[Federal Register Volume 75, Number 189 (Thursday, September 30, 2010)]
[Rules and Regulations]
[Pages 60321-60327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24573]



40 CFR Part 180

[EPA-HQ-OPP-2009-0616; FRL-8844-1]

Spinosad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation revises tolerances for residues of spinosad in 
or on hog, fat; hog, meat; hog, meat byproducts; poultry meat 
byproducts. Elanco Animal Health (A Division of Eli Lilly & Company) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective September 30, 2010. Objections and 
requests for hearings must be received on or before November 29, 2010, 
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-2009-0616. 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: Samantha Hulkower, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 603-0683; e-mail address: 
[email protected].


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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 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-2009-0616 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
November 29, 2010. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2

[[Page 60322]]

may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0616, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of October 26, 2009 (74 FR 55003) (FRL-
8794-2), 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 
9F7543) by Elanco Animal Health (A Division of Eli Lilly & Company), 
2001 West Main Street, Greenfield, IN 46140. The petition requested 
that 40 CFR 180.495 be amended by reducing established tolerances for 
residues of the insecticide spinosad, a fermentation product of 
Saccharopolyspora spinosa, which consists of two related active 
ingredients: Spinosyn A (Factor A: CAS No. 131929-60-7) or 2-[(6-deoxy-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; 
CAS No. 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-a-L-manno-
4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on 
milk from 7 parts per million (ppm) to 5 ppm; milk, fat from 80 ppm to 
40 ppm; cattle, goat, and sheep, fat from 50 ppm to 30 ppm; hog, meat 
from 1.5 ppm to 0.2 ppm; hog, meat byproducts from 8 ppm to 0.6 ppm; 
and hog, fat from 33 ppm to 2.0 ppm. The petition additionally 
requested increases in the existing tolerances for residues of spinosad 
in or on poultry meat byproducts from 0.1 ppm to 0.2 ppm and poultry, 
fat from 1.3 ppm to 1.5 ppm. That notice referenced a summary of the 
petition prepared by Elanco Animal Health, the registrant, which is 
available 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 
concluded that revision of the proposed tolerances in or on hog, fat 
from 2.0 ppm to 5.0 ppm; hog, meat from 0.2 ppm to 0.50 ppm; hog, meat 
byproducts from 0.6 ppm to 2.0 ppm; poultry, meat byproducts from 0.10 
ppm to 0.20 ppm is necessary and revision of the currently-established 
ruminant fat (i.e., cattle, goat, and sheep) and poultry, fat 
tolerances, as proposed by Elanco Animal Health in the petition, is 
unnecessary. The reason for these changes are explained in Unit IV.D.

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 
    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 spinosad including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with spinosad 

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. Spinosad has low acute toxicity via the oral and dermal 
routes of exposure. It is not a dermal sensitizer, nor inhalation, 
primary eye, or primary skin irritant. In subchronic toxicity studies 
conducted in mice treatment-related findings included vacuolation of 
cells of the lymphoid organs, liver, kidney, stomach, female 
reproductive tract, and epididymis, and less severely in the heart, 
lung, pancreas, adrenal cortex, bone marrow, tongue, pituitary gland, 
and anemia. In rats, thyroid follicle epithelial cell vacuolation, 
anemia, multifocal hepatocellular granuloma, cardiomyopathy, and 
splenic histiocytosis were observed following subchronic exposure, in 
dogs microscopic changes in a variety of tissues, anemia, and possible 
liver damage were seen with short-term repeated dosing. In a chronic 
feeding study in dogs, increases in serum alanine aminotransferase, 
aspartate aminotransferase, and triglycerides levels, and the presence 
of tissue abnormalities, including vacuolated cell aggregations, 
arteritis, and glandular cell vacuolation (parathyroid) were seen. 
Vacuolation of thyroid follicular cells, increased absolute and 
relative thyroid weights were observed in a chronic oral toxicity study 
in rats. Spinosad is classified as ``not likely to be carcinogenic to 
humans'' based on lack of evidence for carcinogenicity of spinosad in 
mice and rats. No neurotoxic effects were seen in the acute or 
subchronic neurotoxicity study in rats. In developmental toxicity 
studies, there is no evidence of increased susceptibility following in 
utero exposures in rats and rabbits. In the 2-generation reproduction 
study, no adverse effects were observed on the offspring at dose levels 
that produced parental toxicity.
    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 document ``Spinosad and Spinetoram. Human-Health 
Risk Assessment for Direct-Spray

[[Page 60323]]

