
[Federal Register: August 13, 2009 (Volume 74, Number 155)]
[Rules and Regulations]               
[Page 40753-40760]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au09-11]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0805; FRL-8426-9]

 
Spinetoram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerances for the combined 
residues of spinetoram in or on almond, hulls; nut, tree, group 14; and 
pistachio and establishes tolerances for date; pomegranate; pineapple; 
pineapple, processed residue; spice, subgroup 19B, except black pepper; 
and hop, dried cones. The Interregional Research Project Number 4 (IR-
4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 13, 2009. Objections and 
requests for hearings must be received on or before October 13, 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-2008-0805. 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) 
305-5805.

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: 
hulkower.samantha@epa.gov.

SUPPLEMENTARY INFORMATION:

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 
INFORMATION CONTACT.

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://

[[Page 40754]]

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-2008-0805 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 October 13, 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-2008-0805, 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 
8E7450) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201 W., Princeton, NJ 08540. The petition 
requested that 40 CFR 180.635 be amended by establishing tolerances for 
residues of the insecticide spinetoram, expressed as a combination of:
    XDE-175-J: 1-H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-
ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-
methyl-,(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR);
    XDE-175-L: 1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-
ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-
dimethyl-, (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS);
    ND-J:(2R,3aR,5aR,5bS,9S,13S, 14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and
    NF-J: (2R,3S,6S)-6-([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-
14-methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-
methyltetrahydro-2H-pyran-3-yl(methyl)formamide
in or on the raw agricultural commodities pineapple at 0.02 parts per 
million (ppm); pomegranate at 0.3 ppm; date at 0.1 ppm; spice, subgroup 
19B, except black pepper at 1.7 ppm; hop, dried cones at 22 ppm; and 
pineapple, process residue at 0.08 ppm. Additionally, the petition 
proposed to increase the levels of existing tolerances for nut, tree, 
group 14 and pistachio from 0.04 to 0.08 ppm and almond, hulls from 2.0 
ppm 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 tolerances to higher levels than proposed for almond, hulls; 
nut, tree, group 14; pistachio; pineapple; and pineapple, process 
residue. 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 
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 combined residues of spinetoram on almond, hulls at 19 
ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; date at 
0.10 ppm; pomegranate at 0.30 ppm; pineapple at 0.04 ppm; pineapple, 
processed residue at 0.15 ppm; spice, subgroup 19B, except black pepper 
at 1.7 ppm; and hop, dried cones at 22 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 
children.
    Spinetoram has low acute toxicity via the oral, dermal and 
inhalation routes of exposure. It is a dermal sensitizer but not an eye 
or dermal irritant. In subchronic toxicity studies conducted in rats, 
mice and dogs, spinetoram produces multi-organ toxicity. Treatment had 
no adverse effects on

[[Page 40755]]

survival but decreases in body weight, body weight gain and/or food 
consumption were observed in all three species. Treatment-related 
findings included the presence of a mild anemia, alterations in 
clinical chemistry parameters, increased liver weights, presence of 
histiocytic aggregates of macrophages in various organs and tissues, 
and degeneration with regeneration of the kidney tubules. Dogs appear 
to be the most sensitive species. In the subchronic study with dogs, 
lower thymus weights, atrophy of the thymic cortex, arteritis and/or 
perivascular inflammation in numerous organs with necrosis of the bone 
marrow leading to regenerative anemia was seen. In the chronic study 
with dogs, there were no treatment-related effects on survival, body 
weight, hematology, clinical chemistry or gross pathology. Treatment-
related changes were limited to arteritis and necrosis of the arterial 
walls of the epididymides in males and thymus, thyroid, larynx, and 
urinary bladder in females. It is postulated that chronic treatment 
exacerbated the spontaneous arteritis in genetically predisposed Beagle 
dogs (it is called the ``Beagle Pain Syndrome''). 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. EPA has concluded that 
spinetoram is toxicologically identical to another pesticide, spinosad. 
Based on the structural similarity of spinetoram and spinosad and the 
similarity of the toxicological database for the currently available 
studies, spinetoram is classified as ``not likely to be carcinogenic to 
humans'' based on lack of evidence for carcinogenicity of spinosad in 
mice and rats. No indication of neurotoxicity was observed in the acute 
neurotoxicity screening battery in rats, or in the subchronic and 
chronic toxicity studies conducted on spinetoram. All the mutagenicity 
studies conducted on spinetoram were negative. The no-observed-adverse-
effect-level (NOAEL) derived from the chronic dog study is well 
characterized, and together with the traditional uncertainty/safety 
factors will provide adequate protection for effects observed in 
laboratory animals. Specific information on the studies received and 
the nature of the adverse effects caused by spinetoram as well as the 
NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the 
toxicity studies can be found at http://www.regulations.gov in document 
Human Health Risk Assessment for Application of spinosad to date and 
pomegranate and spinetoram to pineapple, date, pomegranate, hopes, and 
spices (crop subgroup 19B, except black pepper) on page 4 and 
attachment 3 pages 49-54 in docket ID number EPA-HQ-OPP-2008-0805.

