
[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Rules and Regulations]
[Pages 80665-80672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32168]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0727; FRL-9933-41]


Spinosad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
spinosad in or on multiple commodities that are identified and 
discussed later in this document. In addition, this regulation removes 
a number of existing tolerances for residues of spinosad that are 
superseded by tolerances being established in this action. 
Interregional Research Project #4 (IR-4) requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 28, 2015. Objections and 
requests for hearings must be received on or before February 26, 2016, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0727, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave., NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

[[Page 80666]]

     Pesticide manufacturing (NAICS code 32532).

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.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2013-0727 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 
February 26, 2016. 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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0727, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 30, 2013 (78 FR 79359) (FRL-
9903-69), and November 4, 2015 (80 FR 68289) (FRL-9936-13), EPA issued 
a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), 
announcing the filing and subsequent filing of an amendment to 
pesticide petition (PP 3E8204) by IR-4, 500 College Road East, Suite 
201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.495 
be amended by establishing tolerances for residues of the insecticide 
spinosad, a fermentation product of Saccharopolyspora spinosa, 
consisting of two related active ingredients: Spinosyn A (Factor A: CAS 
Registry No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-
manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- 
tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione; and Spinosyn D (Factor D; CAS Registry No. 131929-63-0) or 2-
[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-
(dimethyl-amino)-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-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on the raw 
agricultural commodities: Coffee, green bean at 0.2 parts per million 
(ppm); coffee, instant at 0.4 ppm; coffee, roasted bean at 0.4 ppm; 
cottonseed subgroup 20C at 0.02 ppm; caneberry subgroup 13-07A at 0.7 
ppm; bushberry subgroup 13-07B, except lingonberry at 0.25 ppm; fruit, 
small, vine climbing, except fuzzy kiwifruit subgroup 13-07F at 0.5 
ppm; berry, low growing, subgroup 13-07G, except blueberry, lowbush, 
and cranberry at 1.0 ppm; fruit, pome group 11-10 at 0.2 ppm; 
vegetable, fruiting, group 8-10 at 0.4 ppm; fruit, citrus, group 10-10 
at 0.3 ppm; fruit, stone, group 12-12 at 0.2 ppm; onion, bulb, subgroup 
3-07A at 0.1 ppm; onion, green, subgroup 3-07B at 2.0 ppm; and nuts, 
tree, group 14-12 at 0.1 ppm. In addition, the petitioner proposes 
based upon establishment of the new tolerances above, to remove the 
following established tolerances that are superseded by this action: 
bushberry subgroup 13B at 0.25 ppm; caneberry subgroup 13A at 0.70 ppm; 
fruit, citrus, group 10 at 0.30 ppm; fruit, pome, group 11 at 0.20 ppm; 
fruit, stone, group 12 at 0.20 ppm; grape at 0.50 ppm; Juneberry at 
0.25 ppm; lingonberry at 0.25 ppm; nut tree, group 14 at 0.10 ppm; okra 
at 0.40 ppm; onion, green at 2.0 ppm; pistachio at 0.10 ppm; quinoa, 
grain at 1.0 ppm; salal at 0.25 ppm; strawberry at 1.0 ppm; vegetable, 
bulb, group 3, except green onion at 0.10 ppm; vegetable, fruiting 
group 8 at 0.4 ppm; and cotton, undelinted seed at 0.02 ppm. That 
document referenced a summary of the petition prepared by Dow 
AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filings. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has made 
certain modifications to the petitioned-for tolerances. The reasons for 
these changes are explained in Unit IV.C.

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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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

[[Page 80667]]

