Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations 26369 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. We have 

analyzed this rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. If you 

believe this rule has implications for 

federalism or Indian tribes, please 

contact the person listed in the FOR

FURTHER INFORMATION CONTACT section. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 (42 

U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves 

establishment of a safety zone. It is 

categorically excluded from further 

review under paragraph L60(a) of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 01. A 

Record of Environmental Consideration 

supporting this determination is 

available in the docket where indicated 

under ADDRESSES. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to contact the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and record keeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Add § 165.T09–0242 to read as 

follows: 

§ 165.T09–0242 Safety Zone; Blazing 

Paddles 2018 SUP Race; Cuyahoga River, 

Cleveland, OH. 

(a) Location. The safety zone will 

encompass all waters of the Cuyahoga 

River in Cleveland OH, beginning at 

position 41°29′36′′ N and 081°42′13′′ W 

to the turnaround point at position 

41°28′52′′ N and 081°40′33′′ (NAD 83). 

(b) Enforcement period. This rule will 

be enforced from 8:30 a.m. through 

11:30 a.m. on June 23, 2018. 

(c) Regulations. (1) In accordance with 

the general regulations in § 165.23, entry 

into, transiting, or anchoring within this 

safety zone is prohibited unless 

authorized by the Captain of the Port 

Buffalo (COTP) or his designated onscene representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the COTP or his 

designated on-scene representative. 

(3) The ‘‘on-scene representative’’ of 

the COTP is any Coast Guard 

commissioned, warrant or petty officer 

who has been designated by the COTP 

to act on his behalf. 

(4) Vessel operators desiring to enter 

or operate within the safety zone must 

contact the COTP Buffalo or his onscene representative to obtain 

permission to do so. The COTP or his 

on-scene representative may be 

contacted via VHF Channel 16 or at 

(716) 843–9322. Vessel operators given 

permission to enter or operate in the 

safety zone must comply with all 

directions given to them by the COTP or 

his on-scene representative. 

Dated: June 4, 2018. 

Joseph S. Dufresne, 

Captain, U.S. Coast Guard, Captain of the 

Port Buffalo. 

[FR Doc. 2018–12301 Filed 6–6–18; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0376; FRL–9978–20] 

Acequinocyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acequinocyl in 

or on guava and the tropical and 

subtropical, small fruit, inedible peel, 

subgroup 24A. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

7, 2018. Objections and requests for 

hearings must be received on or before 

August 6, 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–2017–0376, 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 


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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–2017–0376 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 August 6, 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– 

2017–0376, 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 7E8579) by IR–4, 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the insecticide acequinocyl, 

2-(acetyloxy)-3-dodecyl-1,4- 

naphthalenedione, and its metabolite, 2- 

dodecyl-3-hydroxy-1,4-naphthoquinone 

(acequinocyl-OH), expressed as 

acequinocyl equivalents in or on guava 

at 0.9 ppm and the tropical and 

subtropical, small fruit, inedible peel, 

subgroup 24A at 2 ppm. That document 

referenced a summary of the petition 

prepared by Arysta LifeScience, the 

registrant, which is available in the 

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

comment expressing concern about the 

effects of wind turbines on bats was 

received on the notice of filing, but it is 

not relevant to this action. 

EPA is establishing the requested 

tolerances with additional significant 

figures in conformity with Agency 

policy. 

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 acequinocyl 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with acequinocyl 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. 

The target organs of acequinocyl are 

the liver (hepatocyte vacuolization, 

brown pigmented cells and perivascular 

inflammatory cells in liver) and 

hematopoietic system (hemorrhage, 

increased clotting factor times and 

increased platelet counts). There was no 

evidence of neurotoxicity or 

immunotoxicity. There was no evidence 

of carcinogenic potential in either the 

rat or mouse and there was no concern 

for genotoxicity or mutagenicity. 

In rats and rabbits, there was no 

evidence of increased quantitative or 

qualitative fetal susceptibility. For both 

species, maternal effects (clinical signs 

and gross necropsy findings) were 

observed at similar or lower doses than 

those producing fetal effects. In rabbits, 

there were increased incidences of late 

resorptions at the highest dose tested. 

