45844 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations 

mexyl, (acetic acid [(5-chloro-8- 

quinolinyl)oxy]-, 1-methylhexyl ester; 

CAS Reg. No. 99607–70–2) and its acid 

metabolite (5-chloro-8- 

quinolinoxyacetic acid), expressed as 

cloquintocet-mexyl, in or on the 

following commodities: 

* * * * * 

[FR Doc. 2018–19757 Filed 9–10–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0505; FRL–9982–21] 

Spiromesifen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of spiromesifen in 

or on coffee. Bayer CropScience 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

September 11, 2018. Objections and 

requests for hearings must be received 

on or before November 13, 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–2017–0505, 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: 

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–2017–0505 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before November 13, 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– 

2017–0505, 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 February 

27, 2018 (83 FR 8408) (FRL–9972–17), 

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 7E8584) by Bayer 

CropScience, 2 T.W. Alexander Drive, 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of spiromesifen; 2-oxo-3- 

(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-4-yl 3,3- 

dimethylbutanoate, and its enol 

metabolite (4-hydroxy-3-(2,4,6- 

trimethylphenyl)-1-oxaspiro[4.4]non-3- 

en-2-one calculated as the 

stoichiometric equivalent of 

spiromesifen in or on the raw 

agricultural commodities: Coffee bean, 

green at 0.20 parts per million (ppm); 

coffee, instant at 0.20 ppm; and coffee 

bean, roasted at 0.20 ppm. That 

document referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the commodities for which 

tolerances are being established. The 

reason for these changes is explained in 

Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 


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Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations 45845 

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 spiromesifen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with spiromesifen 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. 

Following oral administration of 

spiromesifen, the target organs included 

the thyroid gland for rats and dogs 

(increased thyroid-stimulating hormone 

(TSH), increased thyroxine binding 

capacity, decreased triiodothyronine 

(T3) and thyroxine (T4) levels, colloidal 

alteration, and thyroid follicular cell 

hypertrophy), the liver for rats and dogs 

(increased alkaline phosphatase, alanine 

transaminase (ALT), and decreased 

cholesterol and triglycerides), the spleen 

for rats (atrophy, decreased spleen cell 

count, and increased macrophages), and 

the adrenal gland for mice 

(discoloration, decrease in fine 

vesiculation, and the presence of 

cytoplasmic eosinophilia in zona 

fasciculata cells). For rats, additional 

effects included reduced body weights 

and clinical signs (piloerection, reduced 

motility, spastic gait, and increased 

reactivity when touched). 

There were no adverse effects in rats 

following dermal exposure up to the 

limit dose (1,000 milligrams/kilograms/ 

day (mg/kg/day)). Decreased spleen 

weights were also observed for rats in a 

5-day inhalation toxicity study, along 

with gross pathological findings in the 

lung (dark red areas or foci) and clinical 

signs (e.g., tremors, clonic-tonic 

convulsions, reduced activity, 

bradypnea, etc.). 

While the clinical signs observed in 

rats following oral and inhalation 

exposures could indicate neurotoxicity, 

there was no evidence of neurotoxicity 

in the rest of the toxicological database, 

including the acute neurotoxicity study 

up to the limit dose (2,000 milligrams/ 

kilograms (mg/kg)) and the subchronic 

neurotoxicity study; however, the doses 

tested in the subchronic neurotoxicity 

study were lower than the doses causing 

clinical signs in the 90-day dietary 

study in rats. There was no evidence of 

immunotoxicity in an antibody plaquecell forming assay. 

There was no evidence of increased 

pre- or post-natal susceptibility. In the 

developmental toxicity studies in rats 

and rabbits, maternal effects were 

observed in the absence of fetal effects. 

In the rat two-generation reproductive 

toxicity study, the reported parental 

effects, consisting of decreased spleen 

weights (relative and absolute) and a 

decreasing number of ovarian follicles, 

occurred at a dose level that also caused 

pup body weight decrements during 

lactation. 

Spiromesifen is classified as ‘‘Not 

likely to be Carcinogenic to Humans’’ 

based on the absence of treatmentrelated tumors in two adequate rodent 

carcinogenicity studies. There was no 

concern for mutagenicity or 

genotoxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by spiromesifen 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 the document 

titled, ‘‘Spiromesifen. Human Health 

Risk Assessment in Support of Proposed 

Tolerance for Residues of in/on 

Imported Coffee’’ in docket ID number 

EPA–HQ–OPP–2017–0505. 

