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Commodity Parts per 

million 

*******

Vegetable, brassica leafy, group 5 ........................................................................................................................................................ 4 .0 

Vegetable, bulb, group 3–07 ................................................................................................................................................................. 1 .5 

Vegetable, cucurbit, group 9 ................................................................................................................................................................. 0 .50 

* * * * * * * 

Vegetable, leafy, except brassica, group 4 ........................................................................................................................................... 30 

* * * * * * * 

Vegetable, root, except sugarbeet, subgroup 1B .................................................................................................................................. 0 .90 

*******

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

combined indirect or inadvertent 

residues of the fungicide fluxapyroxad, 

including its metabolites and 

degradates, in or on the commodities 

listed in the table below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only fluxapyroxad, 3-(difluoromethyl)- 

1-methyl-N-(3′,4′,5′-trifluoro[1,1′- 

biphenyl]-2-yl)-1H-pyrazole-4- 

carboxamide in or on the commodity. 

Commodity Parts per 

million 

Nongrass animal feeds, 

group18 ............................... 0 .30 

Peppermint, tops .................... 0 .01 

Spearmint, tops ...................... 0 .01 

[FR Doc. 2014–04164 Filed 2–25–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0093; FRL–9906–17] 

N-(n-octyl)-2-pyrrolidone; 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 N-(n-octyl)-2- 

pyrrolidone (CAS Reg. No. 2687–94–7) 

when used as an inert ingredient 

(solvent) in formulations of pyraflufenethyl herbicide at a maximum 

concentration of 20% weight. Wagner 

Regulatory Associates on behalf of 

Nichino America, Inc. 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-(noctyl)-2-pyrrolidone. 

DATES: This regulation is effective 

February 26, 2014. Objections and 

requests for hearings must be received 

on or before April 28, 2014, 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–2013–0093, 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), EPA West 

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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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–2013–0093 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 28, 2014. 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 

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Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 10679 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0093, 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.htm. 

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 February 

27, 2013 (78 FR 13295) (FRL–9380–2), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (IN–10541) by Nichino 

America, Inc. 4550 New Linden Hill 

Road, Suite 501, Wilmington, DE 19808. 

The petition requested that 40 CFR 

180.1130 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of N-(n-octyl)-2- 

pyrrolidone (CAS Reg. No. 2687–94–7) 

when used as an inert ingredient 

(solvent) in formulations of pyraflufenethyl herbicide at a maximum 

concentration of 20% weight. That 

document referenced a summary of the 

petition prepared by Wagner Regulatory 

Associates, Inc. 7217 Lancaster Pike, 

Suite A, P.O. Box 640, Hockessin, 

Delaware 19707, the petitioner, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

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

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with FFDCA section 

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

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for N-(n-octyl)-2- 

pyrrolidone including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with N-(n-octyl)-2- 

pyrrolidone 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-(n-octyl)-2-pyrrolidone 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. 

Based on the results of acute toxicity 

studies in rats, N-(n-octyl)-2-pyrrolidone 

is classified as having low acute toxicity 

via the oral and dermal routes of 

exposure. It is a dermal irritant and a 

dermal sensitizer. 

In mammals, the primary target is the 

liver. In subchronic feeding studies in 

rats and dogs, N-(n-octyl)-2-pyrrolidone 

generally caused increases in both 

absolute and relative liver weights along 

with reduction in body weight gain/food 

consumption and changes in 

hematological and biochemical 

parameters. No chronic toxicity study is 

available. 

In a developmental toxicity study in 

rats with N-(n-octyl)-2-pyrrolidone, 

there was no evidence of increased 

susceptibility in fetuses as toxic effects 

were observed only at the highest dose 

tested, 800 milligrams/kilograms/day 

(mg/kg/day), in which dams exhibited 

ruffled fur, ventral recumbency, 

somnolence, apathy, dyspnea and 

comatose state. Other adverse effects 

observed were a reduction in food 

consumption and slight body weight 

loss during the first days of dosing and 

reduced corrected body weight gain. 

