Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 32029 

(447) * * * 

(i) * * * 

(D) Eastern Kern Air Pollution Control 

District. 

(1) Rule 432, ‘‘Polyester Resin 

Operations,’’ adopted on March 13, 

2014. 

* * * * * 

(457) * * * 

(i) * * * 

(B) Mojave Desert Air Quality 

Management District. 

(1) Rule 464, ‘‘Oil-Water Separators,’’ 

amended on June 23, 2014. 

* * * * * 

[FR Doc. 2015–13680 Filed 6–4–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0265; FRL–9927–65] 

n-Butyl benzoate; Exemptions From 

the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

exemptions from the requirement of a 

tolerance for residues of n-butyl 

benzoate (CAS Reg. No. 136–60–7) 

when used as an inert ingredient 

(solvent) in pesticide formulations 

applied to growing crops, raw 

agricultural commodities after harvest, 

and animals and when used as an inert 

ingredient in antimicrobial formulations 

in food-contact surface sanitizer 

products at a maximum level in the enduse concentration of 15,000 parts per 

million (ppm). Exponent, Inc., on behalf 

Huntsman Corp., 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 n-butyl benzoate. 

DATES: This regulation is effective June 

5, 2015. Objections and requests for 

hearings must be received on or before 

August 4, 2015, 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–2014–0265, 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 Publishing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&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 

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–2014–0265 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before August 4, 2015. 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– 

2014–0265, 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 October 24, 

2014 (Vol. 79 FR 63594) (FRL–9916–03), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10682) by Exponent, 

Inc., 1150 Connecticut Ave. NW., Suite 

1100, Washington, DC 20035 on behalf 

Huntsman Corp., 8600 Gosling Road, 

The Woodlands, TX 77381. The petition 

requested that 40 CFR 180.910, 180.930, 

and 180.940 be amended by establishing 

an exemption from the requirement of a 

tolerance for residues of n-butyl 

benzoate (CAS Reg. No. 136–60–7) 

when used as an inert ingredient 

(solvent) in pesticide formulations 

applied to growing crops, raw 

agricultural commodities after harvest, 

and animals and when used as an inert 

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32030 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 

ingredient in antimicrobial formulations 

in food-contact surface sanitizer 

products. That document referenced a 

summary of the petition prepared by 

Exponent, Inc., on behalf Huntsman 

Corp., the petitioner, which is available 

in the docket, http://

www.regulations.gov. No tolerancerelated comments were received on the 

notice of filing. 

Based on a review of the data 

submitted in support of this petition, 

EPA has modified the exemption 

requested by limiting the amount of nbutyl benzoate allowed in food contact 

sanitizing solutions to a maximum 

15,000 ppm (1.5%). This limitation is 

based on the Agency’s risk assessment 

which can be found at http://

www.regulations.gov in document ‘‘nButyl Benzoate; Human Health Risk 

Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations,’’ 

in docket ID number EPA–HQ–OPP– 

2014–0265. 

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 n-butyl benzoate 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with n-butyl benzoate 

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 n-butyl benzoate 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. 

In acute oral, dermal, and inhalation 

toxicity studies in rats, n-butyl benzoate 

was found to be slightly toxic to 

nontoxic. In primary eye and dermal 

irritation studies in rabbits, n-butyl 

benzoate was found to be minimally 

irritating. In a dermal sensitization 

study in guinea pigs, n-butyl benzoate 

was not a dermal sensitizer. 

In a combined repeated dose toxicity 

study with the reproduction/

developmental toxicity screening test, nbutyl benzoate was administered daily 

to rats by gavage at doses of 0 (vehicle 

control), 250, 500 and 1,000 mg/kg bw/ 

day. The NOAEL for parental toxicity 

was 1,000 mg/kg/day; the highest dose 

tested. The LOAEL for parental toxicity 

was not observed in this study. The 

NOAEL for embryo-fetal toxicity was 

500 mg/kg bw/day based on increased 

pup mortality on post-natal day zero 

observed at the LOAEL of 1,000 mg/kg/ 

day. 

