Federal Register / Vol. 80, No. 114 / Monday, June 15, 2015 / Rules and Regulations 34065 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart NN—Pennsylvania 

■ 2. In § 52.2020, the table in paragraph 

(e)(1) is amended by revising the entry 

‘‘8-Hour Ozone Maintenance Plan and 

2002 Base Year Emissions Inventory’’ 

for ‘‘Scranton/Wilkes-Barre Area: 

Lackawanna, Luzerne, Monroe and 

Wyoming Counties’’ to read as follows: 

§ 52.2020 Identification of plan. 

* * * * * 

(e) * * * 

(1) * * * 

Name of non-regulatory 

SIP revision 

Applicable geographic 

area 

State 

submittal 

date 

EPA Approval date Additional explanation 

*******

8-Hour Ozone Maintenance Plan and 2002 

Base Year Emissions 

Inventory.

Scranton/Wilkes-Barre 

Area: Lackawanna, 

Luzerne, Monroe and 

Wyoming Counties.

6/12/07 11/14/07 

72 FR 64948.

5/28/14 6/15/15 [Insert Federal 

Register citation].

Revised 2009 and 2018 Motor Vehicle Emission 

Budgets. Revised 2009 and 2018 point source 

inventories. Revised 2018 area source inventory. General conformity budgets for the construction of the Bell Bend Nuclear Power 

Plant. See sections 52.2043 and 52.2052. 

*******

* * * * * 

3. Section 52.2043 is amended by 

adding paragraphs (d), (e), and (f) to 

read as follows: 

§ 52.2043 Control strategy for 

maintenance plans: ozone. 

* * * * * 

(d) As of June 15, 2015, EPA approves 

the following revised 2009 and 2018 

point source inventory for nitrogen 

oxides (NOX) for the Scranton/WilkesBarre 1997 8-Hour Ozone Maintenance 

Area submitted by the Secretary of the 

Pennsylvania Department of 

Environmental Protection: 

Applicable geographic area Year 

Tons 

per 

day 

NOX

Scranton/Wilkes-Barre 1997 

8-Hour Ozone Maintenance Area ........................ 2009 7.7 

Scranton/Wilkes-Barre 1997 

8-Hour Ozone Maintenance Area ........................ 2018 5.8 

(e) As of June 15, 2015, EPA approves 

the following revised 2018 area source 

inventory for nitrogen oxides (NOX) for 

the Scranton/Wilkes-Barre 1997 8-Hour 

Ozone Maintenance Area submitted by 

the Secretary of the Pennsylvania 

Department of Environmental 

Protection: 

Applicable geographic area Year 

Tons 

per 

day 

NOX

Scranton/Wilkes-Barre 1997 

8-Hour Ozone Maintenance Area ........................ 2018 7.5 

(f) As of June 15, 2015, EPA approves 

the following general conformity 

budgets for 2009 and 2018 for nitrogen 

oxides (NOX) for the Scranton/WilkesBarre 1997 8-Hour Ozone Maintenance 

Area submitted by the Secretary of the 

Pennsylvania Department of 

Environmental Protection: 

Applicable geographic area Year 

Tons 

per 

day 

NOX

Scranton/Wilkes-Barre 1997 

8-Hour Ozone Maintenance Area ........................ 2009 1.0 

Scranton/Wilkes-Barre 1997 

8-Hour Ozone Maintenance Area ........................ 2018 1.0 

4. Section 52.2052 is amended by 

adding paragraph (d) to read as follows: 

§ 52.2052 Motor vehicle emissions 

budgets for Pennsylvania ozone areas. 

* * * * * 

(d) As of June 15, 2015, EPA approves 

the following revised 2009 and 2018 

Motor Vehicle Emissions Budgets 

(MVEBs) for nitrogen oxides (NOX) for 

the Scranton/Wilkes-Barre 1997 8-Hour 

Ozone Maintenance Area submitted by 

the Secretary of the Pennsylvania 

Department of Environmental 

Protection: 

Applicable geographic area Year 

Tons 

per 

day 

NOX

Scranton/Wilkes-Barre 1997 

8-Hour Ozone Maintenance Area ........................ 2009 59.3 

Scranton/Wilkes-Barre 1997 

8-Hour Ozone Maintenance Area ........................ 2018 30.5 

[FR Doc. 2015–14440 Filed 6–12–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0176; FRL–9928–63] 

Di-n-butyl carbonate; 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 di-n-butyl 

carbonate (CAS Reg. No. 542–52–9) 

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 pesticide 

formulations in food-contact surfaces 

sanitizer products at a maximum level 


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34066 Federal Register / Vol. 80, No. 114 / Monday, June 15, 2015 / Rules and Regulations 

in the end-use concentration of 15,000 

ppm (1.5%). Exponent Inc., on behalf of 

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 di-n-butyl carbonate. 