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 

LOAEL 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. 

A summary of the toxicological 

endpoints for spiromesifen used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPIROMESIFEN 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) ............. No appropriate toxicological effect attributable to a single dose was observed. Therefore, a dose and 

endpoint were not identified for this risk assessment. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPIROMESIFEN 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 = 2.2 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.022 

mg/kg/day.

cPAD = 0.022 mg/kg/ 

day 

Two-Generation Reproduction Study—Rats 

Parental LOAEL = 8.8 mg/kg bw/day based on 

significantly decreased spleen weight (absolute 

and relative in parental females and F1 males) 

and significantly decreased growing ovarian 

follicles in females. 

Oral short-term (1 to 30 days) and intermediate-term (1–6 months).NOAEL = 2.2 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ...... Two-Generation Reproduction Study—Rats 

Parental LOAEL = 8.8 mg/kg bw/day based on 

significantly decreased spleen weight (absolute 

and relative in parental females and F1 males) 

and significantly decreased growing ovarian 

follicles in females. 

Inhalation short-term (1 to 30 days) 

and intermediate-term (1–6 months).

Inhalation study NOAEC 

= 0.0794 mg/L/day.

UFA = 3x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 30 5-Day Inhalation Toxicity Study—Rats LOAEC = 

0.5143 mg/L/day based on clinical signs (tremors, clonic-tonic convulsions, reduced activity, 

bradypnea, labored breathing, vocalization, 

avoidance reaction, giddiness, piloerection, 

limp, emaciation, cyanosis, squatted posture, 

apathy and salivation), gross pathology (dark 

red areas or foci in the lungs and bloated 

stomachs and pale livers), and decreased 

spleen weights. 

Cancer (Oral, dermal, inhalation) ........ Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of treatment-related tumors in two adequate rodent carcinogenicity studies. 

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). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). NOAEC = non-observed adverse-effect concentration. LOAEC = lowest-observed adverse-effect concentration. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spiromesifen, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing spiromesifen tolerances in 40 

CFR 180.607. EPA assessed dietary 

exposures from spiromesifen 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 spiromesifen; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA; 

2003–2008). As to residue levels in 

food, the chronic (food and water) 

analysis assumed 100 percent crop 

treated (PCT) and tolerance-level 

residues or tolerance-level residues 

adjusted to account for the residue of 

concern. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that spiromesifen 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 PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

spiromesifen. Tolerance level residues 

or tolerance-level residues adjusted to 

account for the residue of concern and 

100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for spiromesifen in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

spiromesifen. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www2.epa.gov/ 

pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. 

Based on the Provisional Cranberry 

model and Pesticide Water Calculator— 

Groundwater (PWC–GW) model, the 

estimated drinking water concentrations 

(EDWCs) of spiromesifen for chronic 

exposures are estimated to be 188 parts 

per billion (ppb) for surface water and 

116 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

chronic dietary risk assessment, the 

water concentration of value 188 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). 

Spiromesifen is currently registered 

for the following uses that could result 

in residential exposures: Ornamentals. 

EPA assessed residential exposure using 

the following assumptions: Short-term 

inhalation exposure to residential 

handlers is expected. A dermal 

assessment (handler and postVerDate Sep<11>2014 16:11 Sep 10, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\FR\FM\11SER1.SGM 11SER1

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Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations 45847 

application) was not conducted since no 

hazard was identified via the dermal 

route. Post-application inhalation 

exposures were not assessed due to the 

low vapor pressure and the expected 

dilution in outdoor sites. Postapplication incidental oral exposure is 

considered unlikely since the use is 

restricted to ornamental plants (turf 

treatment is not permitted). Therefore, 

only short-term inhalation exposure to 

handlers was assessed. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

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 spiromesifen to 

share a common mechanism of toxicity 

with any other substances, and 

spiromesifen does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that spiromesifen 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. 

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 preor post-natal susceptibility. In the 

developmental toxicity studies in rats 

and rabbits, maternal effects were 

observed in the absence of fetal effects. 

