[Federal Register Volume 64, Number 184 (Thursday, September 23, 1999)]
[Rules and Regulations]
[Pages 51451-51460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24696]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300920; FRL-6381-9]
RIN 2070-AB78


Spinosad; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
spinosad in or on succulent shelled pea and bean legumes at 0.02 parts 
per million (ppm), dried shell pea and bean (except soybean) legumes at 
0.02 ppm, and wheat (flour, bran, middlings, and shorts, only) at 0.15 
ppm; cucurbit vegetables at 0.30 ppm; edible-podded legume vegetables 
at 0.30 ppm; soybeans at 0.02 ppm; stone fruits at 0.20 ppm; corn, 
grain, including field, and pop at 0.020 ppm; sorghum, grain at 1.0 
ppm; wheat, grain at 0.020 ppm; forage, fodder, hay, stover, and straw 
of cereal grains at 1.0 ppm; aspirated grain fractions at 20 ppm; 
poultry, fat at 0.20 ppm; and poultry, meat, meat byproducts, and eggs 
at 0.020 ppm. This regulation increases current livestock residue 
tolerances as follows: meat of cattle, goats, hogs, horses and sheep 
from 0.04 to 0.15 ppm, meat by-products of cattle, goats, hogs, horses 
and sheep from 0.20 ppm to 1.0 ppm; fat of cattle, goats, hogs, horses 
and sheep from 0.6 ppm to 3.5 ppm; milk, whole from 0.04 ppm to 0.50 
ppm and milk fat from 0.5 ppm to 5 ppm. This regulation also removes 
time limitations for residues of spinosad on corn, sweet; kernel plus 
cob with husk removed, stover and forage, which expire on June 20, 2001 
and raises the tolerance on corn, sweet, forage to 1.0 ppm. Dow 
AgroSciences requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective September 23, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300920, 
must be received by EPA on or before November 22, 1999.

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'' section. To ensure proper receipt by EPA, your objections 
and hearing requests must identify docket control number OPP-300920 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: William Sproat, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: 703-308- 8587; 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            Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing

[[Page 51452]]

 
                                  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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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-300920. 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 September 16, 1998 (63 FR 49568) (FRL-
6025-8), 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) (Pub. L. 104-170) announcing 
the filing of a pesticide petition (PP) for tolerance by Dow 
AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46254. This notice 
included a summary of the petition prepared by Dow AgroSciences, 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 spinosad, in or 
on cucurbit vegetables at 0.30 parts per million (ppm); legume 
vegetables (succulent including soybeans) at 0.30 ppm; stone fruits at 
0.20 ppm; corn, grain, including field, sweet (K+CHWR), and pop at 
0.020 ppm; sorghum grain at 1.0 ppm; sorghum aspirated grain fractions 
at 3.0 ppm; wheat, grain at 0.020 ppm; forage, fodder, hay, stover, and 
straw of cereal grains at 1.0 ppm; poultry, fat at 0.20 ppm; and 
poultry, meat, meat byproducts at 0.020 ppm; and eggs at 0.020 ppm. The 
petition further requested that the following increases in livestock 
residue tolerances be established: livestock, meat residue tolerance of 
0.10 ppm; livestock, meat byproduct residue tolerance of 0.40 ppm; 
livestock, fat residue tolerance of 1.50 ppm; a milk residue tolerance 
of 0.10 ppm; and a milk fat residue tolerance of 1.50 ppm.
    The proposal for tolerances for legume vegetables (succulent 
including soybeans) was revised by the petitioner at EPA's request to 
reflect separate listings for Crop Subgroup 6A - Edible-podded legume 
vegetables at 0.30 ppm; Crop Subgroup 6B - Succulent shelled pea and 
bean at 0.02 ppm; Crop Subgroup 6C Dried shelled pea and bean at 0.02 
ppm; and soybeans at 0.02 ppm. Based upon EPA's review of data, the 
proposal for tolerances in aspirated grain fractions and livestock 
community need to be revised as follows: aspirated grain fractions 
(20ppm); meat (0.15 ppm), meat by-products (1 ppm), and fat (3.5 ppm) 
of cattle, goats, hogs, horses, and sheep; whole milk (0.50 ppm); and 
milk fat (5 ppm). In addition, tolerances processed wheat commodities 
need to be added as follows; wheat bran, flour, middlings, and shorts 
(0.15 ppm).
    Spinosad (CAS Reg. No. 131929-60-7) is a fermentation product of 
Saccharopolyspora spinosa. Spinosad consists of two related spinosyn 
compounds, Factor A and Factor D, both of which serve as active 
ingredients. They are typically present at an 85:15 A:D ratio. Spinosad 
is currently proposed for use on cucurbit crops including cucumber, 
summer and winter squash, muskmelons (cantaloupe, honeydew, etc.), 
pumpkin, edible gourds, and watermelon to control cabbage looper, 
armyworms, melon worms, pickleworm, rindworms, leafminers, and thrips; 
stone fruit including peaches, plums, cherries, nectarines, prunes and 
apricots to control peach twig borer, oriental fruit moth, leafminers, 
leafrollers, green fruitworm, cherry fruit fly, and western cherry 
fruit fly; succulent beans and peas to control European corn borers, 
armyworms, corn earworms, loopers, thrips, and leafminers; field corn, 
including popcorn, to control European corn borer larvae, armyworms, 
corn earworm, southeastern corn borer, and western bean cutworms; 
sorghum, including milo and grain, to control sorghum midge, armyworms, 
corn earworm, southwestern corn borer, and web worms; soybeans to 
control soybean looper, velvet bean caterpillar, green clover worm, 
armyworms, and corn earworms; and wheat to control armyworms and 
grasshoppers.
    Time-limited tolerances were established for residues of spinosad 
on corn, sweet; kernel plus cob with husk removed, stover and forage, 
based on a preliminary risk assessment. After complete evaluation, the 
Agency has determined that time limitations on sweet corn are 
unnecessary and has established permanent tolerances for spinosad 
residues on sweet corn: kernel plus cob with husk removed, stover and 
forage.
    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

