[Federal Register Volume 63, Number 72 (Wednesday, April 15, 1998)]
[Rules and Regulations]
[Pages 18329-18338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10023]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300644; FRL-5785-7]
RIN 2070-AB78
Spinosad; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes permanent tolerances for residues
of spinosad in or on almonds at 0.02 parts per million (ppm); almond
hulls at 2.0 ppm; apples at 0.2 ppm; apple pomace, wet at 0.5 ppm;
citrus fruits group at 0.3 ppm; citrus pulp, dried at 0.5 ppm; citrus
oil at 3.0 ppm; cottonseed at 0.02 ppm; cotton gin byproducts at 1.5
ppm; fruiting vegetables (except cucurbits) group at 0.4 ppm; Brassica
(cole), leafy vegetables, head and stem subgroup at 2.0 ppm; Brassica
(cole), leafy vegetables, greens subgroup at 10.0 ppm; leafy vegetables
(except Brassica vegetables) group at 8.0 ppm; fat of cattle, goats,
hogs, horses, and sheep at 0.6 ppm; meat of cattle, goats, hogs,
horses, and sheep at 0.04; meat byproducts of cattle, goats, hogs,
horses, and sheep at 0.2 ppm; milk fat at 0.5 ppm; and whole milk at
0.04 ppm. This regulation also removes the time limitation for the
tolerance for residues of spinosad on cottonseed which expires on
November 15, 1999. DowElanco requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170). In addition,
this regulation removes time-limited tolerances set under section
408(1)(6) of the FFDCA, as amended by the FQPA for residues of spinosad
on fruiting vegetables (except cucurbits) group, tomato paste, leafy
vegetables (except Brassica vegetables) group, and Brassica (cole),
leafy vegetables, group at 0.25, 0.50, 10.0, and 10.0 ppm,
respectively. These tolerances were set under the
[[Page 18330]]
section 18 emergency exemption provision of the FQPA and they expire on
September 30, 1998. With this regulation, permanent tolerances are now
being established to replace these time-limited tolerances with the
exception of tomato paste. A tolerance will not be established for
tomato paste because EPA has determined that the maximum amount of
spinosad residues expected in tomato paste is less than the proposed
tolerance for tomatoes. Therefore, no tolerance is required for tomato
paste.
DATES: This regulation is effective April 15, 1998. Objections and
requests for hearings must be received by EPA on or before June 15,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300644], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300644], must also be submitted 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,
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300644]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Beth Edwards, Registration
Division 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location,
telephone number, and e-mail address: Crystal Mall #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 305-5400, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: On February 26, 1997, EPA established a
time-limited tolerance under section 408 and 409 of the FFDCA, 21
U.S.C. 346a(d) and 348 for residues of spinosad on cottonseed (62 FR
8626) (FRL-5590-8). This tolerance expires on November 15, 1999.
DowElanco, on December 11, 1997, requested that the time limitation be
removed based on a cotton gin trash residue study that they had
submitted as a condition of the registration and the time-limited
tolerance. DowElanco also submitted a summary of its petition as
required under the FFDCA as amended by the Food Quality Protection Act
(FQPA) of 1996 (Pub. L. 104-170).
On October 22, 1997, EPA established time-limited tolerances under
section 408(1)(6) of the FFDCA, as amended by the FQPA of 1996 for
residues of spinosad on fruiting vegetables (except cucurbits) group,
tomato paste, leafy vegetables (except Brassica vegetables) group, and
Brassica (cole), leafy vegetables group at 0.25, 0.50, 10.0, and 10.0
ppm, respectively (62 FR 54771) (FRL-5746-6). These tolerances were set
under the Section 18 emergency exemption provision of the FQPA and they
expire on September 30, 1998. These emergency exemption tolerances for
spinosad were granted to control Western Flower Thrips on fruiting
vegetables (excluding cucurbits) in the states of Florida, Georgia and
Arkansas, and to control beet armyworm on leafy vegetables (except
Brassica) and Brassica leafy vegetables in Arizona.