DATES: This regulation is effective June 

15, 2015. Objections and requests for 

hearings must be received on or before 

August 14, 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–2014–0176, 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, Director, 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–2014–0176 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 14, 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– 

2014–0176, 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 January 28, 

2015 (80 FR 4525) (FRL–9921–55), EPA 

issued a document pursuant to FFDCA 

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

the filing of a pesticide petition (PP IN– 

10683) by Exponent Inc., 1150 

Connecticut Ave. NW., Suite 1100, 

Washington, DC 20036, on behalf of 

Huntsman Corporation, 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 di-n-butyl carbonate (CAS Reg. No. 

542–52–9) 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. That document 

referenced a summary of the petition 

prepared by Exponent Inc., on behalf of 

Huntsman Corp., the petitioner, which 

is available in the docket, http://

www.regulations.gov. There were no 

comments received in response to 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 din-butyl carbonoate 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 

‘‘Di-n-Butyl Carbonate; 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– 

2014–0176. 

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; 


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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 di-n-butyl 

carbonate including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with di-n-butyl 

carbonate 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 di-n-butyl carbonate as well as the 

no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in this 

unit. 

Di-n-butyl carbonate acute toxicity 

testing indicate that it has low acute 

oral, dermal and inhalation toxicity 

(acute oral and dermal LD50 > 2,000 

milligrams/kilogram (mg/kg); acute 

inhalation LC50 >8 mg/Liter (mg/L) and 

is non-irritating to the eyes and negative 

for dermal sensitization. Di-n-butyl 

carbonate is irritating to the skin. In a 

combined repeated dose toxicity study 

with the reproductive and 

developmental toxicity screening test, 

di-n-butyl carbonate was administered 

daily to rats by gavage. The di-n-butyl 

carbonate test material did not result in 

any test material related mortality or 

clinical observations in the parental 

animals. No effects were observed in the 

functional observational battery, 

hematology and clotting parameters, 

clinical chemistry parameters, or organ 

weights. No macroscopic findings 

related to the test item were observed. 

No histopathological effects were 

reported in neurological tissues 

(cerebrum, cerebellum, pons, peripheral 

nerve, spinal cord) (cervical, 

midthoracic and lumbar sections) or any 

immunological tissues (bone marrow, 

thymus, spleen, lymph nodes). 

The NOAEL of di-n-butyl carbonate in 

rats is 500 mg/kg bw/day for parental 

animals (males and females) and 500 

mg/kg bw/day for embryo-fetal toxicity. 

The LOAEL is 750 mg/kg bw/day based 

on decreased body weight gain in male 

and female paternal animals and 

embryo-fetal toxicity at 750 mg/kg bw/ 

day as evidenced by increased pre- and 

post-implantation losses and decreased 

total number of pups. 

If ingested di-n-butyl carbonate would 

be readily hydrolyzed by esterases in 

the gut to generate two molar 

equivalents of n-butanol and one molar 

equivalent of carbonic acid. EPA has 

stated for the n-butanol tolerance 

reassessment that once absorbed, nbutanol disappears rapidly from the 

blood. The carbonic acid rapidly 

dissociates into CO2 and water. 

Di-n-butyl carbonate was negative in 

an OCSPP Harmonized Test Guideline 

Bacterial Reverse Mutation Assay (at 

concentrations ranging from 1.5 to 5,000 

ug per plate); no positive mutagenic 

response was observed. 

There are no carcinogenicity studies 

available for di-n-butyl carbonate. 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, di-n-butyl carbonate 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 

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. 

No acute toxicological endpoints have 

been identified for di-n-butyl carbonate; 

therefore no acute exposure assessments 

are warranted. 


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The overall NOAEL for di-n-butyl 

carbonate was established at 500 mg/kg/ 

day. The chronic risk assessment for din-butyl carbonate is based on this 

endpoint and the chronic reference dose 

(cRfD) is therefore 5.0 mg/kg/day. The 

cRfD incorporates a 10X interspecies 

factor and a 10X intraspecies factor. 

Since the FQPA SF has been reduced to 

1X, the cPAD is also 5.0 mg/kg/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to di-n-butyl carbonate, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from di-nbutyl carbonate in food as follows: 

The Agency assessed the dietary 

exposures to di-n-butyl carbonate 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 di-n-butyl carbonate 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 

di-n-butyl carbonate. In the absence of 

specific residue data, EPA has 

developed an approach which 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 din-butyl carbonate 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 EPA 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 di-n-butyl 

carbonate can be found at http://

www.regulations.gov in document ‘‘Din-Butyl Carbonate; 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. 12–23 in docket ID number EPA– 

HQ–OPP–2014–0176. 