[[Page 51453]]

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 on cucurbit 
vegetables at 0.30 parts per million (ppm); edible-podded legume 
vegetables at 0.30 ppm; succulent shelled pea and bean legumes at 0.02 
ppm; dried shell pea and bean (except soybean) legumes at 0.02 ppm; 
soybeans at 0.02 ppm; stone fruits at 0.20 ppm; corn, grain, including 
field, and pop at 0.020 ppm; corn, sweet at 1.0 ppm; sorghum, grain at 
1.0 ppm; wheat, grain at 0.020 ppm; forage, fodder, hay, stover, and 
straw of cereal grains at 1.0 ppm; aspirated grain fractions at 20 ppm; 
poultry, fat, at 0.20 ppm; and poultry, meat, meat byproducts and eggs 
at 0.020 ppm; and wheat (flour, bran, middlings, and shorts, only) at 
0.15 ppm. This regulation increases the current livestock residue 
tolerances as follows: meat, meat by-products, and fat of cattle, 
goats, hogs, horses and sheep from 0.04 to 0.15 ppm, 0.20 ppm to 1.0 
ppm; and 0.6 ppm to 3.5, respectively; and increases milk, whole and 
milk fat from 0.04 ppm to 0.50 ppm and 0.5 ppm to 5 ppm, respectively. 
EPA's assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by are discussed in 
this unit.
    1. Acute toxicity studies with technical grade active ingredient 
spinosad (88 - 90.4%) product: Oral LD50 in the rat is > 
5,000 mg/kg for males and females - Toxicity Category IV; dermal 
LD50 in the rat is > 2,800 mg/kg for males and females - 
Toxicity Category III; inhalation LC50 in the rat is > 5.18 
mg/L - Toxicity Category IV; primary eye irritation in the rabbit 
(slight conjunctival irritation) - Toxicity Category IV; primary dermal 
irritation in the rabbit (no erythema and edema) - Toxicity Category 
IV. Spinosad is not a sensitizer.
    2. Acute toxicity studies with the end-use (44% formulation) 
product for spinosad: Oral LD50 in the rat is > 5,000 mg/kg 
for males and females - Toxicity Category IV; dermal LD50 in 
the rat is > 2,800 mg/kg for males and females - Toxicity Category III; 
inhalation LC50 in the rat is > 5.0 mg/L - Toxicity Category 
IV; primary eye irritation in the rabbit (slight conjunctival 
irritation) - Toxicity Category IV; primary dermal irritation in the 
rabbit (slight transient erythema and edema) - Toxicity Category IV. 
Spinosad is not a sensitizer.
    3. In a subchronic feeding study in rats, the no-observed adverse 
effect level (NOAEL) was 33.9 and 38.8 mg/kg/day for males and females, 
respectively. The lowest observed adverse effect level (LOAEL) was 68.5 
and 78.1 mg/kg/day for males and females, respectively, based on 
decreased body weight gain, anemia, vacuolation in multiple organs 
(kidney, liver, heart, spleen, adrenals, thyroid).
    4. In a subchronic feeding study in mice, the NOAEL was 7.5 mg/kg/
day and the LOAEL was 22.5 mg/kg/day, based on cytoplasmic vacuolation 
in multiple organs (kidney, liver, heart, stomach, lymphoid organs, 
ovary).
    5. In a subchronic feeding study in dogs, the NOAEL was 4.89 mg/kg/
day for males and 5.38 mg/kg/day for females, respectively. The LOAEL 
was 9.73 mg/kg/day for males and 10.5 mg/kg/day for females, 
respectively, based on decreased mean body weights & food consumption, 
and anemia.
    6. In a 21-day dermal study in rats, the NOAEL for systemic effects 
was > 1,000mg/kg/day (limit dose). No systemic toxicity was observed at 
any dose tested.
    7. In a chronic feeding study in dogs, the NOAEL was 2.68 mg/kg/day 
and the LOAEL was 8.22 mg/kg/day, based on increased liver enzymes 
(ALT, AST), triglycerides; vaculated cells (parathyroid), and 
arteritis.
    8. In a chronic feeding carcinogenicity study in mice, the NOAEL 
was 11.4 mg/kg/day for males and 13.8 mg/kg/day for females, 
respectively. The LOAEL was 50.9 mg/kg/day for males and 67.0 mg/kg/day 
for females, respectively, based on decreased body weight gains, 
increased mortality, hematologic effects, increased thickening of the 
gastric mucosa, and histologic changes in the stomach of males.
    9. In a chronic feeding/carcinogenicity study in rats, the NOAEL 
was 9.5 mg/kg/day for males and 12.0 mg/kg/day for females, 
respectively. The LOAEL was 24.1 mg/kg/day for males and 30.3 mg/kg/day 
for females, respectively, based on thyroid follicular cell vacuolation 
(males & females); thyroiditis (females); and increased relative and 
absolute thyroid weights (females).
    10. In a developmental study in rabbits, the maternal NOAEL was 
50 mg/kg/day. The maternal LOAEL was not established. The 
developmental NOAEL was 50 mg/kg/day. The developmental 
LOAEL was not established. No maternal or developmental effects were 
observed at the highest dose tested (HDT) (50 mg/kg/day).
    11. In a developmental study in rats, the maternal NOAEL was 
200 mg/kg/day. The maternal LOAEL was not established. The 
developmental NOAEL was 200 mg/kg/day. The developmental 
LOAEL was not established. No maternal or developmental effects were 
observed at the (HDT) (200 mg/kg/day).
    12. In a 2-generation reproduction toxicity study in rats, the 
systemic NOAEL was 10 mg/kg/day. The systemic LOAEL was 100 mg/kg/day 
based on increased organ weights (heart, liver, kidney, spleen, 
thyroid), histopath lesions in the lungs and mesenteric lymph nodes, 
stomach (female), and prostate. The reproductive NOAEL was 10 mg/kg/
day. The reproductive LOAEL was 100 mg/kg/day based on decreased litter 
size, decreased pup survival, decreased body weight, increased 
incidence of dystocia and/or vaginal bleeding post-partum with 
associated increased mortality of dams.
    13. Studies on gene mutation and other genotoxic effects: in a Gene 
Mutation Assay (Ames Test), there was no appreciable increase in the 
reversion to histidine protrophy of 4 S. typhimurium strains at 1 to 
10,000 g/plate with & without S-9 activation. In a Gene 
Mutation Assay, there was no forward mutation in mouse lymphoma L5178Y 
Tk +/- cells with and without metabolic activation up to 50 g/
ml. In a Structural Chromosomal Aberration Assay In vitro, there was no 
increase in the number of Chinese Hamster Ovary cells with chromosome 
aberrations with ( 20, 26, or 35 g/ml) or without (100, 250, 
or 500 g/ml) activation. In a Micronuclei Test, there was no 
increase