No positive mutagenic response was 

observed for n-butyl benzoate in a 

reverse bacterial mutation assay. 

No chronic toxicity data for n-butyl 

benzoate are available. 

There are no cancer studies available 

for n-butyl benzoate. n-Butyl benzoate is 

metabolized by esterase mediated 

hydrolysis resulting in the formation of 

two major polar metabolites, n-butyl 

alcohol and benzoic acid. Each 

metabolite enters other degradation 

pathways to be rapidly metabolized 

and/or excreted. Based on predicted 

rapid metabolism and excretion, the 

lack of specific target organ toxicity in 

the OCSPP Harmonized Test Guideline 

870.3650 study, the results of 

genotoxicity testing being negative, and 

a Quantitative Structure Activity 

Relationship (QSAR) expert model, 

DEREK Nexus, that indicates no 

structural alerts for carcinogenicity, nbutyl benzote is not expected to be 

carcinogenic. 

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 

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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. 

1. Acute dietary (all populations). 

There were no adverse effects observed 

attributable to a single dose for the 

general population (including infants 

and children) or females 13–49 years of 

age. 

2. Chronic dietary (all populations). 

The chronic population adjusted dose 

(cPAD) of 5 mg/kg/day is established 

based on the NOAEL of 500 mg/kg/day 

from a combined repeated dose toxicity 

study with the reproduction/

developmental toxicity screening test in 

rats. The adverse effects seen in this 

study were increased pup mortality 

observed at the LOAEL of 1,000 mg/kg/ 

day. The Food Quality Protection Act 

(FQPA) safety factor/database 

uncertainty factor of 1X and 10X intraand interspecies uncertainty factors are 

utilized for dietary risk assessment. 

3. Dermal, short- and intermediateterm. The level of concern (LOC) for 

short- and intermediate-term dermal 

exposure is a margin of exposure (MOE) 

of 100 and the assessment is based on 

the NOAEL (500 mg/kg/day) from the 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test in rats. 

4. Inhalation, short- and intermediate 

term. The LOC for short- and 

intermediate-term inhalation exposure 

is a MOE of 100 and the assessment is 

based on the NOAEL (500 mg/kg/day) 

from the combined repeated dose 

toxicity study with the reproduction/

developmental toxicity screening test in 

rats. 

5. Quantification of cancer risk is not 

appropriate since there are no concerns 

for cancer based on data that n-butyl 

benzoate is metabolized by esterase 

mediated hydrolysis resulting in the 

formation of two major polar 

metabolites, n-butyl alcohol and benzoic 

acid, neither substance being a concern 

for cancer. In addition, there is a lack of 

specific target organ toxicity in the 

OCSPP Harmonized Test Guideline 

870.3650 study, the results of 

genotoxicity testing for n-butyl benzoate 

are negative, and QSAR expert model, 

DEREK Nexus, indicates that there are 

no structural alerts for carcinogenicity. 

As such, n-butyl benzote is not expected 

to be carcinogenic. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to n-butyl benzoate, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from n-butyl 

benzoate in food as follows: 

The Agency assessed the dietary 

exposures to n-butyl benzoate as an 

inert ingredient for use in pesticide 

formulations applied to growing crops, 

raw agricultural commodities, and 

livestock as well as an inert ingredient 

for use in food-contact surface sanitizing 

solutions. In the case of dietary 

exposures to n-butyl benzoate as an 

inert ingredient used in pesticide 

formulations applied to growing crops, 

raw agricultural commodities, and 

livestock, a chronic dietary exposure 

assessment was conducted using the 

Dietary Exposure Evaluation Model/

Food Commodity Intake Database 

(DEEM–FCID)TM, Version 3.16. EPA 

used 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. As to residue levels in 

food, no residue data were submitted for 

n-butyl benzoate. In the absence of 

specific residue data, EPA has 

developed an approach that uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. 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 the proposed use of nbutyl benzoate as an inert ingredient in 

food-contact sanitizing pesticide 

products, EPA has utilized a 

conservative, health-protective method 

of estimating dietary intake that is based 

upon conservative assumptions related 

to the amount of residues that can be 

transferred to foods as a result of the 

proposed use. This same methodology 

has been utilized by FDA in estimating 

dietary exposures to antimicrobial 

pesticides used in food-handling 

settings. A complete description of the 

approach used to assess dietary 

exposures resulting from food contact 

sanitizing solution uses of n-butyl 

benzoate can be found at http://

www.regulations.gov in document ‘‘nButyl Benzoate; Human Health Risk 

Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations,’’ 

pp. 13–15 in docket ID number EPA– 

HQ–OPP–2014–0265. 

