Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 33 

examples, each partnership is required 

to file a return under section 6031(a): 

Example 1. During its 2020 taxable year, 

Partnership, a calendar year taxpayer, has 

two partners. One partner, A, is also a 

calendar year partnership. A files a valid 

election under this section with its timely 

filed partnership return for its 2020 taxable 

year. Partnership does not file an election 

under this section. Notwithstanding A’s valid 

election under this section, with respect to 

A’s interest in Partnership, A is subject to the 

rules applicable to partners in a partnership 

subject to the rules under subchapter C of 

chapter 63, including the consistency 

requirements of section 6222 and the 

regulations thereunder. 

Example 2. The facts are the same as 

Example 1 of this paragraph (d)(2). The IRS 

mails to Partnership a notice of final 

partnership adjustment under section 6231 

with respect to Partnership’s 2020 taxable 

year. Partnership timely elects the alternative 

to payment of imputed underpayment under 

section 6226 and the regulations thereunder. 

Partnership must provide A with a statement 

under section 6226 reflecting A’s share of the 

adjustments for Partnership’s 2020 taxable 

year. A is subject to the rules applicable to 

partners in a partnership subject to the rules 

under subchapter C of chapter 63 with 

respect to A’s interest in Partnership. 

(e) Effect of an election—(1) In 

general. An election made under this 

section is an action taken under 

subchapter C of chapter 63 by the 

partnership for purposes of section 

6223. Accordingly, the partnership and 

all partners are bound by an election of 

the partnership under this section 

unless the IRS determines that the 

election is invalid. See § 301.6223–2 for 

the binding nature of actions taken by 

a partnership under subchapter C of 

chapter 63. 

(2) IRS determination that election is 

invalid. If the IRS determines that an 

election under this section for a 

partnership taxable year is invalid, the 

IRS will notify the partnership in 

writing and the provisions of subchapter 

C of chapter 63 will apply to that 

partnership taxable year. 

(f) Applicability date. These 

regulations are applicable to partnership 

taxable years beginning after December 

31, 2017. 

Kirsten Wielobob, 

Deputy Commissioner for Services and 

Enforcement. 

Approved: December 22, 2017. 

David J. Kautter, 

Assistant Secretary of the Treasury (Tax 

Policy). 

[FR Doc. 2017–28398 Filed 12–29–17; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R02–OAR–2017–0013; FRL 9971–28– 

Region 2] 

Approval and Revision of Air Quality 

Implementation Plans; State of New 

York; Regional Haze State and Federal 

Implementation Plans 

Correction 

In rule document 2017–25945 

beginning on page 57126 in the issue of 

Monday December 4, 2017, make the 

following correction: 

§ 52.1670 [Corrected] 

■ In § 52.1670, on page 57130, in the 

table, beneath the column titled ‘‘EPA 

approval date’’, ‘‘11/4/17’’ should read 

‘‘12/4/17’’. 

[FR Doc. C1–2017–25945 Filed 12–29–17; 8:45 am] 

BILLING CODE 1301–00–D 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0717; FRL–9970–03] 

Phenylethyl acetate; Exemption From 

the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of phenylethyl 

acetate (CAS Reg. No. 103–45–7) when 

used as an inert ingredient (solvent) at 

a maximum of 0.015% in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest. Technology Science Group Inc., 

on behalf of Janeil Biosurfactant 

Company, submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. 

DATES: This regulation is effective 

January 2, 2018. Objections and requests 

for hearings must be received on or 

before March 5, 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–2015–0717, 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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/text-idx?&c=

ecfr&tpl=/ecfrbrowse/Title40/40tab_

02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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 


daltland on DSKBBV9HB2PROD with RULES
34 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 

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–2015–0717 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 March 5, 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– 

2015–0717, 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. Petition for Exemption 

In the Federal Register of November 

23, 2015 (80 FR 72941) (FRL–9936–73), 

EPA issued a document pursuant to 

FFDCA section 408, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition (PP IN–10888) by Technology 

Sciences Group Inc., on behalf of Jeneil 

Biosurfactant Company, 400 N. Dekora 

Woods Blvd., Saukville, WI 53080. The 

petition requested that 40 CFR 180.910 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of phenylethyl 

acetate (CAS Reg. No. 103–45–7) when 

used as an inert ingredient (solvent) in 

pesticide formulations applied to 

growing crops and raw agricultural 

commodities after harvest at a 

maximum concentration not to exceed 

0.015% by weight of the pesticide 

formulation. That document referenced 

a summary of the petition prepared by 

Technology Sciences Group Inc., the 

petitioner, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement for 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. . . .’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with FFDCA section 

408(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), 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 phenylethyl 

acetate including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with phenylethyl 

acetate follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by phenylethyl acetate as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

Phenylethyl acetate exhibits relatively 

low acute toxicity via the oral and 

dermal routes of exposure. Phenylethyl 

acetate has been reported to be 

moderately to severely irritating to the 

eyes of rabbits, but only mildly irritating 

to their skin and not dermally 

sensitizing to guinea pigs. 

