[Federal Register Volume 68, Number 131 (Wednesday, July 9, 2003)]
[Rules and Regulations]
[Pages 40791-40803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17212]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0220; FRL-7316-6]


Emamectin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of emamectin and its metabolites in or on Brassica leafy vegetables 
(crop group 5); turnip greens; cotton, undelinted seed; cotton gin 
byproduct; leafy vegetables (except Brassica) (crop group 4); fruiting 
vegetables (crop group 8); and tomato paste. In addition, tolerances 
are established for indirect or inadvertent combined residues of 
emamectin and the associated 8,9-Z isomers in or on milk and fat of 
cattle, goats, hogs, horses, and sheep; meat byproducts, except liver, 
of cattle, goats, hogs, horses , and sheep; liver of cattle, goats, 
hogs, horses, and sheep; and meat of cattle, goat, hogs, horses, and 
sheep. Syngenta Crop Protection, Inc. requested this tolerance 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 July 9, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0220, 
must be received on or before September 8, 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: Thomas C. Harris, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington,

[[Page 40792]]

DC 20460-0001; telephone number: (703) 308-9423; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop Production (NAICS 111, e.g.)
    [sbull] Animal Production (NAICS 112, e.g.)
    [sbull] Food Manufacturing (NAICS 311, e.g.)
    [sbull] Pesticide Manufacturing (NAICS 32532, e.g.)
    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-2003-0220. 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 March 20, 2002 (67 FR 12990) (FRL-6824-
4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (PP 7F4845) by Syngenta Crop Protection, Inc., 
P.O. Box 18300, Greensboro, NC 27419. That notice included a summary of 
the petition prepared by Syngenta Crop Protection, Inc., the 
registrant. There were no comments received in response to the notice 
of filing.
    The original petition requested that 40 CFR 180.505 be amended by 
establishing a tolerance for combined residues of the insecticide 
emamectin benzoate, 4'-epi-methylamino-4'-deoxyavermectin B1 
benzoate (a mixture of a minimum of 90% 4'-epi-methylamino-4'-
deoxyavermectin B1a and a maximum of 10% 4'-epi-methlyamino-
4'deoxyavermectin B1b benzoate), and its metabolites 8,9 
isomer of the B1a and B1b component of the parent 
insecticide in or on the raw agricultural commodities fruiting 
vegetables (except Cucurbits) group at 0.02 parts per million (ppm), 
Brassica leafy vegetables group at 0.025 ppm, leafy vegetables (except 
Brassica) group at 0.1 ppm, cottonseed at 0.025 ppm, cotton gin 
byproducts at 0.5 ppm.
    Based on the EPA analysis of the residue chemistry and 
toxicological databases, the petition was subsequently revised to 
express the tolerance as the combined residues of emamectin, (a mixture 
of a minimum of 90% 4"-epi-methylamino-4"-deoxyavermectin 
B1a and maximum of 10% 4"-epi-methylamino-4"-deoxyavermectin 
B1b) and its metabolites 8,9-isomer of the B1a 
and B1b component of the parent (8,9-ZMA), or 4"-deoxy-4"-
epi-amino-avermectin B1a and 4"-deoxy-4"-epi-amino-
avermectin B1b; 4"-deoxy-4"-epi-amino avermectin 
B1a (AB1a); 4"-deoxy-4"-epi-(N-formyl-N-
methyl)amino-avermectin (MFB1a); and 4"-deoxy-4"-epi-(N-
formyl)amino-avermectin B1a (FAB1a), in or on 
Brassica leafy vegetables (crop group 5) at 0.05 ppm; turnip greens at 
0.05 ppm; cotton, undelinted seed at 0.025 ppm; cotton gin byproduct at 
0.05 ppm; leafy vegetables (except Brassica) (crop group 4) at 0.10 
ppm; fruiting vegetables (crop group 8) at 0.02 ppm; and tomato paste 
at 0.15 ppm. In addition, tolerances are established for indirect or 
inadvertent combined residues of emamectin (MAB1a + 
MAB1b isomers) and the associated 8,9-Z isomers (8,9-
ZB1a + 8,9-ZB1b) in or on milk and fat of cattle, 
goats, hogs, horses, and sheep at 0.003 ppm; meat byproducts, except 
liver, of cattle, goats, hogs, horses, and sheep at 0.005 ppm; liver of 
cattle, goats, hogs, horses, and sheep at 0.020 ppm; and meat of 
cattle, goat, hogs, horses, and sheep at 0.002 ppm. Note that the 
tolerance expression in 40 CFR 180.505 is being changed from emamectin 
benzoate to emamectin since the enforcement method, Method 244-92-3, 
Revision 1, analyzes residues of emamectin MAB1 isomers (not 
emamectin benzoate), 8,9-ZMA, AB1a, MFB1a, and 
FAB1a in/on crops.
    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

[[Page 40793]]