[[Page 51454]]

in the frequency of micronuclei with bone marrow cells from mice 
treated at 0, 500, 100, or 2,000 mg/kg/day for 2 consecutive days. In 
Other Genotoxicty Assays, unscheduled DNA synthesis was not induced up 
to the cytotoxic dose (0.01-1,000 g/ml tested).
    14. In rat metabolism studies, there were no major differences 
between the bioavailability, routes of excretion, or metabolism of 14C-
XDE-105 (Factor A) & 14C-XDE-105 (Factor D) in Fischer 344 rats 
following oral administration as a suspension of 100 mg/kg bwt. The 
major elimination route was fecal excretion for both factors. About 80% 
(Factor A) and 66% (Factor D) was absorbed with about 20% (Factor A) 
and 34% (Factor D) of the dose eliminated unabsorbed in the feces. By 
48 hr post-dosing, >60% (Factor A) & >80% (Factor D) had been recovered 
in the urine and the feces. Based on the terminal half-lives for fecal 
and urinary excretion, the elimination half-life for Factor A ranged 
from 25-42 hr and the half-life for Factor D ranged from 29-33 hr. The 
tissues and carcass contained very low levels of radioactivity at 168 
hr post-dosing, < 0.1% of the administered dose/gram tissue. The 
primary fecal, urinary, and the biliary metabolites were identified as 
the glutathione conjugates of the parent and and O-demethylated XDE-
105. The absorption, distribution, metabolism, and elimination of 14C-
XDE-105 were similar for Factors A & D.
    15. In an acute neurotoxicity study in rats, the NOAEL was 
 2,000 mg/kg/day. In a subchronic neurotoxicity study in 
rats, the NOAEL was  42.7 mg/kg/day in males and 52.1 mg/kg/
day in females, respectively. In chronic neurotoxicity study in rats, 
the NOAEL was  46 mg/kg/day in males and 57 mg/kg/day in 
females, respectively.

