[Federal Register Volume 66, Number 50 (Wednesday, March 14, 2001)]
[Rules and Regulations]
[Pages 14846-14852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6329]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301108; FRL-6774-9]
RIN 2070-AB78
Imazethapyr; Time-Limited Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for the
combined residues of imazethapyr, as its ammonium salt, and its
metabolite in or on rice, grain; rice, straw; rice hulls, and rice,
bran. BASF requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDC), as amended by the Food Quality Protection Act
(FQPA) of 1996. These tolerances will expire on January 1, 2003.
DATES: This regulation is effective March 14, 2001. Objections and
requests for hearings, identified by docket control number OPP-301108,
must be received by EPA on or before May 14, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI.. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301108 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Daniel J. Rosenblatt,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5697; e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Codes Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111............... Crop production
112............... Animal production
311............... Food manufacturing
32532............. Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301108. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson
[[Page 14847]]
Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The PIRIB telephone number is (703)
305-5805.
II. Background and Statutory Findings
In the Federal Register of September 27, 2000 (65 FR 58074) (FRL-
6744-6), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a as amended by the FQPA of 1996 (Public Law 104-170)
announcing the filing of a pesticide petition (PP OF6186) for tolerance
by American Cyanamid. This company has now merged with BASF
Corporation. This notice included a summary of the petition prepared by
American Cyanamid, the initial registrant. There were no comments
received in response to the notice of filing.
The petition requested that 40 CFR 180.447 be amended by
establishing a tolerance for the combined residues of the herbicide
imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1- methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-ethyl-3-pyridine-carboxylic acid) as its free acid or
its ammonium salt (calculated as the acid), and its metabolite 2-[4,5-
dihydro-4-methyl-4-(1- methylethyl-5-oxo-1H-imidazol-2-yl]-5-(1-
hydroxyethyl)3-pyridinecarboxylic acid both free and conjugated in or
on the raw agricultural commodity (RAC) rice. In this time-limited
tolerance rule, EPA is promulgating tolerances for rice grain at 0.3
part per million (ppm), rice straw at 0.2 ppm, rice hulls at 1.5 ppm
and rice bran at 2.5 ppm. These tolerances will expire on January 1,
2003. Establishing a time-limited tolerance will permit the EPA to
evaluate confirmatory data that has not yet been fully evaluated. .
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
imazethapyr and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a tolerance for the combined
residues of imazethapyr (2-[4,5-dihydro-4- methyl-4-(1-methylethyl)-5-
oxo-1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid and 2- [4,5-
dihydro-4-methyl-4-(1-methyethyl-5-oxo-1H-imidazol-2-yl]-5-(1-
hydroxyethyl)-3-pyridine carboxylic acid (free or conjugated) on rice
grain, rice straw, rice hulls, and rice bran. 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 the combined
residues of imazethapyr (2-[4,5-dihydro-4-methyl-4-(1- methylethyl)-5-
oxo-1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid and 2-[4,5-
dihydro- 4-methyl-4-(1-methyethyl-5-oxo-1H-imidazol-2-yl]-5-(1-
hydroxyethyl)-3-pyridine carboxylic acid (free or conjugated) are
discussed below. The toxicological data considered in support of the
proposed tolerances include:
1. Several acute toxicology studies placing technical-grade
imazethapyr in Toxicity Category III and Toxicity Category IV.
2. A 1-year feeding study with dogs fed diets containing 1, 1,000,
5,000, or 10,000 ppm with a systemic no-observed adverse effect level
(NOAEL) of 1,000 25 milligrams/kilogram/day (mg/kg/day) based on
decreased packed cell volume, hemoglobin, and erythrocytes in the blood
of female dogs at the 5,000 ppm 125 mg/kg/day dose level.
3. A 78-week carcinogenicity study in mice fed diets containing 0,
1,000, 5,000, or 10,000 ppm (equivalent to 0, 150, 750, or 1,500 mg/kg/
day) with a systemic NOAEL of 5,000 ppm based on decreased body weight
gain in both sexes at the 10,000 ppm dose level. No carcinogenic
effects were observed under the conditions of the study.
4. A 2-year chronic feeding/carcinogenicity study in rats fed diets
containing 0, 1,000, 5,000, 10,000 ppm (equivalent to 0, 50, 250, or
500 mg/kg/day) with no treatment-related systemic or carcinogenic
effects observed under the conditions of the study.
5. A multi-generation reproduction study in rats fed diets
containing 0, 1,000, 5,000, or 10,000 ppm (equivalent to 0, 50, 250, or
500 mg/kg/day) with no treatment-related systemic or reproductive
effects observed under the conditions of the study.
