FR Doc 05-20209

[Federal Register: October 12, 2005 (Volume 70, Number 196)]
[Rules and Regulations]
[Page 59268-59276]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12oc05-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0260; FRL-7738-8]

Imidacloprid; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance 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 pomegranates.
This action is in response to EPA's granting of an emergency exemption
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizing use of the pesticide on pomegranates. This
regulation establishes a maximum permissible level for residues of
imidacloprid in this food commodity. The tolerance will expire and is
revoked on December 31, 2008.

DATES: This regulation is effective October 12, 2005. Objections and
requests for hearings must be received on or before December 12, 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-2005-0260. 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 S.
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 an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532)
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 on 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 a tolerance 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 pomegranates at 0.20 parts per
million (ppm). This tolerance will expire and is revoked on December
31, 2008. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations.

[[Page 59269]]

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 Pomegranates and FFDCA
Tolerances

The State of California requested the use of imidacloprid on
pomegranates to control whiteflies. The applicant stated that
uncontrolled whitefly populations cause significant problems for
producers. Immature life stages exude honeydew on the trees and
developing fruit, which contribute to the development of molds (which
mar the surface of the pomegranates) and also contribute to the
sunburning of the fruit. Since the introduction of the pest on
pomegranates, cull rates went from 15-30% to 40-50%. This increase in
cull rates is forcing growers and shippers to move fruit from the fresh
market to the juice market, which in turn is causing significant
economic damage. EPA has authorized under FIFRA section 18 the use of
imidacloprid on pomegranates for control of whiteflies in California.
After having reviewed the submission, EPA concurs that emergency
conditions exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of imidacloprid in or on
pomegranates. In doing so, EPA considered the safety standard in
section 408(b)(2) of the FFDCA, and EPA decided that the necessary
tolerance 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 this tolerance without notice and
opportunity for public comment as provided in section 408(l)(6) of the
FFDCA. Although this tolerance will expire and is revoked on December
31, 2008, under section 408(l)(5) of the FFDCA, residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on pomegranates 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
this tolerance at the time of that application. EPA will take action to
revoke this tolerance earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether imidacloprid
meets EPA's registration requirements for use on pomegranates or
whether a permanent tolerance for this use would be appropriate. Under
these circumstances, EPA does not believe that this tolerance serves as
a basis for registration of imidacloprid by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than California to use this pesticide on this
crop 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 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 in the Federal Register of November 26,
1997 (62 FR 62961) 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 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 pomegranates at 0.20 ppm. EPA's assessment of the
dietary exposures and risks associated with establishing the tolerance
follows.

A. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if 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 (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF). Where an additional safety factor is

[[Page 59270]]

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 safty factor
(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 x10⁶ 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
the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for Imidacloprid for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
*Special FQPA SF and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary all populations LOAEL = 42 mg/kg/day FQPA SF = 1X Acute neurotoxicity -
UF = 300............... aPAD = acute RfD....... rat
ARfD = 0.14 mg/kg...... FQPA SF = 0.14 mg/kg... LOAEL = 42 mg/kg, based
upon the decrease in
motor and locomotor
activities observed in
females
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL= 5.7 mg/kg/day FQPA SF = 1X Combined chronic tox/
UF = 100............... cPAD = chr RfD......... carcinogenicity - rat
Chronic RfD = 0.057 mg/ FQPA SF = 0.057 mg/kg/ LOAEL = 16.9 mg/kg/day,
kg/day. day. based upon increased
incidence of
mineralized particles
in thyroid colloid in
males
----------------------------------------------------------------------------------------------------------------
Short-term oral (1-30 days) Oral study NOAEL= 10 mg/ LOC for MOE = 100 Developmental toxicity
kg/day rat
Maternal LOAEL = 30 mg/
kg/day, based upon
decreased body weight
gain and corrected
body weight gain
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1-30 days) Oral study NOAEL= 10 mg/ LOC for MOE = 100 Developmental toxicity
kg/day (dermal rat
absorption rate = Maternal LOAEL = 30 mg/
7.2%) kg/day, based upon
decreased body weight
gain and corrected
body weight gain
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1-30 days) Oral study NOAEL = 10 LOC for MOE = 100 Developmental toxicity
mg/kg/day (inhalation rat
absorption rate = Maternal LOAEL = 30 mg/
100%) kg/day, based upon
decreased body weight
gain and corrected
body weight gain
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Group E Not applicable No evidence of
carcinogenicity in
rats and mice
----------------------------------------------------------------------------------------------------------------
1 UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL
= lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD =
reference dose, MOE = margin of exposure, LOC = level of concern