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 a tolerance for combined residues of 
emamectin, (a mixture of a minimum of 90% 4"-epi-methylamino-4"-
deoxyavermectin B1a and maximum of 10% 4"-epi-methylamino-
4"-deoxyavermectin B1b) and its metabolites 8,9-isomer of 
the B1a and B1b component of the parent (8,9-
ZMA), or 4"-deoxy-4"-epi-amino-avermectin B1a and 4"-deoxy-
4"-epi-amino-avermectin B1b; 4"-deoxy-4"-epi-amino 
avermectin B1a (AB1a); 4"-deoxy-4"-epi-(N-formyl-
N-methyl)amino-avermectin (MFB1a); and 4"-deoxy-4"-epi-(N-
formyl)amino-avermectin B1a (FAB1a), in or on 
Brassica leafy vegetables (crop group 5) at 0.05 ppm; turnip greens at 
0.05 ppm; cotton, undelinted seed at 0.025 ppm; cotton gin byproduct at 
0.05 ppm; leafy vegetables (except Brassica) (crop group 4) at 0.10 
ppm; fruiting vegetables (crop group 8) at 0.02 ppm; and tomato paste 
at 0.15 ppm. In addition, tolerances are established for indirect or 
inadvertent combined residues of emamectin (MAB1a + 
MAB1b isomers) and the associated 8,9-Z isomers (8,9-
ZB1a + 8,9-ZB1b) in or on milk and fat of cattle, 
goats, hogs, horses, and sheep at 0.003 ppm; meat byproducts, except 
liver, of cattle, goats, hogs, horses, and sheep at 0.005 ppm; liver of 
cattle, goats, hogs, horses, and sheep at 0.020 ppm; and meat of 
cattle, goat, hogs, horses, and sheep at 0.002 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerance follows.

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 emamectin 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.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.              Study Type            Results
------------------------------------------------------------------------
870.3100                        Subchronic-        Systemic Toxicity
                                 Feeding-Rat MK-    NOAEL=2.5 mg/kg/day.
                                 0243               Systemic Toxicity
                                                    LOAEL=5 mg/kg/day
                                                    based on tremors,
                                                    hindlimb splaying,
                                                    urogenital staining,
                                                    histological changes
                                                    in brain and spinal
                                                    cord, sciatic and
                                                    optic nerves and
                                                    skeletal muscles in
                                                    males, emaciation,
                                                    reduced body weight
                                                    and reduced food
                                                    consumption in both
                                                    sexes.
------------------------------------------------------------------------
870.3150                        Subchronic-        Systemic Toxicity
                                 Feeding-Dog MK-    NOAEL=0.25 mg/kg.
                                 0243               Systemic Toxicity
                                                    LOAEL=0.50 mg/kg
                                                    based on microscopic
                                                    pathological signs
                                                    of neurotoxicity
                                                    consisting of
                                                    skeletal muscle
                                                    atrophy and white
                                                    matter multifocal
                                                    degeneration in the
                                                    brains of both sexes
                                                    and white matter
                                                    multifocal
                                                    degeneration in the
                                                    spinal cords of
                                                    males.
------------------------------------------------------------------------
870.3200                        21-Day Dermal      No Study Available.
                                 Toxicity-Rat
------------------------------------------------------------------------
870.3700                        Developmental      Maternal Toxicity
                                 Toxicity-Rat MK-   NOAEL=2 mg/kg/day.
                                 0243               Maternal Toxicity
                                                    LOAEL=4 mg/kg/day
                                                    based on a
                                                    significant trend
                                                    towards decreased
                                                    body weight gain
                                                    during the dosing
                                                    period.
                                                    Developmental
                                                    Toxicity NOAEL=4 mg/
                                                    kg/day.
                                                    Developmental
                                                    Toxicity LOAEL=8 mg/
                                                    kg/day based on
                                                    altered growth and
                                                    an increased
                                                    incidence of
                                                    supernumerary rib.
------------------------------------------------------------------------
870.3700                        Developmental      Maternal Toxicity
                                 Toxicity-Rabbit    NOAEL=3 mg/kg/day.
                                 MK-0243            Maternal Toxicity
                                                    LOAEL=6 mg/kg/day
                                                    based on a
                                                    significant trend
                                                    towards decreased
                                                    body weight gain
                                                    during dosing period
                                                    and increased
                                                    clinical signs
                                                    (mydriasis and
                                                    decreased pupillary
                                                    reaction).
                                                    Developmental
                                                    Toxicity NOAEL=6 mg/
                                                    kg/day.
                                                    Developmental
                                                    Toxicity LOAEL=Not
                                                    Determined.
------------------------------------------------------------------------
870.3800                        Reproductive       Systemic Toxicity
                                 Toxicity-Rat MK-   NOAEL=0.6 mg/kg/day.
                                 0244               Systemic Toxicity
                                                    LOAEL=1.8 mg/kg/day
                                                    based on decreased
                                                    body weight gain and
                                                    histopathological
                                                    changes (neuronal
                                                    degeneration in the
                                                    brain and spinal
                                                    cord) in both sexes
                                                    and generations.
                                                    Reproductive
                                                    Toxicity NOAEL=0.6
                                                    mg/kg/day.
                                                    Reproductive
                                                    Toxicity LOAEL=1.8
                                                    mg/kg/day based on
                                                    decreased fecundity
                                                    and fertility
                                                    indices and clinical
                                                    signs (tremors and
                                                    hind limb extension)
                                                    in offspring of both
                                                    generations.
------------------------------------------------------------------------

[[Page 40794]]

