[Federal Register Volume 67, Number 188 (Friday, September 27, 2002)]
[Rules and Regulations]
[Pages 60923-60934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24484]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0195; FRL-7199-5]


Spinosad; Pesticide Tolerances

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation establishes tolerances for residues of 
spinosad in or on fig at 0.10 part per million (ppm); herb, fresh, 
subgroup at 3.0 ppm; herb, dried, subgroup at 22 ppm; vegetable, root 
and tuber, group at 0.10 ppm; caneberry subgroup at 0.70 ppm; grape at 
0.50 ppm; grape, raisin at 0.70 ppm; peanut at 0.02 ppm; and beet, 
sugar, molasses at 0.75 ppm. This regulation also increases established 
tolerances for cattle, meat to 0.50 ppm; cattle, meat byproducts to 2.0 
ppm; cattle, fat to 6.5 ppm; milk to 2.5 ppm; and milk, fat to 27 ppm. 
The Interregional Research Project Number 4 (IR-4) and Elanco Animal 
Health, A Division of Eli Lily and Company, requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act (FQPA) of 1996.

DATES:  This regulation is effective September 27, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0195, 
must be received on or before November 26, 2002.

ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0195 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Sidney Jackson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 305-7610; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112...............  Animal production
                                  311...............  Food manufacturing
                                  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person

[[Page 60924]]

listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to 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.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0195. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of May 3, 2000, 65 FR 2572, FRL-6555-9 and 
August 21, 2002, 67 FR 54200, (FRL-7191-6), EPA issued notices pursuant 
to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public 
Law 104-170), announcing the filing of pesticide petition (PP 0F6115) 
by Elanco Animal Health, a Division of Eli Lilly and Company, 2001 W. 
Main St., Greenfield, IN 46140, and (PP 1E6321, 2E6354, 2E6370, 2E6384, 
2E6400, and 2E6422) by the Interregional Research Project Number 4 (IR-
4), 681 U.S. Highway 1, South, North Brunswick, NJ 08902-3390. 
These notices included summaries of the petitions prepared by Dow 
AgroScience LLC, Indianapolis, IN 46268, the registrant. There were no 
comments received in response to the notices of filing.
    The petitions requested that 40 CFR 180.495 be amended by 
establishing tolerances for residues of the insecticide spinosad, in or 
on food commodities as follows:
    1. PP 1E6321 proposed establishment of a tolerance for fig at 0.1 
ppm,
    2. PP 2E6354 proposed establishment of a tolerance for herbs 
subgroup at 8.0 ppm. The petition was revised to propose tolerances for 
the herb, fresh, subgroup at 3.0 ppm; and the herb, dried, subgroup at 
22 ppm.
    3. PP 2E6384 proposed establishment of tolerances for root 
vegetable subgroup at 0.10 ppm, and dry bulb onion at 0.1 ppm. The 
petition was revised to propose a tolerance for the vegetable, root and 
tuber, group at 0.10 ppm; and a separate tolerance for beet, sugar, 
molasses at 0.75 ppm.
    4. PP 2E6400 proposed establishment of a tolerance for caneberry 
subgroup at 0.7 ppm,
    5. PP 2E6422 proposed establishment of tolerances for grape at 0.6 
ppm, grape juice at 1.2 ppm, and raisin at 0.6 ppm. The petition was 
amended to propose tolerances for grape at 0.50 ppm; and grape, raisin 
at 0.70 ppm. The Agency determined that a tolerance for grape juice is 
not needed.
    6. PP 2E6370 proposed establishment of a tolerance for peanut at 
0.02 ppm,
    7. PP 0F6115 proposed to increase the established tolerances for 
cattle meat, meat byproducts, fat, milk and milk fat. The increased 
tolerances are needed in support of proposed registration for direct 
application to beef and dairy cattle for insect control. Tolerances 
were proposed for cattle, meat at 0.45 ppm; cattle, meat byproducts at 
2.25 ppm; cattle, fat at 5.75 ppm; milk at 0.75 ppm; and milk, fat at 
8.0 ppm. The petition was subsequently revised to propose tolerances 
for cattle, meat at 0.50 ppm; cattle meat byproducts at 2.0 ppm; 
cattle, fat at 6.5 ppm; milk at 2.5 ppm; and milk, fat at 27 ppm.
    Existing tolerances under Sec.  180.495(a) for beet, garden, roots 
at 0.10 ppm, beet, sugar, roots at 0.10 ppm, and tuberous and corm 
vegetables (crop group 1C) at 0.02 ppm are no longer needed and will be 
removed. They are replaced with the new tolerance for vegetable, root 
and tuber, group at 0.10 ppm. Existing tolerances for section 18 
emergency exemption under Sec. 180.495(b) for beet, sugar at 0.020 ppm; 
beet, sugar, molasses at 0.25 ppm; peanut at 0.02 ppm; milk, whole at 
2.0 ppm and milk, fat at 20.0 ppm are also not needed and will be 
removed. Tolerances established by this regulation under Sec. 180.495 
(a) for the vegetable, root and tuber, group at 0.10 ppm; beet, sugar, 
molasses at 0.75 ppm; peanut at 0.02 ppm; milk at 2.5 ppm; and milk, 
fat at 27 ppm obviate the need for these section 18 emergency 
exemptions.
    Spinosad is a fermentation product of Saccharopolyspora spinosa. 
The product consists of two related active ingredients: Spinosyn A 
(Factor A; CAS No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-'N-L-
manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11, 12,13,14,16a,16b-
tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione; and Spinosyn D (Factor D; CAS No. 131929-63-0) or 2-[(6-deoxy-
2,3,4-tri-O-methyl-'N-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a, 16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione. Typically, the two 
factors are present at an 85:15 (A:D) ratio.
    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) 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) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on

