Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7473 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0783; FRL–9941–49] 

Benzyl 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 benzyl acetate 

(CAS Reg. No. 140–11–4), when used as 

an inert ingredient (solvent) in pesticide 

formulations applied to growing crops 

only under 40 CFR 180.920. Technology 

Sciences Group, on behalf of the 

Huntsman Corporation, 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. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of benzyl 

acetate. 

DATES: This regulation is effective 

February 12, 2016. Objections and 

requests for hearings must be received 

on or before April 12, 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–2014–0783, 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 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–2014–0783 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 April 12, 2016. 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– 

2014–0783, 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 Wednesday, 

March 4, 2015 (80 FR 11611) (FRL– 

9922–68), EPA issued a document 

pursuant to FFDCA section 408, 21 

U.S.C. 346a, announcing the filing of a 

pesticide petition ((PP) IN–10748) by 

Technology Sciences Group (TSG) 1150 

18th Street NW., Suite 1000, 

Washington, DC 20036, on behalf of the 

Huntsman Corporation, 8600 Gosling 

Road, The Woodlands, TX 77381. The 

petition requested that 40 CFR 180.920 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of benzyl acetate 

(CAS Reg. No. 140–11–4) when used as 

an inert ingredient (solvent) in pesticide 

formulations applied to growing crops 

only. That document referenced a 

summary of the petition prepared by the 

Huntsman Corporation, 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 


srobinson on DSK5SPTVN1PROD with RULES
7474 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

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 benzyl acetate 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with benzyl 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 benzyl 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. 

Benzyl acetate exhibits low levels of 

toxicity via the dermal route of exposure 

in rabbits and inhalation and oral routes 

of exposure in rats. It is mildly irritating 

to the skin and minimally irritating to 

the eyes in rabbits. It is not a skin 

sensitizer in guinea pigs. 

In a 13-week feeding study in the rat, 

atrophic seminiferous tubules were 

observed in male rats at dose levels of 

12,500 parts per millions (ppm) 

(equivalent to 900 milligrams/kilogram/ 

day (mg/kg/day)). The NOAEL was 

identified as 6,250 ppm (460 mg/kg/

day). In mice, following 13 weeks of 

exposure via the diet, decreased body 

weight and food consumption were 

observed at all doses. The LOAEL was 

3,130 ppm (425 mg/kg/day). A NOAEL 

was not established. 

In a developmental toxicity study in 

the rat, maternal and fetal toxicity were 

observed at 1,000 mg/kg/day. Maternal 

toxicity was manifested as decreased 

body weight and fetal toxicity was 

manifested as reduced body weights, 

increased incidence of dilation of the 

renal pelvis and skeletal variations. 

Although qualitative fetal susceptibility 

is observed, fetal effects occur in the 

presence of maternal toxicity and a clear 

NOAEL of 500 mg/kg/day was 

established for maternal and 

developmental toxicity. 

The potential for benzyl acetate to be 

genotoxic was evaluated in a battery of 

in vivo mammalian genotoxicity studies. 

It was negative in the Ames assay (with 

and without metabolic activation), sister 

chromatid exchange assay, Chinese 

hamster ovary cell assay, mouse 

micronucleus assay and in the dominant 

lethal assay in Drosophila. However, it 

gave a positive response in the mouse 

lymphoma assay. Since other 

chromosomal aberrations assays as well 

as gene mutation assays and a dominant 

lethal assay gave a negative response, it 

is concluded that benzyl acetate is 

unlikely to be mutagenic. 

Evidence of neurotoxicity and 

neuronal degeneration was identified in 

the 13-week studies in rats and mice. 

Signs of neurotoxicity included tremors 

and ataxia that were associated with the 

degeneration of the glial cells in the 

cerebellum and hippocampus at the 

doses ≥12,500 ppm (≥2,000 mg/kg/day). 

Since these effects were induced at 

doses above the limit dose (1,000 mg/

kg/day) and the established cRfD of 1.10 

mg/kg/day, will be protective of these 

effects, the concern is low for these 

effects. 

There is evidence that benzyl acetate 

suppresses immune function in 

mammalian systems in the rat however 

this effect occurs only at a dose that is 

lethal and well above the limit dose. In 

the 13-week feeding study in the rat, a 

decrease in the cellular components of 

the bone marrow, thymus and lymphoid 

follicles was observed at 50,000 ppm 

(3,900 mg/kg/day for males and 4,500 

mg/kg/day for females), the highest dose 

tested and well above the limit dose. 

The NOAEL for this study was 12,500 

ppm (900 mg/kg/day). The potential for 

immunotoxicity is not of concern 

because the effects occur well above the 

limit dose and the exposure to benzyl 

acetate through the proposed use is 

unlikely to occur at such a high dose. 

