40020 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 

C. Revisions to Petitioned-For 

Tolerances 

The Agency has revised the tolerance 

expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

ethalfluralin not specifically mentioned. 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the herbicide 

ethalfluralin, N-ethyl-N-(2-methyl-2- 

propenyl)-2,6-dinitro-4- 

(trifluoromethyl)-benzenamine, in or on 

rapeseed subgroup 20A at 0.05 ppm and 

sunflower subgroup 20B at 0.05 ppm. 

This regulation additionally removes 

established tolerances in or on mustard, 

seed; rapeseed, seed; safflower, seed; 

and sunflower, seed. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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). 

VII. 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 21, 2013. 

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. In § 180.416: 

■ i. Revise the introductory text of 

paragraph (a). 

■ ii. Remove the commodities, 

‘‘Mustard, seed;’’ ‘‘Rapeseed, seed;’’ 

‘‘Safflower, seed;’’ and ‘‘Sunflower, 

seed’’ from the table in paragraph (a). 

■ iii. Add alphabetically the following 

commodities to the table in paragraph 

(a). 

The amendments read as follows: 

§ 180.416 Ethalfluralin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

ethalfluralin, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only the 

residues of ethalfluralin, N-ethyl-N-(2- 

methyl-2-propenyl)-2,6-dinitro-4- 

(trifluoromethyl)benzenamine. 

Commodity Parts per 

million 

* * * * * 

Rapeseed subgroup 20A ...... 0.05 

* * * * * 

Sunflower subgroup 20B ...... 0.05 

* * * * * 

* * * * * 

[FR Doc. 2013–15710 Filed 7–2–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0520; FRL–9390–5] 

Fenbuconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenbuconazole 

in or on pepper. Dow AgroSciences LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

3, 2013. Objections and requests for 

hearings must be received on or before 

September 3, 2013, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

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Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 40021 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0520, 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: Erin 

Malone, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0253; email address: 

malone.erin@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 EPA’s tolerance 

regulations at 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–2012–0520 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 September 3, 2013. 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– 

2012–0520, 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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

28, 2012 (77 FR 59578) (FRL–9364–6), 

EPA issued a document pursuant to 

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

346a(d)(3), announcing the filing of a 

pesticide petition (PP 2F8034) by Dow 

AgroSciences LLC, 9330 Zionsville 

Road, Indianapolis, Indiana 46268. The 

petition requested that 40 CFR 180.480 

be amended by modifying the tolerance 

for residues of the fungicide 

fenbuconazole, alpha-[2-(4- 

chlorophenyl)-ethyl]-alpha-phenyl-3- 

(1H-1,2,4-triazole)-1-propanenitrile, and 

its metabolites RH-9129, cis-5-(4- 

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3 Hfuranone, and RH-9130, trans-5-(4- 

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3 Hfuranone, in or on pepper from 0.4 parts 

per million (ppm) to 1.0 ppm. That 

document referenced a summary of the 

petition prepared by Dow AgroSciences 

LLC, the registrant, which is available in 

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

A comment was received on the notice 

of filing. EPA’s response to this 

comment is discussed in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish 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. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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 fenbuconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fenbuconazole follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its 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. The main target 

organ of fenbuconazole is the liver. 

Increased liver weight, hepatocellular 

hypertrophy, and clinical chemistry 

changes were observed in the rat, dog, 

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40022 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 

