Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations 80275 

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 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 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 

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 16, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.434: 

■ a. Redesignate paragraph (a) as 

paragraph (a)(1). 

■ b. Add a new paragraph (a)(2). 

The amendments read as follows: 

§ 180.434 Propiconazole; tolerances for 

residues. 

(a) General. (1) * * * 

(2) Tolerances are established for 

propiconazole, 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 propiconazole, 1-[[2- 

(2,4-dichlorophenyl)-4-propyl-1,3- 

dioxolan-2-yl]methyl]-1H-1,2,4-triazole, 

in or on the commodity. 

Commodity Parts per 

million 

Tea 1 ..................................... 4.0 

1There are no United States registrations 

for use of propiconazole on tea as of December 24, 2015. 

* * * * * 

[FR Doc. 2015–32328 Filed 12–23–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0730; FRL–9933–39] 

Spinetoram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spinetoram 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 spinetoram that are 

superseded by 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 24, 2015. Objections and 

requests for hearings must be received 

on or before February 22, 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–2013–0730, 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). 


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80276 Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations 

• Food manufacturing (NAICS code 

311). 

• 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/textidx?&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–2013–0730 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 22, 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–

2013–0730, 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 Monday, 

December 30, 2013 (78 FR 79359) (FRL– 

9903–69) and Wednesday, 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 3E8203) by IR–4, 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180 be amended 

by establishing tolerances for the 

combined residues of the insecticide 

spinetoram, expressed as a combination 

of XDE–175–J: 1-;H-as-indaceno[3,2d]

oxacyclododecin-7,15-dione, 2-[(6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-aLmannopyranosyl)oxy]-13-[[(2R,5S,6R)- 

5-(dimethylamino)tetrahydro-6-methyl2Hpyran-2-yl]oxy]-9-ethyl-2,3,3a,4,5,

5a,5b,6,9,10,11,12,13,14,16a,16bhexadecahydro 14-methyl-(2R,3aR,5aR,

5bS,9S,13S,14R,16aS,16bR); XDE–175– 

L: 1H-as-indaceno[3,2d]

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-methyl2Hpyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,

5b,6,9,10,11,12,13,14,16a,16btetradecahydro-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-asindaceno[3,2-d]oxacyclododecin-2-yl 6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-alphaL-manno pyranoside; and NF–J: (2R,3S,

6S)-6-([(2R,3aR,5aR,5bS,9S,13S,

14R,16aS,16bR)-2-[(6-deoxy-3-Oethyl2,4-di-O-methyl-alpha-Lmannopyranosyl)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,16boctadecahydro-1H-as-indaceno[3,2d]

oxacyclododecin-13-yl]oxy)-2-methyl

tetrahydro-2H-pyran-3-yl(methyl)

formamide in or on the following raw 

agricultural commodities: Berry, low 

growing, subgroup 13–07G, except 

blueberry, lowbush, and cranberry at 1.0 

parts per million (ppm); bushberry 

subgroup 13–07B, except lingonberry at 

0.25 ppm; caneberry subgroup 13–07A 

at 0.7 ppm; coffee, green bean at 0.2 

ppm; coffee, instant at 0.4 ppm; coffee, 

roasted bean at 0.4 ppm; cottonseed 

subgroup 20C at 0.04 ppm; fruit, citrus, 

group 10–10 at 0.3 ppm; fruit, pome 

group 11–10 at 0.2 ppm; fruit, small, 

vine climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 0.5 ppm; fruit, 

stone, group 12–12 at 0.2 ppm; nuts, 

tree, group 14–12 at 0.1 ppm; onion, 

bulb, subgroup 3–07A at 0.1 ppm; 

onion, green, subgroup 3–07B at 2.0 

ppm; quinoa, grain at 0.04 ppm; and 

vegetable, fruiting, group 8–10 at 0.4 

ppm. In addition, the petitioner 

proposes based upon establishment of 

the new tolerances above, to remove the 

following established spinetoram 

tolerances that are superseded by this 

action: Bushberry subgroup 13B at 0.25 

ppm; caneberry subgroup 13A at 0.70 

ppm; cotton, undelinted seed at 0.04 

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; 

salal at 0.25 ppm; strawberry at 1.0 

ppm; vegetable, bulb, group 3, except 

green onion at 0.10 ppm; and vegetable, 

fruiting group 8 at 0.4 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. A 

single comment was received on the 

notice of filing, EPA’s response to the 

comment is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has made 

certain modifications to petitioned-for 

actions. 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 


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Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations 80277 

