Imidacloprid; Pesticide Tolerances for Emergency Exemptions

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

[Federal Register: November 7, 2001 (Volume 66, Number 216)]
[Rules and Regulations]
[Page 56225-56233]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no01-16]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301187; FRL-6806-9]
RIN 2070-AB78

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for the
combined residues of imidacloprid in or on almond nutmeat, almond
hulls, and cranberries and modifies the existing time limited
tolerances for stone fruit and prunes. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on almonds, stone fruit, and cranberries. This regulation
establishes maximum permissible levels for residues of imidacloprid in
these food commodities. The tolerances will expire and are revoked on
December 31, 2003.

DATES: This regulation is effective November 7, 2001. Objections and
requests for hearings, identified by docket control number OPP-301187,
must be received by EPA on or before January 7, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301187 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9367; and e-mail address:
ertman.andrew@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected 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-301187. 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, 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

EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance 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, all expressed as parent, in or on almond nutmeat at 0.05 part
per million (ppm), almond hulls at 4.0 ppm, cranberries at 0.5 ppm and
modifying the existing time limited tolerances for stone fruit from 1.0
ppm to 3.0 ppm and prunes from 3.5 ppm to 10.0 ppm. These tolerances
will expire and are revoked on December 31, 2003. EPA will publish a
document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations.
Section 408(1)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the

[[Page 56226]]

requirement for a tolerance for pesticide chemical residues in food
that will result from the use of a pesticide under an emergency
exemption granted by EPA under section 18 of FIFRA. Such tolerances can
be established without providing notice or period for public comment.
EPA does not intend for its actions on section 18 related tolerances to
set binding precedents for the application of section 408 and the new
safety standard to other tolerances and exemptions. Section 408(e) of
the FFDCA allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
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. . . .''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Imidacloprid on Stone Fruit and
Almonds and FFDCA Tolerances

The glassy-winged sharpshooter (GWSS) poses a significant threat to
viticulture throughout California. Native to Southeast United States,
this large leafhopper was inadvertently introduced into Southern
California about 10 years ago. It went unrecognized for several years
due to its similarity to the smoke tree sharpshooter, a native insect.
It is of particular concern to grape growers due to its ability to
transmit Xylella fastidiosa, the bacterium that causes Pierce's
Disease. EPA has authorized under FIFRA section 18 the use of
imidacloprid on stone fruit and almonds for control of the glassy-
winged sharpshooter in California. After having reviewed the
submission, EPA concurs that emergency conditions exist for this State.
EPA has also authorized under FIFRA section 18 the use of
imidacloprid on cranberries for control of cranberry weevils in
Massachusetts. After having reviewed the submission, EPA concurs that
emergency conditions exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of imidacloprid in or on
stone fruit, almonds and cranberries. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerances under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment as provided in section 408(l)(6).
Although these tolerances will expire and are revoked on December 31,
2003, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerances remaining in or on
stone fruit, prunes, almond nutmeat, almond hulls and cranberries after
that date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these tolerances at the time of that
application. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether imidacloprid
meets EPA's registration requirements for use on stone fruit, almonds,
and/or cranberries or whether permanent tolerances for these uses would
be appropriate. Under these circumstances, EPA does not believe that
these tolerances serve as a basis for registration of imidacloprid by a
State for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any States other than California to
use this pesticide on stone fruit and almond or Massachusetts on
cranberries under section 18 of FIFRA without following all provisions
of EPA's regulations implementing section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for imidacloprid, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

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).
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
imidacloprid and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerance for the
combined residues of imidacloprid in or on almond nutmeat at 0.05 ppm,
almond hulls at 4.0 ppm, stone fruit at 3.0 ppm, prunes at 10.0 ppm,
and cranberries at 0.5 ppm. EPA's assessment of the dietary exposures
and risks associated with establishing the tolerance follows.

