[Federal Register Volume 74, Number 183 (Wednesday, September 23, 2009)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22534]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Spinosad; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
spinosad in or on date and pomegranate, and additionally increases
established tolerances in or on almond hulls; tree nut, group 14; and
pistachio. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
DATES: This regulation is effective September 23, 2009. Objections and
requests for hearings must be received on or before November 23, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0810. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; e-mail address: firstname.lastname@example.org.
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0810 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 as required by 40 CFR part 178
on or before November 23, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0810, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of December 3, 2008 (73 FR 73648) (FRL-
8391-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7445) by IR-4, 500 College Rd. East, Suite 201 W., Princeton, NJ
08540. The petition requested that 40 CFR 180.495 be amended by
establishing tolerances for residues of the insecticide, spinosad, a
fermentation product of Saccharopolyspora spinosa, consisting of two
related active ingredients: Spinosyn A (Factor A; CAS131929-
60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D;
CAS131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on pomegranate at
0.3 parts per million (ppm) and date at 0.1 ppm. The petition
additionally requested an increase in the existing tolerances for
residues of spinosad in or on tree nut, group 14 and pistachio from
0.02 to 0.08 ppm; and almond, hulls from 2.0 to 9.0 ppm. That notice
referenced a summary of the petition prepared on behalf of IR-4 by Dow
AgroSciences, LLC, the registrant, which is available to the public in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance levels for almond hulls; tree nut, group
14; and pistachio. The reason for these changes is explained in Unit
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 for the petitioned-for
tolerances for residues of spinosad on almond, hulls at 19 ppm; tree
nut, group 14 at 0.10 ppm; pistachio at 0.10 ppm; date at 0.10 ppm; and
pomegranate at 0.30 ppm. EPA's assessment of exposures and risks
associated with establishing tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
The existing spinosad data indicate that it possesses low acute
toxicity via the oral, dermal, and inhalation routes of exposure. It is
not a dermal irritant, dermal sensitizer or eye irritant. No dermal
toxicity was seen at the limit dose in a 21-day dermal toxicity study
In mice, rats, and dogs, the target organs appeared to be the
liver, kidney, spleen, heart, thyroid, and bone marrow (anemia). In the
mouse subchronic toxicity study, increased vacuolation of cells was
noted in the lymphoid organs, liver, kidney, stomach, female
reproductive tract and epididymis. A similar effect was seen in the
heart, lung, pancreas, adrenal cortex, bone marrow, tongue, pituitary
gland, and anemia but to a less severe degree. The rat subchronic
toxicity study showed evidence of thyroid follicle epithelial cell
vacuolation, anemia, multifocal hepatocellular granuloma,
cardiomyopathy, and splenic histiocytosis. Microscopic changes in a
variety of tissues, anemia and possible liver damage were seen in the
dog subchronic toxicity study. Additionally, long-term dietary
administration of spinosad resulted in increases in serum alanine
aminotransferase, aspartate aminotransferase and triglyceride levels.
Spinosad is classified as ``not likely to be carcinogenic to
humans'' based on the lack of evidence for carcinogenicity in mice and
rats. No evidence of neurotoxicity was seen in any of the submitted
studies, including the acute and subchronic neurotoxicity studies in
rats. Spinosad is negative for mutagenicity in various mutagenicity
No developmental effects were seen in the rat and rabbit
developmental toxicity studies. In a 2-generation reproduction study in
rats, decreased litter size, survival and body weights were observed in
the presence of maternal toxicity (deaths) at the highest dose tested
(HDT). In addition, male rats exhibited chronic active inflammation of
the prostate gland.
Specific information on the studies received and the nature of the
adverse effects caused by spinosad as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Spinosad and Spinetoram. Human-
Health Risk Assessment for Application of Spinosad to Date and
Pomegranate and Spinetoram to Pineapple, Date, Pomegranate, Hops, and
Spices (Crop Subgroup 19B, except black pepper)'' at pages 44-48 in
docket ID number EPA-HQ-OPP-2008-0810.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
The Agency has concluded that spinosad should be considered
toxicologically identical to another pesticide, spinetoram. This
is based on the following: (1) Spinetoram and spinosad are large
molecules with nearly identical structures; and (2) the toxicological
profiles for each are similar (generalized systemic toxicity) with
similar doses and endpoints chosen for human health risk assessment.
Spinosad and spinetoram should be considered toxicologically identical
in the same manner that metabolites are generally considered
toxicologically identical to the parent.
Although, as stated above, the doses and endpoints for spinosad and
spinetoram are similar, they are not identical due to variations in
dosing levels used in the spinetoram and spinosad toxicological
studies. EPA compared the spinosad and spinetoram doses and endpoints
for each exposure scenario and selected the lower of the two doses for
use in human risk assessment.