[[Page 60925]]

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), 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), for tolerances for residues of spinosad on fig at 0.10 ppm; 
herb, fresh, subgroup at 3.0 ppm; herb, dried, subgroup at 22 ppm; 
vegetable, root and tuber, group at 0.10 ppm; caneberry subgroup at 0.7 
0 ppm; grape at 0.50 ppm; grape, raisin at 0.70 ppm; peanut at 0.02 
ppm; beet, sugar, molasses at 0.75 ppm; cattle, meat at 0.50 ppm; 
cattle, meat byproducts at 2.0 ppm; cattle, fat at 6.5 ppm; milk at 2.5 
ppm and milk, fat at 27 ppm. EPA's assessment of exposures and risks 
associated with establishing these tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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 spinosad are 
discussed in the following Table 1 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                                 90-Day oral toxicity        NOAEL = 7.5 mg/kg/day in males and females.
                                          rodents--mouse             LOAEL = 22.5 mg/kg/day in males and
                                                                      females; based on cytoplasmic vacuolation
                                                                      of lymphoid organs, liver, kidney,
                                                                      stomach, female reproductive tract, and
                                                                      epididymis. Other tissues less severely
                                                                      affected are heart, lung, pancreas,
                                                                      adrenal cortex, bone marrow, tongue, and
                                                                      pituitary gland.
----------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 33.9 mg/kg/day in males; 38.8 mg/kg/
                                          rodents--rat                day in females
                                                                     LOAEL = 68.5 mg/kg/day in males; 78.1 mg/kg/
                                                                      day in females based on adrenal cortical
                                                                      vacuolation in males, lymph node
                                                                      histiocytosis in both sexes.
----------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 42.7 mg/kg/day in males; 52.1 mg/kg/
                                          rodents--rat                day in females, highest dose tested (HDT).
                                                                     LOAEL = Not observed in males and females.
----------------------------------------
870.3150                                 90-Day oral toxicity        NOAEL = 4.89 mg/kg/day in males; 5.38 mg/kg/
                                          nonrodents--dog             day in females
                                                                     LOAEL = 9.73 mg/kg/day in males; 10.47 mg/
                                                                      kg/day in females based on microscopic
                                                                      changes in a variety of tissues, clinical
                                                                      signs of toxicity, decreases in mean body
                                                                      weights and food consumption and
                                                                      biochemical evidence of anemia and
                                                                      possible liver damage.
----------------------------------------
870.3200                                 Repeated dose dermal        NOAEL = 1,000 mg/kg/day in males and
                                          toxicity--rabbit (21        females (HDT).
                                          days)                      LOAEL = Not observed.
----------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 200 mg/kg/day (HDT).
                                          rodents--rat               LOAEL = Not observed.
                                                                     Developmental NOAEL = 200 mg/kg/day (HDT).
                                                                     LOAEL = Not observed.
----------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 50 mg/kg/day (HDT).
                                          nonrodents--rabbit         LOAEL = Not observed.
                                                                     Developmental NOAEL = 50 mg/kg/day (HDT).
                                                                     LOAEL = Not observed.
----------------------------------------
870.3800                                 Reproduction and fertility  Parental/systemic NOAEL = 10 mg/kg/day .
                                          effects--rat               LOAEL = 100 mg/kg/day based on increases in
                                                                      heart, kidney, liver, spleen, and thyroid
                                                                      weights (both sexes), corroborative
                                                                      histopathology in the spleen and thyroid
                                                                      (both sexes), heart and kidney (males
                                                                      only), and histopathologic lesions in the
                                                                      lungs and mesenteric lymph nodes (both
                                                                      sexes), stomach (females only), and
                                                                      prostate.
                                                                     Reproductive NOAEL = 10 mg/kg/day.
                                                                     LOAEL = 100 mg/kg/day based on increased
                                                                      incidence of dystocia and/or vaginal
                                                                      bleeding after parturition with associated
                                                                      increases in mortality in the dams.
                                                                     Offspring NOAEL = 10 mg/kg/day.
                                                                     LOAEL = 100 mg/kg/day based on decreases in
                                                                      litter size, survival and body weights.
----------------------------------------
870.4100                                 Chronic toxicity--dog       NOAEL = 2.68 mg/kg/day in males, 2.72 mg/kg/
                                                                      day in females.
                                                                     LOAEL = 8.46 mg/kg/day in males; 8.22 mg/kg/
                                                                      day in females based on increases in serum
                                                                      alanine aminotransferase, aspartate
                                                                      aminotransferase, and triglycerides
                                                                      levels, and the presence of tissue
                                                                      abnormalities, including vacuolated cell
                                                                      aggregations, arteritis, and glandular
                                                                      cell vacuolation (parathyroid).
----------------------------------------

