Imidacloprid; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: April 10, 2001 (Volume 66, Number 69)]
[Rules and Regulations]
[Page 18554-18561]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ap01-20]

[[Page 18554]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301114; FRL-6777-6]
RIN 2070-AB78

Imidacloprid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of imidacloprid in or on edible podded beans, succulent shelled beans,
turnip greens, cilantro, sweet corn, field corn, leaf petiole vegetable
subgroup, and the citrus fruits group. The Interregional Research
Project Number 4 (IR-4) and the Bayer Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act, as amended
by the Food Quality Protection Act of 1996.

DATES: This regulation is effective April 10, 2001. Objections and
requests for hearings, identified by docket control number OPP-301114,
must be received by EPA on or before June 11, 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-301114 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 308-3194; and e-mail
address: brothers.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
Examples of
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-301114. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of July 5, 2000 (65 FR 41455) (FRL-6590-6),
and February 11, 2000 (65 FR 7008) (FRL-6487-9) EPA issued notices
pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act
of 1996 (FQPA) (Public Law 104-170) announcing the filing of pesticide
petitions (PP) for tolerances by IR-4, Technology Centre of New Jersey,
681 US Highway #1 South, North Brunswick, NJ 08902-3390, and Bayer
Corporation, 8400 Hawthorn Road, POB 4913, Kansas City, MO 64120-0013.
These notices included summaries of these petitions prepared by Bayer
Corporation, the registrant. There were no comments received in
response to the notices of filing.
The petitions requested that 40 CFR 180.472 be amended by
establishing tolerances for combined residues of the insecticide
imidacloprid, [(1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl
moiety, in or on the following commodities:
1. PP 0E6101 proposes the establishment of a tolerance for edible
podded beans at 1.0 part per million (ppm).
2. PP 0E6104 proposes the establishment of a tolerance for
succulent shelled beans at 1.0 ppm.
3. PP 0E6156 proposes the establishment of a tolerance for turnip
greens at 3.5 ppm.
4. PP 9E6041 proposes the establishment of a tolerance for cilantro
at 3.5 ppm.
5.PP 0E6106 proposes the establishment of tolerances for sweet corn
grain at 0.05 ppm, sweet corn forage at 0.10 ppm, and sweet corn stover
at 0.20 ppm.
6. PP 6F4682 proposes the establishment of tolerances for field
corn grain at 0.05 ppm, field corn forage at 0.10 ppm, and field corn
fodder at 0.20 ppm.
7. PP 8F4940 proposes the establishment of tolerances for leaf
petiole vegetable subgroup at 6.0 ppm, citrus fruits group at 0.7 ppm,
and citrus dried pulp at 5.0 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to

[[Page 18555]]

mean that ``there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for combined residues of imidacloprid on
edible podded beans at 1.0 ppm, succulent shelled beans at 1.0 ppm,
turnip greens at 3.5 ppm, cilantro at 3.5 ppm, sweet corn grain at 0.05
ppm, sweet corn forage at 0.10 ppm, sweet corn fodder at 0.20 ppm,
field corn grain at 0.05 ppm, field corn forage at 0.10 ppm, field corn
fodder at 0.20 ppm, leaf petiole vegetable subgroup at 6.0 ppm, citrus
fruits group at 0.7 ppm, and citrus dried pulp at 5.0 ppm. EPA's
assessment of exposures and risks associated with establishing these
tolerances follow.

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 imidacloprid are
discussed in Unit II. A. in the Federal Register of March 25, 1998
(FRL-5776-5).

