47296 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 

Federal Register. This final rule 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: July 23, 2012. 

Joan Harrigan Farrelly, 

Director, Antimicrobials 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. Section 180.1317 is added to 

subpart D to read as follows: 

§ 180.1317 Pesticide chemicals; 

exemption from the requirements of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Didecyl dimethyl ammonium 

chloride in or on broccoli resulting from 

the use of Didecyl dimethyl ammonium 

chloride as a seed treatment at a 

treatment concentration of 1200 ppm 

prior to planting by immersion. 

[FR Doc. 2012–19399 Filed 8–7–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0875; FRL–9348–8] 

Flutriafol; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

and amends tolerances for residues of 

Flutriafol [((±)-a-(2-fluorophenyl)-a-(4- 

fluorophenyl)-1H-1,2,4-triazole-1- 

ethanol], including its metabolites and 

degradates in or on multiple 

commodities which are identified and 

discussed later in this document. 

Cheminova A/S, c/o Cheminova, Inc. 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 8, 2012. Objections and requests 

for hearings must be received on or 

before October 9, 2012, 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–2010–0875, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; email address: 

gibson.tamue@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2010–0875 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 October 9, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0875, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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. 


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II. Summary of Petitioned-for Tolerance 

In the Federal Register of December 

15, 2010 (75 FR 78240) (FRL–8853–1), 

EPA issued a notice pursuant to section 

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

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

pesticide petition (PP 0F7771) by 

Cheminova A/S, c/o Cheminova, Inc. 

1600 Wilson Blvd., Arlington, VA 

22209. The petition requested that 40 

CFR part 180 be amended by 

establishing tolerances for residues of 

the fungicide flutriafol, including its 

metabolites and degradates, in or on 

corn, field, forage at 4.0 ppm; corn, 

field, stover at 6.0 ppm; corn, field, 

grain at 0.01 ppm; corn, field, flour at 

0.03 ppm; corn, field, oil at 0.07 ppm; 

corn, field, meal at 0.03 ppm; corn, pop, 

stover at 6.0 ppm; corn, pop, grain at 

0.01 ppm; grape at 1.1 ppm; grape, 

raisin at 2.5 ppm; peanut at 0.08 ppm; 

peanut, hay at 18 ppm; fruit, pome 

(Crop Group 11) at 0.60 ppm; fruit, 

stone (Crop Group 12) at 0.80 ppm; beet, 

sugar, root at 1.5 ppm; beet, sugar, tops 

at 2.5 ppm; beet, sugar, refined at 0.70 

ppm; beet, sugar, molasses at 1.0 ppm; 

beet, sugar, dried pulp at 1.0 ppm; 

wheat, forage at 25 ppm; wheat, hay at 

9.0 ppm; wheat, straw at 6.0 ppm; 

wheat, grain at 0.15 ppm; wheat, grain, 

bran at 0.20 ppm; wheat, grain, germ at 

0.20 ppm; barley, hay at 9.0 ppm; 

barley, straw at 6.0 ppm; barley, grain at 

0.15 ppm; barley, grain, bran at 0.20 

ppm; buckwheat, grain at 0.15 ppm; 

oats, forage at 25 ppm; oats, hay at 9.0 

ppm; oats, straw at 6.0 ppm; oats, grain 

at 0.15 ppm; oats, grain, bran at 0.20 

ppm; rye, forage at 25 ppm; rye, straw 

at 6.0 ppm; rye, grain at 0.15 ppm; 

cattle, liver at 0.12 ppm; goat, liver at 

0.12 ppm; horse, liver at 0.12 ppm; 

sheep, liver at 0.12 ppm; and milk at 

0.02 ppm. The proposed tolerance for 

fruit, pome which is based on new field 

trial data for pears and previously 

submitted data for apples, will replace 

the current tolerance for apples at 0.20 

ppm. That notice referenced a summary 

of the petition prepared by Cheminova 

A/S, c/o Cheminova, Inc, the registrant, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, tolerances for 

corn, field, forage; corn, field, stover; 

corn, field, refined oil; and corn, pop, 

stover were lowered. Tolerances for 

corn, field, flour and corn, field, meal 

were not required. Established 

tolerances for apple; cattle, liver; goat, 

liver; hog, liver; horse, liver; and sheep, 

liver and established rotational crop 

tolerances for corn, field, forage; corn, 

field, stover; corn, field, grain; corn, 

field, refined oil; corn, pop; and corn, 

pop, stover are removed. The proposed 

tolerances for wheat, forage; wheat, hay; 