Use on Poultry and Discontinuation by Voluntary Cancellation of the 
Cattle Pour-On and Direct Cattle Spray Registrations,'' p. 12 in docket 
ID number EPA-HQ-OPP-2009-0616.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors (U/SF) are used in conjunction 
with the POD to calculate a safe exposure level - generally referred to 
as a population-adjusted dose (PAD) or a reference dose (RfD) - and a 
safe margin of exposure (MOE). 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 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.
    A summary of the toxicological endpoints for spinosad used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Spinosad and Spinetoram. Human-Health Risk Assessment for 
Direct-Spray Use on Poultry and Discontinuation by Voluntary 
Cancellation of the Cattle Pour-On and Direct Cattle Spray 
Registrations,'' p. 5 in docket ID number EPA-HQ-OPP-2009-0616.
    The Agency has concluded that spinosad should be considered 
toxicologically identical to another pesticide, spinetoram. This 
conclusion is based on the following: Spinetoram and spinosad are large 
molecules with nearly identical structures; and 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 just stated, 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.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spinosad/spinetoram, EPA considered exposure under the 
petitioned-for tolerances as well as all existing spinosad/spinetoram 
tolerances in 40 CFR 180.495 and 180.635. EPA assessed dietary 
exposures from spinosad in food as follows:
    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; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
the chronic analysis assumed 100 percent crop treated (PCT) for all 
food crop commodities excluding those listed below where PCT estimates 
were incorporated to refine the livestock dietary burden estimates; 
used average field-trial residues for apple, Brassica leafy vegetables, 
citrus, fruiting vegetables, herbs, banana, grape, several cereal 
grains, and strawberry; used tolerance-level residues for the remaining 
food crop commodities; and used Dietary Exposure Evaluation Model 
DEEM(\TM\) (ver. 7.81) 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 factors were assumed; and modeled drinking water estimates. 
Tolerance level hog and poultry residues were assumed while the 
ruminant residue estimates were refined through the incorporation of 
average residues from the feeding/dermal magnitude of the residue 
studies and incorporation of the following projected combined spinosad/
spinetoram PCT estimates to refine the ruminant dietary burden: Leaves 
of root and tuber vegetables - 50%; grain sorghum grain - 5%; soybean 
seed - 5%; and sweet corn forage - 39%.
    Spinosad is registered for application to all of the same crops as 
spinetoram, with similar pre-harvest and retreatment intervals, and 
application rates greater than or equal to spinetoram. Further, both 
products control the same pest species. For this reason, EPA concluded 
it would overstate exposure to assume that residues of both spinosad 
and spinetoram would appear on the same food. Rather, EPA aggregated 
exposure by either assuming that all commodities contain spinosad 
residues (because side-by-side spinetoram and spinosad residue data 
indicated that spinetoram residues were less than or equal to spinosad 
residues) or summing the percentage of a crop that would be treated 
with spinosad and the percentage that would be treated with spinetoram.
    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 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

[[Page 60324]]

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.
    Tolerance level hog and poultry residues were assumed while the 
ruminant residue estimates were refined through the incorporation of 
average residues from the feeding/dermal magnitude of the residue 
studies and incorporation of the following projected combined spinosad/
spinetoram PCT estimates to refine the ruminant dietary burden uses as 
follows: 39% sweet corn forage; 50% leaves of root and tuber 
vegetables; 5% sorghum grain; and 5% soybean seed meal.
    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (USDA/NASS), proprietary market 
surveys, and the National Pesticide Use Database for the chemical/crop 
combination for the most recent 6-7 years. EPA uses an average PCT for 
chronic dietary risk analysis. The average PCT figure for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding to 
the nearest 5%, except for those situations in which the average PCT is 
less than one. In those cases, 1% is used as the average PCT and 2.5% 
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the highest observed maximum 
value reported within the recent 6 years of available public and 
private market survey data for the existing use and rounded up to the 
nearest multiple of 5%.
    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 in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of spinosad. Further information regarding EPA drinking 
water models used in pesticide exposure assessment can be found at 
    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/spinetoram 
for acute exposures are estimated to be 14.419 parts per billion (ppb) 
for surface water and 0.072 ppb for ground water. For chronic exposures 
for non-cancer assessments are estimated to be 6.171 ppb for surface 
water and 0.072 ppb for ground water. EDWCs for spinosad for acute 
exposures are estimated to be 34.5 parts per billion (ppb) for surface 
water and 1.1 ppb for ground water. For chronic exposures for non-
cancer assessments are estimated to be 10.5 ppb for surface water and 
1.1 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. 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).
    Spinosad is currently registered for the following uses that could 
result in residential exposures: Application to turfgrass and 
ornamentals. EPA assessed residential exposure using the following 
assumptions: 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. Spinetoram is 
registered for homeowner applications to gardens, lawns/ornamentals and 
turf grass. Since spinosad and spinetoram control the same pests, EPA 
concludes that these products will not be used for the same uses in 
combination with each other and thus combining spinosad and spinetoram 
residential exposures would overstate exposure.
    There is potential for residential handler and post-application 
exposures to both spinosad and spinetoram. However, since no dermal 
endpoints for either spinetoram or spinosad were identified, only 
short-term incidental oral exposures to toddlers are anticipated from 
the registered turf and ornamental application scenarios for spinosad 
and spinetoram and short-term inhalation exposure to handler/
applicators is anticipated for the registered home garden, turf, and 
ornamental application scenarios.
    Based on the low application rates, granular formulation, and/or 
low vapor pressure, quantitative residential inhalation post-
application exposure assessments were not performed for spinosad or 
spinetoram. The Agency notes that the spinetoram residential-handler 
inhalation MOEs were >=4,300,000 for house garden, home lawns and 
ornamental use; based on this and the low vapor pressure for spinosad, 
the Agency anticipates the post-application residential inhalation 
risks to be negligible.
     EPA notes that for spinosad the registered fruit fly bait 
application scenario permits application to non-crop vegetation and 
this use may result in residential exposures. Based on the application 
rates (fruit fly bait - 0.0003 pounds active ingredients/acre (lb ai/
acre); turf/ornamental - 0.41 lbs ai/acre), EPA concludes that 
residential exposure resulting from the fruit fly application will be 
insignificant when compared to the exposure resulting from homeowner 
uses on the turf/ornamentals. Therefore, quantitative analysis of the 
residential exposure resulting from the fruit fly bait application was 
not performed. Further information regarding EPA standard assumptions 
and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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

