Federal Register / Vol. 79, No. 43 / Wednesday, March 5, 2014 / Rules and Regulations 12401 

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: February 26, 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. In § 180.627, in paragraph (d), add 

alphabetically the following 

commodities to the table to read as 

follows: 

§ 180.627 Fluopicolide; tolerances for 

residues. 

* * * * * 

(d) * * * 

Commodity Parts per 

million 

Corn, field, forage ................. 0.08 

Corn, field, grain ................... 0.01 

Corn, field, stover ................. 0.20 

* * * * * 

[FR Doc. 2014–04832 Filed 3–4–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0949; FRL–9906–47] 

Triflumizole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of triflumizole in 

or on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 5, 2014. Objections and requests 

for hearings must be received on or 

before May 5, 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–2012–0949, 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 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–2012–0949 in the subject line on 


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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 May 5, 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 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0949, 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. Summary of Petitioned-for Tolerance 

In the Federal Register of February 

15, 2013 (78 FR 11126) (FRL–9378–4), 

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 2E8119) by IR–4, 

500 College Road East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.476 be 

amended by establishing tolerances for 

residues of the fungicide triflumizole, 1- 

[1-((4-chloro-2-(trifluoromethyl) 

phenyl)imino)-2propoxyethyl]-1Himidazole, in or on berry, low growing, 

subgroup 13–07G at 2.0 parts per 

million (ppm); fruit, pome, group 11–10 

at 0.5 ppm; fruit, small, vine climbing, 

except fuzzy kiwifruit, subgroup 13–07F 

at 2.5 ppm; and tomato at 1.5 ppm. That 

document referenced a summary of the 

petition prepared by Chemtura, 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 these 

comments is discussed in Unit IV.C. 

In the Federal Register of October 25, 

2013 (78 FR 63938) (FRL–9901–96), 

EPA issued a document pursuant to 

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

346a(d)(3), which amended the notice of 

filing published on February 15, 2013, 

for the pesticide petition (PP 2E8119) 

submitted by IR–4, 500 College Road 

East, Suite 201W., Princeton, NJ 08540. 

The modified petition requested that 40 

CFR 180.476 be amended by 

establishing tolerances for residues of 

the fungicide triflumizole, 1-[1-((4- 

chloro-2-(trifluoromethyl) 

phenyl)imino)-2propoxyethyl]-1Himidazole, in or on berry, low growing, 

subgroup, 13–07G at 2.0 ppm; fruit, 

pome, group 11–10 at 0.5 ppm; fruit, 

small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 2.5 ppm; 

and tomato at 1.5 ppm. The petition also 

requested that EPA amend the existing 

tolerance by modifying the vegetable, 

cucurbit, group 9 tolerance from 0.5 

ppm to 0.8 ppm and, upon approval of 

the tolerances stated in this paragraph, 

by removing established tolerances for 

apple at 0.5 ppm; grape at 2.5 ppm; pear 

at 0.5 ppm; and strawberry at 2.0 ppm. 

Based upon review of the data 

supporting the petition summarized in 

the Notices of Filing, EPA has modified 

the tolerance level needed for the 

cucurbit vegetable group 9. The reason 

for this change is explained in Unit 

IV.D. 

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 triflumizole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with triflumizole 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 liver is the primary target organ 

of triflumizole. Liver effects were seen 

in rat and mouse subchronic and 

chronic/carcinogenicity studies. 

Subchronic effects included increased 

absolute and relative liver weights, 

accumulation of fat droplets, and slight 

hepatocyte centrilobular swelling. With 

increased length of exposure, the types 

of microscopic lesions noted increased 

in number and severity. Chronic effects 

included hepatocyte fatty vacuolization; 

hepatocyte hypertrophy, focal 

inflammation, and necrosis; fatty 

degeneration; eosinophilic foci of 

hepatocyte alteration; hepatic nodules; 

bile duct hyperplasia; and hyaline 

degeneration/fibrosis of the bile duct. 

The dog was less sensitive to the effects 

of triflumizole. In the dog chronic study, 

effects included increased liver weights, 

increased serum alkaline phosphatase 

levels, and a macroscopic hepatic 

lobular pattern and granular texture. A 

very mild, macrocytic anemia was also 

noted and was most likely secondary to 

liver effects. 

