[Federal Register Volume 68, Number 187 (Friday, September 26, 2003)]
[Rules and Regulations]
[Pages 55475-55485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24123]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0264; FRL-7321-4]


Imazapyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
imazapyr [2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-
2-yl]-3-pyridinecarboxylic acid] in or on grass, forage; grass, hay; 
fish; shellfish; fats of cattle, sheep, goats, and horses; kidney of 
cattle, sheep, goats, and horses; meat byproducts (except kidney) of 
cattle, sheep, goats, and horses; meat of cattle, sheep, goats, and 
horses; and milk.. BASF requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA) , as amended by the Food Quality 
Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 26, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0264, 
must be received on or before November 25, 2003.

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

FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division, 
7505C, Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; 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 potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)

[[Page 55476]]

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

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0264. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the`` Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of August 13, 2003 (68 FR 48362) (FRL-7321-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (PP 0F6166) by BASF Corporation, P.O. Box 13528, 
Research Triangle Park, NC 27709-3528. That notice included a summary 
of the petition prepared by BASF Corporation, the registrant. There 
were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.500 be amended by 
establishing a tolerance for residues of the herbicide imazapyr, in or 
on grass, forage at 100 parts per million (ppm); grass, hay at 30 ppm; 
fish at 1.0 ppm; shellfish at 0.10 ppm; fats of cattle, sheep, goats, 
and horses 0.05 ppm; kidney of cattle, sheep, goats, and horses at 0.20 
ppm; meat byproducts (except kidney) of cattle, sheep, goats, and 
horses at 0.05 ppm; meat of cattle, sheep, goats, and horses at 0.05 
ppm; and milk at 0.01 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) of the FFDCA 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) of the FFDCA 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 of the FFDCA 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) of the FFDCA, 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) of the FFDCA, for a tolerance for residues of imazapyr on 
grass, forage at 100 ppm; grass, hay at 30 ppm; fish at 1.0 ppm; 
shellfish at 0.10 ppm; fats of cattle, sheep, goats, and horses 0.05 
ppm; kidney of cattle, sheep, goats, and horses at 0.20 ppm; meat 
byproducts (except kidney) of cattle, sheep, goats, and horses at 0.05 
ppm; meat of cattle, sheep, goats, and horses at 0.05 ppm; and milk at 
0.01 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 imazapyr are 
discussed in Tables 1 and 2 of this unit 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 Toxicity of Imazapyr Technical Grade Active Ingredient (TGAI).
----------------------------------------------------------------------------------------------------------------
        Guideline No/Study Type                    Results                        Toxicity Category
----------------------------------------------------------------------------------------------------------------
870.1100 Acute Oral                      LD50 = >5,000 mg/kg         IV
----------------------------------------------------------------------------------------------------------------

[[Page 55477]]

 
870.1200 Acute Dermal                    LD50 = >2,000 mg/kg         III
----------------------------------------------------------------------------------------------------------------
870.1300 Acute Inhalation                LC50 = >1.3 mg/L            III
                                          (gravimetric) >5.1 mg/L
                                          (nominal)
----------------------------------------------------------------------------------------------------------------
870.2400 Primary Eye Irritation          Corneal Opacity;            I
                                          Conjunctive: redness,
                                          Chemosis & Discharge;
                                          Vascularization of
                                          Cornea; Corrosive:
                                          Irreversible Eye Damage
----------------------------------------------------------------------------------------------------------------
870.2500 Primary Skin Irritation         Non-irritating to slight    IV
                                          erythema and edema
----------------------------------------------------------------------------------------------------------------
870.2600 Dermal Sensitization            Negative
----------------------------------------------------------------------------------------------------------------


