[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Rules and Regulations]
[Pages 3634-3642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1438]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0341; FRL-7691-2]


Imidacloprid; Pesticide Tolerances for Emergency Exemptions

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, ((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 bananas and 
sunflowers. This action is in response to EPA's granting of emergency 
exemptions under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizing use of the pesticide on bananas and 
sunflower seed. This regulation establishes maximum permissible levels 
for residues of imidacloprid in these food commodities. The tolerances 
will expire and are revoked on December 31, 2007.

DATES: This regulation is effective January 26, 2005. Objections and 
requests for hearings must be received on or before March 28, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0341. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 South 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a federal 
or state government agency involved in administration of environmental 
quality programs (i.e., Departments of

[[Page 3635]]

Agriculture, Environment, etc). Potentially affected entities may 
include, but are not limited to:
     Federal or State Government Entity, (NAICS 9241), i.e., 
Departments of Agriculture, Environment, etc.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

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 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, all expressed as parent, in or on bananas at 
1.0 parts per million (ppm) and sunflower at 0.05 ppm. These tolerances 
will expire and are revoked on December 31, 2007. EPA will publish a 
document in the Federal Register to remove the revoked tolerances from 
the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the 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 of the FFDCA 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) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    Section 18 of the 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 of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Imidacloprid on Bananas and Sunflower Seed 
and FFDCA Tolerances

    Imidacloprid was requested by the State of Hawaii for use on 
bananas because of the ineffectiveness of currently registered 
insecticides in controlling the banana leaf aphid, and the insect's 
ability to vector Bananas Bunchy Top Virus (BBTV). EPA has authorized 
under FIFRA section 18 the use of imidacloprid on bananas for control 
of banana aphids in Hawaii. After having reviewed the submission, EPA 
concurs that emergency conditions exist for this State.
    The States of Minnesota, Nebraska, and North Dakota declared crises 
for use of imidacloprid on sunflower seed to control wireworms due to 
the loss of the use of lindane and the lack of a viable alternative to 
control this pest on this crop.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of imidacloprid in 
or on bananas and sunflowers. In doing so, EPA considered the safety 
standard in section 408(b)(2) of the FFDCA, and EPA decided that the 
necessary tolerances under section 408(l)(6) of the FFDCA 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) of the FFDCA. Although these tolerances will expire 
and are revoked on December 31, 2007, under section 408(l)(5) of the 
FFDCA, residues of the pesticide not in excess of the amounts specified 
in the tolerances remaining in or on bananas and/or sunflowers 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 bananas and/or 
sunflower seed 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 State other than Hawaii to use 
this pesticide on bananas and the States of Minnesota, Nebraska, and 
North Dakota to use this pesticide on sunflower seed under section 18 
of FIFRA without following all provisions of EPA's regulations 
implementing FIFRA 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

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exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the FFDCA , EPA has 
reviewed the available scientific data and other relevant information 
in support of this action. EPA has sufficient data to assess the 
hazards of imidacloprid and to make a determination on aggregate 
exposure, consistent with section 408(b)(2) of the FFDCA, for a time-
limited tolerance for combined residues of imidacloprid in or on 
bananas at 1.0 ppm and sunflower at 0.05 ppm. EPA's assessment of the 
dietary exposures and risks associated with establishing these 
tolerances 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 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 (SF) 
is retained due to concerns unique to the FQPA, this additional factor 
is applied to the RfD by dividing the RfD by such additional factor. 
The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the 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 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for imidacloprid used for human risk assessment is shown in 
Table 1:

     Table 1.--Summary of Toxicological Dose and Endpoints for Imidacloprid for Use in Human Risk Assessment
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                                          Dose Used in Risk     Special FQPA SF and LOC  Study and Toxicological
          Exposure Scenario                 Assessment, UF        for Risk Assessment            Effects
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Acute dietary                          LOAEL = 42 mg/kg/day UF  FQPA SF = 1X             Acute neurotoxicity -
all populations......................   = 300                   aPAD = acute RfD / FQPA   rat
                                       Acute RfD = 0.14 mg/kg.   SF = 0.14 mg/kg.        LOAEL = 42 mg/kg, based
                                                                                          upon the decrease in
                                                                                          motor and locomotor
                                                                                          activities observed in
                                                                                          females.
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Chronic dietary                        NOAEL= 5.7 mg/kg/day UF  FQPA SF = 1X             Combined chronic tox/
all populations......................   = 100                   cPAD = chr RfD / FQPA     carcinogenicity - rat
                                       Chronic RfD = 0.057 mg/   SF = 0.057 mg/kg/day.   LOAEL = 16.9 mg/kg/day,
                                        kg/day.                                           based upon increased
                                                                                          incidence of
                                                                                          mineralized particles
                                                                                          in thyroid colloid in
                                                                                          males.
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Short-term oral (1-30 days)            oral study NOAEL= 10 mg/ LOC for MOE = 100        Developmental toxicity
                                        kg/day                   (Residential, includes    rat
                                                                 the FQPA SF)             Maternal LOAEL = 30 mg/
                                                                                          kg/day, based upon
                                                                                          decreased body weight
                                                                                          gain and corrected
                                                                                          body weight gain.
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Short-term dermal (1-30 days)          oral study NOAEL= 10 mg/ LOC for MOE = 100        Developmental toxicity
                                        kg/day (dermal           (Occupational)            rat
                                        absorption rate =        LOC for MOE = 100        Maternal LOAEL = 30 mg/
                                        7.2%)                    (Residential, includes   kg/day, based upon
                                                                 the FQPA SF).            decreased body weight
                                                                                          gain and corrected
                                                                                          body weight gain.
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Short-term inhalation (1-30 days)      oral study NOAEL= 10 mg/ LOC for MOE = 100        Developmental toxicity
                                        kg/day (inhalation       (Occupational)            rat
                                        absorption rate =        LOC for MOE = 100        Maternal LOAEL = 30 mg/
                                        100%)                    (Residential, includes   kg/day, based upon
                                                                 the FQPA SF).            decreased body weight
                                                                                          gain and corrected
                                                                                          body weight gain.
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Cancer (oral, dermal, inhalation)      Group E                  Not applicable           No evidence of
                                                                                          carcinogenicity in
                                                                                          rats and mice.
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[[Page 3637]]

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.472) for the combined residues of imidacloprid, 
in or on a variety of raw agricultural commodities. Meat, milk, poultry 
and egg tolerances have also been established for the combined residues 
of imidacloprid. In conducting dietary exposure assessments EPA used 
the Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\) which incorporates food consumption 
data as reported by respondents in the USDA 1994-1996 and 1998 
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The 1994-1996 
and 1998 data are based on the reported consumption of more than 20,000 
individuals over two non-consecutive survey days. Consumption data are 
averaged for the entire U.S. population and within population subgroups 
for chronic exposure assessment, but are retained as individual 
consumption events for acute exposure assessment. Risk assessments were 
conducted by EPA to assess dietary exposures from imidacloprid in food 
as follows:
    i. Acute exposure. The following assumptions were made for the 
acute exposure assessments: A Tier 1, deterministic acute dietary 
exposure assessment was conducted using tolerance-level residues, 100% 
crop treated (PCT) information for registered and proposed commodities; 
and modified DEEM\TM\ (version 2.0) processing factors for some 
commodities based on guideline processing studies. EPA estimated 
exposure based on the 95th percentile value from this deterministic 
exposure assessment.
    ii. Chronic exposure. The following assumptions were made for the 
chronic exposure assessments: A Tier 2 partially refined, deterministic 
assessment using tolerance-level residue and average weighted PCT 
information and modified DEEM\TM\ (version 2.0) processing factors for 
some commodities based on guideline processing studies.
    iii. Cancer. A quantitative cancer aggregate risk assessment was 
not performed because imidacloprid is not carcinogenic.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(F) 
of the FFDCA 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 PCT as required by section 408(b)(2)(F) 
of the FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows: For the acute 
assessment, 100 PCT was assumed for all registered and proposed 
commodities. For the chronic assessment, average weighted PCT 
information was used for the following commodities: Apple 34%; broccoli 
35%; brussels sprouts 56%; cabbage 14%; cantaloupe 31%; cauliflower 
52%; collards 10%; corn, field 1%; cotton 3%; cucumber 2%; eggplant 
36%; grape 32%; grapefruit 3%; honeydew 26%; kale 30%; lemon 1%; 
lettuce, head 49%; lime 5%; mustard greens 16%; orange 1%; pear 16%; 
pepper 62%; pumpkin 7%; spinach 15%; squash 7%; sugarbeet 1%; tangerine 
9%; tomato 9%; watermelon 6%; wheat 1%. A default value of 1% was used 
for all commodities which were reported as having <1 PCT.
    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 the physical 
characteristics of imidacloprid.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) 
to produce estimates of pesticide concentrations in an index reservoir. 
The screening concentration in ground water (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water EPA will generally use 
FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The 
FIRST model is a subset of the PRZM/EXAMS model that uses a specific 
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model 
includes a percent crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a

