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Spinosad - Pesticide Tolerance 12/99

[Federal Register: January 12, 2000 (Volume 65, Number 8)]
[Page 1802-1809]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300960; FRL-6399-7]
RIN 2070-AB78
Spinosad; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes permanent tolerances for the
insecticide spinosad (Factor A and Factor D). Factor A is 2-[(6-deoxy-
2,3, 4-tri-O-methyl-alpha-L-manno-pyranosyl)oxy]-13-[[5-
(dimethylamino)-tetrahydro-6-methyl-2 H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,6b-tetradecahydro-14-methyl-1 H-as-
Indaceno [3,2-d]oxacyclododecin-7,15-dione. Factor D is 2-[(6-deoxy-
2,3,4-tri-O- methyl-alpha-L-manno-pyranosyl)oxy]-13-[[5-
(dimethylamino)-tetrahydri-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-dimethyl-
1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione. This regulation
establishes tolerances for residues of spinosad in or on the raw
agricultural commodities (RACs ), in or on barley, buckwheat, oats, and
rye (grains) at 0.02 parts per million (ppm); pearl millet, proso
millet, and amaranth (grains) at 1 ppm; teosinte and popcorn (grains)
at 0.02 ppm; grass, forage, fodder and hay group; nongrass animal feed
group at 0.02 ppm; turnip greens at 10 ppm; cilantro, and watercress at
8 ppm; tropical fruits (sugar apple, cherimoya, atemoya, custard apple,
ilama, soursop, biriba, lychee, longan, spanish lime, rambutan,
pulasan, papaya, star apple, black sapote, mango, sapodilla, canistel,
mamey sapote, avocado, guava, feijoa, jaboticaba, wax jambu, starfruit,
passionfruit, acerola, and white sapote) at 0.3 ppm; ti leaves at 10
ppm. Additionally, this rule establishes a tolerance for spinosad on
pistachio at 0.02 ppm under conditional registration.

[[Page 1803]]

These tolerances were requested by the Interregional Research Project
(IR-4), Rutgers, the State University of New Jersey, 681 U.S. Highway
#1 South, North Brunswick, NJ 08902-3390. Spinosad is manufactured by
Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The
IR-4 requested these tolerances under the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective January 12, 2000. Objections and
requests for hearings, identified by docket control number OPP-300960,
must be received by EPA on or before March 13, 2000.

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 control number OPP-300960 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, 401 M St., SW., Washington, DC 20460; telephone
number: (703) 305-7610; and e-mail address: jackson.sidney@epa.gov.

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 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" 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/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-300960. 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 October 14, 1999 (64 FR 55714) (FRL-
6382-7), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of a pesticide petition (PP) for these tolerances
by the IR-4. This notice included a summary of the petition prepared by
Dow AgroScience, the registrant. There were no comments received in
response to the notice of filing.
    The petition requested that 40 CFR 180.495 be amended by
establishing tolerances for residues of the insecticide, in or on the
RACs considered in this rule.
    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 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 in or on the RACs
considered in this rule. EPA's assessment of the dietary exposures and
risks associated with establishing the tolerances 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 spinosad are
discussed in this unit.

[[Page 1804]]