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 spinetoram 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with spinetoram 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 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Spinetoram and spinosad 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 milligram/kilogram/

day (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 postimplantation 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 and 

spinosad as well as the no-observedadverse-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 10, 2015 at 

pp. 31, and 2) ‘‘Spinosad/Spinetoram. 

Addendum to Human Health aggregate 

Risk assessment D415812 (T. Bloem et 

al., 10–Mar–2015) to Support a New Use 

on Quinoa’’, dated November 2015 in 

docket ID number EPA–HQ–OPP–2013– 

0730. 

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 the NOAEL and the 

LOEAL are identified. 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-andassessing-pesticide-risks/assessinghuman-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

Exposure/scenario 

Point of departure 

and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (All Populations) A dose and endpoint of concern attributable to a single dose was not observed. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPINOSAD/SPINETORAM FOR USE IN HUMAN

HEALTH RISK ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Chronic dietary (All populations) NOAEL= 2.49 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 

0.0249 mg/kg/day.

cPAD = 0.0249 mg/

kg/day 

Chronic Toxicity—Dog Study (with spinetoram) LOAEL = 5.36/

5.83 mg/kg/day (males/females) based on arteritis and 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 

30 days) and intermediateterm (1 to 6 months).

NOAEL= 4.9 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE <100.

Subchronic Oral Toxicity—Dog Study (with spinosad) LOAEL = 

9.73 mg/kg/day based on microscopic changes in multiple organs, clinical signs of toxicity, decreases in body weights and 

food consumption, and biochemical evidence of anemia and 

liver damage. 

Inhalation short-term (1 to 30 

days) and Intermediate-Term 

(1–6 months).

Inhalation (or oral) 

study NOAEL= 4.9 

mg/kg/day (inhalation assumed 

equivalent to oral).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE <100.

Subchronic Oral Toxicity—Dog Study (with spinosad) LOAEL = 

9.73 mg/kg/day based on microscopic changes in multiple organs, clinical signs of toxicity, decreases in body weights and 

food consumption, and biochemical evidence of anemia and 

liver damage. 

Cancer (Oral, dermal, inhalation).Classified as ‘‘not likely to be carcinogenic to humans.’’ 

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 spinetoram and spinosad, 

EPA considered exposure under the 

petitioned-for tolerances as well as all 

existing spinetoram tolerances in 40 

CFR 180.635 as well as existing 

spinosad tolerances. EPA assessed 

dietary exposures from spinetoram and 

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 or 

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 assuming that all commodities 

contain spinosad residues (because sideby-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 (DEEMFCID, 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, 

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 spinetoram 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 spinetoram and spinosad in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of spinetoram and 

spinosad. Further information regarding 

EPA drinking water models used in 

pesticide exposure assessment can be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/

about-water-exposure-models-usedpesticide. 

Based on the Surface Water 

Concentration Calculator (SWCC) and 

Screening Concentration in Ground 

Water (SCIGROW) models, the 

estimated drinking water concentrations 

(EDWCs) of spinetoram for acute 


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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 

are estimated to be 5.9 ppb for surface 

water and 0.072 ppb for ground water. 

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 noncancer 

assessments are estimated to be 21.7 

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 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 nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Spinetoram and spinosad 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 postapplication 

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 postapplication (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 zeroday 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 postapplication 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 longterm exposure. 