Triflumizole is classified as not likely 

to be carcinogenic to humans, based on 

a weight of evidence determination 

including the lack of evidence of 

carcinogenicity in studies in rats and 

mice and the absence of a mutagenicity 

concern. 

The oral rat developmental study 

showed an increased qualitative 

susceptibility of the fetus to triflumizole 

in utero. Decreased numbers of viable 

fetuses, increased dead or resorbed 

fetuses, increased numbers of late 

resorptions, decreased fetal body weight 

and increased incidences of cervical ribs 

was seen in the fetuses at the same 

doses at which maternal toxic effects 

were noted. In addition, increased 

incidences of 14th rudimentary ribs 

were observed at the next highest dose. 


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Maternal toxic effects in the rat were 

decreased body weight gain and 

decreased food consumption, increased 

placental weight, and increased 

maternal spleen and liver weights. 

No increased susceptibility of the 

fetus was noted in utero in the rabbit 

developmental study. Fetal effects 

included increased fetal and litter 

incidences of lumbar ribs and decreased 

placental weights, which was also 

included as a maternal toxic effect. 

Maternal toxic effects in the rabbit 

included decreased body weight gain, 

decreased food consumption, and 

decreased placental weights. 

In the 3-generation reproductive 

toxicity study in the rat, offspring effects 

included decreased pup weights, 

survival indices, and litter sizes in both 

F3 litters, reduced litter size in the F1a

litter, increased total-litter mortality in 

the F3a litter, and developmental effects 

in the F1b and F2b progeny. 

Reproductive toxicity, manifested as 

increased gestation length, was 

increased in the F0 dams which were 

pregnant with F1 offspring. Increased 

gestation length can be due to either 

effect in the dams and/or the offspring, 

and this alteration in normal 

reproductive function can result in 

adverse consequences in both dams and 

offspring. Accordingly, there is no 

increased quantitative susceptibility of 

the fetus. There is increased qualitative 

susceptibility in pups; however, a clear 

no-observed-adverse-effect-level 

(NOAEL) for this effect was established 

for these effects, and risk assessment 

endpoints and points of departures 

(PODs) were selected which are 

protective for these effects. 

In acute oral toxicity studies in the rat 

and mouse and an acute inhalation 

study in the rat, animals developed 

neurotoxic signs within 30 to 60 

minutes of administration, which 

resolved within 24 hours in surviving 

animals. Signs included ataxia, 

hypotonia, ventral positioning, urinary 

incontinence, decreased respiration and 

heart rates, decreased locomotor 

movement, lacrimation, salivation, 

ptosis, and/or rhinorrhea. No treatmentrelated histopathological effects were 

found in surviving animals. In the 

chronic rat study, convulsions were 

observed sporadically in all dosage 

groups, but the incidences were 

significantly higher in the high-dose 

females. The majority of the convulsions 

were noted within the first year. 

Cholinesterase activity was also affected 

during the first year of the study, but not 

in a consistent manner. High-dose males 

had decreased plasma and erythrocyte 

cholinesterase activity while high-dose 

females had decreased plasma 

cholinesterase activity only. There were 

no treatment-related effects on 

cholinesterase activity in the brain in 

either sex at any dose and no 

neuropathology was noted. No 

neurotoxic effects were observed in the 

rat subchronic oral toxicity study or the 

mouse subchronic oral toxicity and 

carcinogenicity studies. 

The evidence does not support the 

need for a developmental neurotoxicity 

(DNT) study. This conclusion is 

supported by lack of neurotoxic signs 

noted in the rat subchronic study at any 

dose, and in the adult or offspring in the 

developmental and reproductive 

toxicity studies in the rat. In an 

immunotoxicity dietary study in female 

Bagg Albino (BALB/c) mice, a 

significant decrease in the anti-sheep 

red blood cells immunoglobulin M 

(anti-SRBC IgM) response was observed 

at a dose level of 285.7 milligrams/ 

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

was 28.6 mg/kg/day. The results of the 

immunotoxicity study do not impact the 

PODs selected for dietary and nondietary exposure risk assessments. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by triflumizole as well as 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

entitled ‘‘Triflumizole: Human-Health 

Risk Assessment for the Proposed Uses 

on Greenhouse-Grown Tomato and 

Cucumber; Pome Fruit Group 11–10, 

Small Fruit Vine Climbing except Fuzzy 

Kiwifruit Subgroup 13–07F and Low 

Growing Berry Subgroup 13–07G, 

Except Cranberry’’ on pp. 33–36 in 

docket ID number EPA–HQ–OPP–2012– 

0949. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological PODs and levels of 

concern (LOCs) 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 (UF) 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 nonthreshold 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 triflumizole used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRIFLUMIZOLE 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 13–50 

years of age).