The exposures from food and food 

contact sanitizing are then added 

together for the final dietary exposure 

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 n-butyl 

benzoate, 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). 

There are no current or proposed 

residential uses for n-butyl benzoate, 

however it is possible that n-butyl 

benzoate may be used as an inert 

ingredient in pesticide products that 

may have uses resulting in potential 

residential exposures. A complete 

description of the approach used to 

assess possible residential exposures 

from n-butyl benzoate can be found at 

http://www.regulations.gov in document 

‘‘n-Butyl Benzoate; Human Health Risk 

Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations,’’ 

pp. 16 in docket ID number EPA–HQ– 

OPP–2014–0265. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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32032 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 

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 n-butyl benzoate 

to share a common mechanism of 

toxicity with any other substances, and 

n-butyl benzoate does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that n-butyl benzoate 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. 

There is an evidence of increased 

susceptibility of infants and children in 

the OECD 422 study in rats. In this 

study, the NOAEL for parental toxicity 

was 1,000 mg/kg/day; the highest dose 

tested while the NOAEL for embryofetal toxicity was 500 mg/kg/day based 

on increased pup mortality on postnatal day zero seen at the LOAEL of 

1,000 mg/kg/day. However, the concern 

for this susceptibility is low because 

there is clear NOAEL established in the 

study protecting the offspring, and 

regulatory doses were selected to be 

protective of these effects. No other 

residual uncertainties were identified 

with respect to susceptibility. The 

endpoints and doses selected for the 

dietary risk assessment of n-butyl 

benzoate are protective of adverse 

effects in both offspring and adults. 

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 n-butyl 

benzoate contains acute toxicity, 

subchronic toxicity, reproductive 

toxicity, developmental toxicity, and 

genotoxicity data. No immunotoxicity or 

neurotoxicity study is available; 

however, there was no evidence of any 

triggers for immunotoxicity or 

neurotoxicity in the database. Therefore, 

there is no need for immunotoxicity or 

neurotoxicity study at this time and no 

need for additional uncertainty factor 

for the lack of those studies. 

ii. Although there is evidence that nbutyl benzoate results in increased 

susceptibility in the combined repeated 

dose toxicity study with the 

reproduction/developmental toxicity 

screening test in rats, that study 

identified a clear NOAEL for offspring 

effects, which the Agency is using as the 

endpoint for its assessment. Therefore, 

the concern for these effects is low and 

there is no need for an additional 

uncertainty factor. 

iii. 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, as well as 

conservative assumptions for foodcontact surface sanitizers. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to n-butyl 

benzoate in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by n-butyl 

benzoate. 

E. Aggregate Risks and Determination of 

Safety 

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, n-butyl benzoate 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 n-butyl 

benzoate from food and water will 

utilize 21.0% of the cPAD for the U.S. 

population and 94.1% of the cPAD for 

children 1–2 years old, the population 

group receiving the greatest exposure. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). While n-butyl benzoate 

is not currently used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

short- or intermediate-term residential 

exposure, it is possible that n-butyl 

benzoate could be used in such 

products and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with potential short- and 

intermediate-term residential exposures 

to n-butyl benzoate. 

Using the exposure assumptions 

described in this unit for short-and 

intermediate-term exposures, EPA has 

concluded the combined food, water, 

and residential exposures result in 

aggregate short- and intermediate-term 

MOEs of 320 for adults and 100 for 

children (1–2 years old). EPA’s level of 

concern for n-butyl benzoate is a MOE 

of 100 or below; however these MOEs 

are not of concern based on the highly 

conservative assumptions made 

regarding residential and dietary 

exposures to n-butyl benzoate as 

described in Unit IV. Section C. 