In the Federal Register issues of December 24, 1996 (61 FR 67801)
(FRL-5578-2), October 8, 1997 (62 FR 52558) (FRL-5748-6), and March 4,
1998 (63 FR 10609) (FRL-5774-1), EPA issued notices pursuant to section
408 of the FFDCA, 21 U.S.C. 346a(e) announcing the filing of pesticide
petitions (PP) 7F4797, 7F4871, and 8F4942 for tolerances by DowElanco,
9330 Zionsville Road, Indianapolis IN 46268-1054. These notices
included a summary of the petitions prepared by DowElanco, the
registrant. There were no comments received in response to the notices
of filing.
The petitions requested that 40 CFR 180.495 be amended by removing
the time limitation for the tolerance for residues of the insecticide
spinosad in or on cottonseed at 0.02 ppm and by establishing tolerances
in or on almonds at 0.02 ppm; almond hulls at 2.0 ppm; apples at 0.2
ppm; apple pomace, wet at 0.5 ppm; citrus fruits group at 0.3 ppm;
citrus pulp, dried at 0.5 ppm; citrus oil at 3.0 ppm; cotton gin
byproducts at 1.5 ppm; fruiting vegetables (except cucurbits) group at
0.4 ppm; leafy vegetables (except Brassica vegetables) group at 8.0
ppm; Brassica (cole), leafy vegetables, head and stem subgroup at 2.0
ppm; Brassica (cole), leafy vegetables, greens subgroup at 15.0 ppm;
fat of cattle, goats, hogs, horses, and sheep at 0.7 ppm; meat of
cattle, goats, hogs, horses, and sheep at 0.04 ppm; meat byproducts of
cattle, goats, hogs, horses, and sheep at 0.2 ppm; milk fat at 0.5 ppm;
and whole milk at 0.04 ppm. EPA determined that the requested
tolerances for fat of cattle, goats, hogs, horses, and sheep at 0.7 ppm
and Brassica (cole), leafy vegetables, greens subgroup at 15.0 ppm were
too high based on magnitude of the residue studies. EPA recommended
that the tolerances be set at 0.6 ppm and 10.0 ppm, respectively.
I. Risk Assessment and Statutory Findings
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures
[[Page 18331]]
that occur as a result of pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100 percent or less of the
RfD) is generally considered acceptable by EPA. EPA generally uses the
RfD to evaluate the chronic risks posed by pesticide exposure. For
shorter term risks, EPA calculates a margin of exposure (MOE) by
dividing the estimated human exposure into the NOEL from the
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be
unacceptable. This 100-fold MOE is based on the same rationale as the
100-fold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
II. 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.
[[Page 18332]]
EPA has sufficient data to assess the hazards of spinosad and to make
a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of spinosad on almonds at 0.02
ppm; almond hulls at 2.0 ppm; apples at 0.2 ppm; apple pomace, wet at
0.5 ppm; citrus fruits group at 0.3 ppm; citrus pulp, dried at 0.5 ppm;
citrus oil at 3.0 ppm; cottonseed at 0.02 ppm; cotton gin byproducts at
1.5 ppm; fruiting vegetables (except cucurbits) group at 0.4 ppm; leafy
vegetables (except Brassica vegetables) group at 8.0 ppm; Brassica
(cole), leafy vegetables, head and stem subgroup at 2.0 ppm; Brassica
(cole), leafy vegetables, greens subgroup at 10.0 ppm; fat of cattle,
goats, hogs, horses, and sheep at 0.6 ppm; meat and meat byproducts of
cattle, goats, hogs, horses, and sheep at 0.04 ppm; milk fat at 0.5
ppm; and whole milk at 0.04 ppm. 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 spinosad are
discussed below.
1. Acute toxicity studies with technical spinosad (88% - 90.4%):
Oral LD50 in the rat is > 5,000 milligram/kilogram (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 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;
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 effect level (LOEL) was 68.5 and 78.1
mg/kg/day for males and females, respectively based on decreased body
weight gain, anemia, and vacuolation in multiple organs (kidney, liver,
heart, spleen, adrenals, and thyroid).