[[Page 60926]]

 
870.4200                                 Carcinogenicity-- mouse     NOAEL = 11.4 mg/kg/day in males, 13.8 mg/kg/
                                                                      day in females.
                                                                     LOAEL = 50.9 mg/kg/day in males; 67.0 mg/kg/
                                                                      day in females based on decreased weight
                                                                      gains, increased mortality, the
                                                                      hematologic effects, and the gross finding
                                                                      of increased thickening of the gastric
                                                                      mucosa in females and the histologic
                                                                      changes in the stomach of males.
                                                                     No evidence of carcinogenicity.
----------------------------------------
870.4200                                 Carcinogenicity--mouse      NOAEL not established.
                                                                     LOAEL = 1.1 mg/kg/day in males; 1.3 mg/kg/
                                                                      day in females.
                                                                     No evidence of carcinogenicity.
----------------------------------------
870.4300                                 Chronic/carcinogenicity--   NOAEL = 9.5 mg/kg/day in males, 12.0 mg/kg/
                                          rat                         day in females.
                                                                     LOAEL = 24.1 mg/kg/day in males; 30.3 mg/kg/
                                                                      day in females based on vacuolation of the
                                                                      epithelial follicular cells of the thyroid
                                                                      in both sexes.
                                                                     No evidence of carcinogenicity.
----------------------------------------
870.5300                                 Mouse lymphoma cell/        In a forward mutation assay using mouse
                                          mammalian activation gene   lymphoma cells, spinosad did not induce
                                          forward mutation assay      forward mutations in mouse lymphoma L5178Y
                                                                      Tk+/- cells at concentrations of 0, 1, 5,
                                                                      10, 15, 20, or 35 [mu]g/ml without
                                                                      metabolic activation or at concentrations
                                                                      of 15 through 50 [mu]g/ml with metabolic
                                                                      activation.
----------------------------------------
870.5375                                 In vitro mammalian          In a chromosomal aberrations assay,
                                          cytogenetic assay           spinosad did not increase the number of
                                                                      Chinese hamster ovary (CHO) cells with
                                                                      chromosome aberrations at concentrations
                                                                      of 20, 26, or 35 [mu]g/ml without
                                                                      metabolic activation or at concentrations
                                                                      of 100, 250, or 500 [mu]g/ml with
                                                                      metabolic activation.
----------------------------------------
870.5385                                 Micronucleus assay          In a mouse micronucleus test, spinosad did
                                                                      not increase the frequency of micronuclei
                                                                      in replicate assays with bone marrow cells
                                                                      from ICR mice treated with doses of 0,
                                                                      500, 1,000, or 2,000 mg/kg/day for 2
                                                                      consecutive days.
----------------------------------------
870.5550                                 Unscheduled DNA Synthesis   In the unscheduled DNA synthesis assay
                                                                      using primary rat hepatocytes, Spinosad
                                                                      did not induce unscheduled DNA synthesis
                                                                      (UDS) in adult rat hepatocytes in vitro at
                                                                      concentrations of 0.01 to 5 [mu]g/ml.
                                                                      Concentrations from 10 to 1,000 [mu]g/ml
                                                                      of XDE-105 were cytotoxic.
----------------------------------------
870.6200                                 Acute neurotoxicity-rat     NOAEL = 2,000 mg/kg in males and females
                                                                      (HDT).
                                                                     LOAEL = Not established in both sexes.
----------------------------------------
870.6200                                 Repeat dose neurotoxicity-- NOAEL = 42.7 mg/kg/day in males; 52.1 mg/kg
                                          rat                         /day in females (HDT).
                                                                     LOAEL = Not established in both sexes.
----------------------------------------
870.6200                                 Repeat dose neurotoxicity-- NOAEL = 46.0 mg/kg/day in males; 57.0 mg/kg/
                                          rat                         day in females (HDT).
                                                                     LOAEL = Not established in both sexes.
----------------------------------------
870.7485                                 Metabolism and              At high (100 mg/kg) and single or multiple
                                          pharmacokinetics--rat       low (10 mg/kg) doses, there are no major
                                                                      differences in the bioavailability, routes
                                                                      or rates of excretion or metabolism of
                                                                      \14\ C-XDE-105 (Factor A) following oral
                                                                      administration. The feces were the major
                                                                      route of excretion (82 to 87% of the doses
                                                                      at 168 hours after dosing), and -7-10% of
                                                                      the dose was excreted in the urine.
                                                                      Approximately 70-80% of the dose was
                                                                      absorbed with -20% of the dose eliminated
                                                                      unabsorbed in the feces. Blood levels of
                                                                      \14\ C after the single and multiple 10 mg/
                                                                      kg doses were highest at 1 hour in both
                                                                      sexes. At 168 hour after administration of
                                                                      the low dose, the kidney, liver and fat of
                                                                      males and females had higher levels than
                                                                      other tissues. In the high dose group
                                                                      however, the adrenals (females only),
                                                                      kidney, lymph nodes, fat, and thyroids had
                                                                      higher levels than other tissues. The
                                                                      total radioactivity remaining in the
                                                                      tissues and carcass of the low and high
                                                                      dose animals was <0.6% and <3% of the
                                                                      administered dose, respectively.
                                                                     The primary metabolites excreted were
                                                                      identified as the glutathione conjugates
                                                                      of the parent and O-demethylated XDE-105
                                                                      (Factor A). Metabolites in the tissues
                                                                      were characterized as the -- and O-
                                                                      demethylated (Factor A). The absorption,
                                                                      disposition, and elimination of \14\ C-XDE-
                                                                      105 (Factor A) demonstrated no appreciable
                                                                      differences based on, dose or repeated
                                                                      dosing.
----------------------------------------

