FR Doc 03-14880

[Federal Register: June 13, 2003 (Volume 68, Number 114)]
[Rules and Regulations]
[Page 35303-35315]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn03-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0103; FRL-7310-8]

Imidacloprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as the parent in or on acerola; artichoke, globe;
avocado; banana (import); canistel; corn, pop, grain; corn, pop,
stover; cranberry; currant; elderberry; feijoa; fruit, stone, group 12;
gooseberry; huckleberry; guava; jaboticaba; juneberry; lingonberry;
longan; lychee; mango; mustard, seed; okra; papaya; passionfruit;
persimmon; pulasan; rambutan; salal; sapodilla; sapote, black; sapote,
mamey; Spanish lime; star apple; starfruit; strawberry; vegetable,
leaves of root and tuber, group 2; vegetable, legume, group 6, except
soybean; vegetable, root and tuber, group 1, except sugar beet;
watercress; wax jambu. EPA is also deleting certain imidacloprid
tolerances that are no longer needed as result of this action. The
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) , as
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective June 13, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0103,
must be received on or before August 12, 2003.

ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you an are
agricultural producer, food manufacturer, and pesticide manufacturer
Potentially affected entities may include, but are not limited to:
[sbull] Crop production (NAICS 111)
[sbull] Animal production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] Pesticide manufacturing (NAICS 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 Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0103. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., 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.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the `` Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html
, a
beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of February 5, 2003 (68 FR 5880) (FRL-7287-
5) and March 5, 2003 (68 FR 10464) (FRL-7291-1) EPA issued notices
pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA
(Public Law 104-170), announcing the filing of pesticide petitions
(PP1E6268, 1E6254, 1E6237, 1E6225, 0E6203, 2E6403, 2E6406, 2E6409,
2E6417, 2E6421, 2E6435, 2E6414, 2E6458, and 2E6506) by IR-4, 681 U.S.
Highway 1 South, North Brunswick, NJ 08902-3390 and PP 0E6074 Bayer
CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle
Park, NC 27709. Those notices included summaries of the petitions
prepared by Bayer CropScience, the registrant. One comment was received
in response to the notice of filing of February 5, 2003, from an
individual who requested that information about pesticide tolerances be
available in grocery stores next to the food labels.
The petitions requested that 40 CFR 180.472 be amended by
establishing tolerances for residues of the insecticide imidacloprid,
1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine, and its
metabolites containing the 6-chloropyridinyl

[[Page 35304]]