6. Developmental toxicity studies in rats and rabbits with no
developmental toxicity observed under the conditions of the studies at
dose levels up to and including the highest dose tested (HDT) (1,125
mg/kg/day in rats and 1,000 mg/kg/day in rabbits. In the rat prenatal
developmental study, the maternal (systemic) NOAEL was 375 mg/kg/day
based on clinical signs of toxicity seen in dams at the LOAEL of 1,125
mg/kg/day. The developmental (fetal) NOAEL was 1,125 mg/kg/day HDT. The
developmental LOAEL was not established in this study. In a prenatal
developmental study in rabbits, the maternal (systemic) NOAEL was 300
mg/kg/day based on maternal deaths observed at the LOAEL of 1,000 mg/
kg/day HDT. The developmental (fetal) NOAEL was 1,000 mg/kg/day HDT. In
this study, the developmental LOAEL was not established. In a 2-
generation rat reproduction study, the parental and offspring toxicity
NOAEL was 500 mg/kg/day. The parental and offspring toxicity LOAEL was
not established.
7. Mutagenicity studies include gene mutation assays in bacteria
cells (negative) and Chinese hamster ovary cells (no-dose response);
structural chromosomal aberrations assays in vivo in rat bone marrow
cells (negative) and in vitro in Chinese hamster ovary cells (positive
without activation at levels toxic to cells and negative with
activation); and other genotoxic effects (did not induce unscheduled
DNA synthesis in rat hepatocytes cultured in vitro).
B. Toxicological Endpoints
The dose at which the NOAEL from the toxicology study identified as
[[Page 14848]]
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the lowest dose at which
adverse effects of concern are identified (LOAEL) is sometimes used for
risk assessment if no NOAEL was achieved in the toxicology study
selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for intra
species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for imazethapyr used for human risk assessment is shown in
the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for imazethapyr for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of None None A dose and endpoint
age and general population including attributable to a
infants and children single exposure were
not identified from
the reviewed and
acceptable oral
toxicity studies,
including both
maternal and
developmental toxicity
in the developmental
toxicity studies.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL = 25 mg/kg/day FQPA SF = 10 1-year feeding study--
UF = 100............... cPAD = chronic RfD/FQPA dog
Chronic RfD = .25 mg/kg/ SF =. LOAEL = 125 mg/kg/day
day. 0.025 mg/kg/day........ based on decreased
packed cell volume,
hemoglobin and
erythrocytes seen in
females.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days), and None None EPA concluded that no
intermediate term dermal (1 week to hazard is identified
several months) to support quantifying
(Residential)........................ risk for these
exposure scenarios.
----------------------------------------------------------------------------------------------------------------
Short-term Inhalation (1 to 7 days) Inhalation (or oral) LOC for MOE = 1,000 Rabbit Developmental
(Residential)........................ study (Residential).......... Study
NOAEL= 300 mg/kg/day LOAEL = 1,000 mg/kg/day
(inhalation absorption based on maternal
rate = 100%). deaths seen at the
HDT.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week Inhalation (or oral) LOC for MOE = 1,000 Rabbit Developmental
to several months) study (Residential) Study
(Residential)........................ NOAEL = 300 mg/kg/day LOAEL = 1,000 mg/kg/day
(inhalation absorption based on maternal
rate = 100%). deaths seen at the
HDT.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) EPA determined that a Rat and mouse
cancer risk assessment carcinogenicity
is not necessary. studies were negative
for carcinogenicity.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
unique to the FQPA.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.447) for the residues of the herbicide
imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid as its ammonium salt,
and its metabolite, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-(1-hydroxyethyl)-3-pyridine carboxylic acid, both free
and conjugated, in or on a variety of raw agricultural commodities
including legume vegetables, soybeans, alfalfa, peanuts, corn grain,
endive, and lettuce. Risk assessments were conducted by EPA to assess
dietary exposures from combined residues of imazethapyr in food as
follows:
i. Acute exposure. Acute dietary risk assessments are performed
for a food-use pesticide if a toxicological study has
[[Page 14849]]
indicated the possibility of an effect of concern occurring as a result
of a one day or single exposure. EPA did not perform a quantified acute
dietary risk assessment. In acceptable toxicity studies, no appropriate
endpoint was identified for this exposure duration.
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 1989- 1992- nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: The exposure assessment that supports this time-limited
tolerance is conservative. Tolerance level residues, 100 percent crop
treated, and default processing factors were assumed for all registered
and proposed uses. Percent crop treated estimates and anticipated
residue assumptions were not used in this risk assessment.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for imazethapyr in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of imazethapyr.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. 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 imazethapyr they are further
discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of imazethapyr for acute exposures are estimated
to be 6.34 parts per billion (ppb) for surface water and 2.2 ppb for
ground water. The EECs for chronic exposures are estimated to be 6.13
ppb for surface water and 2.2 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).