wheat, straw; wheat, grain; wheat, grain, 

bran; wheat, grain, germ; barley, hay; 

barley, straw; barley, grain; barley, 

grain, bran; buckwheat, grain; oat, 

forage; oat, hay; oat, straw; oat, grain; 

oat, grain, bran; rye, forage; rye, straw; 

and rye, grain were withdrawn by the 

petitioner. Tolerances were previously 

established on November 9, 2011 for 

banana, grape, raisin; pome and stone 

fruit, sugar beets and for the rotational 

corn crops—sweet, field, and popcorn, 

and cotton. The reasons for these 

changes are explained 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 flutriafol 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with flutriafol 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. Flutriafol has high 

oral acute toxicity in the mouse. It has 

low acute toxicity via the oral, dermal 

and inhalation routes in rats. Flutriafol 

is minimally irritating to the eyes and is 

not a dermal irritant. Flutriafol was not 

shown to be a skin sensitizer when 

tested in guinea pigs. 

Short-term, subchronic, and chronic 

toxicity studies in rats, mice, and dogs 

identified the liver as the primary target 

organ of flutriafol. Hepatotoxicity was 

first evident in the subchronic studies 

(rats and dogs) in the form of increases 

in liver enzyme release (alkaline 

phosphatase), liver weights, and 

histopathology findings ranging from 

hepatocyte vacuolization to 

centrilobular hypertrophy and slight 

increases in hemosiderin-laden Kupffer 

cells. It is noteworthy that with chronic 

exposures, there are no indications of 

progression of liver toxicity in any of 

the species tested. After over 1 year of 

exposure, hepatotoxicity in rats, dogs, 

and mice took the form of minimal to 

severe fatty changes; bile duct 

proliferation/cholangiolarfibrosis; 

hemosiderin accumulation in Kupffer 

cells; centrilobular hypertrophy, and 

increases in alkaline phosphatase 

release. Slight indications of effects in 

the hematopoietic system are 

sporadically seen in the database. These 

effects were manifested in the form of 

slight anemia (rats and dogs) and 

increased platelet, white blood cell, 

neutrophil, and lymphocyte counts 

(mice). These effects, however, were 

minimal in severity. 

Flutriafol is considered to be ‘‘Not 

likely to be Carcinogenic to Humans’’ 

based on the results of the 

carcinogenicity studies in rats and mice. 

The results of the rat chronic toxicity/ 

carcinogenicity study and the mouse 

carcinogenicity study are negative for 

carcinogenicity. All genotoxicity studies 

on flutriafol showed no evidence of 

clastogenicity or mutagenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by flutriafol 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 

‘‘Flutriafol: Human Health Risk 

Assessment for Proposed Uses on Corn, 

Grapes, Peanuts, Pome Fruit (Crop 

Group 11), Stone Fruit (Crop Group 12), 

Sugar Beets, Wheat, Barley, Triticale, 

Buckwheat, Oats, Rye, Teosinte, and 

Imported Bananas,’’ at p. 40 in docket 

ID number EPA–HQ–OPP–2010–0875. 


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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 flutriafol used for human 

risk assessment is shown in the 

following table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUTRIAFOL 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 = 7.5 mg/kg/day ..........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.075 mg/kg/day 

aPAD = 0.075 mg/kg/day.

Developmental study-rabbit LOAEL = 15 

mg/kg/day based on decreased number 

of live fetuses, complete litter resorptions and increased post-implantation 

loss. 

Acute dietary (General population including infants and 

children).

NOAEL = 250 mg/kg/day .........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 2.5 mg/kg/day 

aPAD = 2.5 mg/kg/day.

Neurotoxicity screening battery-rat 

LOAEL = 750 mg/kg/day based on decreased body weight, body-weight gain, 

absolute and relative food consumption, 

and clinical signs of toxicity in both 

sexes: Dehydration, urine-stained abdominal fur, ungroomed coat, ptosis, 

decreased motor activity, prostration, 

limp muscle tone, muscle flaccidity, 

hypothermia, hunched posture, impaired 

or lost righting reflex, scant feces; in 

males: Red or tan perioral substance, 

chromodacryorrhea, chromorhinorrhea 

and labored breathing, and in females: 

piloerection and bradypnea. 

Chronic dietary (All populations) NOAEL= 5 mg/kg/day ..............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.05 mg/kg/day 

cPAD = 0.05 mg/kg/day.