and mouse following subchronic and 

chronic exposure. In the rat (but not the 

dog or mouse), effects on the thyroid 

were also observed. A mechanistic 

study demonstrated that these findings 

are secondary to changes in liver 

metabolic enzyme activities, which 

result in alterations to levels of 

circulating thyroid hormone due to 

increased clearance via increased liver 

metabolism and, eventually, thyroid 

hyperplasia. The rat is significantly 

more sensitive to these effects than 

other species. Clear NOAELs and 

LOAELs were established for these 

findings, and the endpoints selected for 

human health risk assessment are 

protective of the thyroid effects. The 

endpoints are also protective of 

potential thyroid perturbation to 

offspring, as the developmental 

NOAELs were significantly higher than 

the NOAELs for thyroid and liver effects 

in adults (e.g., chronic dietary endpoint 

based on rat chronic/carcinogenicity 

NOAEL of 3 mg/kg/day vs. rat 

developmental NOAEL of 30 mg/kg/ 

day), and no increased quantitative 

susceptibility was observed for thyroid 

and liver effects among the offspring 

relative to the parental animals. Kidney 

and adrenal weights were increased in 

dogs after chronic exposure. Although 

acute and subchronic neurotoxicity 

have not been submitted, EPA 

concluded that these studies are not 

required, taking into consideration the 

lack of observed neurotoxic effects in 

the available studies for fenbuconazole 

as well as many other triazole 

fungicides. There was no evidence of 

increased quantitative or qualitative 

susceptibility to in utero or post-natal 

exposure to fenbuconazole. Since the 

previous assessment, new rabbit 

developmental toxicity and rat 

metabolism studies were submitted; the 

findings of these studies are consistent 

with the data EPA assessed previously 

and do not affect the overall 

characterization of hazard or selection 

of doses and endpoints for risk 

assessment. Fenbuconazole is classified 

as a ‘‘Group C,’’ or possible human 

carcinogen, based on an increased 

incidence of liver tumors in male and 

female mice. A cancer potency factor 

has been used to quantify potential 

cancer risk associated with 

fenbuconazole uses. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenbuconazole as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Fenbuconazole: Human Health Risk 

Assessment for an Increased Tolerance 

for Residues in Peppers and a Label 

Amendment for the Enable 2F Product’’ 

at page 14 in docket ID number EPA– 

HQ–OPP–2012–0520. 

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 

fenbuconazole used for human risk 

assessment is shown in Table 1 of this 

unit. 

A summary of the toxicological 

endpoints for fenbuconazole used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENBUCONAZOLE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–49 years of 

age).

NOAEL = 30 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.3 

mg/kg/day.

aPAD = 0.3mg/kg/ 

day 

Developmental rat study 

LOAEL = 75 mg/kg/day based on increased resorptions, 

postimplantation loss and decreased live fetuses per 

dam. 

Acute dietary (General population including infants and children).None ..................... None ..................... Not selected 

No appropriate single dose and endpoint could be identified for these population groups. 

Chronic dietary (All populations) ............ NOAEL = 3 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.03 

mg/kg/day.

cPAD = 0.03 mg/ 

kg/day 

Combined chronic toxicity/carcinogenicity—Rat 

LOAEL = 30.6/43.1 (M/F) mg/kg/day based on decreased 

body weight gain, increased thyroid weight, and 

hispathological lesions in the liver and thyroid gland. 

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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENBUCONAZOLE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Cancer (Oral, dermal, inhalation) ........... Under the 1986 cancer classification scheme, fenbuconazole was classified as a Group C—Possible 

Human Carcinogen, with a low dose extrapolation model applied to the animal data for the quantification of human risk (Q1*). This classification was based on a statistically significant increase in combined hepatocellular adenomas and/or carcinomas by pair-wise comparison with concurrent controls, 

and significantly increasing trend in both the incidences of adenomas, and combined adenomas/carcinomas, in female mice. The upper bound estimate of unit risk, Q1* (mg/kg/day)¥1 is 3.59 × ¥3 in 

human equivalents. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligrams/kilogram/day. 

NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty 

factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenbuconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fenbuconazole tolerances in 40 

CFR 180.480. For the acute, chronic, 

and cancer dietary exposure 

assessments, EPA used food 

consumption information from the 

United States Department of 

Agriculture’s (USDA) National Health 

and Nutrition Examination Survey/ 

What We Eat In America (NHANES/ 

WWEIA) collected from 2003–2008. In 

addition, EPA assessed dietary 

exposures from fenbuconazole in food 

as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

Such effects were identified for 

fenbuconazole only for females age 13– 

49. As to residue levels in food, EPA 

used tolerance-level residues and 

assumed 100% crop treated for all 

commodities in the acute dietary 

exposure assessment. 

ii. Chronic exposure. As to residue 

levels in food, EPA used a combination 

of tolerance-level residues and, for 

many foods, average residue levels from 

crop field trials. One-hundred percent 

crop treated was assumed for all 

commodities in the chronic dietary 

exposure assessment. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

nonlinear approach is used and a cancer 

RfD is calculated based on an earlier 

noncancer key event. If carcinogenic 

mode of action data are not available, or 

if the mode of action data determines a 

mutagenic mode of action, a default 

linear cancer slope factor approach is 

utilized. Based on the data summarized 

in Unit III.A., EPA has concluded that 

fenbuconazole should be classified as 

‘‘Possibly Carcinogenic to Humans’’ and 

a linear approach has been used to 

quantify cancer risk. 

In its assessment of dietary cancer 

risk, EPA used the same residue levels 

as described for the chronic assessment. 