A summary of the toxicological endpoints for spinosad and
spinetoram used for human risk assessment can be found at http://www.regulations.gov in the document ``Spinosad and Spinetoram. Human-
Health Risk Assessment for Application of Spinosad to Date and
Pomegranate and Spinetoram to Pineapple, Date, Pomegranate, Hops, and
Spices (Crop Subgroup 19B, except black pepper)'' at pages 8 and 21 in
docket ID number EPA-HQ-OPP-2008-0810.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spinosad and spinetoram, EPA considered exposure under the
petitioned-for tolerances as well as all existing spinosad and
spinetoram tolerances in 40 CFR 180.495 and 180.635, respectively. EPA
assessed dietary exposures from spinosad and spinetoram in food as
i. Acute exposure. Quantitative acute dietary exposure and 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 such effects were
identified in the toxicological studies for spinosad and spinetoram;
therefore, a quantitative acute dietary exposure assessment is
ii. Chronic exposure. Spinosad and spinetoram are considered to be
toxicologically equivalent. However, as both products control the same
pest species, EPA concluded that it would overstate exposure to assume
that residues of both chemicals would appear on the same crop.
Therefore, the Agency aggregated exposure from residues of spinosad and
spinetoram by assuming that spinosad residues would be present in all
commodities, because side-by-side spinosad and spinetoram residue data
indicated that spinetoram residues were less than or equal to spinosad
In conducting the chronic dietary exposure assessment EPA used the
food consumption data from the U.S. Department of Agriculture (USDA)
1994-1996 and 1998 Continuing Survey of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed 100 percent crop
treated (PCT) for all food crop commodities; used average field trial
residues for apple, Brassica leafy vegetables, citrus, fruiting
vegetables, herbs, banana, and strawberry; used tolerance-level
residues for the remaining food crop commodities; and used Dietary
Exposure Evaluation Model (DEEM) default processing factors for all
commodities excluding orange juice, field corn (meal, starch, flour,
and oil), grape juice and wheat (flour and germ), where the results
from processing studies were used. Residues in livestock were refined
through the incorporation of a refined dietary burden (average feed
crop residues and combined spinosad and spinetoram PCT estimates) and
through the incorporation of average residues from the feeding and
dermal magnitude of the residue studies.
iii. Cancer. Based on the lack of evidence of carcinogenicity in
rats and mice, EPA has classified spinosad as ``not likely to be
carcinogenic to humans;'' therefore, a quantitative exposure assessment
to evaluate cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition A: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition B: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition C: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
EPA assumed 100 PCT for all food crop commodities. For certain feed
crop commodities, the Agency used combined spinosad and spinetoram
projected PCT (PPCT) information to calculate beef and dairy cattle
burdens as follows:
Sweet corn forage (39%); leaves of root and tuber vegetables (50%);
sorghum grain (5%); and soybean seed meal (5%).
Spinetoram is a recently registered pesticide. EPA estimates an
upper bound of PPCT for a new pesticide use by assuming that its actual
PCT during the initial 5 years of use on a specific use site will not
exceed the recent PCT of the market leader (i.e., the one with the
greatest PCT) on that site. EPA calls this the market leader PPCT
estimate. In this specific case, the new use to be estimated is the
combined use of spinosad together with that of spinetoram, since most
new uses of spinetoram will likely replace a previous use of spinosad.
An average market leader PCT, based on three recent surveys of
pesticide usage, if available, is used for chronic risk assessment. The
average market leader PCT may be based on one or two survey years if
three are not available. Also, with limited availability of data, the
average market leader PCT may be based on a cross-section of state
PCTs. Comparisons are only made among pesticides of the same pesticide
type (i.e., the leading insecticide on the use site is selected for
comparison with the new insecticide), or, for refined estimates, among
pesticides targeting the same pests. The market leader PCTs are used to
determine the average for the same pesticide or for different
pesticides for any year since the same or different pesticides may
dominate for each year. Typically, EPA uses U.S. Department of
Agriculture/National Agricultural Statistics Service (USDA/NASS) as the
source for raw PCT data because it is publicly available. When a
specific use site is not surveyed by USDA/NASS, EPA uses other sources
including proprietary data.
An estimated PPCT, based on the average PCT of the market leaders,
is appropriate for use in chronic dietary risk assessment. This method
of estimating PPCT for a new use of a registered pesticide or a new
pesticide produces a high-end estimate that is unlikely, in most cases,
to be exceeded during the initial 5 years of actual use. Predominant
factors that bear on whether the PPCT could be exceeded may include
PCTs of similar chemistries, pests controlled by alternatives, pest
prevalence in the market and other factors. All relevant information
currently available for predominant factors has been considered for the
combined use of spinetoram and spinosad on each of these several crops.