                                Table 2.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        Dermal and Systemic NOAEL =1,695 mg/kg/day
                                          rodents (rat)               for males and =1,784 mg/kg/day for females
                                                                      highest dose tested (HDT). This was the
                                                                      HDT; therefore, there is no LOAEL.
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28-Day dermal toxicity   Dermal and Systemic NOAEL = 400 mg/kg/day.
                                          (rabbit)                    This was the HDT; therefore, there is no
                                                                      LOAEL.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental      Maternal NOAEL = 300 mg/kg bw/day.
                                          toxicity in rodents (rat)  LOAEL =1,000 mg/kg bw/day, based on
                                                                      salivation.
                                                                     Developmental NOAEL =1,000 mg/kg/day. This
                                                                      was the HDT; therefore, there is no LOAEL.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental      Maternal NOAEL =400 mg/kg bw/day This was
                                          toxicity in nonrodents      the HDT; therefore, there is no LOAEL.
                                          (rabbit)                   Developmental NOAEL =400 mg/kg bw/day. This
                                                                      was the HDT; therefore, there is no LOAEL.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental systemic, reproductive and
                                          effects (rat)               offspring NOAEL =10,000 ppm (738 mg/kg bw/
                                                                      day in males 933.3 mg/kg bw/day in
                                                                      females). This was the HDT; therefore,
                                                                      there is no LOAEL.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity (rodent)   NA; see 870.4300
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity (dog)      NOAEL is =10,000 ppm (250 mg/kg/day). This
                                                                      was the HDT; therefore, there is no LOAEL.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity (rat)       NA; see 870.4300
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity (mouse)     NOAEL =10,000 ppm (1,301 mg/kg/day in males
                                                                      and 1,639 mg/kg/day in females). This was
                                                                      the HDT; therefore, there is no LOAEL.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined Chronic/           Increase in brain astrocytomas in male rats
                                          carcinogenicity (rat)       for which there was a statistically
                                                                      significant positive trend, but which was
                                                                      not statistically significant in pairwise
                                                                      comparison to controls. The CPRC
                                                                      considered the astrocytomas in the male
                                                                      rats unrelated to treatment because there
                                                                      was no statistically significant pairwise
                                                                      increase. Dosing was considered to be
                                                                      adequate based on the HDT of 10,000 ppm
                                                                      which exceeds the limit dose of 7000 ppm
                                                                      for mice.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Bacterial reverse mutation  Negative up to 5,000 [mu]g/plate.
                                          (Ames Assay)
----------------------------------------------------------------------------------------------------------------
870.5300                                 In vitro mammalian cell     Negative up to toxic doses (5,000 [mu]g/ml)
                                          gene mutation               with and without activation.
----------------------------------------------------------------------------------------------------------------
870.5375                                 In vitro mammalian          Negative up to toxic doses (5,000 [mu]g/ml)
                                          chromosome aberration       with and without activation.
                                          (CHO)
----------------------------------------------------------------------------------------------------------------

[[Page 55478]]

 
870.5450                                 Rodent Dominant Lethal      Reported as negative (though unacceptable).
----------------------------------------------------------------------------------------------------------------
870.5550                                 Unscheduled DNA synthesis   Reported as negative (though unacceptable).
                                          (RPH)
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              No sex-related differences in absorption
                                          pharmacokinetics (rat)      were apparent. Within 48 hours of
                                                                      treatment, >90% of the administered dose
                                                                      was recovered in the excreta suggesting
                                                                      that elimination of the labeled test
                                                                      material was rapid. No specific
                                                                      sequestering tissues or organs were
                                                                      identified. Seven days after treatment,
                                                                      essentially all the test material had been
                                                                      eliminated. Rats that received the test
                                                                      material by intravenous injection excreted
                                                                      87-95% of the administered dose in the
                                                                      urine and approximately 6% into the feces.
                                                                      This suggests that 15-28% if the
                                                                      administered dose recovered in the feces
                                                                      represents unabsorbed material.
                                                                     Metabolite characterization studies show
                                                                      that essentially all of the test material
                                                                      was excreted unchanged. Two minor
                                                                      metabolites CL 252,974 and CL 60,032 were
                                                                      detected in the urine or feces of treated
                                                                      rats; however, their contribution combined
                                                                      was <0.5% of the administered dose. Up to
                                                                      12 additional unidentified metabolites
                                                                      were isolated, but they constituted >3% of
                                                                      the administered dose. Based on the
                                                                      results, the study author suggests that
                                                                      what limited metabolism of CL 243,997
                                                                      occurs, proceeds through hydrolysis to
                                                                      form the 2-carbonyl derivatives: CL
                                                                      252,974 and CL 60,032.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration          NA
----------------------------------------------------------------------------------------------------------------