NOAEL = 10 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.1 mg/ 

kg/day.

aPAD = 0.1 mg/kg/ 

day 

Developmental Toxicity Study—Rat. 

Developmental LOAEL = 35 mg/kg/day based on decreased 

numbers of viable fetuses, increased dead or resorbed 

fetuses, increased numbers of late resorptions, decreased 

fetal body weight, and increased incidences of cervical ribs. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRIFLUMIZOLE 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 

Acute dietary (General population including infants and 

children).

NOAEL = 25 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.25 

mg/kg/day.

aPAD = 0.25 mg/kg/ 

day 

Acute Neurotoxicity Study—Rat. 

LOAEL = 100 mg/kg/day based on FOB findings (neuromuscular impairment) and decreased locomotor activity. 

Chronic dietary (All populations) LOAEL = 3.5 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 3x UFL

Chronic RfD = 0.012 

mg/kg/day.

cPAD = 0.012 mg/ 

kg/day.

Combined Chronic. 

Toxicity/Carcinogenicity Study—Rat. 

Based on liver toxicity (eosinophilic foci in male rats and fatty 

vacuolation and inflammation and necrosis in female rats). 

Dermal short-term (1 to 30 

days).

Dermal (or oral) 

study NOAEL = 

3.5 mg/kg/day 

(dermal absorption 

rate = 3.5%.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Multi-generation Reproduction Study—Rat. 

LOAEL = 8.5 mg/kg/day based on decreased pup body weight, 

mortality, reduced litter size, and increased incidence of 

hydroureter and space between the body wall and organs 

were observed at 8.5 mg/kg/day. In addition, gestation length 

was increased in the dams of F1a, F2a, and F3a intervals at 

the LOAEL of 8.5 mg/kg/day. 

Inhalation short-term (1 to 30 

days).

Oral study NOAEL = 

3.5 mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Multi-generation Reproduction Study—Rat. 

LOAEL = 8.5 mg/kg/day based on decreased pup body weight, 

mortality, reduced litter size, and increased incidence of 

hydroureter and space between the body wall and organs 

were observed at 8.5 mg/kg/day. In addition, gestation length 

was increased in the dams of F1a, F2a, and F3a intervals at 

the LOAEL of 8.5 mg/kg/day. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based a weight of evidence determination including 

the lack of evidence of carcinogenicity in studies in rats and mice and the absence of a mutagenicity concern. 

FOB = functional observational battery. FQPA SF = Food Quality Protection Act Safety Factor. 

LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 

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). UFL = use of a LOAEL to extrapolate a NOAEL. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to triflumizole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing triflumizole tolerances in 40 

CFR 180.476. EPA assessed dietary 

exposures from triflumizole 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 triflumizole and as noted in Table 

1of this unit, separate acute endpoints 

and PODs were selected for females of 

child-bearing age (13–49) and the 

general population including infants 

and children. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). A 

conservative acute dietary assessment 

was conducted using tolerance-level 

residues, and 100 percent crop treated 

(PCT). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s NHANES/WWEIA. As 

to residue levels in food, a partially 

refined chronic dietary assessment was 

conducted using average residues from 

supervised field trials, and PCT 

estimates for currently registered 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that triflumizole does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and 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. 


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• 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: 

Apple: 25%; cantaloupe: 10%; cherry: 

25%; cucumber: 2.5%; filbert: 5%; 

grape: 5%; honeydew: 15%; pear: 45%; 

pumpkin: 5%; squash: 5%; strawberry: 

25%; and watermelon: 5%. 

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 

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 is 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 triflumizole 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 triflumizole in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of triflumizole. 

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 

triflumizole for acute exposures are 

estimated to be 98 parts per billion 

(ppb) for surface water and 3.1 ppb for 

ground water and for chronic exposures 

are estimated to be 22 ppb for surface 

water and 3.1 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 98 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 22 ppb was used to assess the 

contribution to 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). 

Triflumizole is currently registered for 

the following uses that could result in 

residential exposures: As a foliar spray 

by home owner and commercial 

applicators to landscape grown trees, 

shrubs, and vines and also for use on 

residential/non-commercially grown 

trees/vines bearing apples, pears and 

grapes. 

