Air quality implementation plans; approval and promulgation; various States: Imidacloprid, 3634-3642 [05-1438]

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register: January 26, 2005 (Volume 70, Number 16)]
[Rules and Regulations]
[Page 3634-3642]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja05-14]

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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 https://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: Sec-18-Mailbox@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 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 (https://www.epa.gov/edocket/), you may

access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180

is available at E-CFR Beta Site Two at https://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

[[Page 3636]]

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: residuemethods@epa.gov.

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: 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. 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

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