4. In a subchronic feeding study in mice, the NOEL was 7.5 mg/kg/
day and the LOEL was 22.5 mg/kg/day based on cytoplasmic vacuolation in
multiple organs (kidney, liver, heart, stomach, lymphoid organs, and
ovary).
5. In a subchronic feeding study in dogs, the NOEL was 4.89 and
5.38 mg/kg/day for males and females, respectively. The LOEL was 9.73
mg/kg/day and 10.5 mg/kg/day based on decreased mean body weights and
food consumption, and anemia.
6. In a 21-day dermal study in rats, the NOEL for systemic effects
was > 1,000 mg/kg/day (limit dose). No systemic toxicity was observed
at any dose tested.
7. In a chronic feeding study in dogs, the NOEL was 2.68 mg/kg/day.
The LOEL was 8.22 mg/kg/day based on increased liver enzymes (ALT,
AST), triglycerides; vacuolated cells (parathyroid), and arteritis.
8. In a carcinogenicity study in mice, the NOEL was 11.4 mg/kg/day.
The LOEL was 50.9 mg/kg/day 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/neurotoxicity study in
rats, the NOEL (systemic) was 9.5 and 12.0 mg/kg/day for males and
females, respectively. The LOEL (systemic) was 24.1 and 30.3 mg/kg/day
for males and females, respectively based on vacuolation of epithelial
follicular cells of the thyroid. The neurological NOEL was 46 and 57
mg/kg/day for males and females, respectively. The neurological LOEL
was not determined.
10. In a developmental study in rabbits, the maternal NOEL was
50 mg/kg/day. The maternal LOEL was not established. The
developmental NOEL was 50 mg/kg/day. The developmental LOEL
was not established.
11. In a developmental study in rats, the maternal NOEL was >200
mg/kg/day. The maternal LOEL was not established. The developmental
NOEL was >200 mg/kg/day. The developmental LOEL was not established.
12. In a two-generation reproduction toxicity study in rats, the
systemic NOEL was 10 mg/kg/day. The systemic LOEL 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 (F), and prostate. The reproductive NOEL was 10 mg/kg/day. The
reproductive LOEL 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 (mouse forward mutation) there was no forward mutation
induction in mouse lymphoma L5178Y Tk +/- cells at concentrations of 0,
1, 5, 10, 15, 20, or 25 g/ml without metabolic activation or
at concentrations of 15 through 50 g/ml with metabolic
activation. In a Structural Chromosomal Aberration Assay in vitro there
was no increase in the number of CHO (chinese hamster ovary) cells with
chromosomal aberrations at concentratioins from 20 to 35 g/ml
(without activation) or concentrations from 100 to 500 g/ml
(with activation). In a Micronucleus Test in mice, there was no
increase in the frequencey of micronuclei in bone marrow cells from
mice treated at concentratioins from 500 to 2,000 g/ml for two
days. In Other Genotoxicity Assays, unscheduled DNA synthesis was not
induced in adult rat hepatocytes in vitro at concentrations of 0.01 to
5 g/ml tested.
14. The results of three metabolism studies are as follows: (i)
Approximately 95% of technical spinosad was eliminated by 24 hours
mainly in the urine (34%), bile (36%), and tissues and carcass (21%).
Metabolites include the glutathione conjugates of the unchanged form as
well as N- and O-demethylated forms of XDE-105 (Factor D). (ii) At 100
mg/kg/dose, the radiolabeled XDE-105 (Factor D) was primarily excreted
in the feces (68%) after 24-hours. The absorption, distribution, and
elimination of 14C-XDE-105 (Factor A) demonstrated no appreciable
differences based on dose or repeated dosing. (iii) At high (100 mg/kg)
doses, there are no major differences in the bioavailability, routes or
rates of excretion or metabolism of 14C-XDE-105 (Factor A) following
oral administration.
15. In an acute neurotoxicity study, groups of Fischer 334 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/
[[Page 18333]]
kg. There were no effects on neurobehavioral endpoints or
histopathology of the nervous system. For neurotoxicity, the NOEL was
2,000 mg/kg/day, highest dose tested (HDT). A LOEL was not
established.
16. 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 neurobehavior endpoints or
histopathology of the nervous system. For neurotoxicity, the NOEL was
42.7 and 52.1 mg/kg/day in males and females,
respectively (HDT).