In the rat two-generation reproductive 

toxicity study, the reported parental 

effects, consisting of decreased spleen 

weights (relative and absolute) and a 

decreasing number of ovarian follicles, 

occurred at a dose level that also caused 

pup body weight decrements during 

lactation. 

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 

spiromesifen is complete. 

ii. There is no indication that 

spiromesifen is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. There is no evidence that 

spiromesifen results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to spiromesifen 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by spiromesifen. 

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, spiromesifen 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 spiromesifen 

from food and water will utilize 68% of 

the cPAD for children 1 to 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 

spiromesifen 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). Spiromesifen 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 spiromesifen. 

Because the level of concern (LOC) for 

inhalation (LOC for MOEs <30) and oral 

(LOC for MOEs <100) exposure differ, 

the aggregate assessment was calculated 

using the aggregate risk index (ARI) 

approach. The ARI was devised as a 

way to aggregate MOEs that have 

dissimilar uncertainty factors. The ARI 

is an extension of the MOE concept and 

as with the MOE, risk increases as the 

ARI decreases. An ARI that is greater 

than or equal to 1 is not of concern. 

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 an 

aggregate ARI of 1.87. Because EPA’s 

level of concern for spiromesifen is an 

ARI of 1 or below, this ARI is not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, spiromesifen is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 


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intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

spiromesifen. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

spiromesifen is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to spiromesifen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry/mass spectrometry (LC/ 

MS/MS)) is available to enforce the 

tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

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 has a MRL for residues of only 

spiromesifen in/on coffee beans of 0.05 

ppm. Since the residue expression for 

the U.S. and Codex tolerances differ and 

since the maximum combined residues 

of spiromesifen and BSN 2060-enol in/ 

on coffee green bean from the field trials 

was greater than 0.1 ppm, 

harmonization with the Codex 

expression/value is not possible. Note 

that BSN 2060-enol is included in the 

tolerance expression due to the 

demonstrated degradation of parent to 

BSN 2060-enol during storage. 

C. Response to Comments 

Three comments were submitted to 

the docket for this action. Two 

comments, one about ‘‘China’s ongoing 

economic war against the United States’’ 

and another about air and water 

pollution in China relative to that of the 

United States, are not relevant to this 

action. The third comment stated in part 

that ‘‘the people drinking coffee should 

not have this toxic chemical as part of 

its drink.’’ 

The Agency recognizes that some 

individuals believe that pesticides 

should be banned on agricultural crops; 

however, the existing legal framework 

provided by section 408 of the FFDCA 

states that tolerances may be set when 

persons seeking such tolerances or 

exemptions have demonstrated that the 

pesticide meets the safety standard 

imposed by that statute. This citizen’s 

comment appears to be directed at the 

underlying statute and not EPA’s 

implementation of it; the citizen has 

made no contention that EPA has acted 

in violation of the statutory framework 

nor have they provided any specific 

information or allegation that would 

support a finding that these tolerances 

are unsafe. 

D. Revisions to Petitioned-For 

Tolerances 

The green coffee bean tolerance being 

established is identical to that proposed 

by the petitioner. EPA has determined 

that separate tolerances for the 

processed commodities of roasted coffee 

bean and instant coffee are unnecessary 

because the processing data indicates 

that combined residues of spiromesifen 

and BSN 2060-enol do not concentrate 

in roasted or instant coffee. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of spiromesifen, including 

its metabolites and degradates, in or on 

coffee, green bean at 0.20 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), nor is it considered a 

regulatory action under 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.). 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations 45849 

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: August 28, 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 § 180.607, add alphabetically the 

commodity ‘‘coffee, green bean’’ and 

footnote 1 to the table in paragraph 

(a)(1) to read as follows: 

§ 180.607 Spiromesifen; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Coffee, green bean 1 ................. 0.20 

* * * * * 

1This use has not been registered in the 

United States as of August 28, 2018. 

* * * * * 

[FR Doc. 2018–19760 Filed 9–10–18; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 300 

[Docket No. 180209155–8589–02] 

RIN 0648–XG458 

International Fisheries; Western and 

Central Pacific Fisheries for Highly 

Migratory Species; Closure of Purse 

Seine Fishery on the High Seas in 2018 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; fishery closure. 