[[Page 60927]]

 
870.7485                                 Metabolism and              Results of these experiments indicated that
                                          pharmacokinetics--rat       at 100 mg/kg dose, the feces were the
                                                                      major route of excretion (84 to 92% of the
                                                                      dose at 168 hours after dosing), and 3-5%
                                                                      of the dose was excreted in the urine.
                                                                      Greater than 68% of the administered
                                                                      radioactivity was recovered in the feces
                                                                      within the first 24 hours following
                                                                      dosing. The excretion kinetics was
                                                                      biphasic with the ' and [beta] excretion
                                                                      halftimes (t[half]) of approximately 6 and
                                                                      30 hours, respectively.
                                                                     The primary metabolites excreted were
                                                                      identified as the glutathione conjugates
                                                                      of the parent and O-demethylated XDE-105
                                                                      (Factor D). Metabolites in the tissues
                                                                      were characterized as the -- and O-
                                                                      demethylated (Factor D). The absorption,
                                                                      disposition, and elimination of \14\ C-XDE-
                                                                      105 (Factor D) demonstrated no appreciable
                                                                      differences based on, dose or repeated
                                                                      dosing.
----------------------------------------
870.7485                                 Metabolism and              The feces contained from 23 to 55% of the
                                          pharmacokinetics--rat       dose (an average of 34%), and the bile had
                                                                      an average of approximately 36% (range of
                                                                      28 to 40%) of the administered
                                                                      radioactivity. Approximately 21% of the
                                                                      dose was found in the tissues and carcass
                                                                      (range of 12 to 26%). The urine and CO2
                                                                      accounted for 3.3 and <0.1% of the dose.
                                                                      The bile excretion rate results suggested
                                                                      an uptake phase for the first 4 hour after
                                                                      dosing which preceded a biphasic decrease
                                                                      in the biliary excretion rate. The maximum
                                                                      rate of bile excretion was -644 :g
                                                                      equivalents per hour at 2-4 hour; then the
                                                                      rate decreased to -123 :g equivalents per
                                                                      hour at the 12-24 hour interval.
                                                                     The results of the study suggested that
                                                                      metabolites in the bile included the
                                                                      glutathione conjugates of the unchanged
                                                                      form, as well as -- and O-demethylated
                                                                      forms of XDE-105 (Factor D).
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which 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 
the LOAEL is sometimes used for risk assessment if no NOAEL was 
achieved in the toxicology study selected. An uncertainty factor (UF) 
is applied to reflect uncertainties inherent in the extrapolation from 
laboratory animal data to humans and in the variations in sensitivity 
among members of the human population as well as other unknowns. An UF 
of 100 is routinely used, 10X to account for interspecies differences 
and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor 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 Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for spinosad used for human risk assessment is shown in the 
following Table 2:

       Table 2.--Summary of Toxicological Dose and Endpoints for Spinosad for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                              FQPA SF* and Level of
         Exposure Scenario              Dose Used in Risk       Concern for Risk       Study and Toxicological
                                         Assessment, UF            Assessment                  Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary                        Not applicable          Not applicable          There were no effects
                                                                                      observed in oral toxicity
                                                                                      studies including oral
                                                                                      developmental toxicity
                                                                                      studies in rats and
                                                                                      rabbits that could be
                                                                                      attributable to a single
                                                                                      dose (exposure).
                                                                                      Therefore, a dose and
                                                                                      endpoint were not selected
                                                                                      for this risk assessment.
------------------------------------

[[Page 60928]]