sensitivities of major identifiable subgroups of consumers, including 
infants and children.
    Spinosad and spinetoram are considered by EPA to be toxicologically 
identical for human health risk assessment based on their very similar 
chemical structures and similarity of the toxicological databases for 
currently available studies. The primary toxic effect observed from 
exposure to spinosad or spinetoram was histopathological changes in 
multiple organs (specific target organs were not identified). 
Vacuolization of cells and/or macrophages was the most common 
histopathological finding noted across both toxicological databases 
with the dog being the most sensitive species. In addition to the 
numerous organs observed with histopathological changes, anemia was 
noted in several studies.
    There was no evidence of increased quantitative or qualitative 
susceptibility from spinosad or spinetoram exposure. In developmental 
studies, no maternal or developmental effects were seen in rats or 
rabbits. In the rat reproduction toxicity studies, offspring toxicity 
was seen in the presence of parental toxicity at approximately the same 
dose for both chemicals (75-100 mg/kg/day). Parental toxicity was 
evidenced by increased organ weights, mortality, and histopathological 
findings in several organs. Offspring effects included decreased litter 
size, survival, and body weights with spinosad while an increased 
incidence of late resorptions and post-implantation loss was seen with 
spinetoram. Dystocia and/or other parturition abnormalities were 
observed with both chemicals.
    Spinosad and spinetoram are classified as having low acute toxicity 
via the oral, dermal, and inhalation routes of exposure. Neither 
chemical is an eye or dermal irritant. Spinetoram was found to be a 
dermal sensitizer. No hazard was identified for dermal exposure; 
therefore a quantitative dermal assessment is not needed. In acute and 
subchronic neurotoxicity studies, there was no evidence of 
neurotoxicity from exposure to spinosad or spinetoram. In an 
immunotoxicity study with spinosad, systemic effects (decreased body 
weights, increased liver weights, and abnormal hematology results) were 
seen at the highest dose tested (141 mg/kg/day); however, there was no 
evidence of immunotoxicity.
    Spinosad and spinetoram are classified as ``not likely to be 
carcinogenic to humans'' based on lack of evidence of carcinogenicity 
in mice and rats and negative findings in mutagenicity assays.
    Specific information on the studies received and the nature of the 
adverse effects caused by spinetoram 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 documents including: (1) ``Spinosad and 
Spinetoram--Human Health Risk Assessment to Support the Section 3 
Registration Request for Application to Coffee and for Updates to 
Several Crop Group/Subgroup Commodity Definitions'', dated March 15, 
2015 at page 31, and (2) ``Spinosad/Spinetoram. Addendum to Human 
Health aggregate Risk assessment D415812 (T. Bloem et al., March 10, 
2015) to Support a New Use on Quinoa'', dated November 19, 2015 in 
docket ID number EPA-HQ-OPP-2013-0727.

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 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    Spinosad and spinetoram should be considered toxicologically 
identical in the same manner that metabolites are generally considered 
toxicologically identical to the parent. Although, as stated above, the 
doses and endpoints for spinosad and spinetoram are similar, they are 
not identical due to variations in dosing levels used in the spinetoram 
and spinosad toxicological studies. EPA compared the spinosad and 
spinetoram doses and endpoints for each exposure scenario and selected 
the lower of the two doses for use in human risk assessment.
    A summary of the toxicological endpoints for spinosad/spinetoram 
used for human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Spinosad/Spinetoram for Use in Human Health Risk
                                                   Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (All populations)..  A dose and endpoint of concern attributable to a single dose was not
                                    observed.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 2.49 mg/kg/    Chronic RfD =        Chronic Toxicity--Dog Study (with
                                    day.                  0.0249 mg/kg/day.    spinetoram)
                                   UFA = 10x...........  cPAD = 0.0249 mg/kg/ LOAEL = 5.36/5.83 mg/kg/day (males/
                                   UFH = 10x...........   day.                 females) based on arteritis and
                                   FQPA SF = 1x........                        necrosis of the arterial walls of
                                                                               the epididymides in males and of
                                                                               the thymus, thyroid, larynx, and
                                                                               urinary bladder in females.
Incidental oral short-term (1 to   NOAEL= 4.9 mg/kg/day  Residential LOC for  Subchronic Oral Toxicity--Dog
 30 days) and intermediate-term    UFA = 10x...........   MOE <100.            Study (with spinosad)
 (1 to 6 months).                  UFH = 10x...........                       LOAEL = 9.73 mg/kg/day based on
                                   FQPA SF = 1x........                        microscopic changes in multiple
                                                                               organs, clinical signs of
                                                                               toxicity, decreases in body
                                                                               weights and food consumption, and
                                                                               biochemical evidence of anemia
                                                                               and liver damage.