Available turf transferable residue 

(TTR) data on spinosad in support of 

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/pesticidescience-and-assessing-pesticide-risks/

standard-operating-proceduresresidential-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/pesticide-scienceand-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 

Food Quality Protection Act Safety 

Factor (FQPA 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 


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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 spinetoram 

and spinosad 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 

spinetoram or spinosad neurotoxicity 

from available acute and subchronic 

neurotoxicity studies in rats and there is 

no need for a developmental 

neurotoxicity study. 

iii. There is no evidence that 

spinetoram or 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 spinetoram and 

spinosad exposure databases. The 

dietary exposure assessment is 

conservative as it assumes 100 PCT and 

residue estimates are based on field trial 

data. Moreover, EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to spinetoram and 

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 and spinosad. 

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, spinetoram and 

spinosad 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 spinetoram and 

spinosad 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 spinetoram and spinosad is not 

expected. 

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 and 

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 and 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 result in aggregate 

MOEs of 220 for children and 1,000 for 

adults. Because EPA’s level of concern 

for spinetoram and spinosad is a MOE 

of < 100, 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, 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 

with spinosad, spinetoram 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 spinetoram 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Method GRM 05.04 is a highperformance liquid chromatography 

(HPLC)/mass spectrometry (MS)/MS 

method which has been determined to 

be adequate for enforcement of existing 

spinetoram plant tolerances. The 

method has been validated on a widevariety of crops and EPA concluded that 

it is sufficient to enforce the tolerances 

established by this action. 

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 MRLs for spinetoram 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, stone, group 12–12 tolerance and 

the Codex MRL are harmonized. But 

harmonization with the currently 

established Codex MRLs is 

inappropriate for the following crop 

groups and subgroups as harmonization 

may result in exceedances of the 

tolerances when the pesticide is applied 

using the labeled instructions: 

Bushberry, subgroup 13–07B; fruit, 

citrus, group 10–10; fruit, pome, group 

11–10; fruit, small, vine climbing, 

except fuzzy kiwifruit, subgroup 13– 

07F; nut, tree, group 14–12; onion, 

green, subgroup 3–07B; and vegetable, 

fruiting, group 8–10. Also, EPA is not 

harmonizing the U.S. tolerance for 

onion, bulb, subgroup 3–07A (0.10 ppm) 


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with the Codex MRL (0.01 ppm). The 

current U.S. spinetoram tolerance of 

0.10 is based on components XDE–175– 

J, XDE–175–L, ND–J, and NF–J, with the 

limit of quantitation (LOQ) for each of 

0.01 ppm. EPA concludes that a 

spinetoram tolerance <0.04 ppm is not 

appropriate and harmonization with a 

Codex MRL at 0.01 ppm is not practical. 

C. Response to Comments 

One comments was received 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 

safety of the spinetoram tolerances; 

section 408 of the FFDCA focuses on the 

potential harms to human health and 

does not permit consideration of effects 

on the environment. 

D. Revisions to Petitioned-for 

Tolerances 

EPA made corrections to several 

commodity definitions to conform to 

current Agency practices and revised 

certain proposed tolerance levels based 

on the available field trial data, the 

Organization for Economic Co-operation 

and Development (OECD) tolerance 

calculation procedures and/or for 

purposes of harmonization, including 

the following: (1) Proposed tolerance of 

0.2 ppm in/on coffee, green bean was 

established at 0.04 ppm; (2) proposed 

tolerance in/on fruit, stone, group 12–12 

at 0.20 ppm, established at 0.30 ppm; (3) 

proposed tolerance in/on caneberry, 

subgroup 13–07A at 0.7 ppm, 

established at 0.80 ppm; (4) proposed 

tolerance in/on bushberry, subgroup 13– 

07B at 0.25 ppm, established at 0.50 

ppm; (5) proposed tolerance in/on berry, 

low growing, subgroup 13–07G, except 

cranberry at 1.0 ppm, established at 0.90 

ppm; and (6) a proposed tolerance of 

0.04 ppm in/on both coffee, instant and 

coffee, roasted bean was determined to 

be unnecessary because the tolerance on 

the raw agricultural commodity covers 

residues on the processed commodities. 