It is the Agency's opinion that it is unlikely that actual combined
PCTs for spinetoram and spinosad will exceed the corresponding
estimated PPCTs during the next 5 years.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions B and C, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which spinosad may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spinosad and spinetoram in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of spinosad and spinetoram. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of spinosad for surface
water are estimated to be 34.5 parts per billion (ppb) for acute
exposures, and 10.5 ppb for chronic exposures. For ground water, the
estimated drinking water concentration is 1.1 ppb.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. As explained above, an acute
dietary risk assessment was not conducted for spinosad and spinetoram.
For chronic dietary risk assessment, the water concentration of value
10.5 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
The Agency has concluded that spinosad and spinetoram are
toxicologically equivalent; therefore, residential exposure to both
spinosad and spinetoram was evaluated. Spinosad is currently registered
for homeowner application to turf grass and ornamentals and spinetoram
is registered for homeowner applications to gardens, lawns/ornamentals
and turf grass.
There is potential for residential handler and postapplication
exposures to both spinosad and spinetoram. Since spinosad and
spinetoram control the same pests, EPA concluded that these products
will not be used in combination with each other and combining the
residential exposures is unnecessary. Short-term residential inhalation
risks were estimated for adult residential handlers, as well as short-
term postapplication incidental oral risks (hand-to-mouth, object-to-
mouth and soil ingestion) for toddlers, based on applications to home
lawns, home gardens and ornamentals. Dermal exposures were not
assessed, since no dermal endpoints of concern were identified in the
toxicology studies for spinosad and spinetoram.
In addition, a registered fruit fly bait application scenario
permits application to non-crop vegetation, which may result in
residential exposures to spinosad. Based on the application rates, EPA
concluded that residential exposure resulting from this scenario would
be insignificant when compared to the residential exposure resulting
from the turf/ornamental application scenarios; therefore, a
quantitative analysis of residential exposure resulting from the fruit
fly bait application scenario is unnecessary and was not performed.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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 has not found spinosad and spinetoram to share a common
mechanism of toxicity with any other substances, and spinosad and
spinetoram do not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that spinosad and spinetoram do not have 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
EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
2. Prenatal and postnatal sensitivity. The following acceptable
studies are available for both spinosad and spinoteram: Developmental
toxicity studies in rats and rabbits and a 2-generation reproduction
study in rats. There is no evidence of increased susceptibility of rat
or rabbit fetuses to
in utero exposure to spinosad or spinetoram. In the spinosad and
spinetoram rat and rabbit developmental toxicity studies, no
developmental toxicity was observed at dose levels that induced
maternal toxicity. In the spinosad 2-generation rat reproduction study,
maternal and offspring toxicity were equally severe, indicating no
evidence of increased susceptibility. In the spinetoram 2-generation
rat reproduction study, no adverse effects were observed in the
offspring at dose levels that produced parental toxicity. Therefore,
there is no evidence of increased susceptibility and there are no
concerns or residual uncertainties for prenatal and/or postnatal
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
i. The toxicity database for spinosad is complete, except for
immunotoxicity testing. Recent changes to 40 CFR part 158 make
immunotoxicity testing (OPPTS Guideline 870.7800) required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA.
There was some evidence of adverse effects on the organs of the
immune system at the LOAEL in three short-term studies with spinosad or
spinetoram. In these studies, anemia was observed in multiple species
(rats, mice and dogs) with the presence of histiocytic aggregates of
macrophages in various organs and tissues (lymph nodes, spleen, thymus,
and bone marrow). Aggregation of macrophages was indicative of immune
stimulation in response to insults of the chemical exposure and was
considered secondary effects of the toxic effect to the hematopoetic
system. Therefore, these effects are not considered to be indicative of
frank immunotoxicity. In the spinetoram chronic toxicity study in dogs,
areteritis and necrosis of the areterial walls of the thymus was seen
in one female dog at the HDT. This finding is attributed to the
exacerbation of the spontaneous arteritis present in genetically
predisposed Beagle dogs (``Beagle Pain Syndrome''), not immunotoxicity.
Further, a clear NOAEL was attained in each of these studies, and the
observed histopathologies were generally observed in the presence of
other organ toxicity. In addition, spinosad and spinetoram do not
belong to a class of chemicals (e.g., the organotins, heavy metals, or
halogenated aromatic hydrocarbons) that would be expected to be
Based on the above considerations, EPA does not believe that
conducting a special series OPPTS Guideline 870.7800 immunotoxicity
study will result in a POD less than the NOAEL of 2.49 miligrams/
kilograms/day (mg/kg/day) already set for spinosad and spinetoram.
