[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Rules and Regulations]
[Page 55475-55485]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-14]
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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: tompkins.jim@epa.gov.
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/http://.
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).
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Guideline No/Study Type Results Toxicity Category
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870.1100 Acute Oral LD50 = >5,000 mg/kg IV
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[[Page 55477]]
870.1200 Acute Dermal LD50 = >2,000 mg/kg III
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870.1300 Acute Inhalation LC50 = >1.3 mg/L III
(gravimetric) >5.1 mg/L
(nominal)
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870.2400 Primary Eye Irritation Corneal Opacity; I
Conjunctive: redness,
Chemosis & Discharge;
Vascularization of
Cornea; Corrosive:
Irreversible Eye Damage
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870.2500 Primary Skin Irritation Non-irritating to slight IV
erythema and edema
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870.2600 Dermal Sensitization Negative
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Table 2.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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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.
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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.
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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.
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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.
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870.4100 Chronic toxicity (rodent) NA; see 870.4300
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870.4100 Chronic toxicity (dog) NOAEL is =10,000 ppm (250 mg/kg/day). This
was the HDT; therefore, there is no LOAEL.
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870.4200 Carcinogenicity (rat) NA; see 870.4300
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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.
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870.5100 Bacterial reverse mutation Negative up to 5,000 [mu]g/plate.
(Ames Assay)
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870.5300 In vitro mammalian cell Negative up to toxic doses (5,000 [mu]g/ml)
gene mutation with and without activation.
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870.5375 In vitro mammalian Negative up to toxic doses (5,000 [mu]g/ml)
chromosome aberration with and without activation.
(CHO)
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[[Page 55478]]
870.5450 Rodent Dominant Lethal Reported as negative (though unacceptable).
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870.5550 Unscheduled DNA synthesis Reported as negative (though unacceptable).
(RPH)
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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.
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870.7600 Dermal penetration NA
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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.
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Special FQPA SF* and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
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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.
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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
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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
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[[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.
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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
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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.''
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* 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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit 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: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
[[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