EPA assessed residential exposure 

using the following assumptions: For 

residential handlers, short-term dermal 

and inhalation exposures are expected 

for triflumizole activities associated 

with use on ornamental plants and 

bearing pome fruit trees. The dermal 

and inhalation endpoints are based on 

the same toxicological effect for 

triflumizole, and therefore the MOEs 

were combined to determine a total risk 

estimates. For post-application, there is 

the potential for short-term dermal 

exposure for adults and children (6–11 

years old), exposed as a result of being 

in an environment that has been 

previously treated with triflumizole on 

landscape ornamentals. Post-application 

exposure from triflumizole use on 

landscape ornamentals for children (1– 

2 years) is expected to be negligible 

based on the following factors: 

• Children young enough to exhibit 

hand-to-mouth behavior would not 

typically play in ornamental beds or tree 

plots. 

• If present, leaf to skin residue 

transfer would be negligible because of 

the minimal frequency and duration of 

contact. 

The residential handler exposure for 

adults from the back pack sprayer 

broadcast use of triflumizole to gardens 

and trees represents the highest 

estimated risk, and was therefore 

combined with the chronic dietary 

exposure for adults (general U.S. 

population), to estimate the highest 

aggregate exposure and risk. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

trac/science/trac6a05.pdf. 

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 triflumizole to 

share a common mechanism of toxicity 

with any other substances, and 

triflumizole does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that triflumizole 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 


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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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is evidence of increased 

qualitative susceptibility following in 

utero exposure to rats in a 

developmental study. Developmental 

toxicity resulted in fetal death as 

compared to maternal toxicity which 

included decreases in body weight gain 

and food consumption and increases in 

placental, spleen, and liver weights. 

No quantitative or qualitative 

evidence of increased susceptibility was 

seen following in utero exposure to 

rabbits in a developmental study. In the 

developmental rabbit study, a cesarean 

section was performed with evaluation 

of 24-hour fetal survival. At this 

interval, fetal survival was decreased. 

EPA does not consider this finding to 

indicate an adverse effect because a 

cesarean section with 24-hour fetal 

survival is more an indicator of fetal 

endurance after being removed from the 

womb than a measurement of treatmentrelated effects on fetal viability and, 

thus, is not appropriate to use to 

ascertain fetal susceptibility. For similar 

reasons, such an endpoint survival is 

not a standard measurement in the 

guideline developmental toxicity 

protocols. In addition, the decreased 24- 

hour fetal survival occurred in isolation 

and only at a high dose level (100 mg/ 

kg/day) which is 10-fold higher than the 

NOAEL of 10 mg/kg/day selected for the 

acute dietary (females 13–49 years of 

age) exposure scenario for which this 

endpoint might be pertinent. Further, 

the 24-hour fetal survival was not 

replicated in a second developmental 

rabbit guideline study. 

Evidence of increased qualitative 

susceptibility in pups was evident in 

the 3-generation reproductive toxicity 

study in the rat; however, the use of the 

NOAEL of 3.5 mg/kg/day (offspring and 

reproductive effects) for incidental oral 

scenarios and short-term dermal and 

inhalation scenarios is protective of 

potential toxicity (observed in the 

developmental and 2-generation 

reproductive toxicity studies) following 

pre- and postnatal exposures. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF for 

the acute risk assessment, and shortterm dermal and inhalation exposure 

scenarios is removed (1X), and for 

chronic risk assessment is reduced to 

3X. A 3X FQPA SF is retained for the 

chronic RfD because it is derived from 

the use of a LOAEL established in the 

combined chronic toxicity/

carcinogenicity study in rats. A 3X 

rather than a 10X is adequate for the 

FQPA SF for the reasons provided 

below: 

• For this chemical, the liver is the 

most sensitive target organ and the 

histopathological lesions seen in the 

target organ is used as the endpoint of 

concern. 

• The Agency is confident that the 

extrapolated NOAEL of 1.2 mg/kg/day 

(LOAEL of 3.5 mg/kg/day ÷ 3 UFL (use 

of a LOAEL to extrapolate a NOAEL) = 

1.2 mg/kg/day) would be protective of 

liver effects in this species because the 

observed liver effects were minimal in 

severity and did not progress into 

malignancy (i.e., no liver tumors were 

seen) even after 2 years of treatment in 

either sex of rats. 