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 di-n-butyl 

carbonate, a conservative drinking water 

concentration value of 100 parts per 

billions (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 di-n-butyl carbonate; 

however, it is possible that di-n-butyl 

carbonate may be used as an inert 

ingredient in pesticide products. A 

highly conservative residential exposure 

assessment was performed in which it 

was assumed that all residential use 

pesticide products would contain di-nbutyl carbonate as an inert ingredient. A 

complete description of the approach 

used to assess possible residential 

exposures from di-n-butyl carbonate can 

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

in document ‘‘Di-n-Butyl Carbonate; 

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–2014–0176. 

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 di-n-butyl 

carbonate to share a common 

mechanism of toxicity with any other 

substances, and di-n-butyl carbonate 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that di-n-butyl carbonate 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 evidence for qualitative 

susceptibility in the OECD 422 study. In 

this study, embryo-fetal toxicity was 

manifested as evidenced by increased 

pre- and post-implantation losses and 

decreased total number of pups in the 

presence of maternal toxicity (decreased 

in body weights). However, considering 

the overall toxicity profile and the 

toxicity endpoints and doses selected 

for di-n-butyl carbonate, the degree of 

concern for the effects observed in the 

di-n-butyl carbonate reproductive and 

developmental toxicity screening study 


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Federal Register / Vol. 80, No. 114 / Monday, June 15, 2015 / Rules and Regulations 34069 

is low. There is a clear NOAEL for the 

offspring effects, and endpoints and 

regulatory doses were selected for use in 

the dietary risk assessment to be 

protective of these effects. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for di-n-butyl 

carbonate summarize the studies 

included in the database. EPA 

concludes that these data are sufficient 

for assessing the effects of di-n-butyl 

carbonate on infants and children. 

ii. There is no indication that di-nbutyl carbonate is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although there is some evidence 

that di-n-butyl carbonate results in 

increased susceptibility in rats, the 

degree of concern for these effects is low 

for the reasons explained in Unit IV.D.2. 

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 as well as 

conservative assumptions regarding 

exposures from food-contact sanitizer 

uses. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to di-n-butyl carbonate 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by di-n-butyl carbonate. 

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, di-n-butyl carbonate 

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 di-n-butyl 

carbonate from food and water will 

utilize 21% of the cPAD for the U.S. 

population and 94% 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 di-n-butyl 

carbonate 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 

di-n-butyl carbonate 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. 

4. Aggregate cancer risk for U.S. 

population. As discussed in Unit IV.A., 

di-n-butyl carbonate 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 di-n-butyl 

carbonate residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method for enforcement 

purposes is not required for di-n-butyl 

carbonate in pesticide formulations 

which include uses on crops for preand post-harvest, 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 

di-n-butyl carbonate on food-contact 

surfaces in antimicrobial applications 

since the Agency is not establishing a 

numerical tolerance for residues of di-nbutyl carbonate in or on any food 

commodities. EPA is establishing a 

limitation on the amount of di-n-butyl 

carbonate 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 di-n-butyl 

carbonate by weight. 

VI. Conclusions 

Therefore, exemptions from the 

requirement of a tolerance is established 

under 40 CFR 180.910, 180.930, and 

180.940(a) for di-n-butyl carbonate (CAS 

Reg. No. 542–52–9) 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 end-use concentration of 15,000 

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 


wreier-aviles on DSK5TPTVN1PROD with RULES
34070 Federal Register / Vol. 80, No. 114 / Monday, June 15, 2015 / Rules and Regulations 

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: June 5, 2015. 

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 § 180.910, 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 

* * * * * 

Di-n-butyl carbonate (CAS 

Reg. No. 542–52–9).

.......... 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 

* * * * * 

Di-n-butyl carbonate (CAS 

Reg. No. 542–52–9).

.......... 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) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

Di-n-butyl carbonate .................................. 542–52–9 When ready for use, the end-use concentration is not to exceed 15,000 ppm. 

*******

* * * * * 

[FR Doc. 2015–14647 Filed 6–12–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0161; FRL–9928–20] 

Sethoxydim; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of sethoxydim in 

or on multiple commodities that are 

identified and discussed later in this 

document. In addition, this regulation 

removes existing tolerances for residues 

of sethoxydim in or on several 

commodities identified later in this 

document that are superseded by this 

action. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

15, 2015. Objections and requests for 

hearings must be received on or before 

August 14, 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–2014–0161, 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: 


wreier-aviles on DSK5TPTVN1PROD with RULES