moiety, all expressed as imidacloprid in or on the raw agricultural
commodities as follows: Bushberry subgroup 13B, lingonberry, juneberry
and salal at 3.5 parts per million (ppm) (PP 1E6268), okra at 1.0 ppm
(PP 1E6254), watercress at 3.5 ppm (PP 1E6237), artichoke at 2.5 ppm
(PP 1E6225), cranberry at 0.05 ppm (PP 0E6203), vegetable, legume,
except soybean, group 6 at 4.0 ppm (PP 2E6403), avocado, papaya, star
apple, black sapote, mango, sapodilla, canistel, and mamey sapote at
1.0 ppm, and lychee, longan, Spanish lime, rambutan, pulasan and
persimmon at 3.0 ppm (PP 2E6406), vegetable, leaves of root and tuber,
group 2 at 4.0 ppm (PP 2E6409), strawberry at 0.5 ppm (PP 2E6417),
fruit, stone, group 12 at 3.0 ppm (PP 2E6421), guava, feijoa,
jaboticaba, wax jambu, starfruit, passionfruit, and acerola at 1.0 ppm
(PP 2E6435), corn, pop, grain at 0.05 ppm and corn, pop, stover at 0.2
ppm (PP 2E6414), mustard seed at 0.05 ppm (PP 2E6458), and vegetable,
root and tuber, except sugar beet, group 1, except sugar beet, at 0.4
ppm (PP 2E6506); imported banana at 0.01 ppm (0E6074). The petition for
imported banana was subsequently amended to propose a tolerance at 0.02
ppm.
EPA is also deleting several established tolerances in Sec.
180.472(a) and Sec. 180.472(b) that are no longer needed, as a result
of this action. The tolerance deletions under Sec. 180.472(b) are
time-limited tolerances established under section 18 emergency
exemptions that are superceded by the establishment of general
tolerances for imidacloprid and its metabolites under Sec. 180.472(a).
The revisions to Sec. 180.472(a) are as follows:
1. Delete bean, edible, podded at 1.0 ppm and bean, succulent,
shelled at 1.0 ppm. Replaced with vegetable, legume, group 6, except
soybean at 4.0 ppm.
2. Delete dasheen, leaves at 3.5 ppm and turnip greens at 3.5 ppm.
Replaced with vegetable, leaves of root and tuber, group 2 at 4.0 ppm.
3. Delete mango at 0.2 ppm. Replaced with mango at 1.0 ppm.
4. Delete potato at 0.3 ppm and vegetable, tuberous and corm,
subgroup at 0.3 ppm. Replaced with vegetable, root and tuber, group 1,
except sugar beet at 0.4 ppm.
The revisions to Sec. 180.472(b) are as follows:
1. Delete the time-limited tolerance for fruit, stone at 3.0 ppm.
Tolerance for fruit, stone, group 12 at 3.0 ppm is established by this
action under 180.472(a).
2. Delete the time-limited tolerance for strawberry at 0.1 ppm.
Tolerance for strawberry at 0.5 ppm is established by this action under
180.472(a).
3. Delete the time-limited tolerance for turnip, roots at 0.3 ppm.
Tolerance for vegetable, root and tuber, group 1, except sugar beet at
0.4 ppm is established by this action under 180.472(a).
4. Delete the time-limited tolerance for turnip, tops at 3.5 ppm.
Tolerance for vegetable, leaves of root and tuber, group 2 at 4.0 ppm
is established by this action under 180.472(a).
EPA has received objections to a time-limited tolerance it
established for residues of imidacloprid on blueberries in connection
with an emergency exemption for such use under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. published
in the Federal Register of January 18, 2002 (67 FR 2580)(FRL-6817-6).
The objections were filed by the Natural Resources Defense Council
(NRDC) and raised several issues regarding aggregate exposure estimates
and the additional safety factor for the protection of infants and
children. NRDC's objections raise complex legal, scientific, policy,
and factual matters and EPA has initiated a public comment period on
them in the Federal Register of June 19, 2002 (67 FR 41628) (FRL-7167-
7), which ended on October 16, 2002. Although that proceeding remains
ongoing, prior to acting on this current tolerance action, EPA reviewed
the imidacloprid-specific objections raised by NRDC and has addressed
them at relevant points throughout this preamble. Since EPA review of
the objections to the time-limited tolerance for blueberry is ongoing,
EPA is not establishing the proposed tolerance for blueberry at this
time. Individual commodity tolerances for the other members of the
bushberry subgroup (currant, elderberry, gooseberry and huckleberry)
are established by this action.
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....''
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 (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for tolerances for combined residues of
imidacloprid on banana (import) at 0.02 ppm; cranberry; mustard, seed;
corn, pop, grain at 0.05 ppm; corn, pop, stover at 0.20 ppm; vegetable,
root and tuber, group 1, except sugar beet at 0.40 ppm; strawberry at
0.50 ppm; acerola; avocado; canistel; feijoa; guava; jaboticaba; mango;
okra; papaya; passionfruit; sapodilla; sapote, black; sapote, mamey;
star apple; starfruit; wax jambu at 1.0 ppm; artichoke, globe at 2.5
ppm; fruit, stone, group 12; lychee; longan; Spanish lime; rambutan;
pulasan; persimmon at 3.0 ppm; currant; elderberry; gooseberry;
huckleberry; juneberry; lingonberry; salal; watercress at 3.5 ppm;
vegetable, leaves of root and tuber, group 2; vegetable, legume, group
6, except soybean at 4.0 ppm.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by imidacloprid are
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.