17. In the 2-year chronic neurotoxicity 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 no evidence of
neurotoxicity. For neuropathology, the NOEL was 0.1% ( 46
mg/kg/day for males and 57 mg/kg/day for females (HDT).
B. Toxicological Endpoints
1. Acute toxicity. EPA did not select a dose and endpoint for an
acute dietary risk assessment due to the lack of toxicological effects
attributable to a single exposure (dose) in studies available in the
data base including oral developmental toxicity studies in rats and
rabbits. In the acute neurotoxicity study the NOEL was 2,000
mg/kg/day.
2. Short - (1 day to 7 days), intermediate- (1 week to several
months), and chronic - term occupational and residential dermal and
inhalation toxicity. EPA did not select a dose or endpoint for short-,
intermediate and long-term dermal risk assessments because (i) lack of
appropriate endpoints; (ii) the combination of molecular structure and
size as well as the lack of dermal or systemic toxicity at 2,000 mg/kg/
day in a 21-day dermal toxicity study in rats which indicates the lack
of dermal absorption; 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 RfD is based on a chronic toxicity study in dogs
using a NOEL of 2.68 mg/kg/day. The LOEL was 8.46 mg/kg/day based on
vacuolation in glandular cells (parathyroid) and lymphatic tissues,
arteritis and increases in serum enzymes such as alanine
aminotransferase, and aspartate aminotransferase, and triglyceride
levels in dogs fed spinosad in the diet at dose levels of 1.44, 2.68,
or 8.46 mg/kg/day for 52 weeks. A 100-fold uncertainty factor (UF) was
applied to the NOEL of 2.68 mg/kg/day to account for inter- and intra-
species variation.
EPA determined that the 10X factor to account for enhanced
sensitivity of infants and children (as required by FQPA) should be
removed. Thus, an uncertainty factor of 100 is adequate and the RfD
remains at 0.027 mg/kg/day.
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 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. (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.
4. Carcinogenicity. There is no evidence of carcinogenicity in
studies in either the mouse or rat.
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 cottonseed at 0.02
ppm (to expire on 11/15/99). Time-limited tolerances for Section 18
emergency exemptions are established under 40 CFR 180.495 for residues
of spinosad in or on Brassica (cole) leafy vegetables at 10 ppm,
fruiting vegetables (except cucurbit vegetables) at 0.25 ppm, leafy
vegetables (except Brassica vegetables) at 10 ppm, and tomato paste at
0.5 ppm. Risk assessments were conducted by EPA to assess dietary
exposures and risks 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 one 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. The RfD used for the chronic dietary
analysis is 0.027 mg/kg/day. In conducting this chronic dietary risk
assessment, EPA made very conservative assumptions: 100% of citrus,
almonds, apples, fruiting (except cucurbit) vegetables, Brassica leafy
vegetables, leafy vegetables, cottonseed, and ruminant commodities
having spinosad tolerances will contain spinosad residues and those
residues will be at the level of the established tolerance. This
results in an overestimate of human dietary exposure. This chronic
dietary risk assessment used 10 ppm tolerances for the leafy vegetables
(except Brassica vegetables) crop group and for the Brassica leafy
vegetables head and stem subgroup from section 18 tolerances that were
established last year. For the section 3 registrations on these groups,
EPA has recommended tolerances of 8 ppm (leafy vegetables) and 2 ppm
(Brassica head and stem leafy vegetables). The use pattern for these
section 18 registrations is identical to the section 3 registrations
proposed in this risk assessment, but due to an incomplete data base at
the time the Section 18s were reviewed, the tolerances were set high
which resulted in a conservative risk assessment. With this action,
these section 18 tolerances are replaced by the new section 3
tolerances. Thus, in making a safety determination for this tolerance,
EPA is taking into account this conservative exposure assessment.