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 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 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 spinetoram/spinosad 
used for human risk assessment can be found at http://
www.regulations.gov in the document Human Health Risk Assessment for 
Application of spinosad to date and pomegranate and spinetoram to 
pineapple, date, pomegranate, hopes, and spices (crop subgroup 19B, 
except black pepper) on page 8 in docket ID number EPA-HQ-OPP-2008-
0805.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spinetoram/spinosad, EPA considered exposure under the 
petitioned-for tolerances as well as all existing spinetoram/spinosad 
tolerances in 40 CFR 180.635. EPA assessed dietary exposures from 
spinetoram/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 
spinetoram/spinosad; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. 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 has 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-

[[Page 40756]]

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.
    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 Surveys of Food Intakes by Individuals 
(CSFII). As to residue levels in food, the chronic analysis assumed 
100% crop treated for all food crop commodities; average field-trial 
residues for apple, Brassica leafy vegetables, citrus, fruiting 
vegetables, herbs, banana, and strawberry; tolerance-level residues for 
the remaining food crop commodities; 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 spinosad processing factors were assumed. Residues in 
livestock were refined through the incorporation of a refined dietary 
burden (average feed-crop residues and percent crop treated estimates) 
and through the incorporation of average residues from the feeding and 
dermal magnitude of the residue studies.
    iii. Cancer. Spinetoram is considered to be ``not likely to be a 
carcinogen to humans'' based on its similarity to another spynosin 
pesticide, spinosad. Preliminary results of a carcinogenicity study in 
mice indicate that spinetoram is not carcinogenic to mice at doses up 
to 37.5 milligram/kilogram/day (mg/kg/day). Consequently, a 
quantitative cancer exposure and risk assessment is not appropriate for 
spinetoram.
    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.
    The EPA assumed 100% crop treated for all food crop commodities; 
however, in calculating beef and dairy cattle dietary burdens, the 
Agency used combined spinosad and spinetoram projected percent crop 
treated (PPCT) information as follows:
    39% sweet corn forage.
    50% leaves of root and tuber vegetables.
    5% sorghum grain.
    5% soybean seed meal.
    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 average 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 use of spinetoram will likely replace 
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 used to determine the average may consist of PCTs 
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 USDA/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 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. 
Of greatest relevance here is that both spinosad and spinetoram control 
a relatively narrow range of pests compared to the market leaders. 
Based on this analysis, EPA believes 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 spinetoram may be applied in a particular area.

[[Page 40757]]

    2. Dietary exposure from drinking water.The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for spinetoram/spinosad in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of spinetoram/spinosad. 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 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 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).
    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. No dermal endpoints for either spinetoram or spinosad were 
identified. Therefore, only short-term incidental oral exposures to 
toddlers were evaluated for the registered turf and ornamental 
application scenarios for spinosad and spinetoram and short-term 
inhalation exposure to handler/applicators for the registered home 
garden, turf, and ornamental application scenarios.
    There is potential for residential handler and post-application 
exposures to both spinosad and spinetoram. 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. Short-term residential inhalation risks were 
estimated for adult residential handlers, as well as short-term post-
application incidental oral risks for toddlers, based on applications 
to home lawns, home gardens and ornamentals.
    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 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.
    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 spinetoram/spinosad to share a common mechanism 
of toxicity with any other substances, and spinetoram/spinosad does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
spinetoram/spinosad 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 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 
factor.
    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 
findings:
    i. The toxicity database for spinetoram is complete, except for 
immunotoxicity testing. Recent changes to 40 CFR part 158 make 
immunotoxicity testing (OPPTS Harmonized 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 chronic study with dogs, areteritis and 
necrosis of the areterial walls of the

[[Page 40758]]

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 immunotoxic.
    Based on the above considerations, 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 uncertainty factor 
does not need to be applied.
    ii. There is no indication that spinetoram/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 spinetoram/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 
study.
    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 commodities and refined livestock 
estimates. These refinements are based on reliable data. The EPA used 
PPCT information when calculating livestock dietary burdens for sweet 
corn forage, leaves of root and tuber vegetables, sorghum grain, and 
soybean seed meal. EPA believes that the PPCT estimates used are 
conservative estimates. EPA made conservative (protective) assumptions 
in the ground water and surface water modeling used to assess exposure 
to spinetoram/spinosad in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
spinetoram/spinosad.