[[Page 35305]]

Table 1.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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870.3200 21/28-Day dermal toxicity NOAEL = 1,000 mg/kg/day (highest dose
(rabbits) tested (HDT))
LOAEL = Not identified
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870.3465 4 Week inhalation toxicity NOAEL = 0.191 mg/liter/day (HDT)
(rat) LOAEL = Not identified
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870.3700 Prenatal developmental Maternal NOAEL = 10 mg/kg/day
toxicity (rats) LOAEL = 30 mg/kg/day based on decreased
body weight gain and decreased corrected
body weight gain.
Developmental NOAEL = 30 mg/kg/day
LOAEL = 100 mg/kg/day based on a slight
increase in the incidence of wavy ribs.
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870.3700 Prenatal developmental Maternal NOAEL = 24 mg/kg/day
toxicity (rabbits) LOAEL = 72 mg/kg/day based on maternal
deaths and decreased maternal absolute
body weights, body weight gains, and food
consumption.
Developmental NOAEL = 24 mg/kg/day
LOAEL = 72 mg/kg/day based on abortion,
total litter resorptions, increased
postimplantation loss due to increased
late resorptions, decreased fetal weights,
and very low incidences of skeletal
alterations.
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870.3800 Reproduction and fertility Parental/Systemic NOAEL = 16.5 mg/kg/day
effects (rats) LOAEL = 47.3 mg/kg/day based on decreased
premating weight gain by F0 males and
females and F1 females and decreased
gestational weight gain by F1 females.
Reproductive NOAEL = 47.3 mg/kg/day (HDT)
LOAEL = not identified
Offspring NOAEL = 16.5 mg/kg/day
LOAEL = 47.3 mg/kg/day based on decreased
pup body weights in both litters of both
generations.
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870.4100 Chronic toxicity (dogs) NOAEL = 72 mg/kg/day (HDT)
LOAEL = Not identified
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870.4200 Carcinogenicity (mice) NOAEL = Males: 208 mg/kg/day; Females: 274
mg/kg/day
LOAEL = Males: 414 mg/kg/day; Females: 424
mg/kg/day based on decreased body weights,
food consumption and water intake.
No evidence of carcinogenicity.
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870.4300 Combined Chronic/ NOAEL = Males: 5.7 mg/kg/day; Females: 7.6
Carcinogenicity (rats) mg/kg/day
LOAEL = Males: 16.9 mg/kg/day; Females:
24.9 mg/kg/day based on thyroid toxicity
(increased incidence of mineralized
particles in thyroid colloid) in males.
No evidence of carcinogenicity.
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870.5100 Gene Mutation Negative in a battery of test.
870.5300
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870.5375 Chromosome aberrations Negative in battery of tests, except at
cytoxic doses in an in vitro mammalian
chromosome aberration test and an in vitro
sister chromatid exchange test.
870.5380
870.5385
870.5395
870.5900
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870.5550 Other genotoxic effects Negative in a battery of tests
870.5575
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870.6200 Acute neurotoxicity NOAEL = not identified.
screening battery rat LOAEL = 42 mg/kg based on decreased motor
and locomotor activities observed in
females.
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870.6200 Subchronic neurotoxicity NOAEL = 9.3 mg/kg/day.
screening battery rat LOAEL = 63.3 mg/kg/day based on decreased
body weight gain.
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870.6300 Developmental Maternal NOAEL = 20 mg/kg/day.
neurotoxicity (rat) LOAEL = 55 mg/kg/day based on decreased
food consumption and body weight gain
during lactation.
Offspring NOAEL = 20 mg/kg/day.
LOAEL = 55 mg/kg/day based on decreased
body weight and body weight gain,
decreased motor activity and decreased
caudate/putamen width in females.
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[[Page 35306]]

870.7485 Metabolism and Methylene-labeled imidacloprid was rapidly
pharmacokinetics rat absorbed. There were no biologically
significant differences between sexes,
dose levels, or route of administration.
Urinary excretion was the major route of
elimination, with a lesser amount
eliminated in feces. Total tissue burden
after 48 hours accounted for only
approximately 0.5% of the recovered
radioactivity, with major sites of
accumulation being the liver, kidney,
lung, skin, and plasma and minor sites
being the brain and testes. There were two
major evident routes of biotransformation.
The first included an oxidative cleavage
of the parent compound to give 6-CNA and
its glycine conjugate. Dechlorination of
this metabolite formed the 6-
hydroxynicotinic acid and its mercapturic
acid derivative. The second included the
hydroxylation of imidazolidine followed by
elimination of water of the parent
compound to give NTN 35884.
In a comparison between [Methylene-14C]
Imidacloprid and [Imidazolidine-4,5-14C]
Imidacloprid, the rates of excretion were
similar; however, the renal portion was
higher with the imidazolidine-labeled test
material. The imidazolidine-labeled test
material also demonstrated higher
accumulation in the tissues, with the
major sites of accumulation being the
liver, kidney, lung, and skin, and the
minor sites being brain and muscle.
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B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species 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 factors
(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 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 2 of this unit:

Table 2.--Summary of Toxicological Dose and Endpoints for Imidacloprid for Use in Human Risk Assessment
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* Special FQPA SF and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
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Acute Dietary all populations LOAEL = 42 mg/kg/day FQPA SF = 1X Acute neurotoxicity -
UF = 300............... aPAD = aRfD/ FQPA SF... rat
Acute RfD = 0.14 mg/kg. = 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 all populations NOAEL= 5.7 mg/kg/day FQPA SF = 1X Combined chronic tox/
UF = 100............... cPAD = cRfD/FQPA SF.... carcinogenicity - rat
Chronic RfD = 0.057 mg/ = 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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[[Page 35307]]

Intermediate-Term Oral (1-6 months) oral study NOAEL= 9.3 LOC for MOE = 100 Subchronic
mg/kg/day (Residential, includes neurotoxicity - rat
the FQPA SF). LOAEL = 63.3 mg/kg/day,
based upon decreased
body weight gain.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1-30 days) oral study NOAEL= 10 mg/ LOC for MOE = 100 Developmental toxicity
kg/day (Residential, includes rat
(dermal absorption rate the FQPA SF). Maternal LOAEL = 30 mg/
= 7.2%)2. kg/day, based upon
decreased body weight
gain and corrected
body weight gain.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1-6 months) oral study NOAEL= 9.3 LOC for MOE = 100 Subchronic
mg/kg/day (Residential, includes neurotoxicity - rat
(dermal absorption rate the FQPA SF). LOAEL = 63.3 mg/kg/day,
= 7.2%)2. based upon decreased
body weight gain.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (> 6 months) oral study NOAEL= 5.7 LOC for MOE = 100 Combined chronic tox/
mg/kg/day (Residential, includes carcinogenicity - rat
(dermal absorption rate the FQPA SF) LOAEL = 16.9 mg/kg/
= 7.2%)2. day, based upon
increased incidence of
mineralized particles
in thyroid colloid in
males.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1-30 days) oral study NOAEL= 10 mg/ LOC for MOE = 100 Developmental toxicity
kg/day (Residential, includes rat
(inhalation absorption the FQPA SF). Maternal LOAEL = 30 mg/
rate = 100%). kg/day, based upon
decreased body weight
gain and corrected
body weight gain.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1-6 oral study NOAEL= 9.3 LOC for MOE = 100 Subchronic
months) mg/kg/day (Residential, includes neurotoxicity - rat
(inhalation absorption the FQPA SF). LOAEL = 63.3 mg/kg/day,
rate = 100%). based upon decreased
body weight gain.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (>6 months) oral study NOAEL= 5.7 LOC for MOE = 100 Combined chronic tox/
mg/kg/day (Residential, includes carcinogenicity - rat
(inhalation absorption the FQPA SF). LOAEL = 16.9 mg/kg/day,
rate = 100%). based upon increased
incidence of
mineralized particles
in thyroid colloid in
males.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) no evidence of Not applicable No evidence of
carcinogenicity for carcinogenicity in
humans rats and mice.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