B. Toxicological Endpoints

    1. Acute toxicity. EPA did not select a dose and endpoint for acute 
dietary risk assessment due to a 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  
2,000 mg/kg/day.
    2. Short- and intermediate-term toxicity. EPA did not select a dose 
or end-point 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; 
and (iii) the lack of long- term exposure based on the current use 
pattern. Therefore, a dermal risk assessment is not required. EPA also 
determined that based on the current use pattern and exposure scenario, 
an inhalation risk assessment is not required.
    3. Chronic toxicity. EPA has established the RfD for spinosad at 
0.027 mg/kg/day. This Reference Dose (RfD) is based on a chronic 
toxicity study in dogs using a NOAEL of 2.7 mg/kg/day. The LOAEL was 
8.46 mg/kg/day based on the occurrence of vacuolation in glandular 
cells (parathyroid) and lymphatic tissues, arteritis, and increases in 
serum enzymes such as alanine aminotranferase, and aspartate 
aminotransferase, and triglyceride levels in dogs fed spinosad in the 
diet at dose levels of 1.44, 2.7, 8.46 mg/kg/day for 52 weeks. A 
hundredfold uncertainty factor (UF) was applied to the NOAEL of 2.7 mg/
kg/day to account for inter- and intra- species variation resulting in 
an RfD of 0.027mg/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 required.

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 raw 
agricultural commodities. Spinosad is registered for use on a number of 
agricultural commodities, including apples, Brassica vegetables, leafy 
vegetables, tuberous and corm vegetables, and fruiting vegetables 
(excluding cucurbits). Additionally, spinosad is registered for pest 
control in turfgrass and ornamental plants. Registered formulations of 
spinosad are Success, SpinTor, Tracer, and Conserve. These formulations 
vary from 1 to 4 lb ai/gallon and may be broadcast, band, or aerially 
applied. Application rates range from 0.023 to 0.156 lb ai/A, depending 
on the target pest and the crop. The maximum seasonal application rate 
is 0.45 lb ai/A. Application intervals are specified as being dependent 
on the pest populations or as a set number of days, ranging from 3 to 
14, depending on the crop. There are label restrictions against too 
many applications per season and/or pest generation, to avoid 
development of pest resistance. Pre-harvest intervals range from 1 to 
28 days, depending on the crop. For most of the commodities in this 
petition, the application rate ranges from 0.023 to 0.094 lb ai/A, with 
total seasonal application not to exceed 0.45 lb ai/acre. Risk 
assessments were conducted by EPA to assess dietary exposures from 
spinosad as follows:
    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. No acute toxicological endpoints were 
identified for spinosad due to the lack of toxicological effects 
attributable to a single exposure (dose). Therefore, the Agency 
concludes that there is a reasonable certainty of no harm from acute 
dietary exposure.
    ii. Chronic exposure and risk. Adequate field trials were completed 
with cucumber, muskmelon, and squash (cucurbit vegetables); snap beans, 
snow peas, and soybean (legume vegetables); cherries, peaches, plums, 
and prunes (stone fruits); and sweet corn, field corn, sorghum, and 
wheat (cereal crops). The field trials and a poultry feeding study 
support the establishment of tolerances on the raw agricultural 
commodities.
    Processing studies for wheat commodities were not submitted with 
the petition and were noted as a data deficiency in the residue 
chemistry review. In the absence of processed commodity data, EPA has 
used the maximum theoretical concentration factor of 8X for wheat, as 
listed in OPPTS Guideline 860.1520, to estimate residues in processed 
wheat commodities. A value of 0.8 ppm has been used for all processed 
wheat commodities for this risk assessment. Additionally, the residue 
chemistry review notes that the tolerance for aspirated grain 
fractions, and hence ruminant commodities, need to be revised.
    EPA performed a chronic dietary (food only) exposure analysis using 
the Dietary Exposure Evaluation Model (DEEM). This model incorporates 
3-day average 1989- 1992 food consumption data from USDA's Continuing 
Survey of Food Intake by Individuals and accumulates exposure to the 
chemical for each commodity. Each analysis assumes uniform distribution 
of spinosad in the commodity supply. As spinosad has been shown to 
partition into milk fat, EPA used data from the previously submitted 
animal feeding study to calculate a spinosad residue for skim milk. 
This value was used to set the residue level for milk-based water. The 
chronic dietary (food only) analysis represents a highly conservative 
estimate of dietary exposure to spinosad. EPA has taken this into 
consideration as part of this human health risk assessment. The Tier 1 
exposure analysis from DEEM estimates that chronic dietary (food only)

[[Page 51455]]