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10x to account for
interspecies differences and 10x for intraspecies 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 (MOE cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for imidacloprid used for human risk assessment is shown in
the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for Imidacloprid 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 general population (NOAEL was not FQPA SF = 3X aPAD = Acute RfD = 0.42 mg/kg
including infants and children established) LOAEL = acute RfD FQPA SF = bwt/day LOAEL = 42 mg/
42 mg/kg/day UF = 100 0.14 mg/kg/day kg bwt/day based on
Acute RfD = 0.42 mg/kg/ decreased motor
day activity in female
rats; additional 3x
FQPA factor for all
population subgroups
to account for
neurotoxicity,
structure-activity
concerns and lack of a
NOAEL.

aPAD = RfD /3 = 0.14 mg/
kg bwt/day.
----------------------------------------------------------------------------------------------------------------

[[Page 18556]]

Chronic Dietary all populations NOAEL= 5.7 mg/kg/day UF FQPA SF = 3X cPAD = Chronic RfD = 0.057 mg/
= 100 Chronic RfD = chronic RfD FQPA SF = kg bwt/day; NOAEL =
0.057 mg/kg/day 0.019 mg/kg/day 5.7 mg/kg bwt/day
based on increased
number of thyroid
lesions at the LOAEL
of 16.9/24.9 mg/kg bwt/
day (males and
females,
respectively);
additional 3x FQPA
factor for all
population subgroups.
----------------------------------------------------------------------------------------------------------------
Short-Intermediate-Long Term Dermal N/A N/A Dermal endpoints were
notidentified due to
demonstratedabsence of
toxicity.

(Residential)
----------------------------------------------------------------------------------------------------------------
Short-Intermediate-Long Term N/A N/A Inhalation endpoints
Inhalation were notidentified due
to demonstratedabsence
of toxicity.

(Residential)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) N/A N/A No evidence of
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 180.472) for the combined residues of imidacloprid
and its metabolites containing the 6-chloropyridinyl moiety, all
expressed as parent, in or on a variety of raw agricultural
commodities. Tolerances, which also include time-limited tolerances,
have also been established in or on a variety of raw agricultural and
animal commodities at levels ranging from 0.02 ppm in eggs to 15 ppm in
raisins, waste. Risk assessments were conducted by EPA to assess
dietary exposures from imidacloprid in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. The Dietary Exposure Evaluation Model (DEEM) 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 assumption was made for the acute exposure
assessment: Tolerance level residues for imidacloprid were used, and a
Tier 1 analysis for 100% crop-treated.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food consumption
as reported by respondents in the USDA 1989-1992- nationwide CSFII and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessment: Tolerance
level residues for imidacloprid were used, and percent crop-treated
information for some crops.
iii. Cancer. Imidacloprid has been classified as a Group E
chemical, no evidence of carcinogenicity for humans. Therefore, a
cancer risk assessment was not conducted.
iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(F) states that the Agency may use data on the actual
percent of food treated for assessing chronic dietary risk only if the
Agency can make the following findings: Condition (1), that the data
used are reliable and provide a valid basis to show what percentage of
the food derived from such crop is likely to contain such pesticide
residue; Condition (2), that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition (3), if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used percent crop treated (PCT) information as follows:
The Agency used PCT information to conduct a routine chronic
dietary exposure analysis for imidacloprid based on likely maximum
percent crop treated as follows: 19% apples, 21% brassica leafy
vegetables, 15% christophine, 15% crenshaws, 15% melons, 15%
watermelon, 15% wintermelon, 13% citrus citron, 6% cotton, 30%
eggplant, 6% grapefruit, 11% grapes, 13% kumquats, 13% lemons, 32%
lettuce-head varieties, 13% limes, 3% oranges, 30% paprika, 2% pears,
3% peppers, 13% tangelos, 13% tangerines, and 10% tomatoes. Other
commodities were assumed to be 100% treated.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute

[[Page 18557]]

dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which imidacloprid
may be applied in a particular area.
2. Dietary exposure from drinking water. Imidacloprid is
persistent, water soluble, and fairly mobile. Thus, residues of
imidacloprid may be transported to both surface and ground waters. As a
condition of registration, the Agency is requiring the submission of
the results of two prospective ground water monitoring studies. Results
from these studies are not yet available. However, estimates of
imidacloprid's residue concentration in surface and ground waters has
been provided by EPA water models.
The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
imidacloprid 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 imidacloprid.
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
Screening Concentration in Ground Water (SCI-GROW), which predicts
pesticide concentrations in ground water. 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 water shed 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 imidacloprid they are
further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the EECs of imidacloprid
for acute exposures are estimated to be 17.4 parts per billion (ppb)
for surface water and 1.4 ppb for ground water. The EECs for chronic
exposures are estimated to be 15.8 ppb for surface water and 1.4 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).
Imidacloprid is currently registered for use on the following
residential non-dietary sites: Turf, home garden and pet uses. Dermal
and inhalation short- and intermediate-term risk assessments were not
conducted for imidacloprid as dermal and inhalation exposure endpoints
were not identified due to the demonstrated absence of toxicity. Short-
and intermediate term oral exposures are not expected for adult
population subgroups. A short-term aggregate risk assessment is
required for hand-to-mouth (oral) exposure for children. The risk
assessment was conducted using the following residential exposure
assumptions: (oral exposure) hand to mouth exposure for children from
home garden, turf, and pet uses.
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 imidacloprid 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,
imidacloprid 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 imidacloprid has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the 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. In assessing the potential
for additional sensitivity of infants and children to residues of
imidacloprid, EPA considered data from developmental toxicity studies
in the rat and rabbit and a 2-generation reproduction study in the rat
(Federal Register September 18, 1998, Unit II. A.). The developmental
toxicity data demonstrated no increased

[[Page 18558]]

sensitivity of rats or rabbits to in utero exposure to imidacloprid. In
addition, the multi-generation reproductive toxicity study did not
identify any increased sensitivity of rats to in utero or postnatal
exposure.
3. Conclusion. Based on the clinical signs of neurological toxicity
in the acute toxicity studies and the requirement for a developmental
neurotoxicity study, EPA concluded that a FQPA safety factor of 3x is
appropriate for this risk assessment. The safety factor of 10x was
reduced to 3x because there was no qualitative or quantitative evidence
of increased susceptibility of fetuses or offspring exposed to
imidacloprid in the prenatal developmental toxicity studies in rats and
rabbits, or in the 2-generation reproduction toxicity study in rats.

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: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
imidacloprid will occupy 23% of the aPAD for the U.S. population, 18%
of the aPAD for females 13 years and older, 35% of the aPAD for all
infants < 1 year old and 46% of the aPAD for children 1-6 years old. In
addition, there is potential for acute dietary exposure to imidacloprid
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 aPAD, as shown in the following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population (48 states) 0.14 23 17.4 1.4 3900
----------------------------------------------------------------------------------------------------------------
All infants (<1 yr) 0.14 35 17.4 1.4 900
----------------------------------------------------------------------------------------------------------------
Children (1-6 yrs old) 0.14 46 17.4 1.4 760
----------------------------------------------------------------------------------------------------------------
Females (13-50 yrs old) 0.14 18 17.4 1.4 3600
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
imidacloprid from food will utilize 24% of the cPAD for the U.S.
population, 38% of the cPAD for all infants <1 years old and 51% of the
cPAD for children 1-6 years old]. Based the use pattern, chronic
residential exposure to residues of imidacloprid is not expected. In
addition, there is potential for chronic dietary exposure to
imidacloprid in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in the
following Table 3:

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD (mg/kg/ % cPAD Water EEC Water EEC Chronic
day) (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population (48 states) 0.019 24 15.8 1.4 490
----------------------------------------------------------------------------------------------------------------
All infants (<1 yr) 0.019 38 15.8 1.4 120
----------------------------------------------------------------------------------------------------------------
Children (1-6 yrs old) 0.019 51 15.8 1.4 92
----------------------------------------------------------------------------------------------------------------
Females (13-50 yrs old) 0.019 18 15.8 1.4 450
----------------------------------------------------------------------------------------------------------------

[[Page 18559]]

