38976 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations 

SUBSTITUTES THAT ARE ACCEPTABLE SUBJECT TO USE CONDITIONS

End-use Substitute Decision Use conditions Further information 

Household refrigerators, 

freezers, 

and combination refrigerators 

and freezers 

(New equipment only).

Isobutane (R600a).

Propane (R290).

R-441A .........

Acceptable 

subject to 

use conditions.

As of September 7, 2018: ................................................

These refrigerants may be used only in new equipment 

designed specifically and clearly identified for the refrigerant (i.e., none of these substitutes may be used 

as a conversion or ‘‘retrofit’’ refrigerant for existing 

equipment designed for a different refrigerant).

These refrigerants may be used only in a refrigerator or 

freezer, or combination refrigerator and freezer, that 

meets all requirements listed in the 2nd edition of the 

Underwriters Laboratories (UL) Standard for Safety: 

Household and Similar Electrical Appliances—Safety—Part 2–24: Particular Requirements for Refrigerating Appliances, Ice-Cream Appliances and IceMakers, UL 60335–2–24, dated April 28, 2017.

Applicable OSHA requirements at 29 CFR part 1910 

must be followed, including those at 29 CFR 1910.106 

(flammable and combustible liquids), 1910.110 (storage and handling of liquefied petroleum gases), 

1910.157 (portable fire extinguishers), and 1910.1000 

(toxic and hazardous substances). 

Proper ventilation should be maintained at all times during the manufacture and storage of equipment containing hydrocarbon refrigerants through adherence to 

good manufacturing practices as per 29 CFR 

1910.106. If refrigerant levels in the air surrounding 

the equipment rise above one-fourth of the lower flammability limit, the space should be evacuated and reentry should occur only after the space has been 

properly ventilated. 

Technicians and equipment manufacturers should wear 

appropriate personal protective equipment, including 

chemical goggles and protective gloves, when handling these refrigerants. Special care should be taken 

to avoid contact with the skin since these refrigerants, 

like many refrigerants, can cause freeze burns on the 

skin. 

A Class B dry powder type fire extinguisher should be 

kept nearby. 

Technicians should only use spark-proof tools when 

working on refrigerators and freezers with these refrigerants. 

Any recovery equipment used should be designed for 

flammable refrigerants. 

Any refrigerant releases should be in a well-ventilated 

area, such as outside of a building. 

Only technicians specifically trained in handling flammable refrigerants should service refrigerators and 

freezers containing these refrigerants. Technicians 

should gain an understanding of minimizing the risk of 

fire and the steps to use flammable refrigerants safely. 

*******

Note: The use conditions in this appendix contain references to certain standards from Underwriters Laboratories Inc. (UL). The standards are incorporated by reference, and the referenced sections are made part of the regulations in part 82: 

1. UL 471. Commercial Refrigerators and Freezers. 10th edition. Supplement SB: Requirements for Refrigerators and Freezers Employing a Flammable Refrigerant 

in the Refrigerating System. Underwriters Laboratories, Inc. November 24, 2010. 

2. UL 484. Room Air Conditioners. 8th edition. Supplement SA: Requirements for Room Air Conditioners Employing a Flammable Refrigerant in the Refrigerating 

System and Appendices B through F. December 21, 2007, with changes through August 3, 2012. 

3. UL 541. Refrigerated Vending Machines. 7th edition. Supplement SA: Requirements for Refrigerated Venders Employing a Flammable Refrigerant in the Refrigerating System. December 30, 2011. 

4. UL Standard 60335–2–24. Standard for Safety: Requirements for Household and Similar Electrical Appliances,—Safety—Part 2–24: Particular Requirements for 

Refrigerating Appliances, Ice-Cream Appliances and Ice-Makers, Second edition, dated April 28, 2017. 

The Director of the Federal Register 

approves the incorporation by reference of 

the material under ‘‘Use Conditions’’ in the 

table ‘‘SUBSTITUTES THAT ARE 

ACCEPTABLE SUBJECT TO USE 

CONDITIONS’’ (5 U.S.C. 552(a) and 1 CFR 

part 51). Copies of UL Standards 471, 484, 

541, and 60335–2–24, may be purchased by 

mail at: COMM 2000, 151 Eastern Avenue, 

Bensenville, IL 60106; Email: orders@

shopulstandards.com; Telephone: 1–888– 

853–3503 in the U.S. or Canada (other 

countries dial 1–415–352–2178); internet 

address: http://www.shopulstandards.com/ 

Catalog.aspx. 

