[Federal Register Volume 68, Number 114 (Friday, June 13, 2003)]
[Rules and Regulations]
[Pages 35303-35315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14880]


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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: 
[email protected].

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
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28-Day dermal toxicity   NOAEL = 1,000 mg/kg/day (highest dose
                                          (rabbits)                   tested (HDT))
                                                                     LOAEL = Not identified
----------------------------------------------------------------------------------------------------------------
870.3465                                 4 Week inhalation toxicity  NOAEL = 0.191 mg/liter/day (HDT)
                                          (rat)                      LOAEL = Not identified
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity (dogs)     NOAEL = 72 mg/kg/day (HDT)
                                                                     LOAEL = Not identified
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

[[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.
----------------------------------------------------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                 * 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 = 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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

[[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: 
[email protected].

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 [email protected], 
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: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

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