The carcinogenicity of benzyl acetate 

in F344/N rats, and B6C3F1 mice using 

was evaluated using the gavage method 

of administration and corn oil as a 

vehicle. There were indications that 

benzyl acetate increased the incidences 

of pancreatic acinar cell adenomas in 

male rats and the incidences of 

hepatocellular adenomas and 

forestomach neoplasms in male and 

female mice. Because of the 

confounding effects of corn oil on the 

incidences of pancreatic neoplasm and 

because of the controversy over the use 

of the gavage route of administration, 

the National Toxicology Program (NTP) 

decided to re-study benzyl acetate using 

the dosed feed route of administration. 

In 1993, the NTP conducted a second 

set of carcinogenicity studies in rats and 

mice using the dose feed route of 

administration. Benzyl acetate was 

administered via the diet to rats and 

mice at doses up to 12,000 ppm (510/ 

575 mg/kg/day, male/female). Toxicity 

was not observed in rats at any dose. In 

mice, males and females exhibited 

reduced body weight throughout the 

entire study at 345/375 mg/kg/day. 

There was no evidence of 

carcinogenicity in mice and rats. Since 

the exposure to benzyl acetate is likely 

to occur via the dietary route in humans 

and there is some uncertainty about the 

use of corn oil in the gavage study, it is 

concluded that benzyl acetate is 


srobinson on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7475 

unlikely to be carcinogenic to humans 

via the dietary route of exposure. 

In metabolism studies approximately 

90% of benzyl acetate is excreted as 

metabolites primarily in the urine after 

oral or percutaneous administration. 

None was detected in the adipose tissue, 

blood, kidney, liver, lung, muscle, skin 

or stomach. The major metabolite in the 

urine was hippuric acid and 95 to 99% 

of the excreted dose was in this form. 

Less than 4% remained in the carcass. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

The point of departure for benzyl 

acetate is 110 mg/kg/day from the NTP 

2-year carcinogenicity study in mice 

(dietary study) based on decreased in 

body weights in both sexes at the 

LOAEL of 345/375 mg/kg/day. There 

was no NOAEL observed in a 90-day 

toxicity study in mice based on the 

effects on body weights seen at all doses 

(lowest dose tested was 3,130 ppm; 

equal to 425 mg/kg/day); however, in a 

carcinogenicity study in mice no effects 

on body weight were seen at 110 mg/kg/ 

day, therefore, the NOAEL for the 

carcinogenicity study would be 

protective of decreased body weights 

seen in a 90-day study in mice. 

Therefore, 90-day toxicity study in mice 

was not selected. This endpoint was 

used for all exposure scenarios. The 

dermal absorption and inhalation 

factors were 100%. The Agency applied 

an interspecies uncertainty factor (10X) 

and an intraspecies uncertainty factor 

(10X); the FQPA safety factor was 

reduced to 1X. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to benzyl acetate, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from benzyl 

acetate in food as follows: 

An acute dietary risk assessment was 

not conducted because no endpoint of 

concern following a single exposure was 

identified in the available studies. A 

chronic dietary exposure assessment 

was completed and performed using the 

Dietary Exposure Evaluation Model 

DEEM–FCIDTM, Version 3.16, 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 that 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. 

Nonpesticidal dietary exposure to 

benzyl acetate (e.g., use as a food 

additive (flavoring agent) were also 

considered as part of aggregate chronic 

dietary risk assessment. 

2. Dietary exposure from drinking 

water. For the purpose of the screeninglevel dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for benzyl 

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). 

Based upon the requested use of 

benzyl acetate, the Agency does not 

expect non-occupational, non-dietary 

exposures. However, there is a potential 

for residential exposure via nonpesticidal uses such as use in cosmetics 

and other, pesticide uses, once it is 

approved. The residential exposure 

could occur via ingestion products 

containing benzyl acetate, and via 

dermal and inhalation routes of 

exposure through use of products 

containing benzyl acetate in residential 

settings. These residential pesticide 

exposures are considered short-term and 

intermediate-term in nature. Residential 

exposures to benzyl acetate as the result 

of its use as a cosmetic ingredient may 

be short-, intermediate- or long-term in 

nature. The aggregate-short term 

exposure assessment for benzyl acetate 

considers exposures from the pesticidal 

and nonpesticidal uses (i.e., flavoring 

agent and cosmetic ingredient) and 

would be protective of any potential 

long-term exposure to benzyl acetate 

resulting from its use in cosmetics as the 

same toxicological point of departure is 

used for all exposure durations and the 

average daily exposure estimates for 

cosmetic use is conservatively applied 

to all exposure durations. 

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 benzyl acetate to share a common 

mechanism of toxicity with any other 

substances, and benzyl 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 benzyl 


srobinson on DSK5SPTVN1PROD with RULES
7476 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

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 Web site at http://

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity 

Qualitative fetal susceptibility was 

observed in the developmental study in 

rats. Maternal (decrease in body weight) 

and fetal (reduced body weights, 

increased incidence of dilation of the 

renal pelvis and skeletal variations) 

toxicity were observed at 1,000 mg/kg/ 

day, the limit dose. Since fetal toxicity 

occurs in the presence of maternal 

toxicity and a clear NOAEL of 500 mg/ 

kg/day was established, the established 

cRfD (1.10 mg/kg/day) will be protective 

of these effects. The potential for 

reproduction toxicity was observed in 

the 13-week dietary study in rats. 