 
870.4100                        Chronic-Feeding-   Systemic Toxicity
                                 Dog MK-0244        NOAEL= 0.25 mg/kg/
                                                    day.
                                                    Systemic Toxicity
                                                    LOAEL=0.5 mg/kg/day
                                                    based on axonal
                                                    degeneration in the
                                                    pons, medulla and
                                                    peripheral nerves
                                                    (sciatic, sural, and
                                                    tibial) in both
                                                    sexes, clinical
                                                    signs of
                                                    neurotoxicity (whole
                                                    body tremors,
                                                    stiffness of the
                                                    hind legs), spinal
                                                    cord axonal
                                                    degeneration, and
                                                    muscle fiber
                                                    degeneration in
                                                    females.
------------------------------------------------------------------------
870.4100                        Chronic Feeding-   Systemic Toxicity
                                 Rat MK-0244        NOAEL=1.0 mg/kg/day.
                                                    Systemic Toxicity
                                                    LOAEL=2.5 mg/kg/day,
                                                    based on increased
                                                    incidence of
                                                    neuronal
                                                    degeneration in the
                                                    brain and spinal
                                                    cord, decreased
                                                    rearing, and an
                                                    increased incidence
                                                    of animals with low
                                                    arousal.
------------------------------------------------------------------------
870.4200                        Carcinogenicity-   Systemic Toxicity
                                 Mouse (78-week)    NOAEL=2.5 mg/kg/day.
                                 MK-0244            Systemic Toxicity
                                                    LOAEL=5.0 mg/kg/day
                                                    for males and 7.5 mg/
                                                    kg/day for females
                                                    based on increased
                                                    mortality, decreased
                                                    weight gain,
                                                    neurological signs,
                                                    and increased
                                                    incidence of
                                                    severity of
                                                    infections. There
                                                    were no signs of
                                                    carcinogenicity in
                                                    this study.
------------------------------------------------------------------------
870.4300                        Chronic Toxicity/  Systemic Toxicity
                                 Carcinogenicity-   NOAEL=1.0 mg/kg/day.
                                 Rat Emamectin      Systemic Toxicity
                                                    LOAEL=2.5/5.0 mg/kg/
                                                    day based on marked
                                                    neural degeneration
                                                    in the brain and
                                                    spinal cord of both
                                                    sexes, brain white
                                                    matter degeneration
                                                    in males, and on
                                                    decreased body
                                                    weight, body weight
                                                    gain, and food
                                                    efficiency in males.
                                                    There were no signs
                                                    of carcinogenicity
                                                    in this study.
                                                    Note: The initial
                                                    dose of the high
                                                    dose group was 5.0
                                                    mg/kg/day. Due to
                                                    unacceptable weight
                                                    loss and/or tremors
                                                    occurring at this
                                                    dose in another
                                                    concurrent study
                                                    (TT91-006-0
                                                    ) during week 9 in
                                                    males and week 11 in
                                                    females, the dose
                                                    was lowered to 2.5
                                                    mg/kg/day starting
                                                    at week 6 in males
                                                    and week 10 in
                                                    females.
------------------------------------------------------------------------
870.5100                        Gene Mutation -    Negative for the
                                 Salmonella MK-     induction of reverse
                                 0243 and L-        gene mutation
                                 660,599; L-
                                 657,831; L-
                                 695,638; L-
                                 930,905
                                 (photometabolite
                                 s of MK-0244)
------------------------------------------------------------------------
870.5300                        Gene Mutation in   Negative for the
                                 Cultured V-79      induction of forward
                                 Chinese Hamster    gene mutations in
                                 Lung Cells MK-     Chinese hamster lung
                                 0243               fibroblast cells up
                                                    to a severely
                                                    cytotoxic
                                                    nonactivated dose of
                                                    0.01mM or a severely
                                                    cytotoxic S9-
                                                    activated dose of
                                                    0.04mM.
------------------------------------------------------------------------
870.5385                        Structural         Negative for the
                                 Chromosome         induction of
                                 Aberration-in      chromosome
                                 vivo mouse bone    aberrations in the
                                 marrowMK-0244      bone marrow cells of
                                                    male CD-1 mice.
------------------------------------------------------------------------
870.5500                        DNA Damage-Rat     Negative for the
                                 hepatocytes MK-    induction of single
                                 0243               strand breaks (SBs)
                                                    in DNA of rat
                                                    hepatocytes.
------------------------------------------------------------------------
870.6200                        Acute Oral         A Neurotoxicity NOAEL
                                 Neurotoxicity -    was not established,
                                 Rat MK-0243        since toxic signs of
                                                    neurotoxicity as
                                                    well as histological
                                                    lesions in the
                                                    brain, spinal cord
                                                    and sciatic nerve
                                                    occurred at all
                                                    doses tested (27.4,
                                                    54.8 or 82.2 mg/kg)
------------------------------------------------------------------------
870.6200                        Subchronic         Neurotoxicity
                                 Neurotoxicity-     NOAEL=1.0 mg/kg/day.
                                 Rat MK-0243        LOAEL=5.0 mg/kg/day
                                                    (highest dose
                                                    tested) based on
                                                    mild tremors,
                                                    posture, rearing,
                                                    excessive
                                                    salivation, fur
                                                    appearance, gait,
                                                    strength, mobility
                                                    and righting reflex.
------------------------------------------------------------------------
870.6200                        2-Week Dietary     Neurotoxicity
                                 Neurotoxicity-CD   NOAEL=2.0 mg/kg/day
                                 -1 Mice MK-0243    (highest dose
                                                    tested). No
                                                    characteristic
                                                    neuronal lesions in
                                                    the brain, spinal
                                                    cord or sciatic
                                                    nerve in mice of
                                                    high dose group (2.0
                                                    mg/kg/day).
------------------------------------------------------------------------
870.6200                        15-day Dietary     Neurotoxicity
                                 Neurotoxicity-CF-  NOAEL=0.075 mg/kg/
                                 1 Mice MK-244      day.
                                                   LOAEL=0.10 mg/kg/day
                                                    based on tremors
                                                    observed beginning
                                                    on day 3, decreases
                                                    in body weight and
                                                    food consumption as
                                                    well as degeneration
                                                    of the sciatic
                                                    nerve.
------------------------------------------------------------------------

[[Page 40795]]