The toxicity database for phenylethyl 

acetate includes only one repeat dose 

toxicity study. In that study, a 

subchronic oral toxicity study via 

gavage, male rats received 73 mg/kg/day 

of phenylethyl acetate. There were no 

adverse effects seen at that dose, which 

was the only dose tested. 

Studies of metabolism following oral 

ingestion suggests, phenylethyl acetate 

is rapidly absorbed, metabolized and 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 35 

excreted in the urine. Phenylethyl 

alcohol, phenylacetic acid and acetic 

acid are the primary metabolites. 

Phenylethyl alcohol is successively 

oxidized to phenylacetaldehyde and 

phenylacetic acid in vivo. 

Phenylacetaldehyde is oxidized by 

inducible aldehyde dehydrogenases and 

cytosolic isoenzymes to phenylacetic 

acid. Phenylacetic acid undergoes 

species-specific conjugation with a 

variety of amino acids, amines, or 

glucuronic acid followed by excretion 

almost exclusively in the urine. All of 

these metabolites are all naturally 

occurring compounds and are normal 

constituents of the human body. No 

toxicological endpoint of concern has 

been identified for any of these 

phenylethyl acetate metabolites. 

The Research Institute for Fragrance 

Materials, Inc. (RIFM) reported results 

of three Ames assays performed on 

phenylethyl acetate. Results of all three 

showed no significant increase in 

reverse mutations in Salmonella 

typhimurium strains TA98, TA100, 

TA1535, or TA1537 in the presence or 

absence of metabolic activation at 

concentrations up to 5000 mg/plate 

phenylethyl acetate. 

No carcinogenicity studies were 

available in the database for phenylethyl 

acetate; however, a DEREK model 

showed no structural alerts for 

carcinogenicity, and the genotoxicity 

studies were negative. 

No immunotoxicity studies were 

available in the database for phenylethyl 

acetate. However, phenylethyl acetate is 

readily metabolized to phenylethyl 

alcohol, phenylacetic acid and acetic 

acid which are all naturally occurring 

compounds and are normal constituents 

of the human body. No toxicological 

endpoint of concern has been identified 

for any of these phenylethyl acetate 

metabolites. 

No neurotoxicity studies were 

available in the database for phenylethyl 

acetate. However, cholinesterase activity 

was not affected nor was there systemic 

toxicity in a study in rats treated via 

gavage with 73 mg/kg/day phenylethyl 

acetate for 140 days. Additionally, the 

chronic reference dose (cRfD) is based 

on this study and any potential 

neurotoxic effects will be protected. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Phenylethyl acetate is readily 

metabolized to phenylethyl alcohol, 

phenylacetic acid and acetic acid which 

are all naturally occurring compounds 

and are normal constituents of the 

human body. No toxicological endpoint 

of concern has been identified for any 

of these phenylethyl acetate metabolites. 

For purposes of conducting a risk 

assessment in support of this action, a 

highly conservative toxicological point 

of departure of 73 mg/kg/day for all 

nonacute exposure durations and routes 

of exposure was selected for 

phenylethyl acetate based on the 

NOAEL from the subchronic rat oral 

toxicity study. A chronic population 

adjusted dose (cPAD) of 0.73 mg/kg/day 

was derived based on the use of the 

POD and 10X inter- and intraspecies 

uncertainty factors and an FQPA Safety 

Factor of 1X. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to phenylethyl acetate, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

phenylethyl acetate in food as follows: 

i. Acute Exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide 

chemical, 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 phenylethyl acetate; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. The chronic 

dietary exposure assessment for this 

inert ingredient utilizes the Dietary 

Exposure Evaluation Model Food 

Commodity Intake Database (DEEM– 

FCID), Version 3.16, EPA, which 

includes food consumption information 

from the U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, ‘‘What 

We Eat In America’’, (NHANES/ 

WWEIA). This dietary survey was 

conducted from 2003 to 2008. In the 

absence of actual residue data, the inert 

ingredient evaluation is based on a 

highly conservative model which 

assumes that the residue level of the 

inert ingredient would be no higher 

than the highest established tolerance 

for an active ingredient on a given 

commodity. Implicit in this assumption 

is that there would be similar rates of 

degradation between the active and 

inert ingredient (if any) and that the 

concentration of inert ingredient in the 

scenarios leading to these highest of 

tolerances would be no higher than the 

concentration of the active ingredient. 