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, 
spinetoram/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 spinetoram/spinosad from food and 
water will utilize 95% 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 (considered to be a background exposure level).
    Spinetoram/spinosad is 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 spinetoram/spinosad.
    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 >=160. 
Short-term aggregate risk does not exceed the LOC for EPA (MOE of 
<100).
    4. Intermediate-term risk. Spinetoram/spinosad is 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 spinetoram/spinosad 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. The Agency considers 
spinetoram to be ``Not Likely to be Carcinogenic to Humans.'' See Unit 
III.C.iii. for more detailed information.
    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 spinetoram/spinosad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    FDA Multiresidue Methods (MRMs): XDE-175-J, XDE-175-L, ND-J, NF-J, 
ND-L, and NF-L were screened through the Food and Drug Administration 
Pesticide Analytical Methods Volume I (PAM I) MRMs. None of the test 
substances were found to be fluorescent using procedures outlined in 
Protocol A. All test substances were subjected to Protocol C, modules 
DG1, DG5, DG13, DG17, and DG18. Test substances were determined to be 
non-chromatographable by the chosen gas chromatography modules 
described in Protocol C. Due to the poor sensitivity of the test 
substances to detection by methods described in Protocol C, no further 
analyses were performed by Protocols D, E, or F. Since the test 
substances are not acids, phenols, or substituted ureas, analyses were 
not performed using Protocols B or G. The test substances were not 
detectable through FDA PAM I Protocols A and C; therefore, these 
methods are unsuitable for enforcement. The MRM results were forwarded 
to the FDA.
    Adequate enforcement methodology. Plants: Method GRM 05.03 (HPLC/
MS/MS). Livestock: Method GRM 05.15 HPLC/mass spectrometry (MS) is 
available to enforce the tolerance expression. 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: residuemethods@epa.gov.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican MRLs 
for residues of spinetoram on the requested crops.

C. Revisions to Petitioned-For Tolerances

    The tolerance expression for spinetoram includes residues of XDE-

[[Page 40759]]

175-J, XDE-175-L, ND-J, and NF-J. EPA is establishing tolerances for 
the following commodities at levels higher than proposed: nut, tree, 
group 14 and pistachio raised to 0.10 ppm; almond, hulls raised to 19 
ppm; pineapple to 0.04 ppm; and pineapple, processed residue 0.15 ppm. 
These changes are based on the residue field trial data and the North 
American Free Trade Agreement (NAFTA) MRL Spreadsheet.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
spinetoram, expressed as a combination of:
    XDE-175-J: 1-H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-
ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro14-
methyl-, (2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR);
    XDE-175-L: 1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-
ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-
dimethyl-, (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS);
    ND-J:(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and
    NF-J: (2R,3S,6S)-6-([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-
14-methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-
methyltetrahydro-2H-pyran-3-yl(methyl)formamide
in or on the following commodities is increased to almond, hulls at 19 
ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; date at 
0.10 ppm; pomegranate at 0.30 ppm; pineapple 0.04 ppm; pineapple, 
processed residue at 0.15 ppm; spice, subgroup 19B, except black pepper 
at 1.7 ppm; and hop, dried cones at 22 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 
note).

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: July 31, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.635 is amended by revising the entries in the table in 
paragraph (a) for almond, hulls; nut, tree, group 14; and pistachio and 
alphabetically adding entries for date; hop, dried cones; pineapple; 
pineapple, processed residue; pomegranate; and spice, subgroup 19b, 
except black pepper, to read as follows:


Sec.  180.635  Spinetoram; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
                                * * * * *
Almond, hulls................................................         19
                                * * * * *
Date.........................................................       0.10
                                * * * * *
Hop, dried cones.............................................         22

[[Page 40760]]


                                * * * * *
Nut, tree, group 14..........................................       0.10
                                * * * * *
Pineapple....................................................       0.04
Pineapple, processed residue.................................       0.15
Pistachio....................................................       0.10
Pomegranate..................................................       0.30
                                * * * * *
Spice, subgroup 19B, except black pepper.....................        1.7
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-19195 Filed 8-12-09; 8:45 am]

BILLING CODE 6560-50-S