In its objections to a separate imidacloprid tolerance action, NRDC
claims that EPA erred by regulating on the basis of a LOAEL for acute
and chronic toxicity. As can be seen from the above table, NRDC is
mistaken with regard to use of a LOAEL for estimating the RfD for
chronic risk. The acute toxicity endpoint was based upon a LOAEL of 42
mg/kg/day from an acute neurotoxicity study in rats. This value was
adjusted with a safety factor of 3X to approximate the value of a
NOAEL. EPA has high confidence that this value of 3x is sufficient for
several reasons. The effect seen at the LOAEL in the acute
neurotoxicity study (decreased motor activity), occurred only in one
sex of the rat (females), was characterized as minimal, and may have
been a result of the use of the gavage dosing in the study. The
decreased motor activity was not replicated following repeated dietary
administration (non-gavage) at lower and higher doses (10, 70 or 200
mg/kg/day) in the subchronic neurotoxicity study in the same species
(rats). Further, using a safety factor of 3X produces a regulatory
endpoint lower than the acute effect levels in other standard studies
for determining an acute endpoint, developmental toxicity studies in
two species, and in another study that is on occasion used for such a
purpose, the developmental neurotoxicity study in rats.
Also in these objections, NRDC claims that EPA failed to calculate
residential risks for some scenarios, based on low toxicity (no
endpoints were chosen). On October 8, 2002, the Health Effects Division
(HED), Hazard Identification Assessment Review Committee (HIARC)
reviewed the hazard database for imidacloprid and established
additional endpoints. Endpoints were chosen for each of the following
exposure scenarios: acute dietary, chronic dietary, short-term oral,
intermediate-term oral, short-term dermal, intermediate-term dermal,
long-term dermal, short-term inhalation, intermediate-term inhalation,
and long-term inhalation. In the current risk assessment (Unit E of
this document), EPA calculated short-term residential risks (oral,
dermal, and inhalation) for both adults and children for a wide-range
of representative scenarios, including applications to lawns,
ornamental plantings, indoor and outdoor potted plants, and dogs and
cats. Based on current residential use patterns for imidacloprid, EPA
expects the duration of exposure to be short-term (1-30 days), and
would not result in intermediate or long-term exposure. EPA also
conducted human health aggregate risk assessments for the following
exposure scenarios: acute aggregate (food + drinking water), short-term
aggregate exposure (food + drinking water + residential), and chronic
aggregate exposure (food + drinking water).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been

[[Page 35308]]

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\T\) 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 1994-96
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. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the USDA [1994-1996/1998] 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%
crop treated (CT) information for registered and proposed commodities;
and modified DEEMTM (version 7.76) processing factors for some
commodities based on guideline processing studies. EPA estimated
exposure based on the 95th percentile value from this deterministic
exposure assessment.
In its objections to a separate imidacloprid tolerance action, NRDC
asserts that EPA erred by relying on the exposure value for the 95th
percentile of the population in estimating exposure. NRDC claims that
this approach leaves 5 percent of the population unprotected. These
comments by NRDC represent a misunderstanding of EPA's exposure
assessments. Although EPA estimated exposure using the 95th percentile,
EPA most definitely was not, however, acting in a manner designed to
protect only 95 percent of the population. To the contrary, EPA's
exposure estimates were designed to reasonably capture the full range
of exposures in each population subgroup.
As explained in its science policy paper on this subject, EPA, in
estimating exposure for population subgroups, generally considers
various population percentiles of exposure between 95 and 99.99,
depending on the extent of overestimation in the residue data used in
the assessment. In each exposure assessment EPA is attempting to
reasonably estimate the full range of exposures in a subgroup.
Accordingly, as EPA noted in its policy paper, just as when OPP uses
the 95th percentile with non-probabilistic exposure assessments OPP is
not suggesting that OPP is leaving 5 percent of the population
unprotected, OPP is not by choosing the 99.9th percentile for
probabilistic exposure assessments concluding that only 99.9 percent of
the population deserves protection. Rather, it is OPP's view that, with
probabilistic assessments, the use of the 99.9th percentile generally
produces a reasonable high-end exposure such that if that exposure does
not exceed the safe level, OPP can conclude there is a reasonable
certainty of no harm to the general population and all significant
population groups. (Office of Pesticide Programs, EPA, Choosing a
Percentile of Acute Dietary Exposure as a Threshold of Regulatory
Concern 31 (March 22, 2000)). Importantly, EPA generally uses a
population percentile of 95 when EPA relies on worst case residue
values - i.e., all crops covered by the tolerance contain residues at
the tolerance value. Even at the 95th percentile of estimated exposure,
actual exposure, when based on this assumption tends to be
significantly overstated. For example, EPA has found that when it uses
realistic residue information (e.g., data from monitoring of the food
supply), that exposure estimates are generally substantially lower even
at the 99.99th percentile.
As noted above, EPA did use the worst case assumption that all food
covered by imidacloprid tolerances would bear residues at the tolerance
level. Hence, EPA believes its exposure estimate is unlikely to
understate exposure; rather, in all likelihood, the estimate probably
substantially overstates exposure.
ii. Chronic exposure. The following assumptions were made for the
chronic exposure assessments: The chronic dietary exposure assessment
was performed using published and proposed tolerance levels, DEEM
default processing factors, and percent crop treated information on
some commodities.
iii. Cancer. A quantitative cancer aggregate risk assessment was
not performed because imidacloprid is not carcinogenic.
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 percent CT as
required by section 408(b)(2)(F) of the FFDCA, EPA may require
registrants to submit data on percent CT.
The Agency used CT information as follows:
For the acute assessment, 100% CT was assumed for all registered
and proposed commodities. For the chronic assessment, average weighted
percent CT 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 in Unit.
III.E. have been met. With respect to Condition 1, percent CT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. EPA uses a weighted average percent CT
for chronic dietary exposure estimates. This weighted average percent
CT 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 percent CT reasonably represents a person's
dietary exposure