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 margin of exposure (MOE). A 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 (SF) 
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 SF.
    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.
    A summary of the toxicological endpoints for imazapyr used for 
human risk assessment is shown in Table 3 of this unit:

      Table 3.--Summary of Toxicological Dose and Endpoints for Imazapyr for Use in Human Risk Assessment.
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF* and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of  none                     none                     An acute dietary
 age and General population including                                                     endpoint was not
 infants and children)                                                                    selected based on the
                                                                                          absence of an
                                                                                          appropriate endpoint
                                                                                          attributable to a
                                                                                          single dose.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      Oral Study               FQPA SF = 1X             1-Year Dog [feeding]
                                       NOAEL= 250 mg/kg/day...  cPAD = chronic RfD/FQPA   Study
                                       UF = 100...............   SF.                     No LOAEL was
                                       Chronic RfD= 2.5 mg/kg/  = 2.5 mg/kg/day........   demonstrated with
                                        day.                                              imazapyr at doses up
                                                                                          to 250 mg/kg/day
                                                                                          (HDT); HIARC
                                                                                          recommended this dose
                                                                                          for RA for imazapyr,
                                                                                          based on skeletal
                                                                                          muscle effects seen in
                                                                                          dogs with structural
                                                                                          analog imazapic
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate- Term          Oral Study               LOC for MOE= NA          1-Year Dog [feeding]
 Incidental Oral (1-30 days and 1-6    NOAEL= 250 mg/kg/day...   (Occupational)           Study
 months)                                                        LOC for MOE =100.......  No LOAEL was
                                                                (Residential, includes    demonstrated with
                                                                 the FQPA SF - At         imazapyr at doses up
                                                                 present time no          to 250 mg/kg/day
                                                                 residential uses).       (HDT); HIARC
                                                                                          recommended this dose
                                                                                          for RA for imazapyr,
                                                                                          based on skeletal
                                                                                          muscle effects seen in
                                                                                          dogs with structural
                                                                                          analog imazapic
----------------------------------------------------------------------------------------------------------------

[[Page 55479]]

 
Short- and Intermediate- and Long-     Oral study NOAEL= 250    LOC for MOE =100         1-Year Dog [feeding]
 Term Dermal (1 to 30 days, 1 to 6      mg/kg/day (dermal        (Occupational)           Study
 months, 6 months)           absorption rate = 100   LOC for MOE =100.......  No LOAEL was
                                        %)                      (Residential, includes    demonstrated with
                                                                 the FQPA SF - At         imazapyr at doses up
                                                                 present time no          to 250 mg/kg/day
                                                                 residential uses).       (HDT); HIARC
                                                                                          recommended this dose
                                                                                          for RA for imazapyr,
                                                                                          based on skeletal
                                                                                          muscle effects seen in
                                                                                          dogs with structural
                                                                                          analog imazapic.
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate- and Long-     Oral study NOAEL= 250    LOC for MOE =100         1-Year Dog [feeding]
 Term Inhalation (1 to 30 days, 1 to    mg/kg/day                (Occupational)           Study
 6 months, >6 months )                 (inhalation absorption   LOC for MOE =100.......  No LOAEL was
                                        rate = 100%.            (Residential, includes    demonstrated with
                                                                 the FQPA SF - At         imazapyr at doses up
                                                                 present time no          to 250 mg/kg/day
                                                                 residential uses).       (HDT); HIARC
                                                                                          recommended this dose
                                                                                          for RA for imazapyr,
                                                                                          based on skeletal
                                                                                          muscle effects seen in
                                                                                          dogs with structural
                                                                                          analog imazapic
----------------------------------------------------------------------------------------------------------------
Cancer Risk                            A quantitative cancer     N/A                     2-Year Chronic
                                        risk assessment is not                            [feeding] Toxicity/
                                        required for imazapyr                             Carcinogenicity Study
                                                                                          in Rats: Group E -
                                                                                          ``no evidence of
                                                                                          carcinogenicity in at
                                                                                          least 2 adequate
                                                                                          animal tests in
                                                                                          different species.''
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF 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 180.500) for the residues of imazapyr, in or on 
corn, field, forage; corn, field, grain; and corn field, stover at 0.05 
ppm. Risk assessments were conducted by EPA to assess dietary exposures 
from imazapyr in food as follows:
    i. Acute exposure. Quantitative 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 was identified for imazapyr.
    ii. Chronic exposure.In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1994-1996 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The dietary exposure analysis assumed 100% crop treated 
tolerances and residues. Based on total food exposure for imazapyr, all 
population subgroups are below 1% cPAD (Chronic Population Adjusted 
Dose).
    iii. Cancer. Imazapyr showed no evidence of carcinogenicity in at 
least 2 adequate animal tests in different species, and therefore, a 
quantitative cancer risk assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for imazapyr 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 imazapyr.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow groundwater. For a screening-level assessment for surface water 
EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. While both FIRST and 
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (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 imazapyr they are further 
discussed in the aggregate risk section E.
    Based on the FIRST and SCI-GROW models the estimated environmental 
concentrations (EECs) of imazapyr for acute exposures are estimated to 
be 137 parts per billion (ppb) for surface water and 1,700 ppb for 
ground water. The EECs for chronic exposures are estimated to be 81 ppb 
for surface water and 1,700 ppb for ground water.
    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). Imazapyr is currently 
registered for use on the following residential sites that could

