21752 Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Rules and Regulations 

EPA APPROVED REGULATIONS IN THE TEXAS SIP—Continued 

State citation Title/subject 

State 

approval/submittal date EPA approval date Explanation 

*******

Subchapter H: Administrative Provisions 

Division 1: Compliance Schedules 

*******

Section 117.9030 ....... Compliance Schedule for Dallas-Fort 

Worth Eight-Hour Ozone Nonattainment Area Major Sources.

6/3/2015 4/13/2016 [Insert Federal Register citation].

* * * * * * * 

Section 117.9130 ....... Compliance Schedule For Dallas-Fort 

Worth Eight-Hour Ozone Nonattainment Area Utility Electric Generation 

Sources.

6/3/2015 4/13/2016 [Insert Federal Register citation].

* * * * * * * 

Division 2: Compliance Flexibility 

Section 117.9800 ....... Use of Emission Credits For Compliance.6/3/2015 4/13/2016 [Insert Federal Register citation].

* * * * * * * 

[FR Doc. 2016–08158 Filed 4–12–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0382; FRL–9944–34] 

Acequinocyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation increases an 

existing tolerance for residues of 

acequinocyl in or on ‘‘Hop, dried 

cones.’’ Arysta LifeScience requested 

this tolerance increase under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

13, 2016. Objections and requests for 

hearings must be received on or before 

June 13, 2016, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2015–0382, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• 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–2015–0382 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 June 13, 2016. Addresses for mail 

and hand delivery of objections and 


jstallworth on DSK7TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Rules and Regulations 21753 

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– 

2015–0382, 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 September 

9, 2015 (80 FR 54257) (FRL–9933–26), 

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 5F8364) by Arysta 

LifeScience North America Corp., 15401 

Weston Pkwy., Suite 150, Cary, NC 

27513. The petition requested to amend 

the tolerance in 40 CFR 180.599 for 

residues of the insecticide acequinocyl 

in or on hop, dried cones from 4.0 parts 

per million (ppm) to 15.0 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. 

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 acequinocyl 

including exposure resulting from the 

tolerance 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 absorption, metabolism, 

distribution, and excretion (ADME) of 

acequinocyl are well characterized. 

Acequinocyl exhibits marginal 

absorption into the plasma (13–16% for 

the 10 mg/kg low dose and 8–9% for the 

500 mg/kg high dose) and relatively 

rapid and complete excretion (24 hours 

for the low dose and 72 hours for the 

high dose), primarily via the bile and 

feces (82.6%) in rats. Acequinocyl 

undergoes nearly complete metabolism 

to hydrolysis products and a 

glucuronide conjugate. There was no 

evidence for selective tissue 

accumulation or sequestration. 

Across species, durations and routes 

of exposure (oral and dermal), the 

primary effects in the acequinocyl 

hazard database are indicative of 

toxicity to 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). In 

an acute neurotoxicity study, there were 

no effects up to the limit dose (2,000 

mg/kg). In a guideline immunotoxicity 

study, there were also no effects up to 

the highest dose tested (45 mg/kg/day). 

In rats and rabbits, there was no 

evidence of increased quantitative or 

qualitative fetal susceptibility with 

clinical signs and gross necropsy 

findings seen in maternal animals at 

similar or lower doses than those 

producing resorptions. In the rat 2- 

generation reproductive toxicity study, 

offspring effects at the mid- and highdoses consisted of swollen body parts, 

protruding eyes, clinical signs, delays in 

pupil development, and increased 

mortality occurring mainly after 

weaning, however these effects were 

observed at the same doses as parental 

effects, and a clear NOAEL was 

established which is being used in 

endpoint selection. There were no 

effects on reproductive parameters. 

There was no concern for genotoxicity 

or mutagenicity. There was no evidence 

of carcinogenic potential in either the 

rat or mouse carcinogenicity studies, or 

in the genotoxicity and mutagenicity 

studies indicating that acequinocyl is 

‘‘not likely’’ to be carcinogenic to 

humans. 

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 ‘‘May 27, 2015: Acequinocyl. 

Human Health Assessment Scoping 

Document in Support of Registration 

Review’’ on page 15 in docket ID 

number EPA–HQ–OPP–2015–0203. 

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 


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21754 Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Rules and Regulations 

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 May 2, 2012 (77 

FR 25904) (FRL–9346–4). 

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. 

No such effects were identified in the 

toxicological studies for acequinocyl; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used 2003–2008 food consumption 

data from the U.S. Department of 

Agriculture’s (USDA’s) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/

WWEIA). Tolerance-level residues, 

Dietary Exposure Evaluation Model 

(DEEM) ver. 7.76 default processing 

factors, and 100 percent crop treated 

(PCT) data were used in the chronic 

dietary assessment. 

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) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

acequinocyl for chronic exposure 

assessments are estimated to be 6.69 

parts per billion (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 the 

chronic dietary risk assessment, the 

water concentration of value 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 landscape 

ornamentals in and around residences, 

businesses, public property, schools, 

interiorscapes, and other nonproduction areas. EPA assessed 

residential exposure using the following 

assumptions: Adult short-term 

residential handler dermal and 

inhalation exposure is anticipated from 

adults applying acequinocyl to trees and 

ornamentals with handheld equipment. 