[[Page 35309]]

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
percent CT over a lifetime. 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 FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The SCI-GROW model is used to predict pesticide
concentrations in shallow groundwater. For a screening-level assessment
for surface water EPA will 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. FIRST and PRZM/EXAMS incorporate an index reservoir
environment, and include 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 screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would 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 in Unit.III.E.
Analysis of monitoring data for degradates (ground water only)
shows that imidacloprid parent is the dominant residue with
imidacloprid urea the most likely degradate. Based on the available
information, modeling of total residue results in only modest increases
over the exposure estimates with parent alone. Based on the FIRST and
SCI-GROW models the estimated environmental concentrations (EECs) of
imidacloprid (total residue) 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 imidacloprid (parent only) for acute exposures are
estimated to be 35.89 parts per billion (ppb) for surface water and
1.43 ppb for ground water. The EECs for imidacloprid (total residue)
for chronic exposures are estimated to be 17.24 ppb for surface water
and 2.09 ppb for ground water. The EECs for imidacloprid (parent only)
for chronic exposures are estimated to be 16.52 ppb for surface water
and 1.43 ppb for ground water.
The New York State Department of Environmental Conservation,
Division of Solid and Hazardous Materials has submitted extensive water
monitoring information from Nassau and Suffolk Counties of New York.
Nassau and Suffolk counties have ground water that is exceptionally
vulnerable to pesticide contamination and have a long history of a
number of pesticides being banned from use in these counties over the
years. In general, the kinds of concentrations of imidacloprid (parent
only) found in the monitoring/observation and private drinking water
wells are in the range expected in highly vulnerable ground water.
Imidacloprid has been detected in approximately 20 (including some
clusters of wells in the same immediate area) out of about 2,000 public
and private water supply and monitoring wells. Imidacloprid was
detected in 24 of the approximately 3,500 well samples analyzed for
imidacloprid in Nassau and Suffolk Counties. Although detection of
imidacloprid in about 20 of 2,000 wells in an area with highly
vulnerable ground water does not demonstrate particularly widespread
ground water contamination, 3 of 2000 wells in this highly vulnerable
ground water have at least one detection greater than the SCI-GROW
groundwater screening concentration for imidacloprid (parent only) at
1.43 ppb. The three samples that exceed the SCI-GROW groundwater ECs
are reported at 2.06 ppb, 5.98, ppb and 6.69 ppb. Since the surface
water model screening levels are greater than the ground water model
screening levels and the detection levels reported from the water
monitoring from Nassau and Suffolk Counties, New York, the Agency will
use the surface water ECs for imidacloprid total residue as a worse
case estimate for drinking water in the aggregate risk assessment.
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.

[[Page 35310]]

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 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.''
EPA does not have, at this time, available data to determine
whether imidacloprid has a common mechanism of toxicity with other
substances. 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/
.