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. Risk assessments were conducted by EPA to assess
dietary exposures from imidacloprid in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. The Dietary Exposure Evaluation Model
(DEEM^TM) analysis evaluated the individual food consumption
as reported by respondents in the U.S. Department of Agriculture (USDA)
1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the acute exposure
assessments: A Tier 1, deterministic acute dietary exposure assessment
was conducted using tolerance-level residues, 100% percent 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 95^th percentile value from this deterministic exposure
assessment.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM^TM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1994-1996 and 1998
nationwide CSFII and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: A

[[Page 59271]]

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 chronic
assessment, average weighted PCT information was used for the following
commodities: Apple 34%; brussels sprouts 56%; broccoli 35%; cabbage
14%; cantaloupe 31%; cauliflower 52%; collards 10%; corn, field 1%;
cotton 3%; cucumber 2%; eggplant 36%; grapefruit 3%; grape 32%; mustard
greens16%; honeydew 26%; kale 30%; lemon 1%; lettuce, head 49%; lime
5%; 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 CT.
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 PC area factor as an adjustment to account for the maximum
percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to imidacloprid they are
further discussed in the aggregate risk sections below.
Based on the 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

[[Page 59272]]

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 residential exposure durations that would result in
intermediate-term 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-term 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 effects from 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to imidacloprid and any other
substances and 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 policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

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 (MOS) will be
safe for infants and children. MOSs are incorporated into EPA risk
assessments either directly through use of a MOE analysis or through
using UF (safety) 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
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 prenatal/postnatal 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% CT 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% CT 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

[[Page 59273]]

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 milligrams/
kilogram/ day (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 U.S. EPA 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 66% 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 estimated environmental concentrations of
imidacloprid in surface water and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ %aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.14 26 36.04 2.09 3600
----------------------------------------------------------------------------------------------------------------
Females (13-49 years) 0.14 17 36.04 2.09 3500
----------------------------------------------------------------------------------------------------------------
Infants (1 year) 0.14 57 36.04 2.09 600
----------------------------------------------------------------------------------------------------------------
Children (1-2 years) 0.14 66 36.04 2.09 470
----------------------------------------------------------------------------------------------------------------

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 imidacloprid in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface water and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in the following Table 3:

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.057 12 17.24 2.09 1800
----------------------------------------------------------------------------------------------------------------
Infants (1 year) 0.057 29 17.24 2.09 400
----------------------------------------------------------------------------------------------------------------
Children (1-2 years) 0.057 38 17.24 2.09 350
----------------------------------------------------------------------------------------------------------------
Females (13-49 years) 0.057 10 17.24 2.09 1600
----------------------------------------------------------------------------------------------------------------

[[Page 59274]]

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 310 for the U.S. population, and
170 for children 1-2 years. These aggregate MOEs do not exceed the
Agency's level of concern for aggregate exposure to food and
residential uses. In addition, short-term DWLOCs were calculated and
compared to the EECs for chronic exposure of imidacloprid in ground
water and surface water. After calculating DWLOCs and comparing them to
the EECs for surface water and ground water, EPA does not expect short-
term aggregate exposure to exceed the Agency's level of concern, as
shown in the following Table 4:

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Aggregate Surface Ground
Population Subgroup MOE (Food + Aggregate Water EEC Water EEC Short-Term
Residential) LOC (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 310 100 17.24 2.09 2400
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 170 100 17.24 2.09 400
----------------------------------------------------------------------------------------------------------------

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).
An intermediate-term aggregate risk assessment was not performed
because, based on the current use patterns, the Agency does not expect
residential exposure durations that would result in intermediate-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 chromatography) 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 for
imidacloprid on pomegranates.

VI. Conclusion

Therefore, the tolerance is established for the combined residues
of imidacloprid, (1-[6-chloro-3-pyridinyl) methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as parent, in or on pomegrantes at 0.20 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. EPA's 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.

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-2005-0260 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 December
12, 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 issue(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

[[Page 59275]]

copies, identified by the docket ID number OPP-2005-0260, 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 issue(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 a time-limited [tolerance] 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
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of 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 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: September 27, 2005.
Donald R. Stubbs,
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 the following
commodity to the table in paragraph (b) to read as follows:

Sec. 180.472 Imidacloprid; tolerances for residues.

* * * * *
(b) * * *

[[Page 59276]]

------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
* * * * *
Pomegranate....................... 0.20 12/31/08
------------------------------------------------------------------------

* * * * *
[FR Doc. 05-20209 Filed 10-11-05; 8:45 am]

BILLING CODE 6560-50-S