You may inspect a copy at U.S. EPA’s Air 

Docket; EPA West Building, Room 3334; 

1301 Constitution Ave. NW, Washington, DC 

or at the National Archives and Records 

Administration (NARA). For questions 

regarding access to these standards, the 

telephone number of EPA’S Air Docket is 

202–566–1742. For information on the 

availability of this material at NARA, call 

202–741–6030, or go to: https://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

* * * * * 

[FR Doc. 2018–16773 Filed 8–7–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0352; FRL–9978–83] 

Spinetoram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spinetoram in 

or on tea, dried and tea, instant. Dow 

AgroSciences, LLC., requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 8, 2018. Objections and requests 

for hearings must be received on or 

before October 9, 2018, 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–2017–0352, 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 


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Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations 38977 

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: 

Michael Goodis, 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). 

• 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–2017–0352 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 October 9, 2018. 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– 

2017–0352, 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 October 23, 

2017 (82 FR 49020) (FRL–9967–37), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 7E8554) by Dow 

AgroSciences LLC, 9330 Zionsville 

Road, Indianapolis, Indiana 46268– 

1054. The petition requested that 40 

CFR 180.635 be amended by 

establishing tolerances for residues of 

the insecticide spinetoram, in or on tea, 

dried at 70 parts per million (ppm) and 

tea, instant at 70 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. 

There were no comments received in 

response to the notice of filing. 

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 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 its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Spinetoram 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, therefore, 

the Agency has assessed and 

summarized the toxicological profile for 

both together. The primary toxic effect 

observed from exposure to spinetoram 

and spinosad 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 

the toxicological database 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 spinetoram or 

spinosad exposure. In developmental 

studies, no maternal or developmental 

effects were seen in rats or rabbits. In 

the rat reproduction toxicity studies, 

offspring toxicity (decreased litter size, 


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survival, and body weights with 

spinosad; increased incidence of late 

resorptions and post-implantation loss 

with spinetoram) was seen in the 

presence of parental toxicity (increased 

organ weights, mortality, and 

histopathological findings) at 

approximately the same dose for both 

chemicals. Dystocia and/or other 

parturition abnormalities were observed 

with both spinetoram and spinosad in 

the reproduction toxicity studies. There 

was no evidence of neurotoxicity, 

immunotoxicity, or carcinogenicity from 

spinetoram exposure. 

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-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Spinosad/Spinetoram. Human Health 

Risk Assessment in Support of Proposed 

Spinetoram Tolerance for Residues in/ 

on Imported Tea’’ at page 8 in docket 

ID number EPA–HQ–OPP–2017–0352 

and in document ‘‘Spinosad/ 

Spinetoram. Draft Human Health Risk 

Assessment for Registration Review,’’ at 

pages 12–17 in docket ID number EPA– 

HQ–OPP–2011–0666. 

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://

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

Spinetoram and spinosad should be 

considered toxicologically identical in 

the same manner that metabolites are 

generally considered toxicologically 

identical to the parent. As a result, 

studies from both toxicological 

databases were considered for endpoint 

selection. 

A summary of the toxicological 

endpoints for spinetoram used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPINETORAM/SPINOSAD 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. 

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 (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. 

Dermal (All durations) ............... No hazard was identified for dermal exposure; therefore, a quantitative dermal assessment is not needed. 

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.’’ 

FQPA SF = Food Quality Protection Act Safety Factor. 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). UFDB = to account for the absence of data or other data deficiency. 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. With the exception 


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of tea, 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 active 

ingredients 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. The risk assessment 

included commodities that have 

tolerances for both spinosad and 

spinetoram as well as commodities 

where only spinosad tolerances are 

established. EPA aggregated exposure by 

assuming that all commodities, with the 

exception of tea, contain spinosad 

(because side-by-side spinetoram and 

spinosad residue data indicated that 

spinetoram residues were less than or 

equal to spinosad residues); for tea, EPA 

assumed spinetoram residues were 

present. EPA assessed dietary exposures 

from 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 spinetoram or spinosad; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA NHANES/WWEIA 

(2003–2008). As to residue levels in 

food, EPA assumed 100 percent crop 

treated (PCT), average field-trial 

residues or tolerance-level residues for 

crop commodities, average residues 

from the livestock feeding studies, 

spinosad residue estimates for fish/ 

shellfish (residues of spinetoram in fish/ 

shellfish are expected to be 

insignificant), and experimental or 

default processing factors. 

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 percent 

crop treated (PCT) information. EPA did 

not use PCT information in the dietary 

assessment for spinetoram. 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 

Pesticide Root Zone Model Ground 

Water (PRZM GW), the estimated 

drinking water concentrations (EDWCs) 

of spinetoram for acute exposures are 

estimated to be 25.9 parts per billion 

(ppb) for surface water and below the 

levels of detection for ground water. For 

chronic exposures for non-cancer 

assessments, the spinetoram EDWCs are 

estimated to be 19.3 ppb for surface 

water and well below the levels of 

detection for ground water. EDWCs of 

spinosad for acute exposures are 

estimated to be 30.6 ppb for surface 

water and below the levels of detection 

for ground water. For chronic exposures 

for noncancer assessments, the 

spinetoram EDWCs are estimated to be 

22.8 ppb for surface water and below 

the levels of detection for ground water. 