Chronic toxicity-dog LOAEL = 20 mg/kg/ 

day based on adverse liver findings (increased liver weights, increased 

centrilobular hepatocyte lipid in the liver, 

and increases in alkaline phosphatase, 

albumin, and triglycerides), increased 

adrenal cortical vacuolation of the zona 

fasciculata, and marked hemosiderin 

pigmentation in the liver and spleen in 

both sexes; mild anemia (characterized 

by decreased hemoglobin, hematocrit, 

and red blood cell count) in the males; 

and initial body-weight losses, decreased cumulative body-weight gains, 

and increased adrenal weights in the females. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the carcinogenicity studies in rats and 

mice. 

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

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference 

dose. mg/kg/day = milligrams/kilogram/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flutriafol, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

flutriafol tolerances in 40 CFR 180.629. 

EPA assessed dietary exposures from 

flutriafol 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 

flutriafol. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 


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Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA made the following 

assumptions for the acute exposure 

assessment: tolerance-level residues or 

tolerance-level residues adjusted to 

account for the residues of concern for 

risk assessment, 100 percent crop 

treated (PCT), and Dietary Exposure 

Evaluation Model (DEEMTM) version 

7.81 default processing factors were 

used. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

made the following assumptions for the 

chronic exposure assessment: tolerancelevel residues or tolerance-level 

residues adjusted to account for the 

residues of concern for risk assessment, 

100 PCT, and DEEMTM version 7.81 

default processing factors were used. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that flutriafol 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. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for flutriafol. Tolerance level residues or 

tolerance-level residues adjusted 

upward to account for the residues of 

concern for risk assessment and 100 

PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the flutriafol 

dietary exposure analysis and risk 

assessment. These simulation models 

take into account data on the physical, 

chemical, and fate/transport 

characteristics of flutriafol. 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 Food Quality Protection 

Act (FQPA) Food Index Reservoir 

Screening Tool (FIRST), and Pesticide 

Root Zone Model/Ground Water 

(PRZM/GW), the estimated drinking 

water concentrations (EDWCs) of 

flutriafol for acute exposures are 

estimated to be 48.8 parts per billion 

(ppb) for surface water and 310 ppb for 

ground water. 

For chronic exposures for non-cancer 

assessments the EDWC’s are estimated 

to be 5.70 ppb for surface water and 202 

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 310 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). Flutriafol 

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.’’ 

Flutriafol is a member of the conazole 

(triazole) class of pesticides. Although 

conazoles act similarly in plants (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 (EPA, 2002). 

In conazoles, however, a variable 

pattern of toxicological responses is 

found; some are hepatotoxic and 

hepatocarcinogenic in mice. Some 

induce thyroid tumors in rats. 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. 

Triazole-derived pesticides can form 

the metabolite 1,2,4-triazole (T) and 

several conjugated triazole metabolites. 

To support existing tolerances and to 

establish new tolerances for triazolederivative pesticides, EPA conducted an 

initial human-health risk assessment for 

exposure to T and the conjugated 

triazole metabolites resulting from the 

use of all current and pending uses of 

any triazole-derived fungicide as of 

September 1, 2005. The risk assessment 

was a highly conservative, screeninglevel 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). In addition, the 

Agency retained the additional 10X 

FQPA SF for the protection of infants 

and children. The assessment included 

evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

complete risk assessment can be found 

in the propiconazole reregistration 

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

Docket Identification (ID) Number EPA– 

HQ–OPP–2005–0497 and an updated 

assessment may be found in docket ID 

EPA–HQ–OPP–2011–0120 in the 

document entitled ‘‘Common Triazole 

Metabolites: Updated Dietary (Food + 

Water) Exposure and Risk Assessment 

to Address the Amended metconazole 

Section 3 Registration to Add uses on 

Tuberous and Corm Vegetables (Group 

1C) and Bushberry Subgroup 13–07B.’’ 

The Agency has determined that the 

proposed application to field and 

popcorn will not result in residues of 

1,2,4-triazole (T), triazolylalanine (TA), 

and triazolylacetic acid (TAA) greater 

than the estimates incorporated in the 

most recent assessment. Therefore, a 

revised triazole metabolite assessment is 

not needed. 

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. 


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2. Prenatal and postnatal sensitivity. 