[[Page 3638]]

coarse screen for sorting out pesticides for which it is highly 
unlikely that drinking water concentrations would ever exceed human 
health LOC.
    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 FIRST and SCI-GROW models the EECs of imidacloprid for 
acute exposures are estimated to be 36.04 parts per billion (ppb) for 
surface water and 2.09 ppb for ground water. The EECs for chronic 
exposures are estimated to be 17.24 ppb for surface water and 2.09 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: Granular products for application to 
lawns and ornamental plants; ready-to-use spray for application to 
flowers, shrubs and house plants; plant spikes for application to 
indoor and outdoor residential potted plants; ready-to-use potting 
medium for indoor and outdoor plant containers; liquid concentrate for 
application to lawns, trees, shrubs and flowers; ready-to-use liquid 
for directed spot application to cats and dogs. In addition, there are 
numerous registered products intended for use by commercial applicators 
to residential sites. These include gel baits for cockroach control; 
products intended for commercial ornamental, lawn and turf pest 
control; products for ant control; and products used as preservatives 
for wood products, building materials, textiles and plastics.
    As these products are intended for use by commercial applicators 
only, they are not be addressed in terms of residential pesticide 
handler. The risk assessment was conducted using the following 
residential exposure assumptions: EPA has determined that residential 
handlers are likely to be exposed to imidacloprid residues via dermal 
and inhalation routes during handling, mixing, loading, and applying 
activities. Based on the current use patterns, EPA expects duration of 
exposure to be short-term (1-30 days). EPA does not expect imidacloprid 
to result in exposure durations that would result in intermediate- or 
long-term exposure.
    The scenarios likely to result in adult dermal and/or inhalation 
residential handler exposures are as follows:
     Dermal and inhalation exposure from using a granular push-
type spreader.
     Dermal exposure from using potted plant spikes.
     Dermal exposure from using a plant potting medium.
     Dermal and inhalation exposure from using a garden hose-
end sprayer (dermal and inhalation exposure from using a RTU trigger 
pump spray is expected to be negligible).
     Dermal and inhalation exposure from using a water can/
bucket for soil drench applications.
     Dermal exposure from using pet spot-on.
    EPA has also determined that there is potential for short-term (1 
to 30 days), post-application exposure to adults and children/toddlers 
from the many residential uses of imidacloprid. Due to residential 
application practices and the half-lives observed in the turf 
transferable residue study, intermediate- and long-term post-
application exposures are not expected. The scenarios likely to result 
in dermal (adult and child/toddler), and incidental non-dietary (child/
toddler) short-term post-application exposures are as follows:
     Toddler oral hand-to-mouth exposure from contacting 
treated turf.
     Toddler incidental oral ingestion of granules.
     Toddler incidental oral ingestion of pesticide-treated 
soil.
     Toddler incidental oral exposure from contacting treated 
pet.
     Toddler dermal exposure from contacting treated turf.
     Toddler dermal exposure from hugging treated pet/
contacting treated pet.
     Adult dermal exposure from contacting treated turf.
     Adult golfer dermal exposure from contacting treated turf.
     Adolescent golfer dermal exposure from contacting treated 
turf.
     Adult dermal exposure from contacting treated pet.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether 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. Section 408 of the FFDCA 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 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. There is no quantitative or 
qualitative evidence of increased susceptibility of rat and rabbit 
fetuses to in utero exposure in developmental studies. There is no 
quantitative or qualitative evidence of increased susceptibility of rat 
offspring in the multi-generation reproduction study. There is evidence 
of increased qualitative susceptibility in the rat developmental 
neurotoxicity study, but the concern is low since:
    i. The effects in pups are well-characterized with a clear NOAEL;
    ii. The pup effects occur in the presence of maternal toxicity with 
the same NOAEL for effects in pups and dams; and,

[[Page 3639]]

    iii. The doses and endpoints selected for regulatory purposes are 
protective of the pup effects noted at higher doses in the 
developmental neurotoxicity study.
    Therefore, there are no residual uncertainties for pre-natal/post-
natal toxicity in this study.
    3. Conclusion. There is a complete toxicity data base for 
imidacloprid and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X SF to protect infants and children should be reduced to 1X 
for the following reasons:
     The toxicological database is complete for FQPA 
assessment.
     The acute dietary food exposure assessment utilizes 
existing and proposed tolerance level residues and 100 PCT information 
for all commodities. By using these screening-level assessments, actual 
exposures/risks will not be underestimated.
     The chronic dietary food exposure assessment utilizes 
existing and proposed tolerance level residues and PCT data verified by 
the Agency for several existing uses. For all proposed uses, 100 PCT is 
assumed. The chronic assessment is somewhat refined and based on 
reliable data and will not underestimate exposure/risk.
     The dietary drinking water assessment utilizes water 
concentration values generated by model and associated modeling 
parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations which will not 
likely be exceeded.
     The residential handler assessment is based upon the 
residential standard operating procedures (SOPs) in conjunction with 
chemical-specific study data in some cases and the Pesticide Handlers 
Exposure Database (PHED) unit exposures in other cases. The majority of 
the residential post-application assessment is based upon chemical-
specific turf transferrable residue data or other chemical-specific 
post-application exposure study data. The chemical-specific study data 
as well as the surrogate study data used are reliable and also are not 
expected to underestimate risk to adults as well as to children. In a 
few cases where chemical-specific data were not available, the SOPs 
were used alone. The residential SOPs are based upon reasonable worst-
case assumptions and are not expected to underestimate risk. These 
assessments of exposure are not likely to underestimate the resulting 
estimates of risk from exposure to imidacloprid.