Modeled estimates of drinking water 

concentration were directly entered into 

the dietary exposure model. For chronic 

dietary risk assessment, the water 

concentration of value 22.8 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). 

EPA assessed residential exposure 

using the following assumptions: The 

use on tea will not result in residential 

exposure; however, spinetoram and 

spinosad are currently registered for 

uses that could result in residential 

exposures including home lawns and 

pet (cats/kittens) spot-on applications; 

therefore, there is potential for 

residential handler and post-application 

exposures to both spinetoram and 

spinosad. 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 the following ‘‘worstcase’’ residential exposure scenarios as: 

(1) Adult residential handler (inhalation 

exposure from applications to lawns 

and turf) and (2) child (1–<2 years) 

(hand-to-mouth exposures from postapplication exposure to turf). Because 

EPA’s level of concern for spinetoram is 

a MOE below 100, the MOEs for both of 

these residential exposure scenarios are 

not of concern. In addition, the shortterm assessment is protective of 

intermediate-term exposure as the shortand intermediate-term PODs are 

identical. 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 spinetoram to 

share a common mechanism of toxicity 

with any other substances, and 

spinetoram does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that spinetoram does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 


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D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of increased 

prenatal or postnatal susceptibility. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for spinetoram 

is adequate for FQPA SF consideration. 

ii. There is no evidence of 

neurotoxicity from spinetoram 

exposure. 

iii. There is no evidence that 

spinetoram results in increased pre- or 

post-natal susceptibility in rats or 

rabbits. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

EPA made conservative (protective) 

assumptions in assessing exposures and 

these assessments will not 

underestimate the exposure and risks 

posed by 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, spinetoram is 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 

from food and water will utilize 72% 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 is not expected; 

therefore, the chronic dietary estimate 

represents the chronic aggregate 

estimate. 

3. Short- and Intermediate-term risk. 

Short- and Intermediate-term aggregate 

exposures takes into account short-term 

and intermediated-term residential 

exposures plus chronic exposure to food 

and water (considered to be a 

background exposure level). Spinetoram 

is currently registered for uses that 

could result in short- and intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures to 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 780 for adults (handler) and 

200 for children (post-application). 

Because EPA’s level of concern for 

spinetoram is a MOE below 100, these 

MOEs are not of concern. In addition, 

the short-term assessment is protective 

of intermediate-term exposure as the 

short- and intermediate-term PODs are 

identical. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

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 

Adequate enforcement methodology 

is available for both plant and livestock 

commodities. Method GRM 05.03 

(HPLC/MS/MS) is an acceptable method 

for the determination of spinetoram 

residues in a variety of crops. Methods 

GRM 05.15 and GRM 06.08 (HPLC/MS) 

are acceptable methods for 

determination of spinetoram residues in 

bovine and poultry tissues, milk, cream, 

and eggs. Both methods are available to 

enforce the tolerance expression. 

The methods may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

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. 

The Codex has not established a MRL 

for spinetoram. 

V. Conclusion 

Therefore, tolerances are established 

for residues of spinetoram, expressed as 

the combined residues of XDE–175–J: 1- 

H-as-indaceno[3,2-d]oxacyclododecin7,15-dione, 2-[(6-deoxy-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-[(6-deoxy-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-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- 


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Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations 38981 

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-methyla-L-mannopyranosyl) oxy]-9-ethyl-14- 

methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,

9,10,11,12,13,14,15,16a,16b-octade

cahydro-1H-as-indaceno[3,2-d]

oxacyclododecin-13-yl]oxy)-2- 

methyltetrahydro-2H-pyran-3- 

yl(methyl)formamide, in or on tea, dried 

at 70 parts per million (ppm) and tea, 

instant at 70 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); or Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). 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: July 24, 2018. 

Michael Goodis, 

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 add alphabetically the 

entries for ‘‘Tea, dried’’; and ‘‘Tea, 

instant’’; and footnote 1 to the table in 

paragraph (a) to read as follows: 

§ 180.635 Spinetoram; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Tea, dried 1 ........................... 70 

Tea, instant 1 ......................... 70 

* * * * * 

1There are no U.S. registrations as of August 8, 2018 for use on tea. 

* * * * * 

[FR Doc. 2018–16989 Filed 8–7–18; 8:45 am] 

BILLING CODE 6560–50–P 


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