• Retention of the 3X UFL results in 

an extrapolated NOAEL of 1.2 mg/kg/

day (LOAEL 3.5 mg/kg/day ÷ 3 UFL= 1.2 

mg/kg/day). This value, at a minimum, 

is approximately 10-fold lower than all 

the NOAELs established in the database 

with the other studies as shown in this 

unit. 

The FQPA SF provides adequate 

protection of infants and children based 

on the following findings: 

i. The toxicity database for 

triflumizole is complete. Although no 

subchronic inhalation data is available 

EPA has waived that data requirement. 

In determining the need for a 

subchronic inhalation study, EPA’s 

weight of evidence decision process 

included both hazard and exposure 

considerations as well as incorporation 

of a presumed 10X Database Uncertainty 

Factor (UFdb) for the lack of this study. 

Specifically, with regard to exposure 

considerations, the Agency’s LOC in the 

evaluating the need for the subchronic 

inhalation study is a MOE of 1,000 for 

inhalation exposure, which includes the 

10X inter-species extrapolation factor, 

10X intra-species variation factor, and 

the 10X UFdb. For trifumizole, 

residential inhalation exposures 

resulted in MOEs higher than the LOC 

of 1,000 when using an oral POD. This 

indicates that the lack of an inhalation 

study does not reduce the overall 

confidence in the risk assessment or 

result in an uncertainty (i.e., the study 

will not provide a POD sufficiently low 

to result in a risk of concern). Because 

EPA’s decision to waive the subchronic 

inhalation study essentially 

incorporates an additional 10X UFdb 

(i.e., the study was only waived because 

risks were at least 10X lower than 

required by use of the inter- and 

intraspecies safety factors), a second 

additional 10X FQPA SF is not being 

retained for the protection of infants and 

children due to the absence of this 

study. 

ii. Signs of neurotoxicity were seen in 

the acute oral and inhalation studies in 

the rat and mouse. Signs of 

neurotoxicity (neuromuscular 

impairment and decreased locomotor 

activity) were noted in the acute 

neurotoxicity study at mid and high 

doses. As a result, the endpoint from 

this study was used to assess acute 

dietary risks from one-day exposures to 

triflumizole in the diet of the general 

population. There were no treatmentrelated neuropathological findings 

observed in either sex in the acute 

neurotoxicity study. No evidence of 

neurotoxicity was seen in the submitted 

subchronic neurotoxicity study. 

Likewise, neuropathological evaluation 

of study animals in the subchronic 

neurotoxicity study did not reveal any 

treatment-related histological effects of 

the central and peripheral nervous 

systems. A DNT study is not required 

based on the lack of neurotoxicity in the 

rat subchronic neurotoxicity study, and 

in the adult or offspring in the 

developmental and reproductive 

toxicity studies in the rat. 

iii. As noted in Unit III.D.2., there is 

evidence of increased qualitative 

susceptibility following in utero 

exposure to rats in a developmental 

study and pre- and or postnatal 

exposure in a 3-generation reproductive 

toxicity study in the rat; however, there 

are no residual uncertainties, and the 

use of associated RfDs will be protective 

of the pre- and postnatal toxicity 

following an acute dietary exposure, 

and short-term dermal and inhalation 

exposures. 

No quantitative or qualitative 

evidence of increased susceptibility was 

seen following in utero exposure to 

rabbits in a developmental study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary food exposure 

assessment utilizes tolerance-level 

residues, Dietary Exsposure Evaluation 

Model (DEEM 7.81) default processing 

factors (where available), and 100 PCT 

information for all commodities. By 

using these screening-level assessments, 

actual exposures/risks will not be 

underestimated. The chronic dietary 


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Federal Register / Vol. 79, No. 43 / Wednesday, March 5, 2014 / Rules and Regulations 12407 

food exposure assessment utilizes 

average field trial residues, and percent 

crop treated information for established 

tolerances. Some empirical processing 

factors were used in the chronic 

assessment along with DEEM 7.81 

default processing factors (where 

available). The chronic assessment is 

partially refined; however, since it is 

based on reliable, high-end data, it will 

not underestimate exposure/risk. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to triflumizole in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children 6–11 years old and expects 

post application exposure for children 

below 6 years to be negligible. These 

assessments will not underestimate the 

exposure and risks posed by 

triflumizole. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, EPA performed separate 

acute risk assessments for females 13 to 

49 years old and for the general 

population, including infants and 

children, based on different endpoints 

and aPADs. For females aged 13–49, 

acute dietary exposure to triflumizole 

from food and water will occupy 66% 

of the aPAD chosen for that population 

subgroup. For the general population 

and population subgroups other than 

females aged 13–49, acute dietary 

exposure to triflumizole is greatest for 

children 1–2 years old. That subgroup 

will occupy 40% of the applicable 

aPAD. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to triflumizole 

from food and water will utilize 39% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of triflumizole is not expected. 