 
870.6200                        Dietary            Neurotoxicity NOAEL
                                 Neurotoxicity-CF-  <0.1 mg/kg/day. One
                                 1 Mice L-660,599   of the low-dose
                                 Supplementary      males had tremors,
                                 Study              hunched posture and
                                                    piloerection on day
                                                    14.
------------------------------------------------------------------------
870.6300                        Developmental      Maternal Toxicity
                                 Neurotoxicity-     NOAEL=3.6/2.5 mg/kg/
                                 Rat MK-0244        day (highest dose
                                                    tested).
                                                   Developmental
                                                    Neurotoxicity
                                                    NOAEL=0.10 mg/kg/day
                                                    (lowest dose
                                                    tested). The LOAEL
                                                    is 0.60 mg/kg/day
                                                    based on the dose-
                                                    related decrease in
                                                    open field motor
                                                    activity in females
                                                    at postnatal day 17.
------------------------------------------------------------------------
870.7485                        Metabolism-Rat     Radiolabeled MAB1a
                                 MAB1a              benzoate is rapidly
                                                    absorbed,
                                                    distributed and
                                                    excreted following
                                                    oral and i.v.
                                                    administration. The
                                                    feces was the major
                                                    route of excretion
                                                    in oral and i.v.
                                                    groups, while <1% of
                                                    the administered
                                                    dose was recovered
                                                    in the urine 7 days
                                                    post dosing. Tissue
                                                    distribution and
                                                    bioaccumulation
                                                    appeared minimal.
                                                    The metabolism of
                                                    MAB1a benzoate
                                                    appears to involve
                                                    primarily N-
                                                    demethylation to
                                                    AB1a. AB1a was the
                                                    only metabolite
                                                    detected in the
                                                    feces while
                                                    unmetabolized parent
                                                    compound represented
                                                    a large amount of
                                                    the radioactivity.
------------------------------------------------------------------------
870.7485                        Bioequivalence-    The study
                                 Dog MK-0243        demonstrated that MK-
                                 solvate/           0243 benzoate MTBE
                                 monohydrate        solvate and MK-0243
                                                    benzoate monohydrate
                                                    were bioequivalent
                                                    in male dogs
                                                    following oral
                                                    administration as
                                                    indicated by similar
                                                    plasma levels for
                                                    the two compounds.
------------------------------------------------------------------------
870.7485                        Bioequivalence-    The study
                                 Dog MK-0243        demonstrated that
                                 benzoate/HCL       benzoate and HCl
                                 salts              salts are
                                                    bioequivalent after
                                                    oral administration
                                                    in male beagle dogs.
------------------------------------------------------------------------
870.7600                        Dermal Absorption- Dermal Absorption was
                                 Rhesus Monkey      approximated at
                                 MAB1a, MK-244      1.79% of the
                                                    administered dose.
------------------------------------------------------------------------
Key: MK-0243 = hydrochloride (adduct) or salt of emamectin; MK-0244 =
  benzoic acid (adduct) or salt of emamectin.

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 intraspecies differences.
    As explained below in Unit III.D.3, EPA determined that the special 
FQPA SF be reduced to 1x. However, EPA also determined that an 
additional 3x Modifying Uncertainty Factor (UFM) is required 
for application of the endpoint (based on the 15-day mouse 
neurotoxicity study) to acute- and short-term scenarios, to account for 
the steepness of the dose-response curve and the severity of effects at 
the LOAEL (death and neuropathology). A 3x UFM was judged to 
be adequate (as opposed to a 10X) because: (1) A NOAEL was established 
in this study; (2) although the effects of concern are seen after 
repeated dosing, the NOAEL here is used for a single exposure risk 
assessment; and (3) the most sensitive endpoint in the most sensitive 
species is selected. For intermediate- and chronic/long-term scenarios, 
EPA determined that a 10x UFM is required to account for 
steepness of the dose-response curve, severity of effects at the LOAEL 
(death and neuropathology), and the use of a short-term study for long-
term risk assessment.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (SF) 
is retained due to concerns unique to the FQPA, this additional factor 
is applied to the RfD by dividing the RfD by such additional factor. 
The acute or chronic population adjusted dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the 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 as1 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

[[Page 40796]]

departure to exposure (MOEcancer = point of departure/
exposures) is calculated. A summary of the toxicological endpoints for 
emamectin used for human risk assessment is shown in the following 
Table 2:

      Table 2.--Summary of Toxicological Dose and Endpoints for emamectin 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)        NOAEL = 0.075 mg/kg/day  Special FQPA SF = 1      15-day mouse
                                       UF = 300...............  aPAD = acute RfD/ FQPA   LOAEL = 0.1 mg/kg/day
                                       Acute RfD = 0.00025 mg/   SF = 0.00025 mg/kg/day.  based tremors on day 3
                                        kg/day.                                           of dosing.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 0.075 mg/kg/day   Special FQPA SF = 1      15-day mouse
                                       UF = 1,000.............  cPAD = chronic RfD/FQPA   LOAEL = 0.1 mg/kg/day
                                       Chronic RfD = 0.000075    SF = 0.000075 mg/kg/     based on moribund
                                        mg/kg/day.               day.                     sacrifices, clinical
                                                                                          signs of
                                                                                          neurotoxicity,
                                                                                          decreases in body
                                                                                          weight and food
                                                                                          consumption and
                                                                                          histopathological
                                                                                          lesions in the sciatic
                                                                                          nerve.
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral (1-30        Toxicological endpoints were not selected since there are no residential
 days)                                      uses at the present time and thus no potential exposure via this
                                                                        scenario.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral (1-   Toxicological endpoints were not selected since there are no residential
 6 months)                                  uses at the present time and thus no potential exposure via this
                                                                        scenario
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 30 days)       Oral study NOAEL= 0.075  Occupational LOC for     15-day mouse
                                        mg/kg/day (dermal        MOE = 300                LOAEL = 0.1 mg/kg/day
                                        absorption rate = 1.8    Residential LOC for      based on moribund
                                        %)                       MOE: N/A.                sacrifices, clinical
                                                                                          signs of
                                                                                          neurotoxicity,
                                                                                          decreases in body
                                                                                          weight and food
                                                                                          consumption and
                                                                                          histopathological
                                                                                          lesions in the sciatic
                                                                                          nerve.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 to 6       Oral study NOAEL= 0.075  Occupational LOC for     15-day mouse
 months)                                mg/kg/day (dermal        MOE = 1,000             LOAEL = 0.1 mg/kg/day
                                        absorption rate = 1.8   Residential LOC for       based on moribund
                                        %)                       MOE: N/A.                sacrifices, clinical
                                                                                          signs of
                                                                                          neurotoxicity,
                                                                                          decreases in body
                                                                                          weight and food
                                                                                          consumption and
                                                                                          histopathological
                                                                                          lesions in the sciatic
                                                                                          nerve.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (>6 months)             Long term dermal exposure is not expected and there are no residential
                                           uses at the present time. Therefore, quantification of risk is not
                                                                        required.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 30 days)   Oral study NOAEL= 0.075  Occupational LOC for     15-day mouse
                                        mg/kg/day                MOE = 300               LOAEL = 0.1 mg/kg/day
                                       (inhalation absorption   Residential LOC for       based on moribund
                                        rate = 100%).            MOE: N/A.                sacrifices, clinical
                                                                                          signs of
                                                                                          neurotoxicity,
                                                                                          decreases in body
                                                                                          weight and food
                                                                                          consumption and
                                                                                          histopathological
                                                                                          lesions in the sciatic
                                                                                          nerve.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 to 6   Oral study NOAEL= 0.075  Occupational LOC for     15-day mouse
 months)                                mg/kg/day (inhalation    MOE = 1,000             LOAEL = 0.1 mg/kg/day
                                        absorption rate =       Residential LOC for       based on moribund
                                        100%)                    MOE: N/A.                sacrifices, clinical
                                                                                          signs of
                                                                                          neurotoxicity,
                                                                                          decreases in body
                                                                                          weight and food
                                                                                          consumption and
                                                                                          histopathological
                                                                                          lesions in the sciatic
                                                                                          nerve.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (>6 months)        Not required; long term occupational exposure is not expected and there
                                         are no residential uses at the present time. Therefore, quantification
                                                                of risk is not required.
----------------------------------------------------------------------------------------------------------------
*The reference to the special FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.505) for the combined residues of emamectin and 
its metabolites, in or on a variety of raw agricultural commodities and 
livestock. Tolerances range from 0.002 to 0.05. Risk assessments were 
conducted by EPA to assess dietary exposures from emamectin 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[reg]) analysis evaluated the individual food 
consumption 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 following 
assumptions were made for the acute exposure assessments: A highly 
refined, Tier 3, acute dietary exposure assessment was conducted for 
the general U.S. population and various population subgroups. This was 
a probabilistic assessment using anticipated residue estimates from the

[[Page 40797]]