[[Page 60325]]

pesticide's residues and ``other substances that have a common 
mechanism of toxicity.''
     EPA has not found spinosad/spinetoram to share a common mechanism 
of toxicity with any other substances, and spinosad/spinetoram does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
spinosad/spinetoram does 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 Food Quality 
Protection Act (FQPA) SF. In applying this provision, EPA either 
retains the default value of 10X, or uses a different additional SF 
when reliable data available to EPA support the choice of a different 
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat and 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 did not induce maternal toxicity. In the 
spinosad 2-generation reproduction studies, maternal and offspring 
toxicity were equally severe, indicating no evidence of increased 
susceptibility. In the spinetoram 2-generation reproduction study, no 
adverse effects were observed on 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 pre-natal and/or post-natal toxicity.
    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 spinetoram is complete, except for 
immunotoxicity testing. Recent changes to 40 CFR part 158 make 
immunotoxicity testing (OPPTS Harmonized Test Guideline 870.7800) 
required for pesticide registration; however, the existing data are 
sufficient for endpoint selection for exposure/risk assessment 
scenarios, and for valuation 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 chronic study with dogs, areteritis and 
necrosis of the areterial walls of the thymus was seen in one female 
dog at the highest dose tested (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 considerations in this Unit, EPA does not believe that 
conducting a special series 870.7800 immunotoxicity study will result 
in a POD less than the NOAEL of 2.49 mg/kg/day already set for spinosad 
and spinetoram. Consequently, an additional database UF does not need 
to be applied.
    ii. There is no indication that spinosad is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that spinosad results 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 utilized 100 PCT and 
tolerance-level residues, and DEEM\TM\ default processing factors for 
all registered and proposed crop commodities and all food commodities 
from livestock except commodities from ruminants. EPA used PCT 
information when calculating livestock dietary burdens for ruminants 
from sweet corn forage, leaves of root and tuber vegetables, sorghum 
grain, and soybean seed meal. EPA believes that the PCT estimates used 
are conservative estimates. EPA made conservative (protective) 
assumptions in the ground water and surface water modeling used to 
assess exposure to spinosad/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 

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from 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 is not expected to pose an acute risk.
    2. Chronic risk. Since there are no registered/proposed uses which 
result in chronic residential exposures, the chronic aggregate exposure 
assessment consists of exposure from food and water. 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 94% of the cPAD for children 1-2 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

[[Page 60326]]

(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 
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of >=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 the 
exposure to spinosad and spinetoram through food and water, which has 
already been 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 rats and mice 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

    Adequate methods are available for enforcement of the ruminant and 
hog tolerances. Method RES 94094 (GRM 95.03; ruminant and hog); Method 
RES 95114 (ruminant and hog); GRM 95.15 (poultry). Data pertaining to 
Multiresidue Methods (MRMs) testing of spinosyns A, D, B, and K and N-
demethyl spinosyn D were forwarded to the Food and Drug Administration 
(FDA) for review.
     The method 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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Codex does have a MRLs for combined residues of spinosyn A and D 
in/on fat from mammals other than marine at 2 ppm and edible offal at 
0.5 ppm and Canada does have MRLs for residues of spinosyn A and D in/
on hog fat at 5.0 ppm, hog meat byproducts at 1.0 ppm, and hog meat at 
0.2 ppm. For the most part, these international tolerances are lower 
than the level of the hog tolerances being established today. The Codex 
values were set in 2004. At that time only the diets of cattle (beef 
and dairy) were considered in establishing the MRLs, which were then 
considered adequate for all mammals, including hogs. However, the 
United States calculates hog exposure based on specific diets for 
finishing and breeder hogs. These diets are high in grains and grain 
byproducts and would not have included forages and other commodities 
present in the cattle diet. The diets considered were different, 
leading to different calculated exposures, leading to different MRL/
tolerance estimates for the hog commodities. Accordingly, given the 
manner in which the Codex values were chosen, EPA does not believe it 
is appropriate to harmonize with the Codex levels.