[[Page 80668]]

 
Inhalation short-term............  Inhalation (or oral)  Residential LOC for  Subchronic Oral Toxicity--Dog
(1 to 30 days) and Intermediate-    study NOAEL= 4.9 mg/  MOE <100.            Study (with spinosad)
 Term (1-6 months).                 kg/day (inhalation                        LOAEL = 9.73 mg/kg/day based on
                                    assumed equivalent                         microscopic changes in multiple
                                    to oral).                                  organs, clinical signs of
                                   UFA = 10x...........                        toxicity, decreases in body
                                   UFH = 10x...........                        weights and food consumption, and
                                   FQPA SF = 1x........                        biochemical evidence of anemia
                                                                               and liver damage.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)            Classified as ``not likely to be carcinogenic to humans''.
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LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE =
  margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
  chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spinosad and spinetoram, EPA considered exposure under the 
petitioned-for tolerances as well as all existing spinosad tolerances 
in 40 CFR 180.495 and existing spinetoram tolerances. EPA assessed 
dietary exposures from spinosad and spinetoram 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 or spinetoram; 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-by-side spinetoram 
and spinosad residue data indicated that spinetoram residues were less 
than or equal to spinosad residues).
    In conducting the chronic dietary exposure assessment for 
spinetoram, EPA used the Dietary Exposure Evaluation Model--Food 
Consumption Intake Database (DEEM-FCID, ver. 3.16) which incorporates 
food consumption data from the United States Department of Agriculture 
(USDA) National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA; 2003-2008). The chronic analysis assumed 100 
percent crop treated (PCT), average field-trial residues or tolerance-
level residues for crop commodities, average residues from the 
livestock feeding studies, residue estimates for fish/shellfish, 
experimental processing factors when available, and modeled drinking 
water estimates.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that spinosad does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and 100 percent crop treated (PCT) 
information were used. 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.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for spinosad and spinetoram in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of spinosad. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) and 
Screening Concentration in Ground Water (SCIGROW) models, the estimated 
drinking water concentrations (EDWCs) of spinosad for acute exposures 
are estimated to be 25.0 ppb for surface water and 1.1 ppb for ground 
water. For chronic exposures for non-cancer assessments, EDWCs of 
spinosad are estimated to be 21.7 ppb for surface water and 1.1 ppb for 
ground water. EDWCs of spinetoram for acute exposures are estimated to 
be 8.6 parts per billion (ppb) for surface water and 0.072 ppb for 
ground water. For chronic exposures for non-cancer assessments, EDWCs 
of spinetoram are estimated to be 5.9 ppb for surface water and 0.072 
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 21.7 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,

[[Page 80669]]