    1. Acute toxicity. Spinosad has low acute toxicity. The rat oral
lethal dose (LD)50 is 3,738 milligrams/kilograms (mg/kg) for
males and >5,000 mg/kg for females, whereas the mouse oral
LD50 is >5,000 mg/kg. The rabbit dermal LD50 is
>5,000 mg/kg and the rat inhalation lethal concentration
(LC)50 is >5.18 milligrams/liter (mg/L) air. In addition,
spinosad is not a skin sensitizer in guinea pigs and does not produce
significant dermal or ocular irritation in rabbits. End use
formulations of spinosad that are water-based suspension concentrates
have similar low acute toxicity profiles.
    2. Genotoxicity. Short-term assays for genotoxicity consisting of a
bacterial reverse mutation assay (Ames test), an in vitro assay for
cytogenetic damage using the Chinese hamster ovary cells, an in vitro
mammalian gene mutation assay using mouse lymphoma cells, an in vitro
assay for DNA damage and repair in rat hepatocytes, and an in vivo
cytogenetic assay in the mouse bone marrow (micronucleus test) have
been conducted with spinosad. These studies show that spinosad does not
elicit a genotoxic response.
    3. Reproductive and developmental toxicity. Spinosad caused
decreased body weight (bwt) in maternal rats given 200 milligrams/
kilograms/day (mg/kg/day) by gavage, the highest dose tested (HDT).
This was not accompanied by either embryo toxicity, fetal toxicity, or
teratogenicity. The no observed adverse effect levels (NOAELs) for
maternal toxicity and fetal toxicity in rats were 50 and 200 mg/kg/day,
respectively. A teratology study in rabbits showed that spinosad caused
decreased bwt gain and a few abortions in maternal rabbits given 50 mg/
kg/day, the HDT. Maternal toxicity was not accompanied by either embryo
toxicity, fetal toxicity, or teratogenicity. The NOAELs for maternal
and fetal toxicity in rabbits were 10 and 50 mg/kg/day, respectively.
In a 2-generation reproduction study in rats, parental toxicity was
observed in both males and females given 100 mg/kg/day, the HDT.
Perinatal effects (decreased litter size and pup weight) at 100 mg/kg/
day were attributed to maternal toxicity. The NOAEL for maternal and
pup effects was 10 mg/kg/day.
    4. Subchronic toxicity. Spinosad was evaluated in 13-week dietary
studies and showed NOAELs of 4.89 and 5.38 mg/kg/day, respectively in
male and female dogs; 6 and 8 mg/kg/day, respectively in male and
female mice; and 33.9 and 38.8 mg/kg/day, respectively in male and
female rats. No dermal irritation or systemic toxicity occurred in a
21-day repeated dose dermal toxicity study in rabbits given 1,000 mg/
kg/day.
    5. Chronic toxicity. Based on chronic testing with spinosad in the
dog and the rat, EPA has set a reference dose (RfD) of 0.027 mg/kg/day
for spinosad. The RfD has incorporated a 100-fold uncertainty factor
(UF) to the NOAELs found in the chronic dog study to account for
interspecies and intraspecies variation. The NOAELs shown in the dog
chronic study were 2.68 and 2.72 mg/kg/day, respectively for male and
female dogs. The NOAELs (systemic) shown in the rat chronic/
carcinogenicity/neurotoxicity studies were 9.5 and 12.0 mg/kg/day,
respectively for male and female rats. Using the Guidelines for
Carcinogen Risk Assessment published September 24, 1986 (51 FR 33992),
it is proposed that spinosad be classified as Group E for
carcinogenicity (no evidence of carcinogenicity) based on the results
of carcinogenicity studies in two species. There was no evidence of
carcinogenicity in an 18-month mouse feeding study and a 24-month rat
feeding study at all dosages tested. The NOAELs shown in the mouse
carcinogenicity study were 11.4 and 13.8 mg/kg/day, respectively for
male and female mice. A maximum tolerated dose was achieved at the top
dosage level tested in both of these studies based on excessive
mortality.
    6. Animal metabolism. There were no major differences in the
bioavailability, routes or rates of excretion, or metabolism of
spinosyn A and spinosyn D following oral administration in rats. Urine
and fecal excretions were almost completed in 48-hours post dosing. In
addition, the routes and rates of excretion were not affected by
repeated administration.
    7. Metabolite toxicology. The residue of concern for tolerance
setting purposes is the parent material spinosyn A and spinosyn D.
Thus, there is no need to address metabolite toxicity.
    8. Endocrine disruption. There is no evidence to suggest that
spinosad has an effect on any endocrine system.