[[Page 55480]]

result in non-occupational, non-dietary exposure: Driveways, parking 
areas, brick and gravel pathways, patios, and along sidewalks and bare 
ground. In addition to residential sites on which imazapyr is 
registered, there is the possibility of recreational exposure for post 
application exposure from the registered use on golf courses and 
fairgrounds and exposure from incidental ingestion and dermal exposure 
from swimming in treated water from the proposed aquatic weed control 
use. The risk assessment was conducted using the following exposure 
assumptions:
    i. Residential handler. Short-term (1 to 30 days) dermal and 
inhalation exposure from mixing, loading and application via sprinkler 
can could occur. For the Outdoor Residential Exposure Task Force study 
reviewed, the Health Effects Division (HED) used a hose-end sprayer as 
surrogate data for the sprinkler can scenario. The registered label 
states that the product offers long-term weed control and prevents re-
growth for up to one year with a single application; therefore only 
short-term handler exposures are anticipated.
    ii. Residential post-application. Adults and children are 
anticipated to have short-term dermal exposures; however, given that 
the product is not intended for lawn use, dermal exposures by adults 
and children are considered to be negligible as compared to 
recreational post-application exposures. (See fairground post-
application). However, toddlers could potentially ingest soil from 
treated bare ground in the residential use scenario. The assumptions 
used to assess the soil ingestion scenario were: Day of treatment 
residues are assumed to be available for short-term exposure, toddler 
body weight is estimated at 15 kg, 100 % of application rate is 
available in the top 1 cm of soil for soil ingestion exposures, and a 
toddler can possibly ingest 100 mg soil/day.
    iii. Golfer post-application. Golfer exposure assumptions are: One 
round of golf (18 holes) takes 4 hours and an average golfer plays 18 
times per year, so short-term dermal exposures are anticipated. 
Inhalation exposures are considered to be negligible since the vapor 
pressure of imazapyr was reported by the registrant to be <2x 
10-\7\ mm Hg (vs. HED ExpoSAC vapor pressure threshold of 1 
x 10-\5\ mm Hg). 5% of the maximum application rate is 
available as turf transferrable residues (TTR) available on Day 0 
(assumes no dissipation). The transfer coefficient (TC) for dermal 
exposure is assumed to be 500 cm2/hr based on golfers wearing short 
pants and short-sleeved shirts. The exposure estimate for child golfers 
is 1.7 times the adult exposure estimate to account for differences in 
body weight and surface area. Maximum labeled application rate is 
0.0041 lb ae/A broadcast liquid formulation applications.
    iv. Fairground post-application.--a. The following assumptions were 
used to assess dermal exposures to adults and toddlers after contact 
with treated lawns: Adult and toddler body weights are 70 kg and 15 kg 
respectively, 5% of the maximum application rate represents fraction of 
imazapyr available as dislodgeable foliar reside (DFR) on the day of 
treatment. Dermal TC for adults is 14,500 cm2/hr, and for toddlers, 
5,200 cm2/hr with an exposure duration of 2 hours.
    b. To assess hand-to-mouth exposures for toddlers after contact 
with treated turf, the following assumptions were used: residues are 
assumed to be available for the short-term and intermediate-term 
exposure durations. Toddler body weight is 15 kg, hand surface area is 
20 cm2, and a toddler performs 20 hand-to-mouth events per hour for 
short-term exposures. 5% of application rate represents fraction of 
imazapyr available for transfer to hands on the day of treatment with a 
50% saliva extraction factor. 100% of the application rate is available 
in the top 1 cm of soil for soil ingestion exposures, and a toddler can 
ingest 100 mg of soil a day. The exposure duration is 2 hours per day.
    c. To assess object-to-mouth exposures for toddlers after contact 
with treated turf, the following assumptions were used: Residues are 
assumed to be available for the short-term and intermediate-term 
exposure durations, the toddlers' body weight is 15 kg, 20% of the 
application rate is available as dislodgeable residues on the day of 
treatment, the object area is 25 cm2, 100% of the application rate is 
available in the top 1 cm of soil for soil ingestion exposures,a 
toddler can ingest 100 mg of soil a day, and the exposure duration is 2 
hours per day.
    v. Swimmer post-application. For incidental ingestion and dermal 
exposure, the following assumptions are made: The worst-case estimate 
of imazapyr in the top one-foot of the water column in a treated 
waterbody is 550 ppb. 100% of this concentration is assumed available 
for ingestion at a rate of 0.05 L/hr. The exposure duration is 2 hours 
a day for non-competitive adult and child swimmers. Body weights of 70 
kg for adults, 29 kg for children, and 15 kg for toddlers are assumed. 
For dermal exposure, the body surface area of an adult is 20,670 cm2 
and 14,580 cm2 for toddlers and children. The permeability coefficient 
is assumed at 5.85 x 10-\5\ cm/hr.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether imazapyr 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, 
imazapyr 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 imazapyr 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. Section 408 of the FFDCA provides that EPA shall 
apply an additional ten-fold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. No prenatal or postnatal 
sensitivity was found.
    3. Conclusion. There is a complete toxicity data base for imazapyr 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. The Agency has determined 
that the Special FQPA SF of 10x can be reduced to 1x because:

[[Page 55481]]

    i. Lack of concern for pre- and post-natal toxicity.
    ii. No qualitative/quantitative evidence of increased 
susceptibility of rat or rabbit fetuses to in utero exposure was 
reported in the developmental studies at doses up to 1,000 mg/kg/day 
(limit dose) in the rat and 400 mg/kg/day (HDT) in the rabbit.
    iii. There is no concern for developmental neurotoxicity resulting 
from exposure to imazapyr. While there were no neurotoxicity studies 
available from the published literature, there was no evidence of 
neurotoxicity/neuropathology in adult animals in the available studies.
    iv. The toxicology database is complete based on the developmental 
studies in the rat and rabbit and the 2-generation reproduction study 
in the rat
    v. No developmental neurotoxicity (DNT) study was required.
    vi. No residual uncertainties were identified in the exposure 
database.
    vii. The chronic dietary food exposure assessment utilizes 
tolerance level residues and 100% CT information for all commodities. 
By using these screening level assumptions, actual exposures/risks will 
not be underestimated.
    viii. The dietary drinking water assessment utilizes water 
concentration values generated by models and associated modeling 
parameters which are designed to provide conservative, health-
protective, high-end estimates of water concentrations which will not 
likely be exceeded.
    ix. Residential exposure and risk were assessed using standard 
assumptions from Science Advisory Council on Exposure (Expo SAC) 
Standard Operating Procedure (SOP). These assumptions are not expected 
to underestimate risk.