Developmental effects such as reduced 

body weight and delay in skeletal 

ossification were observed only in the 

presence of maternal toxicity. No 

reproductive toxicity, immunotoxicity 

or neurotoxicity data are available for N- 

(n-octyl)-2-pyrrolidone, 

There were three genotoxicity studies 

available in the database for N-(n-octyl)- 

2-pyrrolidone. An Ames test, a mouse 

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lymphoma assay and a mouse 

micronucleus test all showed negative 

results for genotoxicity of N-(n-octyl)-2- 

pyrrolidone. 

No carcinogenicity studies were 

available in the database for N-(n-octyl)- 

2-pyrrolidone. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK11, 

to determine if there were structural 

alerts for potential carcinogenicity for 

N-(n-octyl)-2-pyrrolidone. No structural 

alerts for carcinogenicity were identified 

for N-(n-octyl)-2-pyrrolidone. In the 

absence of any structural alerts and lack 

of mutagenicity concerns, N-(n-octyl)-2- 

pyrrolidone 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. 

A summary of the toxicological 

endpoints for N-(n-octyl)-2-pyrrolidone 

used for human risk assessment is given 

below: 

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) was established based on the 

NOAEL (30 mg/kg/day) from a 90-day 

oral toxicity study in dogs. The adverse 

effects seen in this study were several 

statistically significant changes in 

hematology and clinical chemistry 

parameters and statistically significant 

dose-related increases in both absolute 

and relative liver weights at the LOAEL 

of 90 mg/kg/day. A Food Quality 

Protection Act (FQPA) safety factor/

database uncertainty factor of 3X is 

utilized for dietary risk assessment. 

3. Dermal, short-term (1–30 days). The 

level of concern (LOC) for short-term 

dermal exposure is a Margin of 

Exposure (MOE) of 300 between 

estimated human exposure and the 

NOAEL (30 mg/kg/day) from the 90-day 

oral toxicity study in dogs. An FQPA 

safety factor/database uncertainty factor 

of 3X is utilized for dermal, short-term, 

assessment. 

4. Inhalation, short-term (1–30 days). 

The level of concern (LOC) for shortterm inhalation exposure is a MOE of 

300 between estimated human exposure 

and the NOAEL (30 mg/kg/day) from the 

90-day oral toxicity study in dogs. An 

FQPA safety factor/database uncertainty 

factor of 3X for the short-term inhalation 

assessment. 

Quantification of cancer risk is not 

appropriate since there are no concerns 

for cancer based on SAR analysis of N- 

(n-octyl)-2-pyrrolidone. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to N-(n-octyl)-2-pyrrolidone, 

EPA considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from N-(noctyl)-2-pyrrolidone in food as follows: 

In conducting the chronic dietary 

exposure assessment 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-(n-octyl)-2- 

pyrrolidone. 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 N-(n-octyl)-2- 

pyrrolidone, EPA made specific 

adjustments to the dietary exposure 

assessment to account for the use 

limitations of N-(n-octyl)-2-pyrrolidone 

as an inert ingredient in cotton defoliant 

formulations containing thidiazuron 

and diuron as active ingredients as well 

as the proposed use as an inert 

ingredient in formulations of pyraflufen 

ethyl herbicide at a maximum 

concentration of 20% weight. 

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-(noctyl)-2-pyrrolidone, a conservative 

drinking water concentration value of 

100 parts per billion (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). 

The proposed use of N-(n-octyl)-2- 

pyrrolidone is as an inert ingredient in 

pyraflufen ethyl formulations which 

have uses resulting in potential 

residential exposures. A screening level 

residential exposure and risk 

assessment was conducted based on the 

use pattern and application rates of 

pyraflufen ethyl products. 

EPA assessed residential exposure 

using the following assumptions: All 

residential exposures are considered 

short-term in duration. The residential 

handler assessment included short-term 

exposures via the dermal and inhalation 

routes from treating golf courses, 

ornamental turf lawns, road sides, parks 

and sports fields. In terms of postapplication exposure, there is the 

potential for dermal post-application 

exposure for individuals as result of 

being in an environment that has been 

previously treated with N-(n-octyl)-2- 

pyrrolidone. Short-term dermal 

exposures were assessed for adults, 

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children 1–2 and adult/child golfer. The 

scenarios used in the aggregate 

assessment were those that resulted in 

the highest exposures. 