A. 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 endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF).

[[Page 56227]]

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 level of concern (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 x10-6 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 females 13-50 years of NOAEL = Not Determined FQPA SF = 3 Acute Neurotoxicity -
age LOAEL = 42 mg/kg/day... aPAD = acute RfD/FQPA Rats
UF = 100............... SF = 0.14 mg/kg/day. LOAEL = 42 mg/kg/day
Acute RfD = 0.42 mg/kg/ based on decreased
day. motor activity in
female rats.
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population NOAEL = Not Determined FQPA SF = 3 Acute Neurotoxicity -
including infants and children LOAEL = 42 mg/kg/day... aPAD = acute RfD/FQPA Rats
UF = 100............... SF = 0.14 mg/kg/day. LOAEL = 42 mg/kg/day
Acute RfD = 0.42 mg/kg/ based on decreased
day. motor activity in
female rats.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations NOAEL= 5.7 mg/kg/day FQPA SF = 3 Combined Chronic
UF = 100............... cPAD = chronic RfD/FQPA Toxicity/
Chronic RfD = 0.057 mg/ SF = 0.019 mg/kg/day. Carcinogenicity - Rats
kg/day. LOAEL = 16.9 (males)
24.9 (females) mg/kg
bwt/day based on
increased number of
thyroid lesions.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days) N/A N/A No dermal or systemic
(Residential)........................ toxicity was seen in a
21-day dermal toxicity
study in rabbits
following repeated
dermal applications of
imidacloprid at 1,000
mg/kg bwt/day (Limit-
Dose) for 3 weeks.
Therefore, this risk
assessment is not
required.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to N/A N/A No dermal or systemic
several months) toxicity was seen in a
(Residential)........................ 21-day dermal toxicity
study in rabbits
following repeated
dermal applications of
imidacloprid at 1,000
mg/kg bwt/day (Limit-
Dose) for 3 weeks.
Therefore, this risk
assessment is not
required.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to N/A N/A No dermal or systemic
lifetime) toxicity was seen in a
(Residential)........................ 21-day dermal toxicity
study in rabbits
following repeated
dermal applications of
imidacloprid at 1,000
mg/kg bwt/day (Limit-
Dose) for 3 weeks.
Therefore, this risk
assessment is not
required.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days) N/A N/A A short-term inhalation
(Residential)........................ endpoint was not
identified due to the
demonstrated absence
of toxicity.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week N/A N/A Based on the LC₅₀ of
to several months) >5.33 mg/L (Limit-
(Residential)........................ Dose), imidacloprid is
placed in Toxicity
Category IV.
Additionally, the
vapor pressure for
imidacloprid is
relatively low (6.9 x
10-9 torr). Therefore,
a separate risk
assessment via this
route is not required.
----------------------------------------------------------------------------------------------------------------

[[Page 56228]]

Long-Term Inhalation (several months N/A N/A Based on the LC₅₀ of
to lifetime) >5.33 mg/L (Limit-
(Residential)........................ Dose), imidacloprid is
placed in Toxicity
Category IV.
Additionally, the
vapor pressure for
imidacloprid is
relatively low (6.9 x
10-9 torr). Therefore,
a separate risk
assessment via this
route is not required.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) N/A N/A Imidacloprid has been
classified by the
Agency as a Group E
chemical, no evidence
of carcinogenicity for
humans, thus, a cancer
risk assessment is not
required.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances, some time-
limited, are currently established (40 CFR 180.472) for the combined
residues of the insecticide imidacloprid and its metabolites containing
the 6-chloropyridinyl moiety, all expressed as parent, 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 one day
or single exposure. The Dietary Exposure Evaluation Model
(DEEMTM) 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 acute exposure assessments: 100% crop treated and tolerance
level residues.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEMTM 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
assessments: Tolerance level residues and some percent crop treated
data used of selected commodities.
iii. Cancer. Imidacloprid has been classified by the Agency as a
Group E chemical, no evidence of carcinogenicity for humans, thus, a
cancer risk assessment is not required.
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 tolerance level residues and some percent crop
treated data on selected commodities. 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 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. 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

[[Page 56229]]