Atrophy of seminiferous tubules was 

observed in males at 12,500 ppm (900 

mg/kg/day). However, the concern for 

reproduction toxicity is low since 

effects occurred at a high dose and a 

clear NOAEL of 6,250 ppm (460 mg/kg/ 

day) was established. Therefore, the 

established cRfD will be protective of 

this effect. In addition, no female 

reproductive parameters were affected 

in the developmental toxicity study in 

rats. 

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 benzyl 

acetate contains the following studies 

that are adequate to evaluate the 

potential toxicity of benzyl acetate for 

infants and children: A thirteen week 

feeding study in the rat, a 13-week 

feeding study in the mouse, a 

developmental toxicity study in the rat, 

several in vivo and in vitro mutagenicity 

studies, and carcinogenicity studies in 

mice and rats via gavage and dietary 

studies. 

ii. Evidence of neurotoxicity and 

neuronal degeneration seen in a 

thirteen-week study was determined not 

to exceed levels of concern since the 

effects occurred at doses that were well 

above the limit dose (1,000 mg/kg/day). 

The established cRfD is 1.10 mg/kg/day 

therefore is protective of these effects. 

iii. Qualitative fetal susceptibility was 

observed in the developmental study in 

rats. Maternal (decrease in body weight) 

and fetal (reduced body weights, 

increased incidence of dilation of the 

renal pelvis and skeletal variations) 

toxicity were observed at 1,000 mg/kg/ 

day, the limit dose. Since fetal toxicity 

occurs in the presence of maternal 

toxicity and a clear NOAEL of 500 mg/ 

kg/day was established, the established 

cRfD (1.10 mg/kg/day) will be protective 

of these effects. The potential for 

reproduction toxicity was observed in 

the 13-week dietary study in rats. 

Atrophy of seminiferous tubules was 

observed in males at 12,500 ppm (900 

mg/kg/day). However, the concern for 

reproductive toxicity is low since effects 

occurred at a high dose and a clear 

NOAEL of 6,250 ppm (460 mg/kg/day) 

was established. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to benzyl 

acetate in drinking water. EPA used 

similarly conservative assumptions to 

assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by benzyl acetate. 

E. Aggregate Risks and Determination of 

Safety Section 

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, benzyl 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 benzyl acetate 

from food and water will utilize 62.9% 

of the cPAD for children ages 1 to 2, the 

population group receiving the greatest 

exposure. 

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). 

Benzyl acetate is likely to be used as 

an inert ingredient in pesticide products 

that are 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 benzyl acetate. Using the 

exposure assumptions described in this 

unit for screening-level short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 150 for children ages 1 to 2 and 

260 for adults. Because EPA’s level of 

concern for benzyl acetate 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). 

Because no intermediate-term adverse 

effect was identified, benzyl acetate is 

not expected to pose an intermediateterm risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in the 

dietary carcinogenicity studies in mice 

and rats, benzyl acetate 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 benzyl 

acetate residues. 

V. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 


srobinson on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7477 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for benzyl 

aceetate (CAS Reg. No. 140–11–4) when 

used as an inert ingredient (solvent) in 

pesticide formulations applied to 

growing crops only. 

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 

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: February 4, 2016. 

Susan Lewis, 

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 § 180.920 add alphabetically the 

entry ‘‘Benzyl acetate’’ to the table to 

read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

Benzyl acetate (CAS 

Reg. No. 140–11–4).

............ Solvent 

* * * * * 

[FR Doc. 2016–02815 Filed 2–11–16; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 14–226; FCC 15–118] 

Broadcast Licensee-Conducted 

Contests 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, 

information collection requirements 

adopted in the Commission’s Report 

and Order relating to the Amendment of 

the Commission’s Rules Related to 

Broadcast Licensee-Conducted Contests. 

This document is consistent with the 

Report and Order, which stated that the 

Commission would publish a document 

in the Federal Register announcing 

OMB approval and the effective date of 

the rule. 

DATES: The amendments to 47 CFR 

73.1216, published at 80 FR 64354, 

October 23, 2015, are effective on 

February 12, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Cathy Williams by email at 

Cathy.Williams@fcc.gov and telephone 

at (202) 418–2918. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on February 

3, 2016, OMB approved information 

collection requirements contained in the 

Commission’s Report and Order, FCC 

15–118, published at 80 FR 64354. The 

OMB Control Number is 3060–1209. 

The Commission publishes this 

document as an announcement of the 

effective date of those information 

collection requirements. 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 

received OMB approval on February 3, 

2016, for the information collection 


srobinson on DSK5SPTVN1PROD with RULES