In addition, the Agency is updating 

the tolerance expression for spinetoram 

as follows to reflect current EPA 

policies: ‘‘Tolerances are established for 

residues of the insecticide spinetoram, 

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 XDE–175–J: 1-H-as-indaceno[3,2d]

oxacyclododecin-7,15-dione, 2-[(6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-aLmannopyranosyl)oxy]-13-[[(2R,5S,6R)- 

5-(dimethylamino)tetrahydro-6-methyl2H-pyran2-yl]oxy]-9-ethyl-2,3,3a,4,5,

5a,5b,6,9,10,11,12,13,14,16a,16bhexadecahydro-14methyl-,(2R,3aR,5aR,

5bS,9S,13S,14R,16aS,16bR); XDE–175–

L: 1H-as-indaceno[3,2d]

oxacyclododecin-7,15-dione, 2-[(6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-a-L

mannopyranosyl)oxy]-13-[[(2R,5

S,6R)-5-(dimethylamino)tetrahydro-6- 

methyl-2H-pyran2-yl]oxy]-9-ethyl-2,3,

3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-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-methyl13-[[(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,16boctadecahydro-1H-as-indaceno[3,2- 

d]oxacyclododecin-2-yl-6-deoxy-3-Oethyl-2,4-di-O-methyl-a-Lmannopyranoside; 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-a-Lmannopyranosyl)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,16boctadecahydro-1H-as-indaceno[3,2-d]

oxacyclododecin-13-yl]oxy)- 

2methyltetrahydro-2H-pyran-3- 

yl(methyl)formamide, calculated as the 

stoichiometric equivalent of spinetoram. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide 

spinetoram, including its metabolites 

and degradates, in or on the 

commodities listed below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only the sum of XDE–175–J: 1-H-asindaceno[3,2-d]oxacyclododecin-7,15- 

dione,2-[(6deoxy-3-O-ethyl-2,4-di-Omethyl-a-L-mannopyranosyl)oxy]-13- 

[[(2R,5S,6R)- 

5(dimethylamino)tetrahydro-6-methyl2H-pyran-2yl]oxy]-9-ethyl-2,3,3a,4,5,5a,

5b,6,9,10,11,12,13,14,16a,16bhexadecahydro-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- 

[(6deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)- 

5(dimethylamino)tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,

6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-dimethyl-,(2S,

3aR,5aS,5bS,9S,13S,14R,16aS,16bS);

ND–J: (2R,3aR,5aR,5bS,9S,13S,14R,R,

16aS,16bR)-9-ethyl-14-methyl-13[[(2S,

5S,6R)-6-methyl-5-(methylamino)

tetrahydro-2H-pyran-2-yl]oxy]-7,15- 

dioxo2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,

14,15,16a,16b-octadecahydro-1H-asindaceno[3,2d]oxacyclododecin-2-yl-6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranoside; 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-a-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,16boctadecahydro-1H-as-indaceno[3,2d] 

oxacyclododecin-13-yl]oxy)-2- 

methyltetrahydro-2H-pyran-3-yl(methyl)

formamide, calculated as the 

stoichiometric equivalent of spinetoram 

in or on berry, low growing, subgroup 

13–07G, except cranberry at 0.90 ppm; 

bushberry, subgroup 13–07B at 0.50 

ppm; caneberry subgroup 13–07A at 

0.80 ppm; coffee, green bean at 0.04 

ppm; cottonseed subgroup 20C at 0.04 

ppm; fruit, citrus, group 10–10 at 0.30 

ppm; fruit, pome, group 11–10 at 0.20 

ppm; fruit, small, vine climbing, 

subgroup 13–07F, except fuzzy kiwifruit 

at 0.50 ppm; fruit, stone 12–12 at 0.30 

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 2.0 ppm; quinoa, grain at 0.04 ppm; 

and vegetable, fruiting, group 8–10 at 

0.40 ppm. In addition, EPA is removing 

the following existing spinetoram 

tolerances that are superseded by this 

action including: Bushberry subgroup 

13B at 0.25 ppm; caneberry subgroup 

13A at 0.70 ppm; cotton, undelinted 

seed at 0.02 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; salal at 0.25 ppm; 

strawberry at 1.0 ppm; vegetable, bulb, 

group 3, except green onion at 0.10 

ppm; and vegetable, fruiting group 8 at 

0.4 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 


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80282 Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations 

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 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.635, in paragraph (a): 

■ a. Revise the introductory text. 