 
Chronic Dietary all populations      NOAEL = 2.7 mg/kg/day   FQPA SF = 1x            Chronic Toxicity Study in
                                     UF = 100..............  cPAD = chronic RfD....   Dogs
                                     Chronic RfD = 0.027 mg/ FQPA SF= 0.027 mg/kg/   LOAEL = 8.22 mg/kg/day
                                      kg/day.                 day.                    based on the occurrence of
                                                                                      vacuolation in glandular
                                                                                      cells (parathyroid) and
                                                                                      lymphatic tissues,
                                                                                      arteritis, and increases
                                                                                      in serum alanine
                                                                                      aminotranferase, and
                                                                                      aspartate
                                                                                      aminotransferase, and
                                                                                      triglyceride levels.
------------------------------------
Incidental Oral (Short-Term, 1 to    NOAEL = 4.9 mg/kg/day   FQPA SF = 1x            Subchronic Feeding Study in
 30 days)(Residential)                                       LOC for MOE = 100.....   Dogs
                                                                                     LOAEL = 9.73 mg/kg/day
                                                                                      based on microscopic
                                                                                      changes in multiple
                                                                                      organs, clinical signs of
                                                                                      toxicity, decreases in
                                                                                      mean body weights and food
                                                                                      consumption and
                                                                                      biochemical evidence of
                                                                                      anemia and possible liver
                                                                                      damage.
------------------------------------
Incidential Oral (Intermediate-      NOAEL = 2.7 mg/kg/day   FQPA SF = 1x            Chronic Toxicity Study in
 Term, 1 to 6 months)(Residential)                           LOC for MOE = 100.....   Dogs
                                                                                     LOAEL = 8.22 mg/kg/day
                                                                                      based on vacuolation in
                                                                                      glandular cells
                                                                                      (parathyroid) and
                                                                                      lymphatic tissues,
                                                                                      arteritis, and increases
                                                                                      in serum alanine
                                                                                      aminotransferase,
                                                                                      aspartate
                                                                                      aminotransferase, and
                                                                                      triglyceride levels.
------------------------------------
Dermal (Any time period)             Not applicable.         Not applicable.         Short-, Intermediate-, and
 (Residential)                                                                        Long-Term dermal risk
                                                                                      assessments were not
                                                                                      performed because: (1)
                                                                                      Lack of concern for pre
                                                                                      and/or post natal
                                                                                      toxicity; (2) the
                                                                                      combination of molecular
                                                                                      structure and size as well
                                                                                      as the lack of dermal or
                                                                                      systemic toxicity at 1000
                                                                                      mg/kg/day in a 21-day
                                                                                      dermal toxicity study in
                                                                                      rats which indicates poor
                                                                                      dermal absorption; and (3)
                                                                                      the lack of long-term
                                                                                      exposure based on the
                                                                                      current use pattern.
------------------------------------
Inhalation (Short-Term, 1-30 days)   Oral NOAEL = 4.9 mg/kg/ FQPA SF = 1x            Subchronic Feeding Study in
 (Residential)                        day (absorption =      LOC for MOE = 100.....   Dogs
                                      100%)                                          LOAEL = 9.73 mg/kg/day
                                                                                      based on microscopic
                                                                                      changes in a multiple
                                                                                      organs, clinical signs of
                                                                                      toxicity, decreases in
                                                                                      mean body weights and food
                                                                                      consumption and
                                                                                      biochemical evidence of
                                                                                      anemia and possible liver
                                                                                      damage.
------------------------------------
Inhalation (Intermediate-Term, 1-6   Oral NOAEL = 2.7 mg/kg/ FQPA SF = 1x            Chronic Toxicity Study in
 months)(Residential)                 day (absorption =      LOC for MOE = 100.....   Dogs
                                      100%)                                          LOAEL = 8.22 mg/kg/day
                                                                                      based on vacuolation in
                                                                                      glandular cells
                                                                                      (parathyroid) and
                                                                                      lymphatic tissues,
                                                                                      arteritis, and increases
                                                                                      in serum alanine
                                                                                      aminotransferase,
                                                                                      aspartate
                                                                                      aminotransferase, and
                                                                                      triglyceride levels.
------------------------------------
Inhalation (Long-Term, 6  Oral NOAEL = 2.7 mg/kg/ FQPA SF = 1x            Chronic Toxicity Study in
 months) (Residential)                day (absorption =      LOC for MOE = 100.....   Dogs
                                      100%)                                          LOAEL = 8.22 mg/kg/day
                                                                                      based on vacuolation in
                                                                                      glandular cells
                                                                                      (parathyroid) and
                                                                                      lymphatic tissues,
                                                                                      arteritis, and increases
                                                                                      in serum alanine
                                                                                      aminotransferase,
                                                                                      aspartate
                                                                                      aminotransferase, and
                                                                                      triglyceride levels.
------------------------------------
Cancer (oral, dermal, inhalation)    Not applicable.         Not applicable.         Spinosad is classified as a
                                                                                      ``Not Likely'' carcinogen.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor 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 180.495) for the residues of spinosad, in or on a 
variety of raw agricultural commodities. Spinosad is registered for use 
on a large number of agricultural commodities. Due to Section 18 
emergency exemption use for control of Mediterranean fruit fly, 
tolerances for residues of spinosad have been established at 0.02 ppm 
for all agricultural commodities not covered by other pesticide 
tolerances. Risk assessments were conducted by EPA to assess dietary 
exposures from spinosad 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. An endpoint was not identified for acute dietary 
exposure and risk assessment because no effects were observed in oral 
toxicity studies including developmental toxicity studies in rats or 
rabbits that could be attributable to a single dose (exposure). 
Therefore, an acute dietary exposure assessment was not performed.
    ii. Chronic exposure. Spinosad chronic dietary exposure assessments 
were conducted using the Dietary Exposure Evaluation Model (DEEM \TM\) 
software Version 7.76, which incorporates consumption data from USDA's 
1989-1992- nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII) and accumulated exposure to the chemical for each commodity. 
The chronic dietary (food only) analysis represents a moderately 
refined estimate of dietary exposure to spinosad due to the use of 
default