exposure will occupy 74% of the cPAD for children ages 1-6 years (the 
highest-exposed population subgroup). Exposure estimates for all adult 
populations are less than 39% of the cPAD. The primary contributor to 
chronic dietary exposure is milk, which alone occupies 30% of the cPAD 
for children 1-6 yrs.
    Exposure estimates for all population subgroups except those 
specific to infants and children were similar to that of the general 
U.S. population (0.0092 mg/kg/day, 34% cPAD), ranging from 0.0073 mg/
kg/day (27% cPAD) for seniors 55+ years to 0.0105 mg/kg/day (39% cPAD) 
for peoples of non-Hispanic/non-white/non-black origins. The similarity 
of the exposure estimates across these subgroups indicates that 
exposure to spinosad is not heavily affected by ethnic, seasonal, or 
regional dietary influences (note that since the FQPA Safety Factor was 
reduced to 1x, the cPAD and the RfD are equal).
    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's Metabolism Assessment Review Committee 
determined that the spinosyn Factors A and D are not expected to reach 
groundwater (2/10/98). In order to assess drinking water exposures, EPA 
used the screening models PRZM (Pesticide Root Zone Model) and EXAMS 
(Exposure Analysis Modeling Systems) 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 cole crops (0.13 lb ai/A/application, 0.45 lb ai/A/
season). The EEC value is over 500 times less than the lowest DWLOC . 
Based on these studies, the Agency concludes that drinking water is not 
expected to be a significant source of exposure to spinosad.
    i. Acute exposure and risk. No acute toxicity endpoints were 
determined from testing and the Agency concludes that there is 
reasonable certainty of no harm from acute risk from drinking water. No 
acute risk is expected.
    ii. Chronic exposure and risk. Based on dietary (food only) 
exposures EPA has back-calculated Drinking Water Levels of Comparison 
(DWLOCs) for spinosad. The DWLOCs range from 70 g/L to 620 
g/L; these values are well above the chronic Tier II estimated 
environmental concentration of 0.092 g/L. Although exposure to 
spinosad via drinking water may occur, exposure is not expected to 
exceed the calculated DWLOCs for any population subgroup.
    3. From non-dietary exposure. No acute dietary, cancer, or short-, 
intermediate-, or chronic-term dermal or inhalation endpoints were 
identified by the Agency. 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./A.), 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 which are 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 common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether spinosad has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
spinosad does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that spinosad has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

    Conservative assumptions have been made throughout this risk 
assessment. Residue estimates used in the dietary assessment are at 
published, proposed, or suggested tolerance levels. The two exceptions 
to this are wheat processed commodities, which are based on a highly 
conservative maximum theoretical concentration factor, and milk-based 
water, which is conservatively based on a theoretical maximum residue 
concentration calculated for skim milk. Estimated concentration of 
spinosad in drinking water is also quite conservative. Because of the 
nature of the spinosad molecule, the low application rate, and need to 
use a chronic oral toxicological endpoint, EPA does not believe it 
appropriate to aggregate the potential residential exposure to spinosad 
via turf grass with other oral (dietary + drinking water) exposures. As 
drinking water is not expected to be a significant route of exposure to 
spinosad, dietary (food only) exposure is the only route of concern. 
Thus, exposures to spinosad from its proposed uses on cucurbit 
vegetables, legume vegetables, stone fruits, corn, sorghum, and wheat, 
taken in conjunction with other registered and pending uses of 
spinosad, are below the Agency's level of concern.
    1. Acute risk. Because no acute dietary endpoint was determined 
from

[[Page 51456]]

toxicity testing, the Agency concludes that there is a reasonable 
certainty of no harm from acute aggregate risk.
    2. Chronic risk. Using the TMRC 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 
ages 1-6 with 74% of the cPAD. EPA generally has no concern for 
exposures below 100% of the RfD because the RfD represents the level at 
or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to human health.. 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 by EPA. 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 chronic aggregate risk solely is the sum 
of food + water.
    4. Aggregate cancer risk for U.S. population. The Agency has 
determined that 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 pre-and post-natal toxicity and the 
completeness of the database 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 inter- 
and intra-species 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. Developmental toxicity studies. In a prenatal developmental 
toxicity study, groups of pregnant Sprague-Dawley rats (30/group) 
received oral (gavage) administration of Spinosad (88.6%) in aqueous 
0.5% methylcellulose at dose levels of 0, 10, 50, or 200 mg/kg/day 
during gestation days 6 through 17. For maternal toxicity, the NOEL was 
>200 mg/kg/day (HDT); a LOEL was not established. Marginal maternal 
toxicity was reported at this dose level (decreased body weight gain). 
Based upon the results of a range-finding study, which showed maternal 
toxicity (body weight and food consumption decreases at 100 and 300 mg/
kg/day), the dose level of 200 mg/kg/day in the main study was 
considered adequate. For developmental toxicity, the NOEL was >200 mg/
kg/day; a LOEL was not established. In the range-finding study, fetal 
body weight decrements occurred at 300 mg/kg/day.
    In a prenatal developmental toxicity study, groups of pregnant New 
Zealand White rabbits (20/group) received oral (gavage) administration 
of Spinosad (88.6%) in 0.5% aqueous methyl cellulose at doses of 0, 
2.5, 10, or 50 mg/kg/day during gestation days 7 through 19. For 
maternal toxicity, the NOEL was 50 mg/kg/day (HDT); a LOEL 
was not established. At this dose, slight body weight loss was observed 
in the first few days of dosing, but this finding was not supported by 
other signs. In the range-finding study, inanition was observed at 
doses of 100, 200, and 400 mg/kg/day, with significant decreases in 
body weight gain during dosing. All does at these dose levels were 
sacrificed prior to scheduled termination; no fetal data were 
available. No evidence of developmental toxicity was noted. For 
developmental toxicity, the NOEL was 50 mg/kg/day; a LOEL 
was not established. (No fetal effects were noted for fetuses of the 
range-finding study at doses up to 50 mg/kg/day).
    iii. Reproductive toxicity study. In a 2-generation reproduction 
study, groups of Sprague-Dawley rats (30/sex/group) received diets 
containing Spinosad (88.0%) at dose levels of 0, 0.005, 0.02, or 0.2% 
(3, 10, or 100 mg/kg/day, respectively) for two successive generations. 
For parental systemic toxicity, the NOEL was 0.02% (10 mg/kg/day) and 
the LOEL was 0.2% (100 mg/kg/day), based on increased heart, kidney, 
liver, spleen, and thyroid weights (both sexes), histopathology in the 
spleen and thyroid (both sexes), heart and kidney (males), and 
histopathologic lesions in the lungs and mesenteric lymph nodes (both 
sexes), stomach (females), and prostate. For offspring toxicity, the 
NOEL was 0.02% (10 mg/kg/day) and the LOEL was 0.2% (100 mg/kg/day) 
based on decreased litter size, survival (F2), and body weights. 
Reproductive effects at that dose level included increased incidence of 
dystocia and/or vaginal bleeding after parturition with associated 
increase in mortality of dams.
    iv. Neurotoxicity. In an acute neurotoxicity study, groups of 
Fischer 344 rats (10/sex/dose) received a single oral (gavage) 
administration of Spinosad (87.9%) at dose levels of 0, 200, 630, or 
2,000 mg/kg. There were no effects on neurobehavioral endpoints or 
histopathology of the nervous system. For neurotoxicity, the NOEL was 
>2,000 mg/kg (HDT); a LOEL was not established.
    In a subchronic neurotoxicity study, groups of Fischer 344 rats 
(10/sex/dose) were administered diets containing Spinosad at levels of 
0, 0.003, 0.006, 0.012, or 0.06%(0, 2.2, 4.3, 8.6, or 42.7 mg/kg/day 
for males and 2.6, 5.2, 10.4, or 52.1 mg/kg/day for females, 
respectively). There were no effects on neurobehavioral endpoints or 
histopathology of the nervous system. For neurotoxicity, the NOEL was 
42.7 for males and 52.1 mg/kg/day for females 
(HDT).
    In the 2-year chronic toxicity study, groups of Fischer 344 rats 
(65/sex/dose) received diets containing Spinosad at dose levels of 0, 
0.005, 0.02, 0.05, or 0.1% (0, 2.4, 9.5, 24.1, or 49.4 mg/kg/day for 
males and 0, 3.0, 12.0, 30.3, or 62.2 mg/kg/day for females, 
respectively). Neurobehavioral testing performed at 3, 6, 9, and 12 
months of study was negative, and histopathological evaluation of 
perfused tissues at study termination did not identify pathology of the 
central or peripheral nervous system. There was