The model assumes 100 percent crop 

treated (PCT) for all crops and that every 

food eaten by a person each day has 

tolerance-level residues. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is contained 

in the memorandum entitled ‘‘Alkyl 

Amines Polyalkoxylates (Cluster 4): 

Acute and Chronic Aggregate (Food and 

Drinking Water) Dietary Exposure and 

Risk Assessments for the Inerts.’’ 

(D361707, S. Piper, 2/25/09) and can be 

found at http://www.regulations.gov in 

docket ID number EPA–HQ–OPP–2008– 

0738. In the case of phenylethyl acetate, 

an adjustment to the dietary exposure 

analysis was made to account for the 

use at a maximum concentration of 

0.015% in pesticide formulations. As 

part of the aggregate exposure 

assessment, dietary exposures to 

phenylethyl acetate resulting from its 

use as a food flavoring agent are also 

included in the assessment. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for 

phenylethyl acetate, a conservative 

drinking water concentration value of 

100 ppb based on screening level 

modeling was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessments for 

parent compound. These values were 

directly entered into the dietary 

exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Phenylethyl acetate may be used as 

inert ingredient in pesticide products 

that are registered for specific uses that 

may result in indoor or outdoor 

residential exposures. A screening-level 

residential exposure and risk 

assessment was completed utilizing 

conservative residential exposure 

assumptions. The Agency assessed 

short- and intermediate-term dermal 

and inhalation exposures for residential 

handlers that would result from low 

pressure handwand, hose end sprayer 

and trigger sprayer for outdoor scenarios 

of each pesticide type (herbicide, 

insecticide and fungicide) and mopping, 

wiping and aerosol sprays for indoor 

scenarios. The Agency assessed postapplication short-term dermal exposure 

for children and adults as well as shortterm hand-to-mouth exposure for 

children from contact with treated 

lawns. 

Residential exposures to phenylethyl 

acetate may also occur as a result of its 

use as a fragrance component. Estimates 

of these exposures are included in the 


daltland on DSKBBV9HB2PROD with RULES
36 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 

aggregate exposure assessment of 

phenylethyl acetate. 

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 phenylethyl 

acetate to share a common mechanism 

of toxicity with any other substances, 

and phenylethyl acetate does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that phenylethyl acetate 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:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold (10X) margin of safety 

for infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

As part of its assessment, EPA 

evaluated the available toxicity, 

metabolism and exposure data on 

phenylethyl acetate and considered its 

validity, completeness, and reliability, 

as well as the relationship of this 

information to human risk. No hazard 

was identified based on the available 

studies. EPA has identified no residual 

uncertainty with regard to prenatal and 

postnatal toxicity or exposure to 

phenylethyl acetate; therefore, EPA 

concludes that no additional margin of 

exposure (safety) is necessary for the 

protection of infants and children. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information on phenylethyl acetate, 

EPA has determined that there is a 

reasonable certainty that no harm to any 

population subgroup will result from 

aggregate exposure to phenylethyl 

acetate under reasonable foreseeable 

circumstances. Therefore, the 

establishment of an exemption from 

tolerance under 40 CFR 180. 910 for 

residues of phenylethyl acetate when 

used as an inert ingredient in pesticide 

formulations applied on growing crops 

and raw agricultural commodities after 

harvest at a maximum of 0.015% in the 

pesticide formulation, is safe under 

FFDCA section 408. 

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, phenylethyl acetate 

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 phenylethyl 

acetate from food and water will utilize 

<0.01% of the cPAD for children 1–2 

years old, the population group 

receiving the greatest exposure. 