D. 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,
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-/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% 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 % CT 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 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

[[Page 35311]]

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.
In its objections to a separate imidacloprid tolerance action, NRDC
argues that in light of the outstanding data requirement for
prospective groundwater monitoring studies, EPA should have retained a
10X FQPA factor for imidacloprid. EPA disagrees. Two small- scale
prospective ground-water monitoring studies were originally requested
by the Agency in 1994. This request predates the development of the
Tier 1 ground-water screening model in 1997 and the Food Quality
Protection Act of 1996. The field phase of these prospective ground-
water monitoring studies commenced in 1996. Results from these studies
have now been received and the levels of imidacloprid observed (0.1
ppb) are below the screening concentration of 2.09 ppb calculated on
the basis of the SCI-GROW, the Tier 1 ground-water screening model. In
any event, as noted above, since higher values are predicted for
imidacloprid residues in surface water, these higher values were used
in conducting the risk assessment.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 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 groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
imidacloprid will occupy 25% of the aPAD for the U.S. population, 17%
of the aPAD for females 13 to 49 years, 54% of the aPAD for infants < 1
year old and 64% of the aPAD for children 1-2 years. In addition, there
is potential for acute dietary exposure to imidacloprid in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the aPAD, as shown in Table 3 of this unit:

Table 3.--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 25 36.04 2.09 3,700
----------------------------------------------------------------------------------------------------------------
Females 13-49 years 0.14 17 36.04 2.09 3,500
----------------------------------------------------------------------------------------------------------------
Infants <1 year 0.14 54 36.04 2.09 650
----------------------------------------------------------------------------------------------------------------
Children 1-2 years 0.14 64 36.04 2.09 510
----------------------------------------------------------------------------------------------------------------

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 11% of the cPAD for the U.S.
population, 26% of the cPAD for infants < 1 year and 35% 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 and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in Table 4 of this unit:

[[Page 35312]]

Table 4.--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 11 17.24 2.09 1,800
----------------------------------------------------------------------------------------------------------------
Infants <1 year 0.057 26 17.24 2.09 420
----------------------------------------------------------------------------------------------------------------
Children 1-2 years 0.057 35 17.24 2.09 370
----------------------------------------------------------------------------------------------------------------
Females 13-49 years 0.057 8.3 17.24 20.9 1,600
----------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Short-term aggregate risk assessments are needed for adults as
there is potential for both dermal and inhalation handler exposure, and
dermal post-application exposure from the residential uses of
imidacloprid on turf and pets. In addition, short-term aggregate risk
assessments are needed for children/toddlers because there is a
potential for oral and dermal, post-application exposure resulting from
the residential uses of imidacloprid on turf and pets. The pet-
treatment scenario resulted in the lowest combined MOE for adults (MOE
= 400; handler and post-application) and children (MOE = 260; post-
application). The turf-treatment resulted in much lower exposures for
both adults (MOE = 15,000; handler and post-application) and children
(MOE = 1,500; post-application). Therefore, the pet-treatment exposure
estimates were aggregated with the chronic dietary (food) to provide a
worst-case estimate of short-term aggregate risk for the U.S.
population and children 1-2 years old (the child population subgroup
with the highest estimated chronic dietary food exposure).
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 level of concern for aggregate exposure to food and
residential uses. In addition, short-term DWLOCs were calculated and
compared to the EECs for chronic exposure of imidacloprid in ground and
surface water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect short-term aggregate
exposure to exceed the Agency's level of concern, as shown in Table 5
of this unit:

Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Imidacloprid
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 320 100 17.24 2.09 2,400
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old 170 100 17.24 2.09 410
----------------------------------------------------------------------------------------------------------------

4. 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.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to imidacloprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methods are available for determination of
imidacloprid residues of concern in plant (Bayer Gas Chromatography/
Mass Spectrometry (GC/MS) Method 00200) and livestock commodities
(Bayer GC/MS Method 00191). These methods have undergone successful EPA
petition method validations (PMVs), and the registrant has fulfilled
the remaining requirements for additional raw data, method validation,
independent laboratory validation (ILV), and an acceptable confirmatory
method (high performance liquid chromatography/ultraviolet (HPLC/UV)
Method 00357). The methods 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 established Codex maximum residue limits (MRLs) for
imidacloprid in/on the commodities in the subject petitions. There are
currently Canadian and Mexican MRLs for imidacloprid and metabolites
containing the 6-chloropicolyl moiety in potatoes at 0.3 ppm. The
Mexican and Canadian MRLs are not equivalent to the US-recommended
tolerance level. Therefore, harmonization is not possible at this time.

