[Federal Register Volume 65, Number 8 (Wednesday, January 12, 2000)]
[Rules and Regulations]
[Pages 1802-1809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-736]


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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: [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 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 DEEMTM 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 DEEMTM 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 g/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: [email protected].

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 [email protected], 
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: [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

[[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
                      *      *      *      *      *
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 00-736 Filed 1-11-00; 8:45 am]
BILLING CODE 6560-50-F