[[Page 51457]]

no evidence of neurotoxicity. For neuropathology, the NOEL was 0.1% 
(>49.4 mg/kg/day for males and /62.8 mg/kg/day for females).
    Based upon a review of the currently available data base for 
Spinosad, a developmental neurotoxicity study in rats is not required. 
This determination was based upon the following evidence:
    a. The oral LD50 in rats is >5,000 mg/kg.
    b. No indication of abnormalities in the development of the fetal 
nervous system, were observed in the prenatal developmental toxicity 
studies in either rats or rabbits, at minimally toxic maternal oral 
doses up to 200 or 50 mg/kg/day, respectively.
    c. There was no evidence of neurobehavioral toxicity in the acute 
or subchronic neurotoxicity studies in rats, nor in the chronic 
toxicity study in rats.
    d. There was no evidence of neuropathology of the central or 
peripheral nervous system following perfusion of tissues in the acute, 
subchronic, or chronic neurotoxicity studies in rats.
    v. Pre- and post-natal sensitivity. There was no increased 
susceptibility to rats or rabbits following in utero and/or postnatal 
exposure to spinosad.
    vi. Conclusion. 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 two-generation reproduction study in rats, effects in 
the offspring were observed only at or below treatment levels which 
resulted in evidence of parental toxicity. In addition, all 
neurotoxicity studies were negative for effects on the central or 
peripheral nervous system.
    EPA determined that the 10X factor to protect infants and children 
(as required by FQPA) should be removed. The FQPA factor is removed 
because:
    (i) The data provided no indication of increased susceptibility of 
rats or rabbits to in utero and/or post natal 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.
    (ii) No neurotoxic signs have been observed in any of the standard 
required studies conducted.
    (iii) The toxicology data base is complete and there are no data 
gaps. There is a complete toxicity database for spinosad and exposure 
data is complete or is estimated based on data that reasonably accounts 
for potential exposures.
    2. Acute risk. An acute risk assessment is not required because 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 infants and children. 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.
    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 2 parent compounds (spinosyns Factor A and Factor D) need to 
be included in the tolerance expression and used for dietary risk 
assessment purposes.