V. Conclusion

Therefore, the tolerances are established for combined residues of
imidacloprid, its metabolites containing the 6-chloropyridinyl moiety,
all expressed as the parent, in or on banana (import) at 0.02 ppm;
cranberry; mustard, seed; corn, pop, grain at 0.05 ppm; corn, pop,
stover at 0.20 ppm; vegetable, root and tuber, group 1, except sugar
beet at 0.40 ppm; strawberry at 0.50 ppm; acerola; avocado; canistel;
feijoa; guava; jaboticaba; mango; okra; papaya; passionfruit;
sapodilla; sapote, black; sapote, mamey; star apple; starfruit; wax

[[Page 35313]]

jambu at 1.0 ppm; artichoke, globe at 2.5 ppm; fruit, stone, group 12;
lychee; longan; Spanish lime; rambutan; pulasan; persimmon at 3.0 ppm;
currant; elderberry; gooseberry; huckleberry; juneberry; lingonberry;
salal; watercress at 3.5 ppm; vegetable, leaves of root and tuber,
group 2; vegetable, legume, group 6, except soybean at 4.0 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, 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 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-2003-0103 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 August
12, 2003.
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 (1900C),
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 Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA-. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0103, 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 Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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

[[Page 35314]]

Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Since tolerances and exemptions that are established on the
basis of a petition under section 408(d) 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.

VIII. 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
recordkeeping requirements.

Dated: June 2, 2003.
Debra Edwards,
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), 346(a) and 371.

0
2. Section 180.472 is amended:
i. In paragraph (a), in the table, by removing the commodities,
``bean, edible, podded,'' `` bean, succulent, shelled,'' ``dasheen,
leaves,'' ``mango,'' ``potato,'' ``turnip, greens,'' and ``vegetable,
tuberous and corm, subgroup;'' and by alphabetically adding the
following commodities.
ii. In paragraph (b), in the table, by removing the commodities,
``fruit, stone,'' ``strawberry,'' ``turnip, roots,'' and ``turnip,
tops.''
The additions read as follows:

Sec. 180.472 Imidacloprid; tolerances for residues.

(a) * * *

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Acerola.............................................. 1.0
* * * * *
Artichoke, globe..................................... 2.5
Avocado.............................................. 1.0
Bananna\1\........................................... 0.02
* * * * *
Canistel............................................. 1.0
* * * * *
Corn, pop, grain..................................... 0.05
Corn, pop, stover.................................... 0.20
* * * * *
Cranberry............................................ 0.05
Currant.............................................. 3.5
* * * * *
Elderberry........................................... 3.5
* * * * *
Feijoa............................................... 1.0
* * * * *
Fruit, stone, group 12............................... 3.0
Gooseberry........................................... 3.5
* * * * *
Guava................................................ 1.0
* * * * *
Huckleberry.......................................... 3.5
Jaboticaba........................................... 1.0
Juneberry............................................ 3.5
* * * * *
Lingonberry.......................................... 3.5
Longan............................................... 3.0
Lychee............................................... 3.0
Mango................................................ 1.0
* * * * *
Mustard, seed........................................ 0.05
Okra................................................ 1.0
Passionfruit......................................... 1.0
Papaya............................................... 1.0
* * * * *
Persimmon............................................ 3.0
* * * * *
Pulasan.............................................. 3.0
Rambutan............................................. 3.0
Salal................................................ 3.5
Sapodilla............................................ 1.0
Sapote, black........................................ 1.0
Sapote, mamey........................................ 1.0
* * * * *
Spanish lime......................................... 3.0
Star apple........................................... 1.0
Starfruit............................................ 1.0
Strawberry........................................... 0.50
* * * * *
Vegetable, leaves of root and tuber, group 2......... 4.0
Vegetable, legume, except soybean, group 6........... 4.0

[[Page 35315]]

Vegetable, root and tuber, group 1, except sugar beet 0.40
* * * * *
Watercress........................................... 3.5
Wax jambu............................................ 1.0
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registration as of June 13, 2003 for use on
banana.

* * * * *
[FR Doc. 03-14880 Filed 6-12-03; 8:45 am]

BILLING CODE 6560-50-S