Imazethapyr is not registered for use on any sites that would
result in residential exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether imazethapyr has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
imazethapyr does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that imazethapyr has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an
additional 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 margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. The pre- and postnatal
toxicology data base for imazethapyr is complete. There is no evidence
of increased susceptibility to infants and children.
3. Conclusion. There is a complete toxicity data base for
imazethapyr and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. There is no
evidence of qualitative or quantitative susceptibility to infants and
children. No evidence of increased susceptibility was observed in rat
and rabbit fetuses following in utero exposure in the prenatal
developmental toxicity study and also in the 2-generation reproduction
study in rats. However, EPA has not concluded its review process
regarding application of the additional safety factor for infants and
children as to imazethapyr and, therefore, for the purpose of this
action will retain the statutory default factor of an additional 10x.
Once EPA has the opportunity to complete its review of the data on
imazethapyr in this area, the 10x safety factor may be reduced or
removed.
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
[[Page 14850]]
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: 2Liter (L)/70 kilogram (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, 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. EPA did not select a toxicological endpoint for this
exposure duration. A dose and endpoint attributable to a single
exposure were not identified from oral toxicity studies. Therefore, no
quantified acute risk assessment is necessary.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
imazethapyr from food will utilize 1% of the cPAD for the U.S.
population, 3% of the cPAD for All Infants (1 year) and 3% of the cPAD
for Children (1-6 years). There are no residential uses for imazethapyr
that result in chronic residential exposure to imazethapyr. There is
potential for chronic dietary exposure to imazethapyr in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD, as shown in the following Table 2:
Table 2.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to imazethapyr
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC
Population Subgroup cPAD mg/kg/day % cPAD (Food) parts per billion Ground Water EEC Chronic DWLOC (ppb)
(ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.025 1 6.13 2.2 864
All Infants (<1 year) 0.025 3 6.13 2.2 242
Children (1-6 years) 0.025 3 6.13 2.2 243
Females (13-50 years) 0.025 1 6.13 2.2 743
--------------------------------------------------------------------------------------------------------------------------------------------------------
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).
Imazethapyr is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
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).
Imazethapyr is not registered for use on any sites that would
result in residential exposure. 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. The rat and mouse
carcinogenicity studies were negative for carcinogenicity. In light of
these results, EPA determined that a quantified aggregate cancer risk
assessment is not necessary.
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 imazethapyr residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Analytical enforcement methods for the purpose of enforcing
previously established tolerances for imazethapyr have been published
in the Pesticide Analytical Manual Vol-II (PAM-II). CE Determinative
and LC/MS methods for the enforcement of the time-limited tolerances
for rice have been proposed by the registrant. Independent laboratory
validation of these methods have been submitted to EPA. Prior to
publication in PAM-II, and upon request, the analytical methods for the
rice commodities will be available from the Analytical Chemistry Branch
(ACB), BEAD (7503C), Environmental Science Center, 701 Mapes Rd., Fort
George G. Meade, MD 20755-5350; contact Francis D. Griffith, Jr.;
telephone number: (410) 305-2905; e-mail [email protected]. The
Analytical standards for this method are also available from the EPA
National Pesticide Standard Repository at the same location.
B. International Residue Limits
This time-limited tolerance action is not incompatible with that
taken by Codex, Canada, or Mexico as there are no established
tolerances by those entities for imazethapyr on rice.
C. Conditions
Based on confined rotational crop data, crop rotational intervals
of 4 months for wheat and 9.5 months for field corn are necessary. A
45-day pre harvest interval is required.
V. Conclusion
Therefore, the tolerances are established for combined residues of
imazethapyr (2- [4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid) and 2-[4,5-dihydro-
4-methyl-4-(1-
[[Page 14851]]
methylethyl-5-oxo-1H-imidazole-2-yl]-5-(1-hdroxyethyl)-3-pyridine
carboxylic acid (free or conjugated), in or on rice grain, rice straw,
rice hulls, and rice bran.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301108 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 May 14,
2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301108, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: [email protected]. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule,
[[Page 14852]]
the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 1, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.447 is amended as follows:
i. By adding a heading to paragraph (a), designating the text
following the heading as paragraph (a)(1), and alphabetically adding
commodities to the table in newly designated paragraph (a)(1);
ii. By redesignating paragraphs (b) and (c) as paragraphs (a)(2)
and (a)(3);
iii. By adding and reserving new paragraphs (b) and (c); and
iv. By adding a heading to paragraph (d).
The additions read as follows:
Sec. 180.447 Imazethapyr, ammonium salt; tolerance for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * * * * *
Rice, bran 2.5 1/1/03
Rice, grain 0.30 1/1/03
Rice, hulls 1.5 1/1/03
Rice, straw 0.20 1/1/03
* * * * * * *
------------------------------------------------------------------------
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. * * *
[FR Doc. 01-6329 Filed 3-13-01; 8:45 am]
BILLING CODE 6560-50-S