SUMMARY: NMFS announces that the 

U.S. purse seine fishery on the high seas 

in the area of application of the 

Convention on the Conservation and 

Management of Highly Migratory Fish 

Stocks in the Western and Central 

Pacific Ocean (Convention) between the 

latitudes of 20° N and 20° S will close 

as a result of reaching the 2018 limit on 

purse seine fishing effort in that area. 

This action is necessary for the United 

States to implement provisions of a 

conservation and management measure 

adopted by the Commission for the 

Conservation and Management of 

Highly Migratory Fish Stocks in the 

Western and Central Pacific Ocean 

(WCPFC or Commission) and to satisfy 

the obligations of the United States 

under the Convention, to which it is a 

Contracting Party. 

DATES: Effective 00:00 on September 18, 

2018 coordinated universal time (UTC), 

until 24:00 on December 31, 2018 UTC. 

FOR FURTHER INFORMATION CONTACT: Rini 

Ghosh, NMFS Pacific Islands Regional 

Office, 808–725–5033. 

SUPPLEMENTARY INFORMATION: 

U.S. purse seine fishing in the area of 

application of the Convention, or 

Convention Area, is managed, in part, 

under the Western and Central Pacific 

Fisheries Convention Implementation 

Act (16 U.S.C. 6901 et seq.). Regulations 

implementing the Act are at 50 CFR part 

300, subpart O. On behalf of the 

Secretary of Commerce, NMFS 

promulgates regulations under the Act 

as may be necessary to carry out the 

obligations of the United States under 

the Convention, including 

implementation of the decisions of the 

Commission. 

Pursuant to WCPFC Conservation and 

Management Measure 2017–01, NMFS 

issued regulations that established a 

limit of 1,370 fishing days that may be 

used by U.S. purse seine fishing vessels 

on the high seas between the latitudes 

of 20° N and 20° S in the Convention 

Area in calendar year 2018 (see final 

rule at 83 FR 33851, published July 18, 

2018, codified at 50 CFR 300.223). A 

fishing day means any day in which a 

fishing vessel of the United States 

equipped with purse seine gear searches 

for fish, deploys a fish aggregating 

device (FAD), services a FAD, or sets a 

purse seine, with the exception of 

setting a purse seine solely for the 

purpose of testing or cleaning the gear 

and resulting in no catch (see definition 

at 50 CFR 300.211). 

Based on data submitted in logbooks 

and other available information, NMFS 

expects that the 2018 limit of 1,370 

fishing days will be reached, and in 

accordance with the procedures 

established at 50 CFR 300.223(a), 

announces that the purse seine fishery 

on the high seas between the latitudes 

of 20° N and 20° S in the Convention 

Area will be closed starting at 00:00 on 

September 18, 2018 UTC, and will 

remain closed until 24:00 on December 

31, 2018 UTC. Accordingly, it shall be 

prohibited for any fishing vessel of the 

United States equipped with purse seine 

gear to be used for fishing on the high 

seas between the latitudes of 20° N and 

20° S in the Convention Area from 00:00 

on September 18, 2018 UTC until 24:00 

December 31, 2018 UTC, except that 

such vessels will not be prohibited from 

bunkering in that area during that 

period (50 CFR 300.223(a)). Fishing 

means using any vessel, vehicle, aircraft 

or hovercraft for any of the following 

activities, or attempting to do so: (1) 

Searching for, catching, taking, or 

harvesting fish; (2) engaging in any 

other activity which can reasonably be 

expected to result in the locating, 

catching, taking, or harvesting of fish for 

any purpose; (3) placing, searching for, 

or recovering fish aggregating devices or 

associated electronic equipment such as 

radio beacons; (4) engaging in any 

operations at sea directly in support of, 

or in preparation for, any of the 

activities previously described in 

elements (1) through (3) of this 

definition, including, but not limited to, 

bunkering; or (5) engaging in 

transshipment at sea, either unloading 

or loading fish (see definition at 50 CFR 

300.211). As noted above, bunkering 

will not be prohibited in the closure 

area during the closure period. This rule 

does not prohibit lawful fishing with 

purse seine gear within the U.S. 

Exclusive Economic Zone within the 

Convention Area. 

Classification 

There is good cause under 5 U.S.C. 

553(b)(B) to waive prior notice and 


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