The existing spinosad tolerances (published, pending, and including
the Section 18 tolerances) result in a Theoretical Maximum Residue
Contribution (TMRC) that is equivalent to the following percentages of
the RfD: U.S. Population (24% of RfD); Nursing Infants (<1 year old)(
8% of RfD); Non-Nursing Infants (<1 year old) (24% of RfD); Children
(1-6 years old) (34% of RfD); Children (7-12 years old) (29% of RfD);
Northeast Region (25% of RfD); Western Region (27% of RfD); Non-
Hispanic Blacks (27% of RfD); Non-Hispanic Others (37% of RfD); Females
13+ years, Nursing (27% of RfD).
2. From drinking water. The Agency has determined that spinosyns
Factor A and Factor D are immobile in soil and will not leach into
ground water. Based on structure/activity relationships, the Agency
concluded that the spinosad metabolites/fermentation impurities
[[Page 18334]]
(spinosyns Factor B, Factor B of D, Factor K, and other related
factors) were of no more toxicological concern than the two parent
compounds (spinosyns Factor A and Factor D) and therefore, only these
were considered in the drinking water assessment. EPA used the
``Interim Approach for Addressing Drinking Water Exposure in Tolerance
Decision Making'' issued on November 17, 1997. Thus, the PRZM/EXAMS
Models were run to produce estimates of spinosad in surface water. The
primary use of these models is to provide a screen for sorting out
pesticides for which OPP has a high degree of confidence that the true
levels of the pesticide in drinking water will be less than the human
health drinking water levels of concern (DWLOCs). A human health DWLOC
is the concentration of a pesticide in drinking water which would
result in acceptable aggregate risk, after having already factored in
all food exposures and other non-occupational exposures for which OPP
has reliable data. PRZM/EXAMS was used to conduct a Tier 2 surface
water analysis. The Tier 2 estimated drinking water concentration (EEC)
of spinosad from surface water sources is not likely to exceed 0.059
g/L from use on apples, 0.092 g/L from use on
Brassica vegetables, 0.065 g/L from use on cotton, and 0.075
g/L from use on citrus.
i. Acute exposure and risk. Because no acute dietary endpoint was
determined, the Agency concludes that there is a reasonable certainty
of no harm from acute exposure from drinking water.
ii. Chronic exposure and risk. Based on the chronic dietary (food)
exposure and using default body weights and water consumption figures,
chronic drinking water levels of concern (DWLOC) for drinking water
were calculated. The chronic drinking water exposure and risk estimates
are 0.019890 mg/kg/day (690 g/L DWLOC) for the overall U.S.
population; 0.01896 mg/kg/day (570 g/L DWLOC) for females 13+
years, nursing; and 0.016865 mg/kg/day (170 g/L DWLOC) for
children age 1-6 years.
3. From non-dietary exposure. There are no current residential uses
for spinosad. However, the proposed use of a 0.5% spinosad product on
structural lumber may have residential uses. This product is injected
into drilled holes and then sealed after treatment. 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.
4. Cumulative exposure to substances with common mechanism of
toxicity. Spinosad has not yet been grouped with any other insecticides
into a class.
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.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
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 these tolerance actions,
therefore, EPA has not assumed that spinosad has a common mechanism of
toxicity with other substances.
D. Aggregate Risks and Determination of Safety for U.S. Population
Chronic risk. Using the TMRC exposure assumptions described in Unit
I.B. of this Preamble, EPA has concluded that aggregate exposure to
spinosad from food will utilize 24% of the RfD for the U.S. population.
For the most highly exposed populations subgroup, children (1-6 years
old) and non-Hispanic others, chronic dietary (food only) exposure
occupies 34% and 37% of the RfD, respectively. This is a conservative
risk estimate for reasons described above. 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. The chronic
DWLOC for the infants and children subgroup is 170 ppb. The chronic
modeling estimates (EECs) for spinosad residues in surface water are as
high as 0.092 ppb from use on Brassica leafy vegetables. The maximum
estimated concentrations of spinosad in surface water are less than
EPA's levels of concern for spinosad in drinking water as a
contribution to chronic aggregate exposure. Taking into account present
uses and uses proposed in this risk assessment, EPA concludes with
reasonable certainty that residues of spinosad in drinking water (when
considered along with other sources of exposure for which EPA has
reliable data ) would not result in unacceptable levels of aggregate
human health risk at this time. Therefore, the Agency concludes that
there is a reasonable certainty that no harm will result from chronic
aggregate exposure to spinosad residues from food and water.