current and previously submitted field trial data as well as EPA 
percent crop treated (PCT) estimates for a number of commodities. PCT 
estimates used were 1% for cotton commodities; 52% for head lettuce; 
2.5% for the subgroup 4A (leafy greens); 20% for the subgroup 4B (leaf 
petioles), the group 5 (Brassica leafy vegetables), and peppers; and 
11% for tomatoes and its processing commodities. Anticipated residues 
were used for group 5 (Brassica leafy vegetables), group 4 (leafy 
vegetables (except Brassica)), and group 8 (fruiting vegetables). The 
calculation of anticipated residues for tomatoes (a representative 
commodity in group 8) used the following approach: For residues of 
MAB1a and MAB1b which were below the limit of 
detection (< LOD), calculation was based on the MAB1a and 
MAB1b ratio of 9:1; a residue value of 0.0005 ppm ([half] 
LOD) for MAB1a and a residue value of 0.000055 ppm (1/9 of 
the [half] LOD or 1/18 LOD) for MAB1b was reported in the 
assessment. For residues of L'649 and (L'599 + L'831), a residue value 
of 0.0005 ppm (the [half] LOD) was reported if residues were below the 
limit of detection ([reg] (version 7.76) 
concentration factors were used when necessary.
    The acute dietary exposure estimates are below EPA's level of 
concern (< 100% aPAD) at the 99.9th exposure percentile for 
the general U.S. population (29% of the aPAD) and all other population 
subgroups. The most highly exposed population subgroup is children 3-5 
years old, at 58% of the aPAD. The acute assessment was highly refined, 
however, inclusion of additional PCT data and modified concentration/
processing factors could aid in further refining the acute dietary 
assessment.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the (DEEM[reg]) analysis evaluated the individual 
food consumption as reported by respondents in the USDA 1994-1996 and 
1998 nationwide CSFII and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: For chronic exposure and risk assessment, an estimate of 
the residue level in each food or food-form (e.g., orange or orange 
juice) on the food commodity residue list is multiplied by the average 
daily consumption estimate for that food/food form. The resulting 
residue consumption estimate for each food/food-form is summed with the 
residue consumption estimates for all other food/food-forms on the 
commodity residue list to arrive at the total average estimated 
exposure. Exposure is expressed in mg/kg body weight/day and as a 
percent of the cPAD. This procedure is performed for each population 
subgroup. A somewhat refined Tier 2 chronic dietary exposure assessment 
was conducted for the general U.S. population and various population 
subgroups. The assumptions of the assessment were tolerance level 
residues for all commodities except milk (for which anticipated residue 
estimates were used), and PCT estimates for a number of commodities. 
PCT estimates used were 0.4% for cotton commodities; 26% for head 
lettuce; 1.5% for the subgroup 4A (leafy greens); 10% for the subgroup 
4B (leaf petioles), the group 5 (Brassica leafy vegetables), and 
peppers; and 6% for tomatoes and its processing commodities. 
Anticipated residue levels of 0.0003 ppm for milk and skim milk, and 
0.0009 ppm for cream were used. The recommended tolerance level 
residues were used for all other crops and meat products. Additionally, 
default DEEM[reg] (version 7.76) concentration factors were 
used when necessary.
    The chronic dietary exposure estimates are below HED's level of 
concern (<100% cPAD) for the general U.S. population (19% of the cPAD) 
and all population subgroups. The most highly exposed population 
subgroup is children 1-2 years old, at 34% of the cPAD. The chronic 
assessment was somewhat refined; inclusion of ARs, additional PCT 
information, and modified concentration/processing factors would 
further refine the chronic dietary assessment.
    iii. Cancer. Emamectin is classified as a ``not likely'' human 
carcinogen based on the lack of evidence of carcinogenicity in male and 
female rats or male and female mice at doses that were judged to be 
adequate to assess the carcinogenic potential of the chemical.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E) of the FFDCA, 
EPA will issue a data call-in for information relating to anticipated 
residues to be submitted no later than 5 years from the date of 
issuance of this tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information as detailed above under Unit 
III.C.1.i and III.C.1.ii Different PCTs and anticipated residues were 
used for the acute versus the chronic dietary risk from food and feed 
uses as explained in these units.
    The Agency believes that the three conditions listed in Unit 
III.C.1.iv have been met. With respect to Condition 1, PCT estimates 
for existing registrations are derived from Federal and private market 
survey data, which are reliable and have a valid basis. EPA uses a 
weighted average PCT for chronic dietary exposure estimates. This 
weighted average PCT figure is derived by averaging State-level data 
for a period of up to 10 years, and weighting for the more robust and 
recent data. A weighted average of the PCT reasonably represents a 
person's dietary exposure over a lifetime, and is unlikely to 
underestimate exposure to an individual because of the fact that 
pesticide use patterns (both regionally and nationally) tend to change 
continuously over time, such that an individual is unlikely to be 
exposed to more than the average PCT over a lifetime. For acute dietary 
exposure estimates, EPA uses an estimated maximum PCT. The exposure 
estimates resulting from this approach reasonably represent the highest 
levels to which an individual could be exposed, and are unlikely to 
underestimate an individual's acute dietary exposure. For new uses, PCT

[[Page 40798]]

estimates are based on the use of existing alternative insecticides 
against insects that emmamectin will control. 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 emamectin 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 emamectin 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 emamectin.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The screening concentration in ground water (SCI-GROW) model is used to 
predict pesticide concentrations in shallow 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. While both FIRST and PRZM/EXAMS incorporate an 
index reservoir environment, the PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to emamectin they are further 
discussed in the aggregate risk Unit III.E.
    Refined (Tier II) surface water concentrations were developed for 
emamectin and its metabolites with the PRZM/EXAMS model, using an index 
reservoir scenario for the aerial and ground applications of emamectin 
on cotton. The model assumes that emamectin is applied at the maximum 
label rate (0.015 lb active ingredient/acre with a maximum of 0.09 lb 
active ingredient/acre/season for the dispersable granule; and 0.016 lb 
active ingredient/acre with a maximum of 0.064 lb active ingredient/
acre/season for the emulsifiable concentrate). The results indicate 
that emamectin and its metabolites have a very low potential to reach 
surface waters as dissolved species. However, emamectin does have the 
potential to reach surface water bodies through erosion of soil 
particles to which the compound is sorbed. One percent of the 
application rate is assumed to drift from the application site during 
ground application. For the additional proposed aerial application, 5% 
of the application rate is assumed to drift from the application site 
to water bodies.
    Surface water and ground water EECs are based on the PRZM/EXAMS and 
SCI-GROW models respectively. The EECs of emamectin for acute exposure 
are estimated to be 0.298 parts per billion (ppb) for surface water 
from aerial application and 0.293 ppb for surface water from ground 
application. The EEC for chronic exposure is estimated to be 0.080 ppb 
for surface water. Ground water EECs are based on the Tier I SCI-GROW 
model. The EEC of emamectin for both acute and chronic exposure is 
estimated to be 0.006 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this preamble 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). Emamectin is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether emamectin has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
emamectin 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 emamectin has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional ten-fold 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.

[[Page 40799]]