indoor pest control, termiticides, and flea and tick control on pets).
    Spinosad and spinetoram are currently registered for uses that 
could result in residential exposures including lawns, gardens, 
turfgrass, ornamentals, fire ant mounds, and spot-on pet applications. 
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. EPA assessed residential exposure for both spinosad 
and spinetoram using the most conservative residential exposure 
scenarios for either chemical.
    EPA assessed residential exposure using the following assumptions: 
Residential handler (short-term inhalation exposures) and post-
application (short-term incidental oral) exposures are expected as a 
result of the following registered uses: (1) application of spinosad to 
gardens, turfgrass, ornamentals and fire ant mounds; (2) application of 
spinetoram to lawns, gardens, and ornamentals; and (3) spot-on 
application of spinetoram to cats and kittens. The Agency determined 
the ``worst-case'' scenarios for handler and post-application exposures 
as: (1) adult residential handler inhalation exposure from mixing/
loading/applying liquid formulations to turf via backpack sprayer, and 
(2) child (1-<2 years) residential post-application incidental oral 
(hand-to-mouth) exposure from liquid formulation on turf/home gardens/
ornamentals. These worst-case exposure estimates were used in the 
aggregate assessment of residential exposure to spinosad and 
spinetoram.
    Aggregating exposure resulting from the turf and pet uses was not 
conducted as the products control different pests and, therefore, 
application on the same day is unlikely. Use survey data indicate that 
concurrent use of separate pesticide products that contain the same 
active ingredient to treat the same or different pests does not 
typically occur. Furthermore, a number of issues are considered when 
combining residential exposure scenarios, including whether aggregating 
additional uses is appropriate in light of the already conservative 
assumptions inherent in the assessment. When assessing individual 
short-term residential postapplication exposure scenarios, EPA assumes 
exposure occurs to zero-day residues (i.e., day of application 
residues) day after day. EPA also assumes that an individual performs 
the same postapplication activities, intended to represent high end 
exposures as described in the Residential SOPS, day after day for the 
same amount of time every day (i.e., no day to day variation), although 
doing intense contact activities on the day of application subsequent 
to application for multiple chemicals would not be anticipated. Once 
calculated, these exposure estimates are then compared to points of 
departure that are typically based on weeks of dosing in test animals. 
For spinosad/spinetoram, the short-term risk assessment has the 
additional conservatism of basing the level of concern for short-term 
exposure (30-days) on a toxicity study involving continuous exposure 
over 90 days.
    Current EPA policy requires assessment for residential post-
application exposures of short- (1 to 30 days), intermediate- (1 to 6 
months), and long-term (greater than 6 months) exposures from spot-on 
products due to the preventative nature of these products and the 
potential for extended usage in more temperate parts of the country. 
However, for spinetoram, there is no progression of toxicity with time; 
therefore, the short-term assessment is protective of intermediate- and 
long-term exposure.
    Available turf transferable residue (TTR) data on spinosad in 
support of the turf uses and spinetoram data on dislodgeable residues 
from petting after topical administration to cats were incorporated 
into the exposure assessment. Spinosad and spinetoram dislodgeable-
foliar residue (DFR) studies are unnecessary at this time as there is 
no hazard via the dermal route of exposure.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticides-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found spinosad or spinetoram to share a common 
mechanism of toxicity with any other substances, and neither spinosad 
nor spinetoram appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that spinosad and spinetoram do not have a common mechanism 
of toxicity with other substances. For information regarding EPA's 
efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's Web site at http://www2.epa.gov/pesticides-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 was no evidence of 
increased quantitative or qualitative susceptibility of rat and rabbit 
fetuses to in-utero exposure to spinetoram or spinosad. In 
developmental studies, no maternal or developmental effects were seen 
in rats or rabbits. In the rat reproduction toxicity studies, offspring 
toxicity was seen in association with parental toxicity at 
approximately the same dose for both spinetoram and spinosad. 
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 spinosad and spinetoram is complete. 
There is no evidence of neurotoxicity, developmental/reproductive 
toxicity, immunotoxicity, mutagenicity, or carcinogenicity from 
spinetoram or spinosad exposure. Therefore, no additional database 
uncertainty factor (UF) is needed.
    ii. There is no indication of spinosad or spinetoram neurotoxicity 
from available acute and subchronic

[[Page 80670]]

neurotoxicity studies in rats and there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that spinosad or spinetoram 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 spinosad 
and spinetoram exposure databases. The dietary exposure assessment is 
conservative as it assumes 100 PCT and residue estimates are based on 
field trial data and fish nature of the residue studies. Moreover, EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to spinosad and spinetoram 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 spinosad and spinetoram.

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 and spinetoram are not expected to pose an acute risk.
    2. Chronic risk. 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 64% of the 
cPAD for children 1-2 years old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
spinosad and spinetoram is not expected.
    3. Short- and Intermediate-term risks. Short-term aggregate 
exposure takes into account short-term residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level).
    Spinosad and spinetoram are currently registered for uses that 
could result in short-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short-term residential exposures to spinosad and 
spinetoram.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 220 for children 
1-2 years old and 1,000 for adults 20-49 years old. Because EPA's level 
of concern for spinosad and spinetoram is a MOE of 100 or below, these 
MOEs are not of concern.
    EPA has concluded that the combined intermediate-term and long-term 
food, water, and residential exposures result in aggregate MOEs that 
will not fall below the short-term aggregate MOEs since there is no 
progression of spinetoram toxicity with time. Because EPA's level of 
concern for spinetoram and spinosad is a MOE of 100 or below, these 
MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, spinosad is not expected to pose a cancer risk to humans.
    5. 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 residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method RES 94025 (GRM 94.02) is a 
high-performance liquid chromatography method with ultraviolet 
detection (HPLC/UV)) is available to enforce the tolerance expression. 
Additional methods have also been determined to be adequate for 
tolerance enforcement purposes.
    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; email address: 
residuemethods@epa.gov.