B. Toxicological Endpoints

    1. Acute toxicity. EPA did not select a dose and endpoint for an
acute dietary risk assessment due to the lack of toxicological effects
attributable to a single exposure (dose) in studies available in the
data base including oral developmental toxicity studies in rats and
rabbits. In the acute neurotoxicity study, the NOAEL was not shown at
2,000 mg/kg/day, HDT. A risk assessment is not necessary as no
appropriate endpoint is available.
    2. Short- and intermediate- term toxicity. Short- (1 day to 7
days), intermediate- (1 week to several months), and chronic-term
occupational and residential dermal and inhalation toxicity. EPA did
not select a dose or endpoint for short-, intermediate-, and long-term
dermal risk assessments because:
    i. Lack of appropriate endpoints.
    ii. The combination of molecular structure and size as well as the
lack of dermal or systemic toxicity at 2,000 mg/kg/day in a 21-day
dermal toxicity study in rats which indicates the lack of dermal
absorption.
    iii. The lack of long-term exposure based on the current use
pattern. EPA also determined that based on the current use pattern and
exposure scenario, an inhalation risk assessment is not appropriate.
    3. Chronic toxicity. EPA has established the RfD for spinosad at
0.027 mg/kg/day. This RfD is based on a NOAEL of 2.68 mg/kg/day
established in a chronic toxicity study in dogs. The lowest observed
adverse effect level (LOAEL) was 8.46 mg/kg/day based on vacuolation in
glandular cells (parathyroid) and lymphatic tissues, arteritis and
increases in serum enzymes such as alanine aminotransferase, and
aspartate aminotransferase, and triglyceride levels in dogs fed
spinosad in the diet at dose levels of 1.44, 2.68, or 8.46 mg/kg/day
for 52 weeks. A 100-fold UF was applied to the NOAEL of 2.68 mg/kg/day
to account for interspecies and intraspecies variation. The resulting
RfD was calculated to be 0.027 mg/kg/day.
    4. Carcinogenicity. There is no evidence of carcinogenicity in
studies in either the mouse or rat. Therefore, a carcinogenic risk
assessment is not appropriate.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40
CFR 180.495) for the residues of spinosad, in or on a variety of plant
and livestock commodities ranging from 0.02 ppm in almonds to 10 ppm in
the Brassica leafy vegetable and greens subgroup. Tolerances are
pending or were recently issued for use on cucurbit vegetables, stone
fruits, legume vegetables, corn, sorghum, and wheat. The Agency used
the Dietary Exposure Evaluation Model (DEEM) to estimate dietary (food
only) exposure to spinosad. This analysis assumes that 100% of crops
with spinosad tolerances (requested, published, and pending) are
treated and that those crops contain tolerance-level residues of
spinosad (Tier 1). A number of the exotic fruits

[[Page 1805]]

