safety Factor, LOC = level of concern
\1\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.447) for the combined residues of imazethapyr, 
its metabolite CL 288511, and its metabolite CL 182704 in or on a 
variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from imazethapyr in food 
as follows:
    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. Since there were no developmental effects and the 
toxicological effects seen in the rabbit and rat developmental toxicity 
studies occurred after several days of dosing or at doses above the 
limit dose, acute (single dose) risk assessment for both the general 
population and the female 13-50 years old population subgroup was 
considered inappropriate. Therefore, an acute dietary risk assessment 
was not conducted.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM[reg]) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: The chronic dietary assessment assumed tolerance level 
residues for all registered and proposed commodities excluding corn 
grain (conservative corn grain residue estimate of 0.15 ppm was used). 
DEEM[reg] default processing factors and 100% crop treated were assumed 
for all registered and proposed commodities.
    iii. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for imazethapyr 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 imazethapyr.
    EPA determined that the residue of concern in drinking water is 
only imazethapyr. EPA provided ground (SCI-GROW; 8.97 [mu]g/l) and 
surface water (rice paddy model; peak and average - 93.18 [mu]g/l) 
estimated environmental concentrations (EECs) for imazethapyr. The 
ground and surface water EECs were generated assuming a single 
application of imazethapyr at 0.094 lbs ae/acre (highest registered/
proposed single application rate).
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use EECs from these models 
to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead, drinking water levels of comparison (DWLOCs) are calculated 
and used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Since DWLOCs address total aggregate exposure to imazethapyr they are 
further discussed in the aggregate risk sections in Unit IV.E. of this 
preamble.
    Based on the rice paddy and SCI-GROW models the EECs of imazethapyr 
for chronic exposures are estimated to be 93.18 [mu]g/L (parts per 
billion (ppb)) for surface water and 8.97 [mu]g/L (ppb) for ground 
water. Because the Agency determined that an acute (single dose) risk 
assessment for both the general

[[Page 55328]]

population and the female 13-50 years old population subgroup was 
considered inappropriate (see unit III. C.1.i.), EECs of imazethapyr 
for acute exposures were not estimated.
    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).
    Imazethapyr 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 imazethapyr 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, 
imazethapyr 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 imazethapyr has a common mechanism of toxicity 
with other substances.
    EPA has recently developed a framework that it proposes to use for 
conducting cumulative risk assessments on substances that have a common 
mechanism of toxicity. This guidance was issued for public comment on 
January 16, 2002 (67 FR 2210-2214) and is available from the OPP 
Website at: http://www.epa.gov/pesticides/trac/science/cumulative_guidance.pdf. Before undertaking a cumulative risk assessment, the 
Agencv will follow procedures for identifying chemicals that have a 
common mechanism of toxicity as set forth in the ``Guidance for 
Identifying Pesticide Chemicals and Other Substances that Have a Common 
Mechanism of Toxicity'' (64 FR 5795-5796, February 5, 1999).

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 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 margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. EPA concluded that there is 
no quantitative or qualitative evidence of increased susceptibility 
following in utero exposure to imazethapyr in the rat and rabbit 
developmental toxicity studies. There is no quantitative and 
qualitative evidence of increased susceptibility following pre- or 
postnatal exposure to imazethapyr in the 2-generation reproduction 
study in rats.
    3. Conclusion. There is a complete toxicity database for 
imazethapyr and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. The FQPA SFC 
concluded that the safety factor could be removed (1x) for imazethapyr 
because the toxicological database is complete for FQPA assessment; 
there is no indication of quantitative or qualitative increased 
susceptibility of rats or rabbits to in utero and/or postnatal 
exposure; a developmental neurotoxicity study is not required; and the 
dietary (food and drinking water) exposure assessments will not 
underestimate the potential exposures for infants and children.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA are used to calculate DWLOCs: 2L/70 kg 
(adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default 
body weights and drinking water consumption values vary on an 
individual basis. This variation will be taken into account in more 
refined screening-level and quantitative drinking water exposure 
assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Because no acute endpoint was identified for 
imazethapyr, no acute risk is expected from acute exposures.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
imazethapyr from food will utilize <1% of the cPAD for the U.S. 
population, <1% of the cPAD for all infants (<1 year old) and <1% of 
the cPAD for children (1-12 years old). There are no residential uses 
for imazethapyr that result in chronic residential exposure to 
imazethapyr. In addition, there is potential for chronic dietary 
exposure to imazethapyr in drinking water. After calculating DWLOCs and 
comparing them to the EECs for surface and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD, as shown in 
the following Table 3:

[[Page 55329]]



              Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Imazethapyr
----------------------------------------------------------------------------------------------------------------
                                                                          Surface       Ground
             Population Subgroup              cPAD mg/kg/     % cPAD     Water EEC    Water EEC    Chronic DWLOC
                                                  day         (Food)       (ppb)        (ppb)          (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                       2.5           <1        93.18         8.97         8.7e+04
----------------------------------------------------------------------------------------------------------------
 All Infants (<1 year old)                            2.5           <1        93.18         8.97         2.5e+04
----------------------------------------------------------------------------------------------------------------
 Children (1-6 years old)                             2.5           <1        93.18         8.97         2.5e+04
----------------------------------------------------------------------------------------------------------------
 Children (7-12 years old)                            2.5           <1        93.18         8.97         2.5e+04
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                             2.5           <1        93.18         8.97         7.5e+04
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                               2.5           <1        93.18         8.97         8.7e+04
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                                 2.5           <1        93.18         8.97         8.7e+04
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                               2.5           <1        93.18         8.97         8.7e+04
----------------------------------------------------------------------------------------------------------------

    3. Determination of safety. Based on these risk assessments, 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 imazethapyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Paul Golden, USEPA/OPP/BEAD/ACB, Environmental Science 
Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone number: 
(410) 305-2960; e-mail address: [email protected]

B. International Residue Limits

    Codex, Canada, and Mexico do not have maximum residue limits (MRLs) 
for residues of imazethapyr and CL 288511 in/on rice.

C. Conditions

    The following will be imposed as conditions of registration of 
imazethapyr on rice: successful pesticide method validation (PMV) and 
radiovalidation of the rice, crayfish, and livestock enforcement 
methods, and submission of an acceptable crayfish residue and ruminant 
feeding studies.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid, its metabolite CL 
288511, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-
yl]-5-(1-hydroxyethyl)-3-pyridine carboxylic acid, and its metabolite 
CL 182704, 5-[1-(beta-D-glucopyranosyloxy)ethyl]-2-[4,5-dihydro-4-
methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-pyridinecarboxylic 
acid, in or on rice grain at 0.5 parts per million (ppm), rice straw at 
0.3 ppm. In addition, a tolerance is established for combined residues 
of imazethapyr and its metabolite CL 288511 in or on crayfish and meat 
byproducts of cattle, goat, hog, horse, and sheep at 0.10 ppm.

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 ID number OPP-2002-0189 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 October 
28, 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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your written 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.''

[[Page 55330]]

    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.
    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 ID number OPP-2002-0189, 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: [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).

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

[[Page 55331]]

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: August 21, 2002.
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.

    2. Section 180.447 is revised to read as follows:


Sec. 180.447  Imazethapyr; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo- 
1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid, applied as its 
acid or ammonium salt, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
 
                                                              Commodity
 
------------------------------------------------------------------------
Legume vegetables..........................................          0.1
Soybeans...................................................          0.1
------------------------------------------------------------------------

    (2)Tolerances are established for the sum of the residues of the 
herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo- 
1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid; its metabolite CL 
288511, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-
yl]-5-(1-hydroxyethyl)-3-pyridine carboxylic acid; and its metabolite 
CL 182704, 5-[1-(beta-D-glucopyranosyloxy)ethyl]-2-[4,5-dihydro-4-
methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-pyridinecarboxylic 
acid, applied as its acid or ammonium salt, in or on the following 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................          3.0
Alfalfa, hay...............................................          3.0
Peanut.....................................................          0.1
Rice, bran.................................................          1.2
Rice, grain................................................         0.20
Rice, straw................................................         0.15
------------------------------------------------------------------------

    (3) A tolerance is established for the sum of residues of the 
herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo- 
1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid, and its 
metabolite CL 288511, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5- oxo-
1H-imidazol-2-yl]-5-(1-hydroxyethyl)-3-pyridine carboxylic acid, 
applied as its acid or ammonium salt, in or on the following 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts....................................         0.10
Corn, field, forage........................................          0.1
Corn, field, grain.........................................          0.1
Corn, field, stover........................................          0.1
Crayfish...................................................         0.10
Goat, meat byproducts......................................         0.10
Hog, meat byproducts.......................................         0.10
Horse, meat byproducts.....................................         0.10
Sheep, meat byproducts.....................................         0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with 
regional registration, as defined in Sec. 180.1(n) of this chapter, are 
established for the sum of residues of the herbicide imazethapyr, 2- 
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
ethyl- 3-pyridine carboxylic acid, as its ammonium salt, and its 
metabolite, 2- [4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-(1- hydroxyethyl)-3-pyridine carboxylic acid, both 
free and conjugated, applied as its acid or ammonium salt, in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Endive (escorole)..........................................          0.1
Lettuce, head..............................................          0.1
Lettuce, leaf..............................................          0.1
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 02-22093 Filed 8-28-02; 8:45 am]
BILLING CODE 6560-50-S