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 Office of Water are used to calculate 
DWLOCs: 2 liter (L)/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, the Office of Pesticide Programs (OPP) concludes 
with reasonable certainty that exposures to the pesticide in drinking 
water (when considered along with other sources of exposure for which 
OPP has reliable data) would not result in unacceptable levels of 
aggregate human health risk at this time. Because OPP 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, OPP 
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. No acute risk from exposure to imazapyr is expected 
because there were no toxic effects of concern attributable to a single 
dose identified in available data.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to imazapyr 
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 
ages 1-2 years old. Based the use pattern, chronic residential exposure 
to residues of imazapyr is not expected. In addition, there is 
potential for chronic dietary exposure to imazapyr 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 Table 4 of this unit:

               Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Imazapyr.
----------------------------------------------------------------------------------------------------------------
                                                                Maximum
                                                   Chronic      Chronic       Ground      Surface      Chronic
        Population Subgroup         cPAD (mg/kg/     Food        Water        Water        Water       DWLOC\3\
                                        day)       Exposure   Exposure\1\   EEC\2\ ppb   EEC\2\ ppb      ppb
                                                 (mg/kg/day)  (mg/kg/day)
----------------------------------------------------------------------------------------------------------------
U.S. Population                             2.5      0.00034        2.499        1,700           81       87,000
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                  2.5     0.000273        2.499        1,700           81       25,000
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                    2.5     0.000828        2.499        1,700           81       25,000
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old)                    2.5      0.00073        2.499        1,700           81       25,000
----------------------------------------------------------------------------------------------------------------
Children (6-12 years old)                   2.5     0.000499        2.499         1700           81       75,000
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years old)                     2.5     0.000309        2.499        1,700           81       75,000
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years old)                    2.5     0.000267        2.499        1,700           81       87,000
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                   2.5     0.000257        2.499        1,700           81       87,000
----------------------------------------------------------------------------------------------------------------

[[Page 55482]]

 
Adults (50+ years old)                      2.5     0.000287        2.499        1,700           81      87,000
----------------------------------------------------------------------------------------------------------------
\1\maximum water exposure (mg/kg/day) = cPAD (mg/kg/day) - food exposure (mg/kg/day)
\2\The crop producing the highest level was used.
\3\DWLOC calculated as follows: DWLOC = (maximum water exposure (mg/kg/day)) * (body weight (kg)) * (1,000 [mu]g/
  mg)/water consumption (liter/day)

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Imazapyr is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for imazapyr. Short-term aggregate risk assessments are 
required for adults as there is potential for both dermal and 
inhalation handler exposure, and dermal post-application exposure from 
the residential and recreational uses of imazapyr on turf and swimmer 
exposure. In addition, short-term aggregate risk assessments are 
required for children and toddlers because there is a potential for 
oral and dermal post-application exposure resulting from the 
residential uses of imazapyr on turf and from swimming. The short-term 
residential handler scenario results in the highest exposure for 
adults. Therefore, for adults, the homeowner handler scenario was 
aggregated with the chronic dietaryfood exposure for the U.S. General 
population. The swimmer scenario resulted in the highest exposure for 
toddlers and children. Therefore, the swimmer scenario exposure 
estimates were aggregated with the chronic dietary (food) to provide a 
worst-case estimate of short-term aggregate risk for children 1-2 years 
old.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 75,000 for the United States 
population, and 55,000 for children 1-2 years old. These aggregate MOEs 
do not exceed the Agency's level of concern, an MOE of 100, for 
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic 
exposure of imazapyr in ground and surface water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect short-term aggregate exposure to exceed the Agency's 
level of concern, as shown in Table 5 of this unit:

                     Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Imazapyr
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate     Surface       Ground
                                              Aggregate MOE     Level of      Water        Water      Short-Term
            Population Subgroup                  (Food +        Concern       EEC\3\       EEC\3\      DWLOC\4\
                                             Residential)\1\    (LOC)\2\    ([mu]g/L)    ([mu]g/L)      (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                     75,000            100           81        1,700       87,000
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                              55,000            100           81        1,700      25,000
----------------------------------------------------------------------------------------------------------------
\1\Aggregate MOE = [NOAEL / (Avg Food Exposure + Residential Exposure)]
\2\The level of concern (target MOE) includes 10X for interspecies extrapolation and 10X for intraspecies
  variation (MOE<100)
\3\The crop producing the highest level was used
\4\DWLOC calculated as follows: DWLOC = (maximum water exposure (mg/kg/day)) * (body weight (kg)) * (1,000 [mu]g/
  mg)/water consumption (liter/day)

