[Federal Register Volume 74, Number 183 (Wednesday, September 23, 2009)]
[Rules and Regulations]
[Pages 48402-48408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22534]



40 CFR Part 180

[EPA-HQ-OPP-2008-0810; FRL-8434-2]

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: nollen.laura@epa.gov.


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 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.

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-

[[Page 48403]]

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 rabbits.
    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 

[[Page 48404]]

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

[[Page 48405]]

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

[[Page 48406]]

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 
greatest exposure.
    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 
already been

[[Page 48407]]

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.

V. Conclusion

    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 
U.S.C. 804(2).

[[Page 48408]]

List of Subjects in 40 CFR Part 180

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

    Dated: September 8, 2009.
Lois Rossi,
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
                                                    * * * * *
Date..................................................                                                      0.10
                                                    * * * * *
Nut, tree, group 14...................................                                                      0.10
                                                    * * * * *
Pistachio.............................................                                                      0.10
Pomegranate...........................................                                                      0.30
                                                    * * * * *

* * * * *

[FR Doc. E9-22534 Filed 9-22-09; 8:45 am]