The potential impact of in utero and 

perinatal flutriafol exposure was 

investigated in three developmental 

toxicity studies (two in rats, one in 

rabbits) and two multigenerational 

reproduction toxicity studies in rats. In 

the first of two rat developmental 

toxicity studies, a quantitative 

susceptibility was observed (delayed 

ossification or non-ossification of the 

skeleton in the fetuses) at a lower dose 

than maternal effects. In the second rat 

developmental study, a qualitative 

susceptibility was noted. Although 

developmental toxicity occurred at the 

same dose level that elicited maternal 

toxicity, the developmental effects 

(external, visceral, and skeletal 

malformations; embryo lethality; 

skeletal variations; a generalized delay 

in fetal development; and fewer live 

fetuses) were more severe than the 

decreased food consumption and bodyweight gains observed in the dams. For 

rabbits, intrauterine deaths occurred at 

a dose level that also caused adverse 

effects in maternal animals. In the 2- 

generation reproduction studies, a 

qualitative susceptibility was also seen. 

Effects in the offspring—decreased litter 

size and percentage of live births 

(increased pup mortality) and liver 

toxicity—can be attributed to the 

systemic toxicity of the parental animals 

(decreased body weight and food 

consumption and liver toxicity). 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for flutriafol is 

complete. 

ii. There is no concern for 

neurotoxicity with flutriafol. Signs of 

neurotoxicity were reported in the acute 

and subchronic neurotoxicity studies at 

the highest dose only; however, these 

effects were primarily seen in animals 

that were agonal (at the point of death) 

and thus, are not indicative of 

neurotoxicity. In addition, there was no 

evidence of neurotoxicity in any 

additional short-term studies in rats, 

mice, and dogs, or in the long-term 

toxicity studies in rats, mice, and dogs. 

A developmental neurotoxicity study 

(DNT) is not required given these 

results. 

iii. There are no residual uncertainties 

for pre- and/or post-natal toxicity. 

Though there is evidence for increased 

susceptibility in the prenatal studies in 

rats and rabbits and the 2-generation 

reproduction study in rats, there are no 

concerns for the offspring toxicity 

observed in the developmental and 

reproductive toxicity studies for the 

following reasons: 

a. Clear NOAELs and LOAELs were 

established in the fetuses/offspring; 

b. The dose-response for these effects 

are well defined and characterized; 

c. Developmental endpoints are used 

for assessing acute dietary risks to the 

most sensitive population (females 13– 

49) as well as all other short- and 

intermediate-term exposure scenarios; 

and 

d. The chronic reference dose is 

greater than 300-fold lower than the 

dose at which the offspring effects were 

observed in the 2-generation 

reproduction studies. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level (or higher) residues. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to flutriafol in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by flutriafol. 

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, the acute dietary 

exposure from food and water to 

flutriafol will occupy 24% of the aPAD 

for females 13–49 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to flutriafol from 

food and water will utilize 42% of the 

cPAD for all infants less than 1 year old 

the population group receiving the 

greatest exposure. There are no 

residential uses for flutriafol. Based on 

the explanation in Unit III.C.3., 

regarding residential use patterns, 

chronic residential exposure to residues 

of flutriafol 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). Flutriafol is not 

registered for any use patterns that 

would result in short-term residential 

exposure. Therefore, the short-term 

aggregate risk is the sum of the risk from 

exposure to flutriafol through food and 

water and will not be greater than the 

chronic aggregate risk. 

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). 

Flutriafol is not registered for any use 

patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to flutriafol through food and 

water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

flutriafol 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 flutriafol 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Gas Chromatography/Nitrogen/ 

Phosphorus detector (GS/NPD) method 

for proposed tolerances and method 

ICIA AM00306 for ruminant liver) are 

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 


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Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 47301 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRLs for flutriafol; 

therefore, harmonization is not an issue. 

C. Revisions to Petitioned-for Tolerances 

Based on the analysis of the residue 

trial data and Organization for 

Economic Cooperation and 

Development (OECD) tolerance 

calculation procedures, tolerances for 

corn, field, forage; corn, pop, stover; and 

corn, field, stover were lowered. 

Established rotational crop tolerances 

for corn, field forage; corn, field, stover; 

corn, field, grain; corn, field, refined oil; 

corn, pop; and corn, pop, stover are 

removed as they are superseded by 

tolerances for direct application to the 

growing crop. The established tolerance 

for apple is removed and superseded by 

the previously established higher 

tolerance for fruit, pome, group 11–09. 