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 Concentrations in Ground Water (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 imidacloprid they are
further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of imidacloprid for acute exposures are estimated
to be 4.1 parts per billion (ppb) for surface water and 1.1 ppb for
ground water. The EECs for chronic exposures are estimated to be 0.1
ppb for surface water and 1.1 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: Ornamentals (e.g., flowering and foliage
plants, ground covers, turf, and lawns), tobacco, golf courses,
walkways, recreational areas, household or domestic dwellings (indoor/
outdoor), and cats/dogs. The risk assessment was conducted using the
following exposure assumptions: Short- and intermediate-term oral
exposure are not expected for adult population subgroups. However,
since imidacloprid is registered for use on turf, home gardens and
pets, the Agency has identified potential short-term oral exposures to
children for these uses. Thus, a residential short-term risk assessment
via the oral route is required.
The DWLOC for short-term exposure to imidacloprid was calculated
relative to the aPAD which was utilized for estimating risk for short-
term oral exposure to imidacloprid. To calculate the DWLOC for short-
term exposure relative to an acute toxicity endpoint, the sum of
average dietary food exposure and the oral exposure from imidacloprid
home garden, turf, and pet uses was subtracted from the aPAD to obtain
the maximum allowable short-term exposure to imidacloprid in drinking
water (Chronic food exposure = 0.011 mg/kg/day. Oral exposure from home
garden and turf uses = 0.0059 mg/kg bwt/day, oral exposure from pet
uses = 0.10 mg/kg bwt/day). DWLOCs were then calculated using default
body weights and drinking water consumption figures, and then compared
to the chronic water number.
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).

C. 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. Developmental toxicity studies. In a developmental toxicity
study with Sprague-Dawley rats, groups of pregnant animals (25/group)
received oral administration of imidacloprid (94.2%) at 0, 10, 30, or
100 mg/kg bwt/day during gestation days 6 through 16. Maternal toxicity
was manifested as decreased body weight gain at all dose levels and
reduced food consumption at 100 mg/kg bwt/day. No treatment-related
effects were seen in any of the reproductive parameters (i.e.,
Caesarean section evaluation). At 100 mg/kg bwt/day, developmental
toxicity manifested as wavy ribs (fetus =7/149 in treated vs. 2/158 in
controls and litters, 4/25 vs. 1/25). For maternal toxicity, the LOAEL
was 10 mg/kg bwt/day (LDT) based on decreased body weight gain; a NOAEL
was not established. For developmental toxicity, the NOAEL was 30 mg/kg
bwt/day and the LOAEL was 100 mg/kg bwt/day based on increased wavy
ribs.
In a developmental toxicity study with Chinchilla rabbits, groups
of 16 pregnant does were given oral doses of imidacloprid (94.2%) at 0,
8, 24 or 72 mg/kg bwt/day during gestation days 6 through 18. For
maternal toxicity, the NOAEL was 24 mg/kg bwt/day and the LOAEL was 72
mg/kg bwt/day based on mortality, decreased body weight gain, increased
resorptions, and increased abortions. For developmental toxicity, the
NOAEL was 24 mg/kg bwt/day and the LOAEL was 72 mg/kg bwt/day based

[[Page 56230]]

on decreased fetal body weight, increased resorptions, and increased
skeletal abnormalities.
3. Reproductive toxicity study. In a 2-generation reproductive
toxicity study, imidacloprid (95.3%) was administered to Wistar/Han
rats at dietary levels of 0, 100, 250, or 700 ppm (0, 7.3, 18.3, or
52.0 mg/kg bwt/day for males and 0, 8.0, 20.5, or 57.4 mg/kg bwt/day
for females). For parental/systemic/reproductive toxicity, the NOAEL
was 250 ppm (18.3 mg/kg bwt/day) and the LOAEL was 750 ppm (52 mg/kg
bwt/day), based on decreases in body weight in both sexes in both
generations. Based on these factors, the Agency determined that the
review be revised to indicate the parental/systemic/reproductive NOAEL
and LOAEL to be 250 and 700 ppm, respectively, based upon the body
weight decrements observed in both sexes in both generations.
4. Prenatal and postnatal sensitivity. The developmental toxicity
data demonstrated no increased sensitivity of rats or rabbits to in
utero exposure to imidacloprid. In addition, the multi-generation
reproductive toxicity study data did not identify any increased
sensitivity of rats to in utero or postnatal exposure. Parental NOAELs
were lower or equivalent to developmental or offspring NOAELs.
5. Conclusion. There is a need for a developmental neurotoxicity
study for assessment of potential alterations of functional
development. However, the Agency has determined that this data gap does
not preclude the establishment/continuance of tolerances. The 10X
safety factor to account for enhanced sensitivity of infants and
children (as required by FQPA) was reduced to 3x and the factor applies
to all population subgroups.