No dermal or inhalation endpoints were identified. Due to the
nature of the non-dietary use, EPA believes that the use of spinosad in
treating structural lumber will not result in any exposure through the
oral route. Therefore, the chronic aggregate risk is the sum of food
and water.
[[Page 18335]]
E. Aggregate Cancer Risk for U.S. Population
The RfD Committee determined that there is no evidence of
carcinogenicity in studies in either the mouse or rat. Therefore, a
carcinogenic risk assessment is not required.
F. 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 two-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from pesticide exposure during prenatal development
to one or both parents. 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 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 MOE
and 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. a. 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% methycellulose at dose levels of 0,10, 50, 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.
b. 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 two-generation reproduction
study, groups of Sprague-Dawley rats (30/sex/group) received diets
containing spinosad (88%) at dose levels of 0, 0.005, 0.02, or 0.2% (3,
10, or 10 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. a. 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.
b. In a subchronic neurotoxicity study, groups of Fisher 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).
c. 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 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).
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 account for enhanced
sensitivity of 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
two-generation reproduction study in rats, effects in the offspring
were observed only at or below treatment
[[Page 18336]]
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.
2. Acute risk. An acute risk assessment is not required because no
acute toxicological endpoints were identified for spinosad.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to spinosad
from food will utilize 34% of the RfD for children age 1-6 years old.
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 to infants and children from aggregate exposure to
spinosad residues.
G. Endocrine Disruption
EPA is required to develop a screening program to determine whether
certain substances (including all pesticides and inerts) ``may have an
effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect...'' The Agency is
currently working with interested stakeholders, including other
government agencies, public interest groups, industry and research
scientists in developing a screening and testing program and a priority
setting scheme to implement this program. Congress has allowed 3 years
from the passage of FQPA (August 3, 1999) to implement this program. At
that time, EPA may require further testing of this active ingredient
and end use products for endocrine disrupter effects.
III. 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. These
methods are adequate for regulation of the tolerance expression.
Method RES 94094 (method for determination of spinosad residues in
ruminant commodities using HPLC/UV) underwent successful independent
lab validation and EPA lab validation. This method is adequate for
regulation of the tolerance expression.
Method RES 95114 (method for determination of spinosad residues in
ruminant commodities using immunoassay) underwent successful
independent lab validation and EPA lab validation.This method is
adequate for regulation of the tolerance expression.
C. Magnitude of Residues
Adequate residue data were provided to support tolerances of 0.02
ppm for almonds; 2.0 ppm for almond hulls; 0.2 for apples; 2.0 ppm for
the head and stem subgroup of the Brassica leafy vegetables crop group;
10.0 ppm for the greens subgroup of the Brassica leafy vegetables crop
group; 0.3 ppm for the citrus fruits crop group; 0.02 ppm on
cottonseed; 1.5 ppm on cotton gin byproducts; 0.4 ppm for the fruiting
vegetables (except cucurbit vegetables) crop group; and, 8.0 ppm for
the leafy vegetables (except Brassica vegetables ) crop group.
Processing data provided for apples indicated concentration of
residues in wet apple pomace. Based on the concentration factor of 5.6X
and the highest average field trial (HAFT) residue level of 0.089 ppm
for apples, the data support a tolerance of 0.5 ppm for wet apple
pomace.
Processing data provided for citrus indicated concentration of
residues in dried citrus pulp and citrus oil. Based on the
concentration factor of 2.4X in dried pulp and 12.7X in oil and the
highest average field trial (HAFT) residue level of 0.200 ppm for
oranges, the data support tolerances of 0.5 ppm for dried citrus pulp
and 3.0 ppm for citrus oil.
Processing data provided for cottonseed did not indicate any
concentration of residues in meal or hulls. No tolerances are required
for processed cotton commodities.
There are no livestock feedstuffs associated with Brassica leafy
vegetables, fruiting vegetables, and leafy vegetables.