    2. Prenatal and postnatal sensitivity. EPA concludedthat there is 
low concern, and no residual uncertainty, for pre- and/or postnatal 
toxicity resulting from exposure to emamectin, based on the following:
    i. 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 evidence of increased 
susceptibility of rat offspring in the two generation reproduction 
study, however, an increase in qualitative susceptibility was 
determined. EPA determined that the concern is low because:
    (a) There was a clear NOAEL for offspring toxicity.
    (b) Effects unique to offspring (decreased fertility in 
F1 adults, and clinical signs (tremors and hind limb 
extensions during and following lactation)) were seen at the same dose 
that caused parental systemic toxicity (decreased body weight gain and 
histopathological lesions in the brain and spinal cord).
    (c) The decreased fertility seen in F1 adults may have 
been due to histopathological lesions in the brain and central nervous 
system (seen in both F0 and F1 generations), 
rather than due to a direct effect on the reproductive system.
    ii. There is evidence of increased qualitative and quantitative 
susceptibility in the rat developmental neurotoxicity study, but EPA 
determined that the concern is low because: Although multiple offsping 
effects (including decreased pup body weight, head and body tremors, 
hind limb extension and splay, changes in motor activity and auditory 
startle) were seen at the highest dose, and no maternal effects were 
seen at any dose, there was a clear NOAEL for offspring toxicity at the 
low dose, and the offspring LOAEL (at the mid dose) is based on a 
single effect seen on only one day (decreased motor activity on PND 17) 
and no other offspring toxicity was seen at the LOAEL.
    3. Conclusion. EPA concluded that the toxicology database was 
complete for FQPA purposes and that there are no residual uncertainties 
for pre-/post-natal toxicity. Based on the quality of the data, EPA 
determined that the special FQPA SF should be reduced to 1x. However, 
as explained in Unit III.3.B. of this preamble, EPA determined that an 
additional 3x or 10x modifying uncertainty factor should be used for 
short-term or intermediate-term exposure, respectively. The 
recommendation for the 1x FQPA SF is based on the following:
    [sbull] The toxicological database is complete for FQPA assessment.
    [sbull] The acute dietary food exposure assessment utilizes 
anticipated residue estimates based on carefully reviewed field trial 
data and PCT data verified by EPA for several commodities (100% crop 
treated was assumed for remaining commodities). By using the 
99.9th percentile exposure values for comparison to the 
aPAD, actual risks are not likely to be underestimated.
    [sbull] The chronic dietary food exposure assessment utilizes 
tolerance level residue estimates and PCT data verified by EPA for 
several commodities (100% crop treated was assumed for remaining 
commodities). This assessment is somewhat refined and based on reliable 
data that is not likely to underestimate exposure/risk.
    [sbull] 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.
    [sbull] There are no proposed or existing residential uses for 
emamectin.

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 ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of 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 (at the 
99.9th percentile) from food to emamectin will occupy 29% of 
the aPAD for the U.S. population, 23% of the aPAD for females 13 years 
and older, 51% of the aPAD for all infants (<1 year old) and 58% of the 
aPAD for children 3-5 years old. In addition, there is potential for 
acute dietary exposure to emamectin 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 the following Table 3:

[[Page 40800]]



                       Table 3.--Aggregate Risk Assessment for Acute Exposure to Emamectin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                      0.00025           29        0.298        0.006          6.2
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                           0.00025           51        0.298        0.006          1.2
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                             0.00025           50        0.298        0.006          1.3
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old)                             0.00025           58        0.298        0.006          1.0
----------------------------------------------------------------------------------------------------------------
Children (6-12 years old)                            0.00025           36        0.298        0.006          1.6
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years old)                              0.00025           27        0.298        0.006          6.4
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years old)                             0.00025           20        0.298        0.006          7.0
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                            0.00025           23        0.298        0.006          5.8
----------------------------------------------------------------------------------------------------------------
Adults (50+ years old)                               0.00025           22        0.298        0.006          6.9
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to emamectin 
from food will utilize 19% of the cPAD for the U.S. population, 17% of 
the cPAD for females 13 years and older, 9% of the cPAD for all infants 
(<1 year old) and 34% of the cPAD for children 1-2 years old. There are 
no residential uses for emamectin that result in chronic residential 
exposure to emamectin. In addition, there is potential for chronic 
dietary exposure to emamectin 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 the following Table 4:

               Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to emamectin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 cPAD (mg/      % cPAD     Water EEC    Water EEC     Chronic
                                                     kg)         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                     0.000075           19        0.080        0.006          2.1
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                          0.000075            9        0.080        0.006         0.68
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                            0.000075           34        0.080        0.006         0.49
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old)                            0.000075           31        0.080        0.006         0.52
----------------------------------------------------------------------------------------------------------------
Children (6-12 years old)                           0.000075           23        0.080        0.006         0.58
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years old)                             0.000075           17        0.080        0.006          2.2
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years old)                            0.000075           17        0.080        0.006          2.2
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                           0.000075           17        0.080        0.006          1.9
----------------------------------------------------------------------------------------------------------------
Adults (50+ years old)                              0.000075           16        0.080        0.006          2.2
----------------------------------------------------------------------------------------------------------------

    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). Emamectin is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Emamectin is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    5. Aggregate cancer risk for U.S. population. Emamectin is 
classified as a ``not likely'' human carcinogen based on the lack of 
evidence of carcinogenicity in male and female rats or male and female 
mice at doses that were judged to be adequate to assess the 
carcinogenic potential of the chemical. Therefore, EPA does not expect 
it to pose a cancer risk. As a result, a quantitative cancer dietary 
exposure analysis was not performed.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to emamectin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method (HPLC-fluorescence) for the enforcement of 
tolerances for residues of emamectin and its metabolites in/on plant 
commodities has been validated by EPA

[[Page 40801]]

and submitted to the FDA for inclusion in the Pesticide Analytical 
Manual (PAM) Vol. II. In addition, an analytical method (HPLC-
fluorescence) for the enforcement of tolerances for residues of 
emamectin and its metabolites in/on ruminant commodities has been 
submitted to EPA for review. The ruminant method has been validated by 
an independent laboratory but EPA validation is required as a condition 
of registration.

B. International Residue Limits

    There are currently no Codex, Canadian, or Mexican maximum residue 
limits on emamectin or its metabolites.