D. 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 + chronic non-dietary, non-occupational 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 imidacloprid 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
imidacloprid on 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 24% of the aPAD for the U.S. population, 18%
of the aPAD for females 13 years and older, 47% of the aPAD for non-
nursing infants less than 1 year old and 47% of the aPAD for children
1-6 years old. In addition, despite the potential for acute dietary
exposure to imidacloprid in drinking water, after calculating DWLOCs
and comparing them to conservative model estimated environmental
concentrations of imidacloprid in 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 0.14 24% 4.1 1.1 3,900
----------------------------------------------------------------------------------------------------------------
Children 1-6 0.14 47% 4.1 1.1 740
----------------------------------------------------------------------------------------------------------------

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 26% of the cPAD for the U.S.
population, 68% of the cPAD for non-nursing infants and 58% of the cPAD
for children 1-6 years old. Based on the use pattern, chronic
residential exposure to residues of imidacloprid is not expected. In
addition, despite the potential for chronic dietary exposure to
imidacloprid in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
imidacloprid in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in the
following Table 3:

[[Page 56231]]

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD (mg/ % cPAD Water EEC Water EEC Chronic
kg/day) (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.019 26 0.1 1.1 490
----------------------------------------------------------------------------------------------------------------
Non-nursing Infants 0.019 68 0.1 1.1 60
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old 0.019 58 0.1 1.1 90
----------------------------------------------------------------------------------------------------------------

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).
Imidacloprid is currently registered for uses that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for imidacloprid.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 350 for children 1-6 years old
(the population sub-group of concern. These aggregate MOEs do 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
water 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 Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old 350 300 0.1 1.1 200
----------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Though residential exposure could occur with the use of
imidacloprid, no toxicological effects have been identified for
intermediate-term toxicity. Therefore, the aggregate risk is the sum of
the risk from food and water, which were previously addressed.
5. Aggregate cancer risk for U.S. population. Imidacloprid has been
classified by the Agency as a Group E chemical, no evidence of
carcinogenicity for humans, thus, a cancer risk assessment is not
required.
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 imidacloprid residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (example - gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

There are no CODEX, Canadian, or Mexican Maximum Residue Limits for
imidacloprid on stone fruit, almonds or cranberries.

VI. Conclusion

Therefore, the tolerance is 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, all expressed as parent, in or on almond nutmeat at 0.05 ppm,
almond hulls at 4.0 ppm, cranberries at 0.5 ppm, and the exisiting time
limited tolerance for stone fruit is modified from 1.0 ppm to 3.0 ppm
and for prunes is modified from 3.5 ppm to 10.0 ppm.

VII. 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-301187 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 January
7, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR

[[Page 56232]]

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 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 VII.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 the docket control number OPP-301187, 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).

VIII. Regulatory Assessment Requirements

This final rule establishes time-limited tolerances under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted from review under Executive Order
12866 due to its lack of significance, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require 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 FIFRA section 18 exemption under FFDCA
section 408, such as the tolerances 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

[[Page 56233]]

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.

IX. 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: October 15, 2001.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

2. Section 180.472 is amended by revising the entries for
``cranberries,'' ``stone fruit, crop group 12,'' and ``prunes'' and
adding commodities to the table in paragraph (b) to read as follows:

Sec. 180.472 Imidacloprid; tolerances for residues.

* * * * *
(b)* * *

------------------------------------------------------------------------
Parts Expiration/
Commodity per Revocation
million Date
------------------------------------------------------------------------
Almond, hulls.................................... 4.0 12/31/03
Almond, nutmeat.................................. 0.05 12/31/03
* * * * *
Cranberries...................................... 0.5 12/31/03
* * * * *
Prunes........................................... 10.0 12/31/03
Stone fruit...................................... 3.0 12/31/03
* * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-27601 Filed 11-6-01; 8:45 am]
BILLING CODE 6560-50-S

Imidacloprid; Pesticide Tolerances for Emergency Exemptions

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