EPA also assumed 100% crop treated, 

except for the percent crop treated 

estimates described in Unit III.C.1.iv., 

below. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such Data Call-Ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

existing uses as follows for the cancer 

assessment: Almonds: 5%; apples: 5%; 

apricots: 5%; blueberries: 55%; cherries: 

15%; grapefruit: 40%; nectarines: 5%; 

oranges: 5%; peaches: 15%; pecans: 

10%; plums/prunes: 1%; sugar beets: 

1%; tangelos: 10%; tangerines: 1%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

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40024 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations are taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which fenbuconazole may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fenbuconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fenbuconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fenbuconazole for acute exposures are 

estimated to be 24.1 parts per billion 

(ppb) for surface water and 0.031 ppb 

for ground water, for chronic exposures 

for non-cancer assessments are 

estimated to be 16.5 ppb for surface 

water and 0.031 ppb for ground water, 

and for chronic exposures for cancer 

assessments are estimated to be 11.7 

ppb for surface water and 0.031 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 24.1 ppb was 

used to assess the contribution from 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 16.5 ppb was used to assess the 

contribution from drinking water. For 

cancer dietary risk assessment, the 

water concentration of value 11.7 ppb 

was used to assess the contribution from 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Fenbuconazole is not registered for any 

specific use patterns that would result 

in residential exposure. 

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.’’ 

Fenbuconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

fungi by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same, sequence of 

major biochemical events. In conazoles, 

however, a variable pattern of 

toxicological responses is found: Some 

conazoles are hepatotoxic and 

hepatocarcinogenic in mice, some 

induce thyroid tumors in rats, and some 

induce developmental, reproductive, 

and neurological effects in rodents. 

Furthermore, the conazoles produce a 

diverse range of biochemical events 

including altered cholesterol levels, 

stress responses, and altered DNA 

methylation. It is not clearly understood 

whether these biochemical events are 

directly connected to their toxicological 

outcomes. Thus, there is currently no 

evidence to indicate that conazoles 

share common mechanisms of toxicity 

and EPA is not following a cumulative 

risk approach based on a common 

mechanism of toxicity for the conazoles. 

For information regarding EPA’s 

procedures for cumulating effects from 

substances found to have a common 

mechanism of toxicity, see EPA’s Web 

site at http://www.epa.gov/pesticides/ 

cumulative. 

Fenbuconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole as well as the common triazole 

conjugates (triazolylalanine, 

triazolylacetic acid, and triazolylpyrivic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

fenbuconazole, EPA conducted human 

health risk assessments for exposure to 

1,2,4-triazole and the common triazole 

conjugates resulting from the use of all 

current and pending uses of any 

triazole-derived fungicide. The risk 

assessment is a highly conservative, 

screening-level evaluation in terms of 

hazards associated with common 

metabolites (e.g., use of a maximum 

combination of uncertainty factors) and 

potential dietary and non-dietary 

exposures (i.e., high end estimates of 

both dietary and non-dietary exposures). 

The assessment includes evaluations of 

risks for various subgroups, including 

those comprised of infants and children. 

The Agency’s complete risk assessment 

is found in the propiconazole 

reregistration docket at http:// 

www.regulations.gov, docket 

identification (ID) number EPA–HQ– 

OPP–2005–0497. 

Aggregate risk from exposure to the 

common triazole metabolites were 

recently estimated by the Agency (1 

May 2013) and found to be not of 

concern. An updated dietary exposure 

and risk analysis for the common 

triazole metabolites 1,2,4-triazole (T), 

triazolylalanine (TA), triazolylacetic 

acid (TAA), and triazolylpyruvic acid 

(TP), reflecting the revised tolerance for 

residues of fenbuconazole in/on pepper 

was completed on May 21, 2013. Given 

that the updated dietary risk estimate 

increased by less than 1% relative to the 

previous assessment, new aggregate risk 

estimates were not made, and aggregate 

risk estimates for the common triazole 

metabolites remain below the Agency’s 

level of concern. These documents may 

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

by searching for the following titles and 

docket numbers: ‘‘Common Triazole 

Metabolites: Updated Aggregate Human 

Health Risk Assessment to Address The 

New Section 3 Registrations For Use of 

Prothioconazole on Bushberry Crop 

Subgroup 13–07B, Low Growing Berry, 

Except Strawberry, Crop Subgroup 13– 

07H, and Cucurbit Vegetables Crop 

Group 9; Use of Flutriafol on Coffee; 

and Ipconazole on Crop Group 6’’ 

(located in docket ID number EPA–HQ– 

OPP–2012–0876) and ‘‘Common 

Triazole Metabolites: Updated Dietary 

(Food + Water) Exposure and Risk 

Assessment to Address the Revised 

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Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 40025 

Tolerance for Residues of 

Fenbuconazole in Peppers’’ (docket ID 

number EPA–HQ–OPP–2012–0520). 