The established tolerances for cattle; 

liver; goat, liver; hog, liver; horse, liver; 

and sheep, liver are replaced by 

tolerances for meat byproducts of cattle, 

goat, hog, horse, and sheep. Based on 

the results from the field corn 

processing study, tolerances for corn, 

field, flour and corn, field, meal are not 

needed. Tolerances for wheat, forage; 

wheat, hay; wheat, straw; wheat, grain; 

wheat, bran; wheat, germ; barley, hay; 

barley, straw; barley, grain; barley, 

grain, bran; buckwheat, grain; oat, 

forage; oat, hay; oat, straw; oat, grain; 

oat, grain, bran; rye, forage; rye, straw; 

rye, grain were withdrawn by the 

petitioner. Tolerances were previously 

established on November 9, 2011 for 

banana; grape; grape, raisin; pome and 

stone fruit; sugar beets and for the 

rotational crops, field and popcorn, and 

cotton. 

V. Conclusion 

Therefore, tolerances are established 

for residues of flutriafol, [((±)-a-(2- 

fluorophenyl)-a-(4-fluorophenyl)-1H1,2,4-triazole-1-ethanol], including its 

metabolites and degradates, in or on 

corn, field, forage at 0.75 ppm; corn, 

field, stover at 1.5 ppm; corn, field, 

grain at 0.01 ppm; corn, field, refined oil 

at 0.02 ppm; corn, pop at 0.01 ppm; 

corn, pop, stover at 1.5 ppm; cattle, 

meat byproducts at 0.07 ppm; goat, meat 

byproducts at 0.07 ppm; hog, meat 

byproducts at 0.02 ppm; horse, meat 

byproducts at 0.07 ppm and sheep, meat 

byproducts at 0.07 ppm. This final rule 

deletes established tolerances for apple; 

cattle; liver; goat, liver; hog, liver; horse, 

liver; and sheep, liver. This final rule 

also deletes established rotational crop 

tolerances for corn, field, forage; corn, 

field, stover; corn, field, grain; corn, 

field, refined oil; corn, pop; and corn, 

pop, stover. 

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) (Pub. L. 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: July 27, 2012. 

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. Section 180.629 is amended as 

follows: 

■ i. Remove the entries for ‘‘Apple’’; 

‘‘Cattle, liver’’; ‘‘Goat, liver’’; ‘‘Hog, 

liver’’; ‘‘Horse, liver’’; and ‘‘Sheep, 

liver’’ from the table to paragraph (a). 

■ ii. Add alphabetically the entries for 

‘‘Cattle, meat byproducts’’; ‘‘Corn, field, 

forage’’; ‘‘Corn, field, grain’’; ‘‘Corn, 

field, refined oil’’; ‘‘Corn, field, stover’’; 


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47302 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 

‘‘Corn, pop’’; ‘‘Corn, pop, stover’’; ‘‘Goat 

meat byproducts’’; ‘‘Hog, meat 

byproducts’’; ‘‘Horse meat byproducts’’; 

and ‘‘Sheep meat byproducts’’ to the 

table in paragraph (a). 

■ iii. Remove the entries for ‘‘Corn, 

field, forage’’; ‘‘Corn, field, grain’’; 

‘‘Corn, field, refined oil’’; ‘‘Corn, field, 

stover’’; ‘‘Corn, pop’’; and ‘‘Corn, pop, 

stover’’ from the table in paragraph (d). 

The added entries read as follows: 

§ 180.629 Flutriafol; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Cattle, meat byproducts ..... 0 .07 

Corn, field, forage ............... 0 .75 

Corn, field, grain ................. 0 .01 

Corn, field, refined oil ......... 0 .02 

Corn, field, stover ............... 1 .5 

Corn, pop ............................ 0 .01 

Corn, pop, stover ................ 1 .5 

* * * * * 

Goat, meat byproducts ....... 0 .07 

* * * * * 

Hog, meat byproducts ........ 0 .02 

Horse, meat byproducts ..... 0 .07 

* * * * * 

Sheep, meat byproducts .... 0 .07 

* * * * * 

* * * * * 

[FR Doc. 2012–19317 Filed 8–7–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[EPA–R08–RCRA–2010–0933; FRL–9712–3] 

South Dakota: Final Authorization of 

State Hazardous Waste Management 

Program Revisions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The EPA is granting final 

authorization of the changes to the 

hazardous waste program revisions 

submitted by South Dakota. The Agency 

published a Proposed Rule on December 

27, 2010, and provided for public 

comment. No comments were received 

on the Resource Conservation and 

Recovery Act (RCRA) program issues. 