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 N-(n-octyl)-2- 

pyrrolidone to share a common 

mechanism of toxicity with any other 

substances, and N-(n-octyl)-2- 

pyrrolidone 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-(n-octyl)-2-pyrrolidone 

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. 

No evidence of increased susceptibility 

was seen in the developmental toxicity 

study on N-(n-octyl)-2-pyrrolidone. The 

maternal and developmental toxicity 

NOAEL was 200 mg/kg bw/day based 

on reduced body weight gain in dams 

and mean fetal body weight and delay 

in skeletal ossification at the LOAEL of 

800 mg/kg bw/day. No reproductive 

toxicity study is available N-(n-octyl)-2- 

pyrrolidone. 

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 3X for all scenarios. 

That decision is based on the following 

findings: 

i. The toxicity database for N-(noctyl)-2-pyrrolidone consists of 90-day 

oral toxicity studies in rats and dogs, 

several mutagenicity studies and a 

developmental toxicity study. While 

there are no reproductive, neurotoxicity 

and chronic toxicity studies for N-(noctyl)-2-pyrrolidone, there is no 

evidence of effects on reproductive 

parameters or of any effects suggestive 

of neurotoxicity from the available 

subchronic studies. Additionally, the 

most sensitive endpoint selected seen in 

the 90-day dog oral toxicity study is 

based on hematological and clinical 

chemistry parameters; increases in both 

absolute and relative liver weights; and 

reduction in body weight gain/food 

consumption—effects which are not 

expected to be progressive and for 

which the resultant exposure 

assessment is likely to be protective of 

chronic effects and characterize toxicity 

potential of N-(n-octyl)-2-pyrrolidone. 

Although additional data are unlikely to 

indicate more sensitive effects, EPA has 

retained a FQPA factor of 3X as a 

database uncertainty factor. No 

inhalation toxicity studies were 

available in the database; however, the 

only potential inhalation exposure to N- 

(n-octyl)-2-pyrrolidone is to pesticide 

applicators, and, even assuming that 

such exposure has some relevance to 

decisions on the FQPA safety factor, the 

inhalation exposure to N-(n-octyl)-2- 

pyrrolidone is negligible in comparison 

to exposure under other pathways. In 

these circumstances, neither retention 

or removal of the FQPA safety factor 

would have a meaningful impact on 

assessment of risk from inhalation 

exposure. 

ii. No evidence of immunotoxicity 

was observed in the available database. 

Slight change in the clinical 

pathological parameters (decreases in 

albumin/globulin ratio and globulin 

levels) were not considered as an 

indication of an immunotoxic response 

since no effects on blood lymphocytes 

and no adverse findings in the spleen 

and thymus. Therefore, an 

immunotoxicity study is not required. 

iii. There are no residual uncertainties 

identified in the exposure databases. As 

described earlier, EPA used worst case 

assumptions for the dietary food 

exposure assessment. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to N-(n-octyl)- 

2-pyrrolidone in drinking water. EPA 

used similarly conservative assumptions 

to assess residential post application 

exposure of children as well as 

incidental oral exposure of children 

1–2. These assessments will not 

underestimate the exposure and risks 

posed by N-(n-octyl)-2-pyrrolidone. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, N-(n-octyl)-2- 

pyrrolidone 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-(n-octyl)-2- 

pyrrolidone from food and water will 

utilize 59.37% of the cPAD for children 

1–2 years old, the population group 

receiving the greatest exposure. The 

chronic dietary exposure estimates for 

the total U.S. population was 14.31%. 

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). N-(n-octyl)-2- 

pyrrolidone is currently 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 N-(noctyl)-2-pyrrolidone. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 1,122 for adults and 291 for 

children 1–2. EPA’s level of concern for 

N-(n-octyl)-2-pyrrolidone is a MOE of 

300 or below, however these MOEs are 

not of concern based on the highly 

conservative assumptions made 

regarding residential and dietary 

exposures to N-(n-octyl)-2-pyrrolidone. 

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4. Intermediate-term risk. 