■ b. Remove from the table in paragraph 

(a) the entries for: Bushberry subgroup 

13B at 0.25 ppm; caneberry subgroup 

13A at 0.70 ppm; cotton, undelinted 

seed at 0.02 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; salal at 0.25 ppm; 

strawberry at 1.0 ppm; vegetable, bulb, 

group 3, except green onion at 0.10 

ppm; and vegetable, fruiting group 8 at 

0.4 ppm. 

■ c. Add alphabetically the following 

commodities to the table in paragraph 

(a). 

The revision and additions read as 

follows: 

§ 180.635 Spinetoram; tolerance for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide spinetoram, 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 XDE–175–J: 

1-H-as-indaceno[3,2-d]oxacyclododecin7,15-dione,2-[(6deoxy-3-O-ethyl-2,4-diO-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-asindaceno[3,2-d]oxacyclododecin-7,15- 

dione,2-[(6deoxy-3-O-ethyl-2,4-di-Omethyl-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- 

dioxo2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,

14,15,16a,16b-octadecahydro-1H-asindaceno[3,2d]oxacyclododecin-2-yl-6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranoside; 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-a-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,16boctadecahydro-1H-as-indaceno[3,2d]

oxacyclododecin-13-yl]oxy)-2-

methyltetrahydro-2H-pyran-3-yl(methyl)

formamide, calculated as the 

stoichiometric equivalent of spinetoram. 

Commodity Parts per 

million 

* * * * * 

Berry, low growing, subgroup 13–07G, except 

cranberry ......................... 0 .90 

* * * * * 

Bushberry subgroup 13– 

07B .................................. 0 .50 

Caneberry subgroup 13– 

07A .................................. 0 .80 

* * * * * 

Coffee, green bean ............. 0 .04 

* * * * * 

Cottonseed subgroup 20C 0 .04 

* * * * * 

Fruit, citrus, group 10–10 ... 0 .30 

Fruit, pome, group 11–10 ... 0 .20 

Fruit, small, vine climbing, 

subgroup 13–07F, except 

fuzzy kiwifruit ................... 0 .50 

Fruit, stone 12–12 .............. 0 .30 

* * * * * 

Nut, tree, group 14–12 ....... 0 .10 

* * * * * 

Onion, bulb, subgroup 3– 

07A .................................. 0 .10 

Onion, green, subgroup 3– 

07B .................................. 2 .0 

* * * * * 

Quinoa, grain ...................... 0 .04 

* * * * * 

Vegetable, fruiting, group 

8–10 ................................ 0 .40 

* * * * * 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations 80283 

* * * * * 

[FR Doc. 2015–32329 Filed 12–23–15; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 54 

[WC Docket Nos. 13–184 and 10–90; FCC 

14–189] 

Modernizing the E-rate Program for 

Schools and Libraries 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the 

Commission announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, the 

information collection associated with 

the Commission’s Second E-rate 

Modernization Report and Order and 

Order on Reconsideration (Second Erate Modernization Order). This 

document is consistent with the 

(Second E-rate Modernization Order, 

which stated that the Commission 

would publish a document in the 

Federal Register announcing the 

effective date of those rules. 

DATES: 47 CFR 54.504(a)(1)(iii), 

published at 80 FR 5961, February 4, 

2015, is effective December 24, 2015. 

FOR FURTHER INFORMATION CONTACT: 

James Bachtell, Wireline Competition 

Bureau at (202) 418–7400 or TTY (202) 

418–0484. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on December 

2, 2015, OMB approved, for a period of 

three years, the new information 

collection requirements contained in the 

Commission’s Second E-rate 

Modernization Order, FCC 14–189, 

published at 80 FR 5961, February 4, 

2015. The OMB Control Number is 

3060–0806. The Commission publishes 

this document as an announcement of 

the effective date of 47 CFR 

54.504(a)(1)(iii). 

If you have any comments on the 

burden estimates listed below, or how 

the Commission can improve the 

collections and reduce any burdens 

caused thereby, please contact Nicole 

Ongele, Federal Communications 

Commission, Room 1–A620, 445 12th 

Street SW., Washington, DC 20554. 