There was one comment from the South 

Dakota State Deputy Attorney General 

regarding Indian country language. No 

further opportunity for comment will be 

provided. 

DATES: This final rule is effective on 

August 8, 2012. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–R08–RCRA–2010–0933. All 

documents in the docket are listed on 

the Federal eRulemaking Portal: http:// 

www.regulations.gov. Publicly available 

docket materials are available either 

electronically through 

www.regulations.gov or in hard copy at: 

EPA Region 8, from 8 a.m. to 3 p.m., 

1595 Wynkoop Street, Denver, Colorado 

80202, contact: Moye Lin, phone 

number (303) 312–6667, email address: 

lin.moye@epa.gov, or SDDENR, from 9 

a.m. to 5 p.m., Joe Foss Building, 523 E. 

Capitol, Pierre, South Dakota 57501, 

contact: Carrie Jacobson, phone number 

(605) 773–3153. 

FOR FURTHER INFORMATION CONTACT: 

Moye Lin, 303–312–6667, 

lin.moye@epa.gov or Carrie Jacobson, 

phone number (605) 773–3153, 

Carrie.Jacobson@state.sd.us. 

SUPPLEMENTARY INFORMATION: 

I. Authorization of Revisions to South 

Dakota’s Hazardous Waste Program 

On April 1, 2010, South Dakota 

submitted a final complete program 

revision application seeking 

authorization of their changes in 

accordance with 40 CFR 271.21. We 

now make a Final decision that South 

Dakota’s hazardous waste program 

revisions satisfy all of the requirements 

necessary to qualify for Final 

authorization. For a list of rules that 

become effective with this Final Rule 

please see the Proposed Rule published 

in the December 27, 2010 Federal 

Register at 75 FR 81187. 

Response to Comments: The EPA 

proposed to authorize South Dakota’s 

State Hazardous waste management 

Program revisions published in the 

December 27, 2010 Federal Register at 

75 FR 81187. The EPA received only 

one comment from the state of South 

Dakota objecting to the EPA’s definition 

of Indian country, where the state is not 

authorized to administer its program. 

Specifically, the state disagreed that all 

‘‘trust land’’ in South Dakota is Indian 

country. With this Final Rule the EPA 

is clarifying that Indian country lands 

within the exterior boundary of the 

Yankton Reservation are excluded from 

the state’s authorized program. Further 

explanation of this interpretation of 

Indian country can be found at 67 FR 

45684 through 45686 (July 10, 2002). 

II. Statutory and Executive Order 

Reviews 

The Office of Management and Budget 

has exempted this action from the 

requirements of Executive Order 12866 

(58 FR 51735, October 4, 1993), and 

therefore this action is not subject to 

review by OMB. This action authorizes 

State requirements for the purpose of 

RCRA 3006 and imposes no additional 

requirements beyond those imposed by 

State law. Accordingly, I certify that this 

action will not have a significant 

economic impact on a substantial 

number of small entities under the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.). Because this action authorizes 

preexisting requirements under State 

law and does not impose any additional 

enforceable duty beyond that required 

by State law, it does not contain any 

unfunded mandate or significantly or 

uniquely affect small governments, as 

described in the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). For 

the same reason, this action also does 

not significantly or uniquely affect the 

communities of Tribal governments, as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). This 

action will not have substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government, as 

specified in Executive Order 13132 (64 

FR 43255, August 10, 1999), because it 

merely authorizes State requirements as 

part of the State RCRA hazardous waste 

program without altering the 

relationship or the distribution of power 

and responsibilities established by 

RCRA. This action also is not subject to 

Executive Order 13045 (62 FR 19885, 

April 23, 1997), because it is not 

economically significant and it does not 

make decisions based on environmental 

health or safety risks. This rule is not 

subject to Executive Order 13211, 

‘‘Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355 (May 

22, 2001)) because it is not a significant 

regulatory action under Executive Order 

12866. 

Under RCRA 3006(b), EPA grants a 

State’s application for authorization as 

long as the State meets the criteria 

required by RCRA. It would thus be 

inconsistent with applicable law for 

EPA, when it reviews a State 

authorization application, to require the 

use of any particular voluntary 

consensus standard in place of another 

standard that otherwise satisfies the 

requirements of RCRA. Thus, the 

requirements of section 12(d) of the 


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