B. Analytical Enforcement Methodology

    Method GRM 94.02 (method for determination of spinosad residues in 
cottonseed and related commodities using HPLC/UV) underwent successful 
independent lab validation and EPA lab validation and has been 
submitted to FDA for inclusion in PAM II as Method I. Additional 
methods have been submitted for other crop matrices leafy vegetables - 
GRM 95.17; citrus - GRM 96.09; tree nuts - GRM 96.14; fruiting 
vegetables - GRM 95.04; and cotton gin byproducts - GRM 94.02.S1. All 
of these methods are essentially similar to GRM 94.02 and have been 
submitted to FDA for inclusion in PAM II as letter methods. Method GRM 
94.02 is adequate for regulation of the tolerance expression.
    Method GRM 95.03.R1 (method for determination of spinosad residues 
in ruminant commodities using HPLC/UV) underwent successful validation 
by EPA's lab. The method was forwarded to FDA for inclusion in PAM II 
as a Roman numeral method.
    Method RES 95114 (method for determination of spinosad residues in 
ruminant commodities using immunoassay) has also successfully passed 
validation by EPA's lab. The method was forwarded to FDA for inclusion 
in PAM II as a Roman numeral method.
    Multi residue Methods (GLN 860.1360) - The results of subjecting 
spinosad to FDA Multi residue testing were previously reviewed . 
Spinosyns Factor A and D were not recovered from any of the protocols. 
The results have been sent to FDA.
    Adequate enforcement methodology (example - gas chromotography) 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

    The residue of concern for spinosad is parent spinosad (as 
specified in 40 CFR 180.495), which is made up of Spinosyn Factors A 
and D. Because of the non-systemic nature of spinosad, these residues 
are primarily found on the surfaces of treated commodities.
    Adequate field trials were completed with cucumber, muskmelon, and 
squash (cucurbit vegetables); snap beans, snow peas, and soybean 
(legume vegetables); cherries, peaches, plums, and prunes (stone 
fruits); and sweet corn, field corn, sorghum, and wheat (cereal crops). 
The field trials and a poultry feeding study support the establishment 
of tolerances.
    Field trials for the legume vegetables did not include 
representative commodities from Crop Subgroups 6B (succulent shelled 
pea and bean) and 6C (dried shelled pea and bean). Tolerance-level 
residues of 0.02 ppm were assumed for these subgroups in the risk 
assessment.
    Processing studies for wheat commodities were not submitted with 
the petition. In the absence of processed

[[Page 51458]]

commodity data, EPA has used the maximum theoretical concentration 
factor of 8X for wheat, as listed in Office of Prevention, Pesticides, 
and Toxic Substances (OPPTS) Guideline 860.1520, to estimate residues 
in processed wheat commodities. A value of 0.15 ppm has been used for 
all processed wheat commodities for this risk assessment. Additionally, 
because of the amount of spinosad residue found in corn, sorghum, and 
wheat products, as well as those commodities with existing residue 
tolerances that are potentially used in animal rations , the tolerances 
for aspirated grain fractions, and hence ruminant commodities, need to 
be revised as indicated under ``SUPPLEMENARY INFORMATION'' of this 
document.

D. International Residue Limits

    No CODEX, Canadian, or Mexican maximum residue levels (MRLs) have 
been established for residues of spinosad on any crops.

V. Conclusion

    Therefore, tolerances are established for residues of spinosad in 
or on succulent shelled pea and bean legumes at 0.02 parts per million 
(ppm), dried shell pea and bean (except soybean) legumes at 0.02 ppm, 
and wheat (flour, bran, middlings, and shorts, only) at 0.15 ppm; 
cucurbit vegetables at 0.30 ppm; edible-podded legume vegetables at 
0.30 ppm; soybeans at 0.02 ppm; stone fruits at 0.20 ppm; corn, grain, 
including field, and pop at 0.020 ppm; sorghum, grain at 1.0 ppm; 
wheat, grain at 0.020 ppm; forage, fodder, hay, stover, and straw of 
cereal grains at 1.0 ppm; aspirated grain fractions at 20 ppm; poultry, 
fat at 0.20 ppm; and poultry, meat, meat byproducts, and eggs at 0.020 
ppm. This regulation increases current livestock residue tolerances as 
follows: meat of cattle, goats, hogs, horses and sheep from 0.04 to 
0.15 ppm, meat by-products of cattle, goats, hogs, horses and sheep 
from 0.20 ppm to 1.0 ppm; fat of cattle, goats, hogs, horses and sheep 
from 0.6 ppm to 3.5 ppm; milk, whole from 0.04 ppm to 0.50 ppm and milk 
fat from 0.5 ppm to 5 ppm. This regulation also removes time 
limitations for residues of spinosad on corn, sweet; kernel plus cob 
with husk removed, stover and forage, which expire on June 20, 2001 and 
raises the tolerance on corn, sweet, forage to 1.0 ppm. As a condition 
of registration, field trials on representative commodities from Crop 
Subgroups 6B (succulent shelled pea and bean) and 6C (dried shelled pea 
and bean), and processing studies for wheat commodities are required.