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 United Nations 
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 maximum residue limits (MRLs) for spinosad are currently 
established in or on several of the relevant crops or crop groups or 
subgroups affected by this action. EPA harmonizes with existing Codex 
MRLs whenever feasible. The recommended fruit, small, vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F and raisin tolerances and the 
Codex MRLs are harmonized. But harmonization with the Codex MRLs for 
the following tolerances is inappropriate as doing so may result in 
exceedances of the tolerances when the pesticide is applied using the 
labeled instructions: Fruit, pome, group 11-10; nut, tree, group 14-12; 
and cottonseed, subgroup 20C. Harmonization with the currently 
established vegetable, fruiting, group 8-10 Codex MRL is inappropriate 
as the Codex MRL is too high to allow for enforcement of the labeled 
instructions.

C. Response to Comments

    In response to the notice of filing, EPA received two (2) comments 
on December 4, 2015. One comment was received from a private citizen in 
support of EPA's regulatory initiatives to control potentially harmful 
substances in order to protect human health and the environment.
    The other comment was from the Center for Biological Diversity and 
concerned endangered species, specifically stating that EPA cannot 
approve these new uses prior to completion of consultations with the 
U.S. Fish and Wildlife Service and the National Marine Fisheries 
Service (``the Services''). This comment is not relevant to the 
Agency's evaluation of the safety of the spinosad tolerances;

[[Page 80671]]

section 408 of the FFDCA focuses on potential harms to human health and 
does not permit consideration of effects on the environment.

D. Revisions to Petitioned-For Tolerances

    Based on the available field-trial and processing data and the OECD 
tolerance calculation procedure, EPA: (1) concludes that proposed 
tolerances in or on coffee processed commodities are unnecessary; (2) 
made revisions to proposed tolerance values in order to harmonize with 
Canada and/or Codex MRLs where supporting data allowed; (3) made 
revisions to the commodity definitions to conform with current Agency 
practices, and (4) is reducing the requested tolerance for coffee, 
green bean from 0.2 ppm to 0.04 ppm. Also, although a spinosad 
tolerance in/on quinoa, grain was requested at 1.0 ppm for the purpose 
of harmonizing with the Codex cereal grain MRL, EPA is establishing a 
tolerance at 0.02 ppm. EPA considered the fact that the Codex MRL is 
based on post-harvest treatment and, therefore, is not reflective of 
the proposed foliar-only quinoa application scenario. Based on the 
available wheat grain data and adjusting these data for the proposed 
application rate, EPA concluded that a 0.02-ppm spinosad tolerance in/
on quinoa grain is appropriate.
    In addition, the Agency is updating the tolerance expression for 
spinosad as follows to reflect current EPA policies: Tolerances are 
established for residues of the insecticide spinosad, including its 
metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only the sum of spinosyn A (Factor A: CAS # 
131929-60-7; (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-
tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione); and spinosyn D (Factor D; 
CAS # 131929-63-0; (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-
2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-
amino)-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-methyl-1H-
as-indaceno[3,2-d]oxacyclododecin-7,15-dione), calculated as the 
stoichiometric equivalent of spinosad.

V. Conclusion

    Therefore, EPA is establishing tolerances for residues of the 
insecticide spinosad, including its metabolites and degradates, in or 
on the following commodities. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
spinosyn A (Factor A: CAS # 131929-60-7; 
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-
[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione; and spinosyn D (Factor D; 
CAS # 131929-63-0; (2S,3aR,5aS,5bS,9S,13S, 14R,16aS,16bS)-2-[(6-deoxy-
2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-
amino)-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-methyl-1H-
as-indaceno[3,2-d]oxacyclododecin-7,15-dione, calculated as the 
stoichiometric equivalent of spinosad, in or on berry, low growing, 
subgroup 13-07G, except cranberry at 0.90 ppm; bushberry, subgroup 13-
07B at 0.40 ppm; caneberry subgroup 13-07A at 1.0 ppm; coffee, green 
bean at 0.04 ppm; cottonseed subgroup 20C at 0.02 ppm; fruit, citrus, 
group 10-10 at 0.30 ppm; fruit, pome, group 11-10 at 0.20 ppm; fruit, 
small, vine climbing, subgroup13-07F, except fuzzy kiwifruit at 0.50 
ppm; fruit, stone 12-12 at 0.20 ppm; nut, tree, group 14-12 at 0.10 
ppm; onion, bulb, subgroup 3-07A at 0.10 ppm; onion, green, subgroup 3-
07B at 4.0 ppm; quinoa, grain at 0.02 ppm; and vegetable, fruiting, 
group 8-10 at 0.40 ppm. In addition, EPA is removing the following 
existing spinosad tolerances that are superseded by this action 
including: Bushberry subgroup 13B at 0.25 ppm; caneberry subgroup 13A 
at 0.70 ppm; fruit, citrus, group 10 at 0.30 ppm; fruit, pome, group 11 
at 0.20 ppm; fruit, stone, group 12 at 0.20 ppm; grape at 0.50 ppm; 
Juneberry at 0.25 ppm; lingonberry at 0.25 ppm; nut tree, group 14 at 
0.10 ppm; okra at 0.40 ppm; onion, green at 2.0 ppm; pistachio at 0.10 
ppm; strawberry at 1.0 ppm; vegetable, bulb, group 3, except green 
onion at 0.10 ppm; vegetable, fruiting group 8 at 0.4 ppm; and cotton, 
undelinted seed at 0.02 ppm. In addition, EPA is increasing the 
existing tolerance for grape, raisin to 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action 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 FFDCA section 408(n)(4). 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require