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. 

In the rat and rabbit developmental 

toxicity studies and the 2-generation 

study in rats, all effects in the pups 

occurred in the presence of maternal 

toxicity, including changes in body 

weight and body weight gains in rats 

and decreased food consumption and 

clinical signs in rabbits. Developmental 

effects included increased postimplantation loss and decreased live 

fetuses per dam in the rat 

developmental study; increased early 

resorptions in the rabbit developmental 

study; and decreased mean pup body 

weight, increased number of stillborn 

pups, decreased number of total 

offspring delivered, and decreased 

viability index of pups in the two 

generation study in rats. No increased 

qualitative or quantitative susceptibility 

was observed in any of the studies. In 

the rat developmental toxicity study, 

although a decrease in the number of 

live fetuses per litter was observed at 

the LOAEL, this effect was due largely 

to reduced implantation sites, which 

may reflect maternal toxicity. 

Additionally, the increases in 

postimplantation loss and early 

resorptions were marginal at the 

LOAEL. Therefore, the findings in this 

study were not considered indicative of 

increased offspring susceptibility. In the 

rabbit developmental study, 

developmental effects were observed at 

a higher dose than maternal effects. In 

the rat reproduction study, effects on 

pup viability were observed at a dose 

that resulted in maternal mortality 

during delivery. There was no evidence 

of neurotoxicity in any of the studies 

available in the toxicology database. 

Therefore, a developmental 

neurotoxicity study is not required. 

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 is complete, 

except for an immunotoxicity study; 

however, due to the lack of any 

evidence of immunotoxicity based upon 

the available studies, EPA does not 

believe that an immunotoxicity study 

will result in a lower point-of-departure 

than those being relied upon for the 

present risk assessments. Therefore, an 

uncertainty factor is not required to 

account for the lack of this study. 

ii. There is no evidence of 

neurotoxicity in the available database, 

and a developmental neurotoxicity 

study is not required. 

iii. There is no evidence that 

fenbuconazole results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary exposure assessment 

is a screening-level assessment, utilizing 

tolerance-level residues and assuming 

100% crop treated. The chronic dietary 

exposure assessment is slightly refined, 

utilizing some tolerance-level residues 

and some average residue levels from 

crop field trials and assuming 100% 

crop treated. The cancer dietary 

exposure assessment is also slightly 

refined, utilizing the same residue 

estimates as for the chronic assessment 

and some percent crop treated 

estimates. EPA made conservative 

(protective) assumptions in the ground 

water and surface water modeling used 

to assess exposure to fenbuconazole in 

drinking water. There are no registered 

residential uses for fenbuconazole. 

These assessments will not 

underestimate the exposure and risks 

posed by fenbuconazole. 

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. The only population subgroup 

that is relevant for an acute assessment 

is females of child-bearing age (i.e., 

females 13–49 years old). The acute risk 

estimate that results from this analysis 

is 2.9% of the acute population adjusted 

dose (aPAD) at the 95th percentile of 

exposure. This risk estimate is 

considerably lower than EPA’s level of 

concern (100% of the aPAD). 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fenbuconazole 

from food and water will utilize 6.7% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for fenbuconazole. 

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). For fenbuconazole, 

there are no residential uses and 

therefore a short-term aggregate risk 

assessment was not needed. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

There are no residential uses for 

fenbuconazole at this time, therefore an 

intermediate-term risk assessment was 

not needed. 

5. Aggregate cancer risk for U.S. 

population. Fenbuconazole is classified 

as a Group C (possible human) 

carcinogen under the Agency’s 1986 

Cancer Guidelines, based on increased 

incidences of liver tumors in male and 

female mice and thyroid tumors in male 

rats. Using the conservative exposure 

assumptions described in this unit for 

cancer risk from chronic exposure and 

an upper bound estimate of unit risk 

(Q1*) of 3.59 × 10¥3 (mg/kg/day)¥1, 

EPA has derived a cancer risk estimate 

of 2.2 × 10¥6 from dietary exposure to 

fenbuconazole. 