Please include the OMB Control 

Number, 3060–0806, in your 

correspondence. The Commission will 

also accept your comments via the 

Internet if you send them to PRA@

fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an email to fcc504@

fcc.gov or call the Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 

received OMB approval on December 2, 

2015, for the information collection 

requirements contained in the 

Commission’s rule at 47 CFR 

54.504(a)(1)(iii). 

Under 5 CFR part 1320, an agency 

may not conduct or sponsor a collection 

of information unless it displays a 

current, valid OMB Control Number. 

No person shall be subject to any 

penalty for failing to comply with a 

collection of information subject to the 

Paperwork Reduction Act that does not 

display a current, valid OMB Control 

Number. The OMB Control Number is 

3060–0806. 

The foregoing document is required 

by the Paperwork Reduction Act of 

1995, Pub. L. 104–13, October 1, 1995, 

and 44 U.S.C. 3507. 

The total annual reporting burdens 

and costs for the respondents are as 

follows: 

OMB Control Number: 3060–0806. 

OMB Approval Date: December 2, 

2015. 

OMB Expiration Date: December 31, 

2018. 

Title: Universal Service—Schools and 

Libraries Universal Service Program, 

FCC Forms 470 and 471. 

Form Numbers: FCC Forms 470 and 

471. 

Respondents: State, local or tribal 

government public institutions, and 

other not-for-profit institutions. 

Number of Respondents and 

Responses: 52,700 respondents, 82,090 

responses. 

Estimated Time per Response: 3.5 

hours for FCC Form 470 (3 hours for 

response; 0.5 hours for recordkeeping; 

4.5 hours for FCC Form 471 (4 hours for 

response; 0.5 hours for recordkeeping). 

Frequency of Response: On occasion, 

annual reporting, and recordkeeping 

requirements. 

Obligation to Respond: Required to 

obtain or retain benefits. Statutory 

authority for this information collection 

is contained in 47 U.S.C. 151–154, 201– 

205, 218–220, 254, 303(r), 403, and 405. 

Total Annual Burden: 334,405 hours. 

Total Annual Cost: No cost. 

Privacy Act Impact Assessment: No 

impact(s). 

Nature and Extent of Confidentiality: 

There is no assurance of confidentiality 

provided to respondents concerning this 

information collection. However, 

respondents may request materials or 

information submitted to the 

Commission or to the Administrator be 

withheld from public inspection under 

47 CFR 0.459 of the Commission’s rules. 

Needs and Uses: The Commission 

seeks to revise OMB 3060–0806 to 

conform this information collection to 

the program changes set forth in the 

Second Report and Order and Order on 

Reconsideration (Second E-Rate 

Modernization Order) (WC Docket No. 

13–184, WC Docket No. 10–90, FCC 14– 

189; 80 FR 5961, February 4, 2015). 

Collection of the information on FCC 

Forms 470 and 471 is necessary so that 

the Commission and the Universal 

Service Administrative Company 

(USAC) have sufficient information to 

determine if entities are eligible for 

funding pursuant to the schools and 

libraries support mechanism (the E-rate 

program), to determine if entities are 

complying with the Commission’s rules, 

and to prevent waste, fraud, and abuse. 

In addition, the information is necessary 

for the Commission to evaluate the 

extent to which the E-rate program is 

meeting the statutory objectives 

specified in section 254(h) of the 1996 

Act, and the Commission’s own 

performance goals established in the 

Report and Order and Further Notice of 

Proposed Rulemaking (E-rate 

Modernization Order), 79 FR 49160, 

August 19, 2014 and Second E-rate 

Modernization Order, 80 FR 5961, 

February 4, 2015. This information 

collection is being revised to modify 

FCC Form 471 pursuant to program and 

rule changes in the Second E-rate 

Modernization Order and to 

accommodate USAC’s new online portal 

as well as the requirement that all FCC 

Forms 471 be electronically filed. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

[FR Doc. 2015–32321 Filed 12–23–15; 8:45 am] 

BILLING CODE 6712–01–P 


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