[[Page 80672]]

Agency consideration of voluntary consensus standards pursuant to 
section 12(d) of the National Technology Transfer and Advancement Act 
(NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action 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: December 15, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.495, paragraph (a):
0
a. Revise the introductory text.
0
b. Remove the entries in the table for ``Bushberry subgroup 13B''; 
``Caneberry subgroup 13A''; ``Cotton, undelinted seed''; ``Fruit, 
citrus, group 10''; ``Fruit, pome, group 11''; ``Fruit, stone, group 
12''; ``Grape''; ``Juneberry''; ``Lingonberry''; ``Nut tree, group 
14''; ``Okra''; ``Onion, green''; ``Pistachio''; ``Salal''; 
``Strawberry''; ``Vegetable, bulb, group 3, except green onion''; and 
``Vegetable, fruiting, group 8''.
0
c. Revise the entry in the table for ``Grape, raisin''.
0
d. Add alphabetically entries to the table for ``Berry, low growing, 
subgroup 13-07G, except cranberry''; ``Bushberry subgroup 13-07B''; 
``Caneberry subgroup 13-07A''; ``Coffee, green bean''; ``Cottonseed 
subgroup 20C''; ``Fruit, citrus, group 10-10''; ``Fruit, pome, group 
11-10''; ``Fruit, small, vine climbing, subgroup13-07F, except fuzzy 
kiwifruit''; ``Nut, tree, group 14-12''; ``Onion, bulb, subgroup 3-
07A''; ``Onion, green, subgroup 3-07B''; ``Quinoa, grain''; and 
``Vegetable, fruiting, group 8-10''.
    The additions and revision read as follows:


Sec.  180.495  Spinosad; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide spinosad, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
spinosyn A (Factor A: CAS # 131929-60-7; 
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-
[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-
,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione; and spinosyn D (Factor D; 
CAS # 131929-63-0; (2S,3aR,5aS,5bS,9S,13S, 14R,16aS,16bS)-2-[(6-deoxy-
2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-
amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-indaceno[3,2-d]oxacyclododecin-7,15-dione, calculated as the 
stoichiometric equivalent of spinosad.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry.......        0.90
 
                                * * * * *
Bushberry subgroup 13-07B...................................        0.40
Caneberry subgroup 13-07A...................................         1.0
 
                                * * * * *
Coffee, green bean..........................................        0.04
 
                                * * * * *
Cottonseed subgroup 20C.....................................        0.02
 
                                * * * * *
Fruit, citrus, group 10-10..................................        0.30
Fruit, pome, group 11-10....................................        0.20
Fruit, small, vine climbing, subgroup13-07F, except fuzzy           0.50
 kiwifruit..................................................
Fruit, stone 12-12..........................................        0.20
 
                                * * * * *
Grape, raisin...............................................         1.0
 
                                * * * * *
Nut, tree, group 14-12......................................        0.10
 
                                * * * * *
Onion, bulb, subgroup 3-07A.................................        0.10
Onion, green, subgroup 3-07B................................         4.0
 
                                * * * * *
Quinoa, grain...............................................        0.02
 
                                * * * * *
Vegetable, fruiting, group 8-10.............................        0.40
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-32168 Filed 12-24-15; 8:45 am]
 BILLING CODE 6560-50-P