Since it is unknown whether 

resorptions occurred from toxicity to 

maternal animals or the fetuses, the 

resorptions are considered maternal and 

developmental adverse effects. In the rat 


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two-generation reproduction toxicity 

study, there was increased quantitative 

offspring susceptibility. Offspring 

effects consisted of hemorrhagic effects, 

swollen body parts (head and 

extremities), protruding eyes, clinical 

signs (bloody encrusted nose, cold to 

touch, red urine, blue colored eyes and 

extremities, paleness), delays in pupil 

development, and increased mortality 

occurring mainly after weaning. The 

increased incidences of hemorrhagic 

effects post-weaning indicate toxicity to 

the hematopoietic system. While there 

were no parental effects up to the 

highest dose tested, hematological 

effects (changes in partial and activated 

partial thromboplastin times) were 

observed in adult animals in other 

studies at the same dose causing the 

offspring effects, but were not measured 

in the two-generation reproduction 

toxicity study. As a result, using a 

weight-of-evidence approach that 

considers the findings from the twogeneration reproduction toxicity study 

in context of the full toxicological 

database, parental toxicity would be 

anticipated at the same doses as 

offspring effects if additional 

evaluations had been performed, 

particularly hematological 

measurements. There were no effects on 

reproductive parameters. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by acequinocyl 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 ‘‘Acequinocyl. Human Health Risk 

Assessment to Support the Petition for 

Tolerance for Residues in/on Guava and 

Tropical and Subtropical, Small Fruit, 

Inedible Peel, Subgroup 24A’’ on page 

numbers 29–31 in docket ID number 

EPA–HQ–OPP–2017–0376. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

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

A summary of the toxicological 

endpoints for acequinocyl used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of January 18, 2017 

(82 FR 5409) (FRL–9956–85). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to acequinocyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing acequinocyl tolerances in 40 

CFR 180.599. EPA assessed dietary 

exposures from acequinocyl 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. 

Such effects were identified for 

acequinocyl. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). As 

to residue levels in food, EPA assumed 

tolerance-level residues and 100 percent 

crop treated (PCT) for all proposed and 

registered uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/ 

WWEIA. As to residue levels in food, 

EPA assumed tolerance-level residues 

and 100 PCT for all proposed and 

registered uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that acequinocyl 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 

acequinocyl. Tolerance-level residues 

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 acequinocyl in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of acequinocyl. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS), Provisional 

Cranberry Model, and Screening 

Concentration in Ground Water (SCI– 

GROW) Model, the estimated drinking 

water concentrations (EDWCs) of 

acequinocyl for acute exposures are 

estimated to be 6.69 parts per billion 

(ppb) for surface water and 3.6 × 10¥3

ppb for ground water, and for chronic 

exposures are estimated to be 6.69 ppb 

for surface water and 3.6 × 10¥3 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

both the acute and chronic dietary risk 

assessments, the water concentration 

value of 6.69 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). 

Acequinocyl is currently registered 

for the following uses that could result 

in residential exposures: Use on 

ornamentals for landscapes, gardens, 

and trees. EPA assessed residential 

exposure using the following 

assumptions: Residential handler 

exposures are not expected since all 

registered acequinocyl product labels 

with residential use sites (e.g., 

ornamentals for landscapes, gardens, 

and trees) require that handlers wear 

specific clothing (e.g., long-sleeve shirt/ 

long pants) and/or use personal 

protective equipment (PPE). As a result, 

a residential handler assessment was 

not conducted. 


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Only short-term post-application 

dermal exposure is anticipated for the 

registered residential uses. The 

quantitative exposure/risk assessment 

for residential post-application 

exposures assessed dermal exposures to 

adults for activities associated with 

gardening, dermal exposures to children 

(6 to <11 years old) for activities 

associated with playing in and around 

gardens and gardening, dermal 

exposures to adults associated with 

handling trees and retail plants, and 

dermal exposures to children (6 to <11 

years old) for activities associated with 

playing in and around trees and retail 

plants. 

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 acequinocyl to 

share a common mechanism of toxicity 

with any other substances, and 

acequinocyl does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that acequinocyl 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 is no evidence of an increased 

quantitative or qualitative fetal 

susceptibility in rats or rabbits. In 

isolation, there was evidence of 

increased quantitative offspring 

susceptibility in the two-generation 

reproductive study; however, the 

concern is low since: 

i. The effects in pups are well 

characterized with a clear NOAEL and 

ii. The effects are protected for by the 

selected endpoints. 