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: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to imidacloprid in drinking water (when considered along with 
other sources of exposure for which EPA has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because EPA 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, EPA 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 26% of the aPAD for the U.S. population, 17% 
of the aPAD for females 13 to 49 years, 57% of the aPAD for infants < 1 
year old and 67% of the aPAD for children 1-2 years. In addition, 
despite the potential for acute dietary exposure to imidacloprid in 
drinking water, after calculating DWLOCs and comparing them to 
conservative model EECs of imidacloprid in surface water and ground 
water, EPA does not expect the aggregate exposure to exceed 100% of the 
aPAD, as shown in 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           26        36.04         2.09        3,625
--------------------------------------------------------------
Females 13-49 years                                     0.14           17        36.04         2.09        3,483
--------------------------------------------------------------
Infants <1 year                                         0.14           57        36.04         2.09          603
--------------------------------------------------------------
Children 1-2 years                                      0.14           67        36.04         2.09          472
----------------------------------------------------------------------------------------------------------------

    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 12% of the cPAD for the U.S. 
population, 29% of the cPAD for infants <1 year and 38% of the cPAD for 
children 1-2 years. Based the use pattern, chronic residential exposure 
to residues of imidacloprid is not expected. In addition, there is 
potential for chronic dietary exposure to

[[Page 3640]]

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 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                                        0.057           12        17.24         2.09         1755
--------------------------------------------------------------
Infants <1 year                                        0.057           29        17.24         2.09          405
--------------------------------------------------------------
Children 1-2 years                                     0.057           38        17.24         2.09          353
--------------------------------------------------------------
Females 13-49 years                                    0.057           10        17.24         2.09        1,548
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. The short-term aggregate risk assessment 
estimates risks likely to result from 1 to 30 day exposure to 
imidacloprid residues from food, drinking water, and residential 
pesticide uses. High-end estimates of the residential exposure are used 
in the short-term assessment, and average values are used for food and 
drinking water exposures.
    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 320 for the U.S. population, and 
170 for children 1-2 years. These aggregate MOEs do not exceed the 
Agency's LOC 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 
water and ground water, EPA does not expect short-term aggregate 
exposure to exceed the Agency's LOC, as shown in Table 4:

                   Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate                  Surface       Ground
              Population Subgroup                MOE (Food +   Aggregate    Water EEC    Water EEC    Short-Term
                                                Residential)      LOC         (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                          270          100        17.24         2.09        2,200
--------------------------------------------------------------
Children 1-2 years old                                   130          100        17.24         2.09          205
----------------------------------------------------------------------------------------------------------------

    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).
    Intermediate- and long-term aggregate risk assessments were not 
performed because, based on the current use patterns, the Agency does 
not expect exposure durations that would result in intermediate- or 
long-term exposures.
    5. Aggregate cancer risk for U.S. population. There is no evidence 
of carcinogenicity to humans based on carcinogenicity studies in male 
and female rats and mice. The Agency concludes that pesticidal uses of 
imidacloprid are not likely to pose a cancer risk to humans.
    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 chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits 
(MRLs) for imidacloprid on bananas or sunflower.

VI. Conclusion

    Therefore, the tolerance is established for 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 bananas at 1.0 ppm and 
sunflower at 0.05 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

[[Page 3641]]

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0341 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 March 28, 
2005.
    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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. 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) 564-6255.
    2. 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 ADDRESSES. Mail 
your copies, identified by the docket ID number OPP-2004-0341, to: 
Public Information and Records Integrity Branch, Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in ADDRESSES. You may also send an 
electronic copy of your request via e-mail to: [email protected]. 
Please use an ASCII file format and avoid the use of special characters 
and any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

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

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

VIII. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under section 
408 of the FFDCA. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the FFDCA, 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 section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct

[[Page 3642]]

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. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and record 
keeping requirements.

    Dated: January 14, 2005.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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


0
2. Section 180.472 is amended by alphabetically 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
------------------------------------------------------------------------
                                * * * * *
Banana............................................      1.0     12/31/07
                                * * * * *
Sunflower, seed...................................     0.05     12/31/07
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-1438 Filed 1-25-05; 8:45 am]
BILLING CODE 6560-50-S