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Though 
residential exposure could occur with the use of imazapyr, the short-
term and intermediate-term endpoints are the same and thus the short-
term assessment is conservative for the intermediate-term. Therefore, 
the aggregate risk is the sum of the risk from food and water, which do 
not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Imazapyr is not 
expected to pose a cancer risk because no evidence of carcinogenicity 
was found in at least 2 adequate animal tests in different species.
    6. 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 imazapyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Two methods are currently listed in the Pesticide Analytical Manual 
(PAM) Vol. II for enforcing tolerances of imazapyr in or on corn 
commodities; Method M 2468 is a gas chromatography/mass spectrometry 
(GC/MS) methods with a limit of quantitation (LOQ) of -0.01 ppm for 
imazapyr in or on corn grain, forage and fodder, and Method M 2657 is a 
capillary electrophoresis (CE) method with ultraviolet (UV) detection 
that has a LOQ of 0.05 ppm for imazapyr in or on corn grain, forage and 
fodder.
    CE/UV methods were proposed for determining imazapyr in or on grass 
forage and hay (M 3023), in livestock tissues (M 3184), in milk and 
milk fat (M 3075 and M 3223), and in fish and shellfish tissues (M 
3066). These methods are similar to the current enforcement method M 
2657, and based on the concurrent method recovery data

[[Page 55483]]

submitted, are adequate for collecting data on residues of imazapyr in 
grass forage and hay, cattle tissues and milk, and fish and shellfish.
    The CE/UV Methods M 3023, M 3184, M 3075, and M 3066 have been 
forwarded to the Analytical Chemistry (ACB) for petition method 
validation (PMV) trials. Conclusions regarding the suitability of the 
proposed enforcement methods will be deferred until completion of the 
PMV trials.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRLs) for residues of imazapyr in or on any of the crops involved in 
the proposed new uses.

C. Conditions

    Prior to granting unconditional registration, the registrant will 
be required to address the following issues:
    1. Fish metabolism study
    2. Corn or grass storage stability information or study
    3. Additional spray additive information supporting the grass field 
trials.

V. Conclusion

    Therefore, the tolerance is established for residues of imazapyr in 
or on grass, forage at 100 ppm; grass, hay at 30 ppm; fish at 1.0 ppm; 
shellfish at 0.10 ppm; fats of cattle, sheep, goats, and horses 0.05 
ppm; kidney of cattle, sheep, goats, and horses at 0.20 ppm; meat 
byproducts (except kidney) of cattle, sheep, goats, and horses at 0.05 
ppm; meat of cattle, sheep, goats, and horses at 0.05 ppm; and milk at 
0.01 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0264 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 November 
25, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit 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.1. Mail your 
copies, identified by docket ID number OPP-2003-0264, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

[[Page 55484]]

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA 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 section 408(d) of the FFDCA, 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 section 408(n)(4) of the FFDCA. 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. Congressional Review Act

    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 record 
keeping requirements.


    Dated: September 16, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.500 is revised to read as follows:


Sec.  180.500  Imazapyr; tolerances for residues.

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

 
------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat....................................                     0.05
Cattle, kidney.................................                     0.20
Cattle, meat...................................                     0.05
Cattle, meat byproducts (except kidney)........                     0.05
Corn, field, forage............................                     0.05
Corn, field, grain.............................                     0.05
Corn, field, stover............................                     0.05
Fish...........................................                      1.0
Goats, fat.....................................                     0.05
Goats, kidney..................................                     0.20
Goats, meat....................................                     0.05
Goats, meat byproducts (except kidney).........                     0.05
Grass, forage..................................                      100
Grass, hay.....................................                       30
Horses, fat....................................                     0.05
Horses, kidney.................................                     0.20
Horses, meat...................................                     0.05
Horses, meat byproducts (except kidney)........                     0.05
Milk...........................................                     0.01
Sheep, fat.....................................                     0.05
Sheep, kidney..................................                     0.20
Sheep, meat....................................                     0.05
Sheep, meat byproducts (except kidney).........                     0.05
Shellfish......................................                     0.10
------------------------------------------------------------------------


[[Page 55485]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 03-24123 Filed 9-25-03; 8:45 am]
BILLING CODE 6560-50-S