C. Revisions to Petitioned-For Tolerances

    Elanco Animal Health requested registration for direct spray of 
Elector PSP (EPA Reg. No. 72642-2) to poultry and discontinuation by 
voluntary cancellation of the cattle pour-on and direct cattle spray 
registrations for Elector Insect Control Product (EPA Reg. No. 72642-
1). The petitioner also requested an increase in the currently-
established poultry fat (1.3 ppm to 1.5 ppm), poultry meat (0.10 ppm to 
0.2 ppm), and poultry meat byproducts (0.10 ppm to 0.2 ppm) tolerances 
and a decrease in the currently-established milk (7.0 ppm to 5 ppm), 
milk fat (85 ppm to 40 ppm), hog fat (33 ppm to 2.0 ppm), hog meat (1.5 
ppm to 0.2 ppm), hog meat byproducts (8.0 ppm to 0.6 ppm), and ruminant 
fat (cattle, goat, and sheep - 50 ppm to 30 ppm) tolerances (tolerances 
for combined residues of spinosyns A and D).
    With the elimination of cattle pour-on and direct cattle spray 
uses, ruminants may be exposed to spinosad via consumption of treated 
feed, premise application, and through the feed-through (cattle only) 
and ear tag uses (cattle only). Based on the elimination of the cattle 
dermal application scenario and a recalculation of spinosad residues in 
ruminant commodities from the consumption of treated feed, the 
petitioner requested a reduction in the milk, milk fat, and ruminant 
(cattle, goat, and sheep) fat tolerances. Based on a comparison of the 
estimated total residue without the dermal/premise application and the 
currently-established tolerances, the EPA concludes that revision of 
the currently-established ruminant tolerances is unnecessary. Since 
elimination of the dermal uses does not necessitate a change in the 
current ruminant tolerances, the EPA concludes that residues resulting 
from premise treated are insignificant when compared to the residue 
estimates from the other routes of exposure.
    The petitioner requested a reduction in the hog fat, meat, and meat 
byproducts tolerances. The current hog tolerances were established as 
part of the registration for application of spinosad to stored grains 
where a hog dietary burden of 41.2 ppm was calculated. As a 
conservative surrogate for residues following premise treatment, the 
results from the cattle dermal magnitude of the residue study were used 
(residue data following only premise treatment are not available). EPA 
notes that hogs have a significantly lower maximum reasonably balanced 
dietary burden (MRDB) than ruminants and the residues resulting from 
the premise treatment were therefore considered when establishing a 
tolerance (this is on contrast to ruminants where residues resulting 
from premise treatment were not

[[Page 60327]]

considered). Based on these calculations, the EPA concludes that hog 
tolerance should be lowered as follows: Hog, meat - 0.50 ppm; hog, fat 
- 5.0 ppm; and hog, meat byproducts - 2.0 ppm.
    As part of the current request, the petitioner submitted a poultry 
magnitude of the residue study monitoring spinosad residues following 
both the proposed dermal application scenario (0.9x) and the currently-
registered premise treatment (1x). Based on these data and the current 
poultry MRDB, the EPA concludes that the poultry meat byproducts 
tolerance should be increased to 0.20 ppm (tolerance for the combined 
residues of spinosyns A and D). All other poultry tolerances remain 

V. Conclusion

    Therefore, tolerances are established for residues of spinosad in 
or on poultry at 0.20 ppm poultry, meat byproducts; and tolerances are 
increased as indicated for the following established commodities: Hog, 
fat 5.0 ppm; hog, meat 0.50 ppm; hog, meat byproducts 2.0 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).

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 24, 2010.
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 by revising the following entries in the 
table in paragraph (a) to read as follows:

Sec.  180.495  Spinosad; tolerances for residues.

    (a) * * *

                      Commodity                        Parts per million
                                * * * * *
Hog, fat.............................................                5.0
Hog, meat byproducts.................................                2.0
Hog, meat............................................               0.50
                                * * * * *
Poultry, meat byproducts.............................               0.20
                                * * * * *

* * * * *

[FR Doc. 2010-24573 Filed 9-29-10; 8:45 am]