A ruminant feeding study was submitted. Based on the results of
this study, the data support the following tolerances: fat (or cattle,
goats, hogs, horses, and sheep) at 0.6 ppm; meat (of cattle, goats,
hogs, horses, and sheep) at 0.04 ppm; meat byproducts (of cattle,
goats, hogs, horses, and sheep) at 0.2 ppm; milk fat at 0.5 ppm; and
whole milk at 0.04 ppm. These levels are adequate for the feed items
associated with all existing and proposed uses covered in this risk
assessment.
Requirements for a poultry feeding study have been waived based on
the minimal impact of spinosad residues in a typical poultry diet.
D. International Residue Limits
No CODEX, Canadian, or Mexican MRLs have been established for
residues of spinosad on any crops.
IV. Conclusion
Therefore, the tolerances are established for residues of spinosad
in almonds at 0.02 ppm; almond hulls at 2.0 ppm; apples at 0.2 ppm;
apple pomace, wet at 0.5 ppm; citrus fruits group at 0.3 ppm; citrus
pulp, dried at 0.5 ppm; citrus oil at 3.0 ppm; cottonseed at 0.02 ppm;
cotton gin byproducts at 1.5 ppm; fruiting vegetables (except
cucurbits) group at 0.4 ppm; Brassica (cole), leafy vegetables, head
and stem subgroup at 2.0 ppm; Brassica (cole), leafy vegetables, greens
subgroup at 10.0 ppm; leafy vegetables (except Brassica vegetables)
group at 8.0 ppm; fat of cattle, goats, hogs, horses, and sheep at 0.6
ppm; meat of cattle goats, hogs, horses, and sheep at 0.04; meat
byproducts of cattle, goats, hogs, horses, and sheep at 0.2 ppm; milk
fat at 0.5 ppm; and whole milk at 0.04 ppm.
[[Page 18337]]
In addition, EPA is removing the time limitation for the tolerance
for residues of spinosad on cottonseed. Also, EPA is removing the time
limited tolerances established under section 408(1)(6) of the FFDCA, as
amended by FQPA, in 40 CFR 180.495 (b) Section 18 emergency exemptions.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by June 15, 1998, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is 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 in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). 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.
VI. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300644] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerances 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. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950) and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
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 Envorcement 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 the 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.
[[Page 18338]]
Dated: April 9, 1998.
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. 346a and 371.
2. In Sec. 180.495, paragraphs (a) and (b) are revised to read as
follows:
Sec. 180.495 Spinosad; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide Spinosad. Factor A is 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,6b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione. Factor D is 2-[(6-deoxy-
2,3,4-tri-O-methyl--L-manno-pyranosyl)oxy]-13-[[5-
(dimethylamino)-tetrahydri-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-
1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almonds.................................................... 0.02
Almond hulls............................................... 2.0
Apples..................................................... 0.2
Apple pomace, wet.......................................... 0.5
Brassica (cole), leafy vegetables, greens subgroup......... 10.0
Brassica (cole), leafy vegetables, head and stem subgroup.. 2.0
Cattle, fat................................................ 0.6
Cattle, mbyp............................................... 0.2
Cattle, meat............................................... 0.04
Citrus fruits group........................................ 0.3
Citrus oil................................................. 3.0
Citrus pulp, dried......................................... 0.5
Cotton gin byproducts...................................... 1.5
Cottonseed................................................. 0.02
Fruiting vegetables (except cucurbits) group............... 0.4
Goat, fat.................................................. 0.6
Goat, mbyp................................................. 0.2
Goat, meat................................................. 0.04
Hogs, fat.................................................. 0.6
Hogs, mbyp................................................. 0.2
Hogs, meat................................................. 0.04
Horses, fat................................................ 0.6
Horses, mbyp............................................... 0.2
Horses, meat............................................... 0.04
Leafy vegetables (except Brassica vegetables) group........ 8.0
Milk, fat.................................................. 0.5
Milk, whole................................................ 0.04
Sheep, fat................................................. 0.6
Sheep, mbyp................................................ 0.2
Sheep, meat................................................ 0.04
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(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 98-10023 Filed 4-14-98; 8:45 am]
BILLING CODE 6560-50-F