EPA generally considers cancer risks 

(expressed as the probability of an 

increased cancer case) in the range of 1 

in 1 million (or 1 × 10¥6) or less to be 

negligible. The precision which can be 

assumed for cancer risk estimates is best 

described by rounding to the nearest 

integral order of magnitude on the 

logarithmic scale; for example, risks 

falling between 3 × 10¥7 and 3 × 10¥6

are expressed as risks in the range of 

10¥6. Considering the precision with 

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40026 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 

which cancer hazard can be estimated, 

the conservativeness of low-dose linear 

extrapolation, and the rounding 

procedure described in this unit, cancer 

risk should generally not be assumed to 

exceed the benchmark level of concern 

of the range of 10¥6 until the calculated 

risk exceeds approximately 3 × 10¥6. 

This is particularly the case where some 

conservatism is maintained in the 

exposure assessment. Although the 

fenbuconazole exposure risk assessment 

is somewhat refined, it retains 

significant conservatism in that the 

analysis relies on field trial data and 

assumes 100% crop treated for many 

commodities. Accordingly, EPA has 

concluded the aggregate cancer risk for 

all existing fenbuconazole uses and the 

uses associated with the tolerances 

established in this action fall within the 

range of 1 × 10¥6 and are thus 

negligible. 

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 

fenbuconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(GC/NPD method, TR 34–940–47 and 

TR34–90–47R) is available to enforce 

the tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

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 Nations 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 established an MRL for 

fenbuconazole in or on pepper at 0.6 

ppm. This MRL is different than the 

tolerance established for fenbuconazole 

in the United States. The Codex MRL for 

pepper was most likely established 

before the Enable® 2F formulation was 

proposed for use on peppers and 

includes only residues of the parent 

compound. This new formulation has 

higher residues values ranging up to 0.7 

ppm, and the U.S. tolerance includes 

the two lactone metabolites. 

Harmonization with the 0.6 ppm 

tolerance is not feasible given the 

proposed new use pattern/formulation 

and the observed residue levels. 

C. Response to Comments 

EPA received a comment to the notice 

of filing which said that residue levels 

of fenbuconazole should not be raised. 

The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned on 

agricultural corps. However, the existing 

legal framework provided by section 

408 of the Federal Food, Drug, and 

Cosmetic Act (FFDCA) states that 

tolerances may be set when persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. This citizen’s comment 

appears to be directed at the underlying 

statute and not EPA’s implementation of 

it; the citizen has made no contention 

that EPA has acted in violation of the 

statutory framework. 

V. Conclusion 

Therefore, tolerances are modified to 

establish residues of fenbuconazole in 

or on pepper at 1.0 ppm. Consistent 

with the petition and EPA’s policy for 

clarifying its tolerance expressions, EPA 

is revising the tolerance expression for 

fenbuconazole to clarify that the 

tolerance includes metabolites and 

degradates of fenbuconazole and that 

compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only the sum 

of fenbuconazole, alpha-[2-(4- 

chlorophenyl)-ethyl]-alpha-phenyl-3- 

(1H-1,2,4-triazole)-1-propanenitrile, and 

its metabolites RH-;9129, cis-5-(4- 

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3 Hfuranone, and RH-9130, trans-5-(4- 

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3 Hfuranone, calculated as the 

stoichiometric equivalent of 

fenbuconazole, 

VI. 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 

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Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 40027 

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). 

VII. 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 21, 2013. 

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. In § 180.480 revise paragraph (a) 

introductory text and revise the entry 

‘‘Pepper’’ in the table in paragraph (a) to 

read as follows: 

§ 180.480 Fenbuconazole; tolerances for 

residues. 

(a) Tolerances are established for 

residues of the fungicide fenbuconazole, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of fenbuconazole, alpha-[2-(4- 

chlorophenyl)-ethyl]-alpha-phenyl-3- 

(1H-1,2,4-triazole)-1-propanenitrile, and 

its metabolites RH-9129, cis-5-(4- 

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3 Hfuranone, and RH-9130, trans-5-(4- 

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3 Hfuranone, calculated as the 

stoichiometric equivalent of 

fenbuconazole, in or on the following 

agricultural commodities. 

Commodity Parts per 

million 

* * * * * 

Pepper .................................. 1.0 

* * * * * 

* * * * * 

[FR Doc. 2013–15867 Filed 7–2–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0291; FRL–9389–7] 

Novaluron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of novaluron in 

or on peanut and soybean, seed. 

Makhteshim-Agan of North America 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). This regulation additionally 

deletes the time-limited tolerance for 

strawberry, as that tolerance expired on 

December 31, 2011. 

DATES: This regulation is effective July 

3, 2013. Objections and requests for 

hearings must be received on or before 

September 3, 2013, 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–2012–0291, 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: 

Jennifer Gaines, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5967; email address: 

gaines.jennifer@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 EPA’s tolerance 

regulations at 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–2012–0291 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 September 3, 2013. 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 

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