C. Conditions

    The following studies must be submitted as conditions for product 
registrations related to these tolerances: A storage stability study 
for cotton seed, gin byproducts, and processed commodities which 
reflect the storage intervals and conditions of the submitted field 
trial and processing studies; additional storage stability studies to 
support 19 month storage intervals for bell pepper and tomatoes; a new 
tomato processing study with tomatoes treated at an exaggerated rate 
(up to 5x the maximum proposed seasonal application rate); three 
additional spinach field trials conducted in Regions X, VI, and II (one 
study each) based on OPPTS Guidelines 860.1500; and a 28-day inhalation 
study using the CF-1 mouse. In addition, a successful method validation 
by EPA is required for the high performance liquid chromatography-
fluorescence method submitted for residues in ruminant commodities; the 
registrant is required to make any necessary modifications resulting 
from the EPA method review.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
emamectin, (a mixture of a minimum of 90% 4"-epi-methylamino-4"-
deoxyavermectin B1a and maximum of 10% 4"-epi-methylamino-
4"-deoxyavermectin B1b) and its metabolites 8,9-isomer of 
the B1a and B1b component of the parent (8,9-
ZMA), or 4"-deoxy-4"-epi-amino-avermectin B1a and 4"-deoxy-
4"-epi-amino-avermectin B1b; 4"-deoxy-4"-epi-amino 
avermectin B1a (AB1a); 4"-deoxy-4"-epi-(N-formyl-
N-methyl)amino-avermectin (MFB1a); and 4"-deoxy-4"-epi-(N-
formyl)amino-avermectin B1a (FAB1a), in or on 
Brassica leafy vegetables (crop group 5) at 0.05 ppm; turnip greens at 
0.05 ppm; cotton, undelinted seed at 0.025 ppm; cotton gin byproduct at 
0.05 ppm; leafy vegetables (except Brassica) (crop group 4) at 0.10 
ppm; fruiting vegetables (crop group 8) at 0.02 ppm; and tomato paste 
at 0.15 ppm. In addition, tolerances are established for indirect or 
inadvertent combined residues of emamectin (MAB1a + 
MAB1b isomers) and the associated 8,9-Z isomers (8,9-
ZB1a + 8,9-ZB1b) in or on milk and fat of cattle, 
goats, hogs, horses, and sheep at 0.003 ppm; meat byproducts, except 
liver, of cattle, goats, hogs, horses , and sheep at 0.005 ppm; liver 
of cattle, goats, hogs, horses, and sheep at 0.020 ppm; and meat of 
cattle, goat, hogs, horses, and sheep at 0.002 ppm. Note that the 
tolerance expression in 40 CFR 180.505 is being changed from emamectin 
benzoate to emamectin since the enforcement method, Method 244-92-3, 
Revision 1, analyzes residues of emamectin MAB1 isomers (not 
emamectin benzoate), 8,9-ZMA, AB1a, MFB1a, and 
FAB1a in/on crops.

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-2003-0220 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 September 
8, 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

[[Page 40802]]

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-2003-0220, 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 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 30, 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.

[[Page 40803]]


0
2. Section 180.505 is revised to read as follows:


Sec.  180.505  Emamectin; tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of emamectin, (a mixture of a minimum of 90% 4"-epi-methylamino-4"-
deoxyavermectin B1a and maximum of 10% 4"-epi-methylamino-
4"-deoxyavermectin B1b) and its metabolites 8,9-isomer of 
the B1a and B1b component of the parent (8,9-
ZMA), or 4"-deoxy-4"-epi-amino-avermectin B1a and 4"-deoxy-
4"-epi-amino-avermectin B1b; 4"-deoxy-4"-epi-amino 
avermectin B1a (AB1a); 4"-deoxy-4"-epi-(N-formyl-
N-methyl)amino-avermectin (MFB1a); and 4"-deoxy-4"-epi-(N-
formyl)amino-avermectin B1a (FAB1a), in or on the 
following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproduct......................................        0.050
Cotton, undelinted seed....................................        0.025
Tomato, paste..............................................        0.150
Turnip, greens.............................................        0.050
Vegetable, Brassica, leafy, group 5........................        0.050
Vegetable, fruiting, group 8...............................        0.020
Vegetable, leafy, except Brassica, group 4.................        0.100
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect and inadvertant residues. Tolerances are established 
for indirect or inadvertent combined residues of emamectin 
(MAB1a + MAB1b isomers) and the associated 8,9-Z 
isomers (8,9-ZB1a + 8,9-ZB1b) in or on the 
following commodities when present therein as a result of the 
application of emamectin to crops listed in the table to paragraph (a) 
of this section:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.003
Cattle, liver..............................................        0.020
Cattle, meat...............................................        0.002
Cattle, meat byproducts (except liver).....................        0.005
Cattle, milk...............................................        0.003
Goats, fat.................................................        0.003
Goats, liver...............................................        0.020
Goats, meat................................................        0.002
Goats, meat byproducts (except liver)......................        0.005
Goats, milk................................................        0.003
Hogs, fat..................................................        0.003
Hogs, liver................................................        0.020
Hogs, meat.................................................        0.002
Hogs, meat byproducts (except liver).......................        0.005
Hogs, milk.................................................        0.003
Horses, fat................................................        0.003
Horses, liver..............................................        0.020
Horses, meat...............................................        0.002
Horses, meat byproducts (except liver).....................        0.005
Horses, milk...............................................        0.003
Sheep, fat.................................................        0.003
Sheep, liver...............................................        0.020
Sheep, meat................................................        0.002
Sheep, meat byproducts (except liver)......................        0.005
Sheep, milk................................................        0.003
------------------------------------------------------------------------

[FR Doc. 03-17212 Filed 7-8-03; 8:45 am]
BILLING CODE 6560-50-S