[[Page 60929]]

processing factors, percent crop treated estimates for commodities 
having previously registered uses, and anticipated residues for meat 
and milk.
    iii. Cancer. Spinosad has been classified as ``not likely to be 
carcinogenic in humans'' based on the results of a carcinogenicity 
study in mice and the combined chronic toxicity and carcinogenicity 
study in rats. Therefore, a cancer risk assessment was not performed.
    iv. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(E) 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), 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) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings: Condition 1, that the 
data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of percent crop 
treated (PCT) as required by section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used percent crop treated (PCT) information as follows:
    Almond 5 %; apple 28%; apricot 5%; avocado 5%, bean, snap 9%; 
broccoli 62%; cabbage 32%; cauliflower 54%; celery 78%; collards 24%; 
cherry 5%; eggplant 14%; grapefruit 1%; grape, wine 1%; kale 32%; lemon 
11%; lettuce, head 59%; Lettuce, other 42%; mustard greens 17%; orange 
6%; peach 4%; pepper 45%; pistachio 1%; prune/plum 5%; spinach 32%; 
pumpkin 1%; squash 1%; sweet corn 1%; tangerine 6%; turnip, greens 6%; 
tomato, fresh 30%; tomato, processed 2%; watermelon 1%; cotton 3%; dry 
bean/pea 1%; peanut 1%; potato 1%; wheat, winter 1%.
    The Agency believes that the three conditions listed in this Unit 
have been met. With respect to Condition 1, PCT estimates are derived 
from Federal and private market survey data, which are reliable and 
have a valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which spinosad may 
be applied in a particular area.
    2. Dietary exposure from drinking water. Spinosad and its 
degradates are not very persistent and are relatively immobile. The 
potential for its residues to leach to groundwater and runoff to 
surface water is very low. Spinosad (containing Factors A and D) is 
expected to dissipate rapidly in the environment with a low potential 
to leach or runoff to surface water. Slow metabolic degradation was 
observed only in flooded sediment (half-lives 161-250 days in the 
laboratory, >25 days outdoors). Transformation products (Factor B and 
N-demethyl spinosad Factor D) are persistent (half-lives >6 months) in 
aerobic soil metabolism studies, but are relatively immobile.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
spinosad 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 spinosad.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow groundwater. For a screening-level assessment 
for surface water EPA will use FIRST (a tier 1 model) before using 
PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/
EXAMS model that uses a specific high-end runoff scenario for 
pesticides. 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 screen for sorting out pesticides for which it is 
highly unlikely that drinking water concentrations would exceed human 
health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water.

[[Page 60930]]