Therefore, there are no residual 

uncertainties for pre-/post-natal toxicity. 

Additionally, hematological parameters 

were not measured for the parental 

animals in the two-generation 

reproductive study; however, 

hematological effects were observed in 

adult animals in other oral rat studies at 

the same doses eliciting offspring 

effects. Therefore, considering the 

offspring findings in the two-generation 

reproductive toxicity study in context 

with the full toxicological database, 

there is no concern for offspring 

susceptibility since parental toxicity 

would be anticipated at the same dose 

as offspring effects. 

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 

acequinocyl is complete. 

ii. There is no indication that 

acequinocyl is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence of an 

increased quantitative or qualitative 

fetal susceptibility in rats or rabbits, but 

in isolation there was evidence of 

increased quantitative offspring 

susceptibility in the two-generation 

reproductive study. However, the 

concern is low for the reasons outlined 

above in section III.D.2. 

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 acequinocyl 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children. These 

assessments will not underestimate the 

exposure and risks posed by 

acequinocyl. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

acequinocyl will occupy 71% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to acequinocyl 

from food and water will utilize 71% 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 acequinocyl 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). Acequinocyl 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 acequinocyl. 

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 1140 for adults and 910 for 

children 6–11 years old. Because EPA’s 

level of concern for acequinocyl is a 

MOE of 100 or below, these MOEs are 

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). 


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An intermediate-term adverse effect 

was identified; however, acequinocyl 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 

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 

acequinocyl. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

acequinocyl 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 acequinocyl 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(two high-performance liquid 

chromatography methods with tandem 

mass-spectroscopy detection (HPLC/ 

MS/MS) for determining residues in/on 

fruit and nut commodities (Morse 

Methods Meth-133, Revision #4 and 

Meth-135, Revision #3)) 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. 

The Codex has not established any 

MRLs for acequinocyl on the crops cited 

in this document. 

V. Conclusion 

Therefore, tolerances are established 

for residues of acequinocyl, including 

its metabolites and degradates, in or on 

guava at 0.90 ppm and the tropical and 

subtropical, small fruit, inedible peel, 

subgroup 24A at 2.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), 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.). 

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: May 25, 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 § 180.599, add alphabetically the 

entries ‘‘Guava’’ and ‘‘Tropical and 

subtropical, small fruit, inedible peel, 


sradovich on DSK3GMQ082PROD with RULES
26374 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations 

subgroup 24A’’ to the table in paragraph 

(a) to read as follows: 

§ 180.599 Acequinocyl; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Guava ......................................... 0.90 

* * * * * 

Tropical and subtropical, small 

fruit, inedible peel, subgroup 

24A .......................................... 2.0 

* * * * * 

* * * * * 

[FR Doc. 2018–12297 Filed 6–6–18; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

49 CFR Part 373 

RIN 2126–AC06 

General Technical, Organizational, 

Conforming, and Correcting 

Amendments to the Federal Motor 

Carrier Safety Regulations; Correction 

AGENCY: Federal Motor Carrier Safety 

Administration (FMCSA), DOT. 

ACTION: Final rule; correction. 

SUMMARY: FMCSA corrects the technical 

corrections final rule published on May 

17, 2018, that amended FMCSA 

regulations to make minor changes to 

correct inadvertent errors and 

omissions, remove or update obsolete 

references, ensure conformity with 

Office of the Federal Register style 

guidelines, and improve the clarity and 

consistency of certain regulatory 

provisions. This document corrects an 

amendatory instruction. 

DATES: Effective June 18, 2018. 

FOR FURTHER INFORMATION CONTACT: Mr. 

David Miller, Federal Motor Carrier 

Safety Administration, Regulatory 

Development Division, 1200 New Jersey 

Avenue SE, Washington, DC 20590– 

0001, by telephone at (202) 366–5370 or 

via email at david.miller@dot.gov. Office 

hours are from 9 a.m. to 5 p.m. e.t., 

Monday through Friday, except Federal 

holidays. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2018–10437, appearing on page 22873 

in the Federal Register of Thursday, 

May 17, 2018, the following correction 

is made: 

§ 373.103 [Corrected] 

■ 1. On page 22873, in the third column, 

in amendment 10a., the instruction 

‘‘Withdraw the amendments to 

§ 373.103 published April 16, 2018, at 

83 FR 16224’’ is withdrawn. 

Issued under the authority delegated in 49 

CFR 1.87 on: May 30, 2018. 