4. Aggregate cancer risk for U.S. 

population. Based on data that n-butyl 

benzoate is metabolized by esterase 

mediated hydrolysis resulting in the 

formation of two major polar 

metabolites, n-butyl alcohol and benzoic 

acid. Each metabolite enters other 

degradation pathways to be rapidly 

metabolized and/or excreted, n-butyl 

benzoate is not expected to pose a 

cancer risk to humans. 

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 n-butyl 

benzoate residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method for enforcement 

purposes is not required for n-butyl 

benzoate in pesticide formulations that 

include uses on crops for pre- and postharvest, and on animals, since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

An analytical method is also not 

required for enforcement purposes for nbutyl benzoate on food-contact surfaces 

in antimicrobial applications since the 

Agency is not establishing a numerical 

tolerance for residues of n-butyl 

benzoate in or on any food 

commodities. EPA is establishing a 

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Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 32033 

limitation on the amount of n-butyl 

benzoate that may be used in foodcontact surface antimicrobial 

applications. That 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 food-contact 

surface antimicrobial applications for 

sale or distribution that contains greater 

than 15,000 ppm (1.5%) of n-butyl 

benzoate by weight. 

VI. Conclusions 

Therefore, exemptions from the 

requirement of a tolerance are 

established under 40 CFR 180.910, 

180.930, and 180.940(a) for n-butyl 

benzoate (CAS Reg. No. 136–60–7) 

when used as an inert ingredient 

(solvent) in pesticide formulations 

applied to growing crops, raw 

agricultural commodities after harvest, 

and animals, and when used as an inert 

ingredient in antimicrobial formulations 

in food-contact surface sanitizer 

products at a maximum level in the enduse concentration of 15,000 parts per 

million (ppm). 

VII. Statutory and Executive Order 

Reviews 

This action establishes exemptions 

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 exemptions 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: May 29, 2015. 

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 § 180.910, add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

n-Butyl benzoate 

(CAS Reg. No.136– 

60–7).

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

* * * * * 

■ 3. In § 180.930, add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

n-Butyl benzoate 

(CAS RN 136–60– 

7).

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

* * * * * 

■ 4. In § 180.940(a) add alphabetically 

the inert ingredient to the table to read 

as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

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32034 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 

Pesticide chemical CAS Reg. No. Limits 

*******

n-Butyl benzoate ................. 136–60–7 When ready for use, the end-use concentration is not to exceed 15,000 ppm. 

*******

* * * * * 

[FR Doc. 2015–13818 Filed 6–4–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0207; FRL–9927–66] 

Aluminum Sulfate; 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 aluminum 

sulfate (CAS Reg. No. 10043–01–3) 

under 40 CFR 180.940(a). This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of aluminum sulfate. 

DATES: This regulation is effective June 

5, 2015. Objections and requests for 

hearings must be received on or before 

August 4, 2015, 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–2012–0207, 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 Publishing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&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 the Federal Food, Drug, and 

Cosmetic Act (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–2012–0207 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before August 4, 2015. 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– 

2012–0207, 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. Background and Statutory Findings 

In the Federal Register of May 2, 

2012, (77 FR 25954) (FRL–9346–1), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance petition (PP 1E7933) by 

Exponent Inc., 1150 Connecticut Ave. 

NW., Suite 1100, Washington, DC 

20036, on behalf of Ecolab, Inc., 370 N. 

Wabasha Street, St. Paul, MN 55102. 

The petition requested that 40 CFR part 

180.940(a) be amended by establishing 

an exemption from the requirement of a 

tolerance for residues of aluminum 

sulfate for use as an inert ingredient in 

antimicrobial pesticide formulations 

applied to food-contact surfaces in 

public eating places, dairy-processing 

equipment, and food-processing 

equipment and utensils at a maximum 

end use concentration not to exceed 50 

parts per million (ppm). That document 

referenced a summary of the petition 

prepared by the petitioner Exponent, 

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