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). 

Triflumizole is currently 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 triflumizole. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined worst case scenario (adult 

handlers) for short-term food, water, and 

residential exposures result in an 

aggregate MOE of 180 and an aggregate 

MOE of 600 for children 6–11 years old. 

Because EPA’s LOC for triflumizole is a 

MOE of 100 or below, these MOEs are 

not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, triflumizole is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

triflumizole. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

triflumizole is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to triflumizole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with nitrogen 

phosphorous detector (GC/NPD); 

Method I in PAM Vol. II) is available to 

enforce the tolerance expression. 

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 not established any 

MRLs for triflumizole. 

C. Response to Comments 

A comment was received that 

opposed the establishment of these 

tolerances. Part of the comment opposed 

the manufacturing and selling of this 

product due to potential effects on the 

environment. This is considered 

irrelevant because the safety standard 

for approving tolerances under FFDCA 

section 408 focuses on potential harms 

to human health and does not permit 

consideration of effects on the 

environment. Another part objected to 

the proposed tolerances because of the 

amounts of pesticides/toxic chemicals 

already consumed and carried by the 

American population. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that pesticides should be banned 

completely. However, under the existing 

legal framework provided by FFDCA 

section 408 EPA is authorized to 

establish pesticide tolerances or 

exemptions where persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. 

D. Revisions to Petitioned-For 

Tolerances 

Using the Organization for Economic 

Co-operation and Development (OECD) 

tolerance calculation procedures, it was 

initially determined that the existing 

cucurbit vegetable group 9 tolerance of 

0.5 should be increased to 0.8 ppm. 

However, if the crop group 9 tolerance 


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12408 Federal Register / Vol. 79, No. 43 / Wednesday, March 5, 2014 / Rules and Regulations 

was to be increased to 0.8 ppm, the U.S. 

tolerance will be higher than the 

Canadian MRL of 0.5 ppm. After reexamining the residue data, EPA is 

confident that the 0.5 ppm level will be 

high enough to cover residues from 

maximum use under the pesticide 

registration, and therefore, in order to 

remain aligned with Canada, the 

existing cucurbit vegetable group 9 

tolerance will remain at 0.5 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of triflumizole, 1-[1-((4- 

chloro-2-(trifluoromethyl) 

phenyl)imino)-2propoxyethyl]-1Himidazole, in or on berry, low growing, 

subgroup 13–07G at 2.0 ppm; fruit, 

pome, group 11–10 at 0.5 ppm; fruit, 

small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 2.5 ppm; 

and. tomato at 1.5 ppm. In addition, due 

to the establishment of these tolerances, 

the existing tolerances for apple, pear, 

grape, and strawberry are removed as 

unnecessary. 

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: February 25, 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. In § 180.476: 

■ a. Remove the commodities ‘‘Apple,’’ 

‘‘Grape,’’ ‘‘Pear,’’ and ‘‘Strawberry’’ from 

the table in paragraph (a)(1). 

■ b. Add alphabetically the following 

commodities to the table in paragraph 

(a)(1). 

The amendments read as follows: 

§ 180.476 Triflumizole; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Berry, low growing, subgroup 13–07G, except 

cranberry ......................... 2 .0 

* * * * * 

Fruit, pome, group 11–10 ... 0 .50 

Fruit, small, vine climbing, 

except fuzzy kiwifruit, 

subgroup 13–07F ............ 2 .5 

* * * * * 

Tomato ................................ 1 .5 

* * * * * 

* * * * * 

[FR Doc. 2014–04862 Filed 3–4–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0656; FRL–9906–13] 

Metconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

current tolerances for residues of 

metconazole in or on corn, field, stover 

and corn, pop, stover. BASF 

Corporation, requested these tolerance 

amendments under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 5, 2014. Objections and requests 

for hearings must be received on or 

before May 5, 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–2013–0656, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 


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