do not appear in the DEEM™ consumption data base. The
Agency assumes that exposure via these foods is negligible.
    i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. The Agency did not select a dose and
endpoint for an acute dietary risk assessment due to the lack of
toxicological effects attributable to a single exposure (dose) in
available studies including oral developmental toxicity studies in rats
and rabbits. In the acute neurotoxicity study, the NOAEL was
≥ 2,000 mg/kg/day. The Agency concludes that there is a
reasonable certainty of no harm from acute dietary exposure.
    ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, EPA has made very conservative assumptions: 100% of
the crops and ruminant commodities having spinosad tolerances will
contain spinosad residues and those residues will be at the level of
the established tolerance. Additionally, residues of 0.02 ppm were
assumed for all other food forms to support a pending section 18
action(s) on spinosad for use in controlling Mediterranean Fruit Fly in
Florida and California.
    The Agency used the DEEM™ anaylsis to estimate dietary
(food only) exposure to spinosad. Exposure estimates for all population
subgroups except those specific to infants and children were similar to
that of the general U.S. population (0.009 mg/kg/day, 34% chronic
population adjusted dose (cPAD)). The cPAD is equivalent to the RfD
divided by the FQPA safety factor (SF). For spinosad, EPA has
determined that the additional 10x SF for the protection of infants and
children be reduced to 1x, i.e., removed. Thus, the cPAD of 0.027 mg/
kg/day is equivalent to the chronic RfD.
    Exposure to children ages 1-6 years (the subgroup with the highest
overall estimated exposure) is estimated to be 0.020 mg/kg/day, which
occupies 74% of the chronic cPAD. The primary contributor to chronic
dietary exposure is milk, which alone occupies 30% of the cPAD for
children 1-6 years. Dietary exposure estimates based on the requested
uses of spinosad along with currently registered and pending uses, are
below the Agency's level of concern for all population subgroups,
including those of infants and children.
    2. From drinking water. Monitoring data depicting residue levels of
spinosad in drinking water are not available. Therefore, EPA cannot
perform a quantitative risk assessment for drinking water exposure.
Instead, EPA had used modeled estimated environmental concentrations
(EECs) and back-calculated drinking water levels of comparison (DWLOCs)
to determine whether exposure to spinosad via drinking water is likely
to be of concern.
    EPA concludes that the available data on spinosad show that the
compound is not mobile or persistent, and therefore has little
potential to leach to ground water. Spinosad may however contaminate
surface water upon the release of water from flooded fields to the
environment. Additionally, EPA determined that the spinosyn Factors A
and D are not expected to reach ground water. In order to assess
drinking water exposures, EPA used the screening models Pesticide Root
Zone Model (PRZM) and Exposure Analysis Modeling Systems (EXAMS) to
generate surface water EECs associated with application of spinosad to
various crops. Modeled scenarios were selected because they are
expected to represent roughly the upper 90th percentile for
surface water vulnerability, given the chemical's geographic use range.
The Tier 2 chronic surface water EEC for spinosad is 0.092 μg/L
and is based on application of the insecticide to commodities in this
ruling at rates ranging from 0.023 to 0.094 lb (active ingredient/acre
(ai/acre), with total seasonal application not to exceed 0.045 lb ai/
acre. The EEC value is over 1,000 times less than the lowest DWLOC.
    i. Acute exposure and risk. No acute toxicity endpoints were
determined from testing and the Agency concludes that there is a
reasonable certainty of no harm from acute exposure from drinking
water.
    ii. Chronic exposure and risk. For the most highly exposed
population subgroup, children (1-6 years old), chronic dietary (food
only) exposure occupies 74% of the cPAD. This is a conservative risk
estimate for reasons described above. The lowest chronic DWLOC for the
infants and children subgroup is 170 parts per billion (ppb). The
chronic modeling estimates (EECs) for spinosad residues in surface
water are as high as 0.092 ppb from use on Brassica leafy vegetables.
The maximum estimated concentrations of spinosad in surface water are
less than EPA's levels of concern for spinosad in drinking water as a
contribution to chronic aggregate exposure. Therefore, taking into
account present uses and uses proposed in this risk assessment, EPA
concludes with reasonable certainty that residues of spinosad in
drinking water (when considered along with other sources of exposure
for which the Agency has reliable data) would not result in
unacceptable levels of aggregate human health risk at this time.
    3. From non-dietary exposure. Spinosad is currently registered for
use on the following residential non-food sites: Spinosad is registered
on turf grass, creating a potential for non-dietary oral exposure to
children who ingest grass. To calculate a quantitative dietary risk
from a potential ingestion of grass (in the absence of acute-, short-,
or intermediate-term oral endpoints), EPA would need to default to the
chronic dietary endpoint. This scenario would represent a child eating
grass for > 6 months continuously. Based on the low application rate
for spinosad on turf (0.41 lbs. ai./acre), its non-systemic nature, its
short half-life (especially in sunlight), and the rapid incorporation
of spinosad metabolites into the general carbon pool, EPA believes that
residues of spinosad on turf grass after application would be low and
decrease rapidly over time. EPA believes that it is inappropriate to
perform a quantitative dietary risk representing a chronic scenario
from children eating turf grass. Qualitatively, the risk from children
eating turf grass does not exceed the Agency's level of concern.
    Another registered product contains spinosad for use on structural
lumber may have residential exposure potential, however, the product is
injected into drilled holes and then sealed after treatment. The
product can only be applied by commercial applicators with very minimal
potential risk to the public. Due to the lack of toxicity endpoints
(hazard) and minimal contact with the active ingredient during and
after application, exposure to residential occupants is not expected.
The Agency concludes that there is a reasonable certainty of no harm
from non-dietary exposure.
    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

[[Page 1806]]