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 spinosad they are further discussed in the aggregate risk 
sections below.
    Based on the First and SCI-GROW models the estimated environmental 
concentrations (EECs) of spinosad for chronic exposures is estimated to 
be 2.3 parts per billion (ppb) for surface water and 0.037 ppb for 
ground water. The EECs for spinosad are based on application of the 
insecticide to turf at a maximum of four applications at a rate of 0.41 
pound active per acre per application.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Spinosad is currently 
registered for use on residential turf and ornamentals to control a 
variety of insect pests. The registered residential products for 
spinosad are Conserve SC Turf and Ornamental (EPA Reg No. 62719-291) 
and Conserve Fire Ant Bait (EPA Reg No. 62719-304).
    Conserve Fire Ant Bait is a ready-to-use granular formulation that 
may be applied by homeowners. For adults, residential exposures may 
result from dermal and inhalation exposure while applying Conserve Fire 
Ant Bait and/or from dermal contact with treated turf. However, dermal 
post-application exposure is not of concern since no toxicological 
endpoint was established for dermal exposure. Inhalation exposure is 
not expected due to the low vapor pressure of spinosad and because the 
homeowner product is formulated as a granular. Post-application 
exposure to toddlers was not assessed for the Conserve Fire Ant Bait 
product since children are not likely to ``habit'' lawn areas where 
fire ant mounds are present.
    Conserve SC is labeled for use on turfgrass and ornamentals by 
commercial applicators. Since this product will be applied by 
commercial applicators, homeowner applicator exposure was not assessed. 
For toddlers, dermal and non-dietary oral post-application exposures 
may result from dermal contact with treated turf as well as hand-to-
mouth transfer of residues from turfgrass. Since dermal post-
application exposure is not of concern, only hand-to-mouth, object-to-
mouth and incidential ingestion of soil exposures for the turf and 
ornamental uses were performed. The average aerobic soil metabolism 
half-life of spinosad (containing factors A and D) is 13-14 days. For 
the intermediate-term duration, typical lawn maintenance practices, 
such as mowing and watering, are expected to expedite the dissipation 
of spinosad on turfgrass. Since residue on turf that is available for 
transfer after day 30 is expected to be negligible, intermediate-term 
post-application incidental oral exposures were not assessed.
    The Agency developed exposure formulas and estimated doses to 
theoretically assess residential post-application incidental oral 
exposure scenarios including: (1) Hand-to-mouth, (2) object-to-mouth 
(turfgrass), and (3) incidental ingestion of soil. The resulting 
incidental oral ingestion MOEs from residential use of spinosad on turf 
are as follow:
    [sbull] MOE for oral hand-to-mouth activities on treated lawns is 
800 for short-term (1-30 days).
    [sbull] MOE for oral object-to-mouth (turfgrass) from treated lawns 
is 3300 for short-term.
    [sbull] MOE for incidental ingestion of soil from treated lawns is 
240,000 for short-term.
    [sbull] Combined Incidental Oral MOE (hand-to-mouth, object-to-
mouth, and soil ingestion) is 640. All MOEs are below EPA's level of 
concern.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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 spinosad 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, 
spinosad 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 spinosad 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. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There is no indication of 
increased susceptibility of rat and rabbit fetuses to  in utero and/or 
postnatal exposure.
    3. Conclusion. There is a complete toxicity data base for spinosad 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. EPA determined that the 
10x safety factor to protect infants and children should be removed. 
This recommendation is based on:
    i. There is no evidence of increased susceptibility of rat or 
rabbit fetuses following in utero exposure in the developmental studies 
with spinosad, and there is no evidence of increased susceptibility of 
young rats in the reproduction study with spinosad;
    ii. There are no residual uncertainties identified in the exposure 
databases; the dietary food exposure assessment (chronic only; no acute 
endpoint was identified) is refined using Anticipated Residues 
calculated from field trial data and available percent crop treated 
information (100% crop treated is assumed for proposed new uses) and,
    iii. The dietary drinking water exposure is based on conservative 
modeling estimates,
    iv. OPP's Health Effect Division Residential Standard Operating 
Procedures were used to assess post-application exposure to children as 
well as incidental oral exposure of toddlers, so these assessments do 
not underestimate the exposure and risks posed by spinosad,
    v. A developmental toxicity study is not required.

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

[[Page 60931]]

point of comparison against the model estimates of a pesticide's 
concentration in water (EECs). DWLOCS 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 
DWLOCS, 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 DWLOCS.
    A DWLOCS 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: 2L/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 DWLOCS is calculated for each type of risk assessment 
used: acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Acute aggregate risk consists of the combined 
dietary exposures from food and drinking water sources. The total 
exposure is compared to the acute RfD. An acute RfD was not identified 
since no effects were observed in oral toxicity studies that could be 
attributable to a single dose. Therefore, the Agency concludes that 
there is a reasonable certainty of no harm from acute aggregate 
exposure to spinosad.
    2. Chronic risk. Using the exposure assumptions described in unit C 
for chronic exposure, EPA has concluded that exposure to spinosad from 
food will utilize 30% of the cPAD for the U.S. population, 41% of the 
cPAD for infant <1 year old and 69% of the cPAD for children 1-6 years 
old (subpopulation at greatest exposure). Based the use pattern, 
chronic residential exposure to residues of spinosad is not expected. 
In addition, there is potential for chronic dietary exposure to 
spinosad 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 3:

                                    Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Spinosad
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup              cPAD mg/kg/day           %cPAD (Food)               (ppb)                  (ppb)           Chronic DWLOCS (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                      0.027                   30                      2.3                    0.037                  660
All infants (<1 year old)            0.027                   41                      2.3                    0.037                  160
Children 1-6 years old               0.027                   69                      2.3                    0.037                  85
Children 7-12                        0.027                   45                       2.3                   0.037                  150
Female 13-50                         0.027                   24                      2.3                    0.037                  620
--------------------------------------------------------------------------------------------------------------------------------------------------------

     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).
    Spinosad is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for spinosad.
    Using the exposure assumptions described in unit C for short-term 
exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 600 for the U.S. Population, 260 
for all infants <1 year old, 190 for children 1-6 years old (greatest 
risk subpopulation) and 250 for children 7-12 years old. These 
aggregate MOEs do not exceed the Agency's level of concern for 
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic 
exposure of spinosad in ground and surface water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect short-term aggregate exposure to exceed the Agency's 
level of concern, as shown in the following Table 4:

                     Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Spinosad
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC      DWLOCS
                                                Residential)     (LOC)        (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U. S. Population                                         600          100          2.3        0.037         1400
All infants <1 year old                                  260          100          2.3        0.037          300
Children 1-6 years old                                   190          100          2.3        0.037          230
Children 7-12 years old                                  250          100          2.3        0.037          290
Females 13-50 years                                      760          100          2.3        0.037         1300
----------------------------------------------------------------------------------------------------------------

    4. Aggregate cancer risk for U.S. population. Spinosad has been 
classified as ``not likely to be carcinogenic in humans'' based on the 
results of a carcinogenicity study in mice and the combined chronic 
toxicity

[[Page 60932]]

and carcinogenicity study in rats. Therefore, spinosad is not expected 
to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to spinosad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology using high pressure liquid 
chromatography with ultraviolet detector (HPLC/UV) is available to 
enforce the tolerances in plants. Adequate livestock methods are 
available for tolerance enforcement. Method RES 94094 (GRM 95.03) is an 
HPLC/UV method suitable for determination of spinosad residues in 
ruminant commodities. Method GRM 95.03 has undergone successful 
independent laboratory validation (ILV) and EPA laboratory validation, 
and has been forwarded to FDA for inclusion in PAM Volume II. Method 
GRM 95.15 is another HPLC/UV method suitable for determination of 
spinosad residues in poultry commodities. This method has been 
forwarded to FDA for inclusion in PAM Volume II. Method RES 95114, an 
immunoassay method for determination of spinosad residues in ruminant 
commodities, underwent a successful ILV and EPA laboratory validation. 
It has been submitted to FDA for inclusion in PAM Volume II. The 
methods may be requested from: Paul Golden, US EPA/OPP/BEAD/ACB, 
Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-
5350; telephone number: (410) 305-2960; FAX (410) 305-3091; e-mail 
address: RAM Mailbox.

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue limits (MRLs) have 
been established for residues of spinosad on the caneberry subgroup, 
root and tuber vegetables, the herb subgroup, fig, grape, peanut, or 
livestock commodities.

V. Conclusion

    Therefore, tolerances are established for residues of spinosad, in 
or on fig at 0.10 ppm; herbs, fresh, subgroup at 3.0 ppm; herbs, dried, 
subgroup at 22 ppm; vegetable, root and tuber, group at 0.10 ppm; 
caneberry subgroup at 0.70 ppm; grape at 0.50 ppm; grape, raisin at 
0.70 ppm; peanut at 0.02 ppm; beet, sugar, molasses at 0.75 ppm; 
cattle, meat at 0.50 ppm; cattle, meat byproducts at 2.0 ppm; cattle, 
fat at 6.5 ppm, milk at 2.5; and milk, fat at 27 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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-2002-0195 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 November 
26, 2002.
    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. 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.
    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.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket ID number OPP-2002-0195, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. 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

[[Page 60933]]

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. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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. Submission to Congress and the Comptroller General

    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: September 23, 2002.
 Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.495 is amended as follows:
    a. In the table to paragraph (a) by alphabetically adding the 
entries for beet, sugar, molasses; caneberry subgroup; fig; grape; 
grape, raisin; herb, dried, subgroup; herb, fresh, subgroup; milk; 
peanut; vegetable, root and tuber, group;
    b. By revising the entries for cattle, fat; cattle, meat; cattle, 
meat byproducts; and milk, fat; and
    c. By removing the entries for beet, garden, roots; beet, sugar, 
roots; milk, whole; and tuberous and corm vegetables (crop subgroup 
1C).
    d. In the table to paragraph (b) by removing the entries for beet, 
sugar; beet, sugar, molasses; milk, whole; milk, fat; and peanut.


Sec. 180.495   Spinosad; tolerances for residues.

    (a) * * *

[[Page 60934]]



------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
                                * * * * *
Beet, sugar, molasses.........................         0.75         None
                                * * * * *
Caneberry subgroup............................         0.70         None
                                * * * * *
Cattle, fat...................................          6.5         None
Cattle, meat..................................         0.50         None
Cattle, meat byproducts.......................          2.0         None
                                * * * * *
Fig...........................................         0.10         None
                                * * * * *
 Grape........................................         0.50         None
 Grape, raisin................................         0.70         None
                                * * * * *
Herb, dried, subgroup.........................           22         None
Herb, fresh, subgroup.........................          3.0         None
                                * * * * *
Milk..........................................          2.5         None
Milk, fat.....................................           27         None
                                * * * * *
Peanut........................................         0.02         None
                                * * * * *
Vegetable, root and tuber, group..............         0.10         None
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-24484 Filed 9-26-02; 8:45 am]
BILLING CODE 6560-50-S