[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: sproat.william@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS 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:
furlow.calvin@epa.gov..
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
tompkins.jim@epa.gov , 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: docket@epa.gov. Please use an ASCII file format and avoid the use of
special characters and any form of encryption. Copies of electronic
objections and hearing requests will also be accepted 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