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. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. Because no acute dietary endpoint was determined
from toxicity testing, the Agency concludes that there is a reasonable
certainty of no harm from acute aggregate risk.
    2. Chronic risk. Using the Theoretical Maximum Residue Contribution
(TMRC) taking into account existing spinosad tolerances (published,
pending, and including the necessary section 18 tolerances) exposure
assumptions described in this unit, EPA has concluded that aggregate
exposure to spinosad from food will utilize 34% of the cPAD for the
U.S. population. The major identifiable subgroup with the highest
aggregate exposure is children (1-6 years old). EPA generally has no
concern for exposures below 100% of the cPAD because the cPAD
represents the level at or below which daily aggregate dietary exposure
over a lifetime will not pose appreciable risks to human health.
Despite the potential for exposure to spinosad in drinking water and
from non-dietary, non-occupational exposure, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD. EPA concludes that there
is a reasonable certainty that no harm will result from aggregate
exposure to spinosad residues.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure.
    No dermal or inhalation endpoints were identified. Due to the
nature of the non-dietary use, the Agency believes that the use of
spinosad in treating timbers will not result in any exposure through
the oral route. Therefore, the short-and intermediate-term risk is
equal to the chronic dietary (food and water) risk.
    4. Aggregate cancer risk for U.S. population. There is no evidence
of carcinogenicity in studies in either the mouse or rat.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to spinosad residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children--i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of spinosad, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure gestation. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
systemic toxicity.
    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 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. EPA believes that reliable data
support using the standard uncertainty factor (usually 100 for combined
interspecies and intraspecies variability) and not the additional
tenfold MOE/uncertainty factor when EPA has a complete data base under
existing guidelines and when the severity of the effect in infants or
children or the potency or unusual toxic properties of a compound do
not raise concerns regarding the adequacy of the standard MOE/safety
factor.
    ii. Prenatal and postnatal sensitivity. There was no increased
susceptibility to rats or rabbits following in utero and/or postnatal
exposure to spinosad.
    iii. Conclusion. EPA determined that the 10x should be removed. The
FQPA factor is removed because:
    a. The data provided no indication of increased susceptibility of
rats or rabbits to in utero and/or postnatal exposure to spinosad. In
the prenatal developmental toxicity studies in rats and rabbits and the
2-generation reproduction study in rats, effects in the offspring were
observed only at or below treatment levels which resulted in evidence
of parental toxicity.
    b. No neurotoxic signs have been observed in any of the standard
required studies conducted.
    c. The toxicology data base is complete and there are no data gaps.
    d. Exposure data are complete or are estimated based on data that
reasonably account for potential exposure.
    2. Acute risk. No acute toxicological endpoints were identified for
spinosad. The Agency concludes that there is a reasonable certainty of
no harm to infants and children from aggregate exposure.
    3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to spinosad from food
will utilize 74% of the cPAD for children (1-6 years old). EPA
generally has no concern for exposures below 100% of the cPAD because
the cPAD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to spinosad in drinking
water and from non-dietary, non-occupational exposure, EPA does not
expect the aggregate exposure to exceed 100% ot the cPAD.
    4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    EPA has reviewed the results of plant metabolism studies (apples,
cabbage, cotton, tomatoes, turnips) and livestock metabolism studies
(goat and hen). The metabolism of spinosad in plants and animals is
adequately understood for the purposes of these tolerances. Based on
structure/activity relationships, EPA concluded that the spinosad
metabolites/fermentation impurities (spinosyns Factor B, Factor B or D,
Factor K, and other related Factors) were of no more toxicological
concern than the two parent compounds (spinosyns Factor A and Factor D).
    EPA focused on the following data/information: the overall low
toxicity of spinosad; the low levels of metabolites/fermentation
impurities present; and that spinosad appears to photodegrade rapidly
and become incorporated into the general carbon pool. EPA concluded
that only two parent compounds (spinosyns Factor A and Factor D) need
to be included in the tolerance expression and used for dietary risk
assessment purposes.

[[Page 1807]]

B. Analytical Enforcement Methodology

    The gas chromotography method is available to enforce the tolerance
expression. The method may be requested from: Calvin Furlow, PRRIB,
IRSD (7502C), Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460; telephone number: (703)
305-5229; e-mail address: furlow.calvin@epa.gov.

C. Magnitude of Residues

    Because of limited field studies available for crops considered in
this ruling, the Agency relied on previously submitted field trial data
on similar crops to set tolerances on certain commodities in this
ruling. Specifically, tolerances for oats, barley, buckwheat, and rye
are translated from wheat (0.020 ppm); grass forage, fodder and hay
crop group (Crop Group 17) and nongrass animal feeds crop group (Crop
Group 18) tolerances of 0.02 ppm are based on the low toxicological
properties of spinosad and the proposed use pattern (mound treatment of
fire ants); watercress and cilantro leaves are based on the leafy
vegetable tolerance (Crop Group 4, at 8 ppm); turnip greens and ti
leaves are translated from the Brassica leafy vegetables tolerance
(Crop Subgroup 5B, at 10 ppm); and sugar apple, cherimoya, atemoya,
custard apple, ilama, soursop, biriba, lychee, longan, spanish lime,
rambutan, pulasan, papaya, star apple, black sapote, mango, sapodilla,
canistel, mamey sapote, avocado, guava, feijoa, jaboticaba, wax jambu,
starfruit, passionfruit, acerola, and white sapote are translated from
the citrus fruit group (0.3 ppm).

D. International Residue Limits

    No Codex, Canadian, or Mexican MRLs have been established for
residues of spinosad on any crops.