3. Short-term risk. Dermal and inhalation exposure endpoints were
not identified due to the absence of toxicity. As a result, dermal and
inhalation short term risk assessments are not required for
imidacloprid. Subsequently, short term oral exposures are not expected
for adult population subgroups. However, EPA has identified potential
short-term oral exposures to children for these uses.
Short-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Imidacloprid 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 oral
exposures for children.
Using the exposure assumption described in this unit for short-term
exposure, EPA has concluded that food and residential exposures
aggregated result an aggregate MOE of 350 for children 1-6 years old
(hand to mouth). This aggregate MOE does not exceed the Agency's level
of concern for aggregate exposure to food and residential uses. In
addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of imidacloprid 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 the following Table
4:

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Aggregate Aggregate
MOE (Food + Level of Surface Ground Short-Term
Population Subgroup Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs old 350 300 17.4 1.4 200
----------------------------------------------------------------------------------------------------------------

4. Aggregate cancer risk for U.S. population. Imidacloprid has been
classified as a Group E chemical, no evidence of carcinogenicity for
humans. Accordingly, EPA does not consider imidacloprid to pose a
cancer risk.
5. 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 imidacloprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methods are available for determination of the
regulated imidacloprid residues in plant commodities (Bayer GC/MS
Method 00200 and Bayer HPLC-UV Confirmatory Method 00357). EPA
concludes that these methods are suitable for enforcement purposes on
the subject commodities.

B. International Residue Limits

There are no established Codex, Canadian, or Mexican maximum
residue limits for imidacloprid in/on succulent shelled beans, turnip
greens, celery, citrus, and cilantro; thus, international harmonization
is not an issue.

C. Conditions

Edible podded beans and succulent shelled beans have been made
conditional for a period of three years to allow time to submit data on
shelled dried beans to complete the crop group for bean tolerances.

V. Conclusion

Therefore, these tolerances are established for the combined
residues of imidacloprid, (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl
moiety, in or on edible podded beans at 1.0 ppm, succulent shelled
beans at 1.0 ppm, turnip greens at 3.5 ppm, cilantro at 3.5 ppm, sweet
corn grain at 0.05 ppm, sweet corn forage at 0.10 ppm, sweet corn
fodder at 0.20 ppm, field corn grain at 0.05 ppm, field corn forage at
0.10 ppm, field corn fodder at 0.20 ppm, leaf petiole vegetable
subgroup at 6.0 ppm, citrus fruits group at 0.7 ppm, and citrus dried
pulp at 5.0 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

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

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301114 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 June 11,
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

[[Page 18560]]

the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Office of the
Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301114, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the

[[Page 18561]]

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: March 28, 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 180.472 is amended by revising ``corn, field, fodder,''
``corn, field, forage,'' and ``corn, field, grain'' and alphabetically
adding the remaining commodities to the table in paragraph (a) to read
as follows:

Sec. 180.472 Imidacloprid; tolerances for residues.

(a) * * *

----------------------------------------------------------------------------------------------------------------
Expiration/Revocation
Commodity Parts per million Date
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Beans, edible, podded.................................... 1.0 None
Beans, succulent, shelled................................ 1.0 None
* * * * * *
*
Cilantro................................................. 3.5 None
Citrus, dried pulp....................................... 5.0 None
Citrus, fruits, group.................................... 0.7 None
Corn, field, fodder...................................... 0.20 None
Corn, field, forage...................................... 0.10 None
Corn, field, grain....................................... 0.05 None
Corn, sweet, forage...................................... 0.10 None
Corn, sweet, (K+CWHR).................................... 0.05 None
Corn, sweet, stover...................................... 0.20 None
* * * * * *
*
Greens, turnip........................................... 3.5 None
* * * * * *
*
Vegetable, leaf petiole, subgroup........................ 6.0 None
* * * * * *
*
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 01-8805 Filed 4-9-01; 8:45 am]
BILLING CODE 6560-50-S

Imidacloprid; Pesticide Tolerance

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