Intermediate-term residential aggregate 

exposure takes into account 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Pyraflufen ethyl is not 

currently registered for uses that could 

result in intermediate-term residential 

exposure so an intermediate term risk 

assessment for N-(n-octyl)-2-pyrrolidone 

was not performed. There are also no 

intermediate-term adverse effects 

identified and therefore N-(n-octyl)-2- 

pyrrolidone is not expected to pose an 

intermediate-term risk. 

5. Aggregate cancer risk for U.S. 

population. N-(n-octyl)-2-pyrolidone is 

not expected to be carcinogenic. 

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 N-(n-octyl)- 

2-pyrrolidone residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of N-(n-octyl)-2- 

pyrrolidone in or on any food 

commodities. EPA is establishing a 

limitation on the amount of N-(n-octyl)- 

2-pyrrolidone that may be used in 

pesticide formulations. 

The limitation will be enforced 

through the pesticide registration 

process under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

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

not register any pesticide for sale or 

distribution containing pyraflufen ethyl 

as an active ingredient with 

concentrations of N-(n-octyl)-2- 

pyrrolidone exceeding 20% by weight of 

the pesticide formulation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nation Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRL for N-(n-octyl)-2- 

pyrrolidone. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.1130 for N-(n-octyl)- 

2-pyrrolidone (CAS Reg. No. 2687–94– 

7) when used as an inert ingredient 

(solvent) in formulations of pyraflufenethyl herbicide at a maximum 

concentration of 20% by weight. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule 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 final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (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 of 1995 

(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 18, 2014. 

Lois Rossi, 

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. Revise § 180.1130 to read as 

follows: 

§ 180.1130 N-(n-octyl)-2-pyrrolidone and N- 

(n-dodecyl)-2-pyrrolidone; exemptions from 

the requirement of a tolerance. 

(a) N-(n-octyl)-2-pyrrolidone and N- 

(n-dodecyl)-2-pyrrolidone are exempt 

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Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 10683 

from the requirement of a tolerance 

when used as solvents in cotton 

defoliant formulations containing 

thidiazuron and diuron as active 

ingredients. 

(b) N-(n-octyl)-2-pyrrolidone is 

exempt from the requirement of a 

tolerance when used as a solvent in 

formulations containing pyraflufenethyl as an active ingredient at a 

concentration not to exceed 20% by 

weight. 

[FR Doc. 2014–04099 Filed 2–25–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0389; FRL–9904–92] 

GS-omega/kappa-Hxtx-Hv1a; 

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 GS-omega/

kappa-Hxtx-Hv1a, in or on all food 

commodities when applied or used in 

accordance with label directions and 

good agricultural practices. Vestaron 

Corporation, submitted a petition to the 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of GSomega/kappa-Hxtx-Hv1a under FFDCA. 

DATES: This regulation is effective 

February 26, 2014. Objections and 

requests for hearings must be received 

on or before April 28, 2014, 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–2012–0389, 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), EPA West 

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: 

Susanne Cerrelli, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

BPPDFRNotices@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 the EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0389 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 28, 2014. 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 the EPA without 

prior notice. Submit the non-CBI copy 

of your objection or hearing request, 

identified by docket ID number EPA– 

HQ–OPP–2012–0389, 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 

In the Federal Register of July 25, 

2012 (77 FR 43562) (FRL–9353–6), the 

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 2F8014) 

by Vestaron Corporation, 4717 Campus 

Drive, Ste. 1200, Kalamazoo, MI 49008. 

The petition requested that 40 CFR part 

180 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of GS-omega/

kappa-Hxtx-Hv1a. That document 

referenced a summary of the petition 

prepared by the petitioner Vestaron 

Corporation, which is available in the 

docket, http://www.regulations.gov. No 

comments to the petition for GS-UACTX-Hv1a-SEQ2 tolerance exemption 

were received. A correction for the 

name of the active ingredient was 

published in the Federal Register of 

December 18, 2013 (78 FR 76589) (FRL– 

9904–17). The active ingredient, 

previously known as GS-U-ACTX-Hv1aSEQ2, was revised to GS-omega/kappaHxtx-Hv1a, based on acceptable 

nomenclature for naming peptide toxins 

from spiders. 

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