V. Conclusion

    Therefore, the tolerances are established for residues of spinosad
in or on barley, buckwheat, oats, and rye (grains) at 0.02 parts per
million (ppm); pearl millet, proso millet, and amaranth (grains) at 1
ppm; teosinte and popcorn (grains) at 0.02 ppm; grass, forage, fodder
and hay group; nongrass animal feed group at 0.02 ppm; turnip greens at
10 ppm; cilantro, and watercress at 8 ppm; tropical fruits (sugar
apple, cherimoya, atemoya, custard apple, ilama, soursop, biriba,
lychee, longan, spanish lime, rambutan, pulasan, papaya, star apple,
black sapote, mango, sapodilla, canistel, mamey sapote, avocado, guava,
feijoa, jaboticaba, wax jambu, starfruit, passionfruit, acerola, and
white sapote) at 0.3 ppm; ti leaves at 10 ppm and a tolerance for
spinosad on pistachio at 0.02 ppm under conditional registration.

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 control number OPP-300960 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 March 13,
2000.
    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 (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 260-4865.
    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
judgment of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection." For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., 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, 401 M St., SW.,
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 control number OPP-300960, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., 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: opp-docket@epa.gov. Please use an ASCII file format and avoid the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted

[[Page 1808]]

on disks in WordPerfect 6.1/8.0 file format 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. Regulatory Assessment Requirements

    This final rule establishes tolerances 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). 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 prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require 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).

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: December 28, 1999.

James Jones,
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), (346a) and 371.

    2. Section 180.495, is amended by alphabetically adding commodities
to the table in paragraph (a), and by revising the entry for "apple"
to the table in paragraph (a) to read as follows:

Sec. 180.495  Spinosad; tolerances for residues.

    (a) *  *  *

------------------------------------------------------------------------
                                                     Parts   Expiration/
                     Commodity                        per     Revocation
                                                    million      Date
------------------------------------------------------------------------
                 *        *        *          *        *
Acerola...........................................      0.3         None
                      *      *      *      *      *
Amaranth, grain...................................      1.0         None
Animal feed, nongrass, group......................      0.3         None
                      *      *      *      *      *
Apple.............................................      0.3         None
                      *      *      *      *      *
Atemoya...........................................      0.3         None
                      *      *      *      *      *
Avocado...........................................      0.3         None
                      *      *      *      *      *
Barley............................................      0.3         None
Biriba............................................      0.3         None
                      *      *      *      *      *
Buckwheat, grain..................................      0.02        None
                      *      *      *      *      *
Canistel..........................................      0.3         None
                      *      *      *      *      *
Cherimoya.........................................      0.3         None
                      *      *      *      *      *
Cilantro, leaves..................................      8.0         None
Corn, pop, grain..................................      0.02        None
                      *      *      *      *      *
Custard apple.....................................      0.3         None
                      *      *      *      *      *

Feijoa............................................      0.3         None
                      *      *      *      *      *
Grass, forage, fodder and hay, group..............      0.02        None
 Guava............................................      0.3         None
                      *      *      *      *      *
Ilama.............................................      0.3         None
Jaboticaba........................................      0.3         None
Longan............................................      0.3         None
Lychee............................................      0.3         None

[[Page 1809]]
                      *      *      *      *      *
Mango.............................................      0.3         None
Millet, pearl, grain..............................      1.0         None
                      *      *      *      *      *
Millet, proso, grain..............................      1.0         None
Oat, grain........................................      0.02        None
Papaya............................................      0.3         None
Passionfruit......................................      0.3         None
Pistachio.........................................       0.02        None
                      *      *      *      *      *
Pulasan...........................................      0.3         None
                      *      *      *      *      *
Rambutan..........................................      0.3         None
Rye, grain........................................      0.02        None
Sapodilla.........................................      0.3         None
Sapote, black.....................................      0.3         None
Sapote, mamey.....................................      0.3         None
Sapote, white.....................................      0.3         None
                      *      *      *      *      *
Soursop...........................................      0.3         None
Spanish lime......................................      0.3         None
                      *      *      *      *      *
Star apple........................................      0.3         None
Starfruit.........................................      0.3         None
                      *      *      *      *      *
Sugar apple.......................................      0.3         None
                      *      *      *      *      *
Teosinte, grain...................................      0.3         None
Ti, leaves........................................     10.0         None
                      *      *      *      *      *
Turnip greens.....................................     10.0         None
                      *      *      *      *      *
Watercress........................................      8.0         None
Wax jambu.........................................      0.3         None
                      *      *      *      *      *
------------------------------------------------------------------------