Adult and youth (6–11 years old) shortterm post-application dermal exposure 

to acequinocyl is anticipated after 

application to trees and ornamentals. 

The dermal handler and postapplication residential exposures were 

not included in the short-term aggregate 

assessment because different effects 

were seen in the route-specific dermal 

study compared to the effects seen in 

the oral studies used to select the oral 

and inhalation points of departure. 

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 Web site at 

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

cumulative-assessment-risk-pesticides. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10x) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (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. 

In rats and rabbits, there was no 

evidence of increased quantitative or 

qualitative fetal susceptibility with 

clinical signs and gross necropsy 

findings seen in maternal animals at 

similar or lower doses than those 

producing resorptions. In the rat 2- 

generation reproductive toxicity study, 

offspring effects at the mid- and highdoses consisted of swollen body parts, 

protruding eyes, clinical signs, delays in 

pupil development, and increased 

mortality occurring mainly after 

weaning, however these effects were 


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Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Rules and Regulations 21755 

observed at the same doses as parental 

effects, and a clear NOAEL was 

established which is being used in 

endpoint selection. There were no 

effects on reproductive parameters. 

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 that 

acequinocyl results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies. 

In the rat two-generation reproductive 

toxicity study, offspring effects were 

observed at the same doses as parental 

effects, and a clear NOAEL was 

established which is being used in 

endpoint selection. 

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. 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, acequinocyl 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 acequinocyl 

from food and water will utilize 60% 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 an 

aggregate MOE of 22,000 for adults 20– 

49 years old. Because EPA’s level of 

concern for acequinocyl is a MOE of 100 

or below, this MOE 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, 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 

(high-performance liquid 

chromatography methods with tandem 

mass-spectroscopy detection (HPLC/

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. 

The Codex has not established an 

MRL for acequinocyl on hops. 

V. Conclusion 

Therefore, the existing tolerance for 

residues of acequinocyl, including its 

metabolites and degradates, in or on 

‘‘Hop, dried cones’’ is increased from 

4.0 ppm to 15 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 


jstallworth on DSK7TPTVN1PROD with RULES
21756 Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Rules and Regulations 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 7, 2016. 

Daniel J. Rosenblatt, 

Acting 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, revise the entry for 

‘‘Hop, dried cones’’ in the table in 

paragraph (a) to read as follows: 

§ 180.599 Acequinocyl; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Hop, dried cones ........................ 15 

* * * * * 

* * * * * 

[FR Doc. 2016–08512 Filed 4–12–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 150916863–6211–02] 

RIN 0648–XE563 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Pacific Cod in the 

Bering Sea Subarea of the Bering Sea 

and Aleutian Islands Management Area 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; modification of 

a closure. 

SUMMARY: NMFS is opening directed 

fishing for Pacific cod by catcher vessels 

using trawl gear in the Bering Sea 

subarea of the Bering Sea and Aleutian 

Islands Management Area (BSAI). This 

action is necessary to fully use the B 

season apportionment of the 2016 total 

allowable catch (TAC) of Pacific cod 

allocated to trawl catcher vessels in the 

BSAI. 

DATES: Effective 1200 hrs, Alaska local 

time (A.l.t.), April 11, 2016, through 

2400 hrs, A.l.t., June 10, 2016. 

Comments must be received at the 

following address no later than 4:30 

p.m., A.l.t., April 28, 2016. 

ADDRESSES: You may submit comments 

on this document, identified by NOAA– 

NMFS–2015–0118, by any of the 

following methods: 

• Electronic Submission: Submit all 

electronic public comments via the 

Federal e-Rulemaking Portal. Go to 

www.regulations.gov/#!docketDetail;

D=NOAA-NMFS-2015-0118, click the 

‘‘Comment Now!’’ icon, complete the 

required fields, and enter or attach your 

comments. 

• Mail: Submit written comments to 

Glenn Merrill, Assistant Regional 

Administrator, Sustainable Fisheries 

Division, Alaska Region NMFS, Attn: 

Ellen Sebastian. Mail comments to P.O. 

Box 21668, Juneau, AK 99802–1668. 

Instructions: Comments sent by any 

other method, to any other address or 

individual, or received after the end of 

the comment period, may not be 

considered by NMFS. All comments 

received are a part of the public record 

and will generally be posted for public 

viewing on www.regulations.gov 

without change. All personal identifying 

information (e.g., name, address), 

confidential business information, or 

otherwise sensitive information 

submitted voluntarily by the sender will 

be publicly accessible. NMFS will 

accept anonymous comments (enter ‘‘N/ 

A’’ in the required fields if you wish to 

remain anonymous). 

FOR FURTHER INFORMATION CONTACT: Josh 

Keaton, 907–586–7228. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

BSAI exclusive economic zone 

according to the Fishery Management 

Plan for Groundfish of the Bering Sea 

and Aleutian Islands Management Area 

(FMP) prepared by the North Pacific 

Fishery Management Council under 

authority of the Magnuson-Stevens 

Fishery Conservation and Management 

Act. Regulations governing fishing by 

U.S. vessels in accordance with the FMP 

appear at subpart H of 50 CFR part 600 

and 50 CFR part 679. 

NMFS closed directed fishing for 

Pacific cod by catcher vessels using 

trawl gear in the BSAI under 


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