3. Short-, intermediate- and long-term 

risk. Short-, intermediate- and long-term 

aggregate exposure takes into account 

short-, intermediate- and long-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Phenylethyl acetate is currently used 

as an inert ingredient in pesticide 

products that are registered for uses that 

could result in short- and intermediateterm residential exposure, and there are 

other, non-pesticidal residential uses of 

phenylethyl acetate that could result in 

long-term residential exposures; the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-, intermediate- and long-term term 

residential exposures to phenylethyl 

acetate. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined respective short-, 

intermediate- and long-term term food, 

water, and residential exposures result 

in aggregate margin of exposures (MOE) 

of 560 for adults and 19,000 for 

children. Because EPA’s level of 

concern for phenylethyl acetate is a 

MOE of 100 or below, these MOEs are 

not of concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit IV.A., phenylethyl acetate is not 

expected to pose a cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to phenylethyl 

acetate residues. 

V. Analytical Enforcement Methodology 

Although EPA is establishing a 

limitation on the amount of phenylethyl 

acetate that may be used in pesticide 

formulations, an analytical enforcement 

methodology is not necessary for this 

exemption. The limitation will be 

enforced through the pesticide 

registration process under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), 7 U.S.C. 136 et seq. EPA 

will not register any pesticide for sale or 

distribution for use on growing crops 

with concentrations of phenylethyl 

acetate exceeding 0.015% by weight of 

the formulation. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for phenylethyl 

acetate (CAS Reg. No. 103–45–7) when 

used as an inert ingredient (solvent) in 

pesticide formulations applied to 

growing crops and raw agricultural 

commodities after harvest at a 

maximum of 0.015% in the pesticide 

formulation. 

VII. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 

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). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 37 

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 exemption 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). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 12, 2017. 

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 § 180.910, add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemption from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Phenylethyl acetate (CAS Reg. No. 103–45–7) .......................... Not to exceed 0.015% in pesticide formulation. ......................... Solvent. 

* * * * * * * 

[FR Doc. 2017–28317 Filed 12–29–17; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1, 2, 15, 25, 30, and 101 

[GN Docket No. 14–177, IB Docket Nos. 15– 

256 and 97–95, WT Docket No. 10–112; FCC 

17–152] 

Use of Spectrum Bands Above 24 GHz 

for Mobile Radio Services 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission or FCC) adopts rules for 

specific millimeter wave bands above 24 

GHz. A Proposed Rule document for the 

Second Further Notice of Proposed 

Rulemaking (Second FNPRM) related to 

this Second Report and Order is 

published in this issue of the Federal 

Register. 

DATES: Effective February 1, 2018, 

except for § 25.136, which contain 

information collection requirements that 

are not effective until approved by the 

Office of Management and Budget. The 

Commission will publish a document in 

the Federal Register announcing the 

effective date for the section. Changes to 

the secondary market threshold for 

millimeter wave spectrum, detailed in 

SUPPLEMENTARY INFORMATION, apply as of 

January 2, 2018. 

FOR FURTHER INFORMATION CONTACT: John 

Schauble of the Wireless 

Telecommunications Bureau, 

Broadband Division, at (202) 418–0797 

or John.Schauble@fcc.gov, Michael Ha 

of the Office of Engineering and 

Technology, Policy and Rules Division, 

at 202–418–2099 or Michael.Ha@

fcc.gov, or Jose Albuquerque of the 

International Bureau, Satellite Division, 

at 202–418–2288 or Jose.Albuquerque@

fcc.gov. For information regarding the 

PRA information collection 

requirements contained in this PRA, 

contact Cathy Williams, Office of 

Managing Director, at (202) 418–2918 or 

Cathy.Williams@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Second 

Report and Order (Second R&O), Order 

on Reconsideration, and Memorandum 

Opinion and Order, GN Docket No. 14– 

177, FCC 17–152, adopted on November 

16, 2017 and released on November 22, 

2017. The complete text of this 

document is available for public 

inspection and copying from 8 a.m. to 

4:30 p.m. Eastern Time (ET) Monday 

through Thursday or from 8 a.m. to 

11:30 a.m. ET on Fridays in the FCC 

Reference Information Center, 445 12th 

Street SW, Room CY–A257, 

Washington, DC 20554. The complete 

text is available on the Commission’s 

website at http://wireless.fcc.gov, or by 

using the search function on the ECFS 

web page at http://www.fcc.gov/cgb/ 

ecfs/. Alternative formats are available 

to persons with disabilities by sending 

an email to fcc504@fcc.gov or by calling 

the Consumer & Governmental Affairs 


daltland on DSKBBV9HB2PROD with RULES