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-300920 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
22, 1999.
    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 
Room 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 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' (cite). 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 bymailing 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. of 
this preamble, you should also send a copy of your request to the PIRB 
for its inclusion in the official record that is described in Unit 
I.B.2. of this preamble. Mail your copies, identified by docket number 
OPP-300920, 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 PRIB described in Unit I.B.2. of this preamble. You may 
also send an electronic copy of your request via e-mail to: opp-
[email protected]. Please use an ASCII file format and avoid the use of 
special characters and any form of encryption. Copies of electronic 
objections and hearing requests will also be accepted on disks in 
WordPerfect 5.1/6.1 file format or ASCII file format. Do not include 
any CBI in your electronic copy. You may

[[Page 51459]]

also submit an electronic copy of your request at many Federal 
Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). 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) (Pub. L. 104-4). Nor does 
it require prior consultation with State, local, and tribal government 
officials as specified by Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993) and 
Executive Order 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 27655, May 19,1998), or special 
consideration of environmental justice related issues under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994) or require OMB review in accordance with Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 12612, 
entitled Federalism (52 FR 41685, October 30, 1987). This action 
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 the Federal Food, Drug, and Cosmetic Act, 
21 U.S.C. 346a(b)(4).. 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), Pub. L. 104-
113, section 12(d) (15 U.S.C. 272 note). In addition, 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.

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 rule in the  Federal Register. This rule is not 
a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 9, 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. In Sec. 180.495, by revising paragraph (a) to read as follows:


Sec. 180.495  Spinosad; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide spinosad in or on the food commodities in the table to this 
paragraph. Spinosad is a fermentation product of Saccharopolyspora 
spinosa. The product consists of two related active ingredients: 
Spinosyn A (Factor A; CAS# 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O- 
methyl--L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-
tetrahydro-6-methyl-2H-pyran-2- yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as- 
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; 
CAS# 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl--L-manno-
pyranosyl)oxy]-13-[[5-(dimethyl-amino)- tetrahydro-6-methyl-2H-pyran-2-
yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a, 16b- 
tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione. Typically, the two factors are present at an 85:15 (A:D) ratio.

 
------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Almonds.........................  0.020               None
Almond Hulls....................  2.0                 None
Apples..........................  0.2                 None
Apple pomace....................  0.5                 None
Aspirated grain fractions.......  20                  None
Brassica (cole), leafy            10                  None
 vegetables, greens subgroup.
Brassica (cole), leafy            2.0                 None
 vegetables, head and stem
 subgroup.
Cattle, fat.....................  3.5                 None
Cattle, meat byproducts.........  1.0                 None
Cattle, meat....................  .15                 None
Citrus fruits group.............  .3                  None
Citrus oil......................  3.0                 None
Citrus pulp, dried..............  0.5                 None
Coffee..........................  0.02                8/28/00
Corn, field.....................  0.02                None
Corn, fodder....................  1.0                 None
Corn, forage....................  1.0                 None
Corn, grain.....................  0.02                None
Corn, hay.......................  1.0                 None
Corn, pop.......................  0.02                None
Corn, stover....................  1.0                 None
Corn, straw.....................  1.0                 None
Corn, sweet (K+CWHR)............  0.02                None

[[Page 51460]]

 
Cotton gin byproducts...........  1.5                 None
Cottonseed......................  0.02                None
Cucurbit vegetables (cucumbers,   0.3                 None
 melons, squashes) group.
Fruiting vegetables (except       0.4                 None
 cucurbits) group.
Goat, fat.......................  3.5                 None
Goat, meat byproducts...........  1.0                 None
Goat, meat......................  .15                 None
Hogs, fat.......................  3.5                 None
Hogs, meat byproducts...........  1.0                 None
Hogs, meat......................  .15                 None
Horses, fat.....................  3.5                 None
Horses, meat byproducts.........  1.0                 None
Horses, meat....................  .15                 None
Leafy vegetables (except           8.0                None
 Brassica vegetables group.
Legume vegetables, edible podded  0.30                None
 (Crop Subgroup 6A.
Legume vegetables, dried shell    0.02                None
 pea and bean (Crop Subgroup 6C.
Legume vegetables, succulent      0.02                None
 shelled pea and bean (Crop
 Subgroup 6B).
Milk, fat.......................  5.0                 None
Milk, whole.....................  0.50                None
Poultry, eggs...................  0.02                None
Poultry, fat....................  0.20                None
Poultry, meat byproducts........  0.02                None
Poultry, meat...................  0.02                None
Sheep, fat......................  3.5                 None
Sheep, meat byproducts..........  1.0                 None
Sheep, meat.....................  .15                 None
Sorghum, fodder.................  1.0                 None
Sorghum, forage.................  1.0                 None
Sorghum, grain..................  1.0                 None
Sorghum, hay....................  1.0                 None
Sorghum, stover.................  1.0                 None
Sorghum, straw..................  1.00                None
Soybeans........................  0.02                None
Stone fruits (cherries, peaches,  0.20                None
 plums, prunes) group.
Tuberous and corm vegetables      0.02                None
 (crop subgroup 1C).
Wheat, bran.....................  .15                 None
Wheat, flour....................  .15                 None
Wheat, fodder...................  1.0                 None
Wheat, forage...................  1.0                 None
Wheat, grain....................  0.02                None
Wheat, hay......................  1.0                 None
Wheat, middlings................  0.15                None
Wheat, shorts...................  0.15                None
Wheat, stover...................  1.0                 None
Wheat, straw....................  1.0                 None
------------------------------------------------------------------------

* * * * *

[FR Doc. 99-24696 Filed 9-22-99; 8:45 am]
BILLING CODE 6560-50-F