Larry W. Minor, 

Associate Administrator for Policy. 

[FR Doc. 2018–12032 Filed 6–6–18; 8:45 am] 

BILLING CODE 4910–EX–P 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

49 CFR Part 395 

[Docket No. FMCSA–2017–0360] 

Hours of Service of Drivers of 

Commercial Motor Vehicles; 

Regulatory Guidance Concerning the 

Transportation of Agricultural 

Commodities 

AGENCY: Federal Motor Carrier Safety 

Administration (FMCSA), DOT 

ACTION: Announcement of regulatory 

guidance 

SUMMARY: FMCSA announces regulatory 

guidance to clarify the applicability of 

the ‘‘Agricultural commodity’’ 

exception in the ‘‘Hours of Service 

(HOS) of Drivers’’ regulations. This 

regulatory guidance clarifies the 

exception with regard to: drivers 

operating unladen vehicles traveling 

either to pick up an agricultural 

commodity or returning from a delivery 

point; drivers engaged in trips beyond 

150 air-miles from the source of the 

agricultural commodity; determining 

the ‘‘source’’ of agricultural 

commodities under the exemptions; and 

how the exception applies when 

agricultural commodities are loaded at 

multiple sources during a trip. This 

regulatory guidance is issued to ensure 

consistent understanding and 

application of the exception by motor 

carriers and State officials enforcing 

HOS rules identical to or compatible 

with FMCSA’s requirements. 

DATES: This guidance is applicable on 

June 7, 2018 and expires June 7, 2023. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Thomas Yager, Chief, Driver and Carrier 

Operations Division, Federal Motor 

Carrier Safety Administration, U.S. 

Department of Transportation, 1200 

New Jersey Avenue SE, Washington, DC 

20590, phone (202) 366–4325, email 

MCPSD@dot.gov. 

SUPPLEMENTARY INFORMATION: 

I. Public Participation 

Viewing Comments and Documents 

To view comments, as well as 

documents mentioned in this preamble 

as being available in the docket, go to 

www.regulations.gov and insert the 

docket number, ‘‘FMCSA–2017–0360’’ 

in the ‘‘Keyword’’ box and click 

‘‘Search.’’ Next, click the ‘‘Open Docket 

Folder’’ button and choose the 

document to review. If you do not have 

access to the internet, you may view the 

docket online by visiting the Docket 

Management Facility in Room W12–140 

on the ground floor of the DOT West 

Building, 1200 New Jersey Avenue SE, 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., e.t., Monday through Friday, 

except Federal holidays. 

II. Legal Basis 

The National Highway System 

Designation Act of 1995, Public Law 

104–59, sec. 345, 109 Stat. 568. 613 

(Nov. 28, 1995) (the Act), provided the 

initial exception for drivers transporting 

agricultural commodities or farm 

supplies for agricultural purposes. The 

Act limited the exception to a 100 airmile radius from the source of the 

commodities or distribution point for 

the farm supplies and during the 

planting and harvesting seasons as 

determined by the applicable State. 

The Safe, Accountable, Flexible, 

Efficient Transportation Act: A Legacy 

for Users (SAFETEA–LU) revised this 

provision, redesignated it as new 

section 229 of Title II of the Motor 

Carrier Safety Improvement Act of 1999, 

and defined the terms ‘‘agricultural 

commodity’’ and ‘‘farm supplies for 

agricultural purposes.’’ Public Law 109– 

59, sections 4115 and 4130, 119 Stat. 

1144, 1726, 1743 (Aug. 10, 2005). These 

terms are now defined in 49 CFR 395.2. 

Most recently, the statute was 

amended by section 32101(d) of the 

Moving Ahead for Progress in the 21st 

Century Act (MAP–21), Public Law 

112–141, 126 Stat. 405, 778 (July 6, 

2012). This provision revised the 

description of the exception’s scope and 

extended the applicable distance from 

100 air-miles to 150 air-miles from the 

source. 

III. Background 

The focus of today’s guidance is 

limited to the application of the 150 airmile exception for the transportation of 

‘‘agricultural commodities,’’ 49 CFR 

395.1(k)(1). It does not address ‘‘farm 

supplies for agricultural purposes’’ 


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