Consequently, an additional database uncertainty factor does not need
to be applied.
ii. There is no indication that spinosad and spinetoram are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that spinosad and spinetoram result in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on tolerance-level residues or reliable data from field trial studies
and 100 PCT for all registered and proposed commodities except certain
feed crop commodities. The PPCT estimates used to refine certain feed
crop estimates provide conservative, high-end estimates developed using
the market leader approach that are unlikely to be exceeded.
Conservative ground and surface water modeling estimates were used to
assess exposure to spinosad and spinetoram in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
spinosad and spinetoram.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
spinosad and spinetoram are not expected to pose an acute risk.
2. Chronic risk. Based on the explanation in Unit III.C.3.,
regarding residential use patterns, chronic residential exposure to
residues of spinosad and spinetoram are not expected; therefore, the
chronic aggregate exposure assessment consists of exposures from food
and water only. Using the exposure assumptions described in this unit
for chronic exposure, EPA has concluded that chronic exposure to
spinosad and spinetoram from food and water will utilize 95% of the
cPAD for children 1 to 2 years old, the population group receiving the
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Spinosad and spinetoram are currently registered for uses that
could result in short-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to spinosad and
spinetoram. Using the exposure assumptions described in this unit for
short-term exposures, EPA has concluded the combined short-term food,
water, and residential exposures aggregated result in aggregate MOEs of
greater than or equal to 160 for all population subgroups. As the
aggregate MOEs are greater than 100 for all population subgroups,
including infants and children, short-term aggregate exposure to
spinosad and spinetoram is not of concern to EPA.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Spinosad and spinetoram are not registered for any use patterns
that would result in intermediate-term residential exposure. Therefore,
the intermediate-term aggregate risk is the sum of the risk from
exposure to spinosad and spinetoram through food and water, which has
addressed, and will not be greater than the chronic aggregate risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats at doses that were judged
to be adequate to assess the carcinogenic potential, spinosad and
spinetoram were classified as ``not likely to be carcinogenic to
humans,'' and are not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to spinosad and spinetoram residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Method RES 94025, GRM 94.02 (a high performance liquid
chromatography method with ultraviolet absorption detection (HPLC/UV))
has been adequately validated and determined to be acceptable to
enforce the tolerance expression in plant commodities. In addition, the
following additional methods (which are essentially similar to GRM
94.02) have been submitted for other crop matrices: GRM 95.17 for leafy
vegetables; GRM 96.09 for citrus; GRM 96.14 for tree nuts; GRM 95.04
for fruiting vegetables; and GRM 94.02.S1 for cotton gin byproducts.
These methods have been forwarded to the Food and Drug Administration
(FDA) for inclusion in Pesticide Analytical Methods Volume II (PAM II).
These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; e-mail address:
B. International Residue Limits
There are currently no Canadian maximum residue limits (MRLs)
established for residues of spinosad in or on the crops associated with
this review. Codex MRLs exist for spinosad on almond hull (2 ppm) and
almond nutmeat (0.01 ppm). These MRLs are based on field trial data
which employed a 14-day pre-harvest interval (PHI), while the U.S.
almond hull (19 ppm) and tree nut (0.10 ppm) tolerances are based on a
1-day PHI. Since the U.S. and Codex tolerances are based on different
application scenarios and since the U.S. tolerances are significantly
greater (10x) than those currently established by Codex, harmonization
is not possible.
C. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition, EPA revised
tolerances for certain proposed commodities as follows: almond, hulls
from 9.0 ppm to 19 ppm; nut, tree, group 14 from 0.08 ppm to 0.10 ppm;
and pistachio from 0.08 ppm to 0.10 ppm. EPA revised the tolerance
levels based on analysis of the residue field trial data using the
Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance
for Setting Pesticide Tolerances Based on Field Trial Data.
Therefore, tolerances are established for residues of spinosad,
consisting of two related active ingredients: Spinosyn A (Factor A;
CAS131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-
dione; and Spinosyn D (Factor D; CAS131929-63-0) or 2-[(6-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on almond, hulls at
19 ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; date at
0.10 ppm; and pomegranate at 0.30 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
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). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: September 8, 2009.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.495 is amended in paragraph (a) by revising the entries
in the table for ``Almond, hulls''; ``Nut, tree, group 14'' and
``Pistachio''; and by alphabetically adding entries for ``Date'' and
``Pomegranate'' to the table to read as follows:
180.495 Spinosad; tolerances for residues.
(a) * * *
Commodity Parts per million
* * * * *
Almond, hulls......................................... 19
* * * * *
* * * * *
Nut, tree, group 14................................... 0.10
* * * * *
* * * * *
* * * * *
[FR Doc. E9-22534 Filed 9-22-09; 8:45 am]
BILLING CODE 6560-50-S