32666 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 2, 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 § 180.940, in the table in 

paragraph (a), alphabetically add the 

following inert ingredient to read as 

follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

Sodium bisulfate ........................................ 7681–38–1 When ready for use, the end-use concentration is not to exceed 2,000 ppm. 

*******

[FR Doc. 2014–13229 Filed 6–5–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0654 and EPA–HQ– 

OPP–2013–0655; FRL–9910–38] 

Flutriafol; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes, 

amends, and removes tolerances for 

residues of flutriafol 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 June 

6, 2014. Objections and requests for 

hearings must be received on or before 

August 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–2013–0654 and 

EPA–HQ–OPP–2013–0655, is available 

at http://www.regulations.gov or at the 

Office of Pesticide Programs Regulatory 

Public Docket (OPP Docket) in the 

Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

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Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 32667 

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 the appropriate docket ID 

number, EPA–HQ–OPP–2013–0654 

and/or EPA–HQ–OPP–2013–0655, for 

the pesticide petition of interest in the 

subject line on the first page of your 

submission. All objections and requests 

for a hearing must be in writing, and 

must be received by the Hearing Clerk 

on or before August 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 the appropriate docket ID number, 

EPA–HQ–OPP–2013–0654 and/or EPA– 

HQ–OPP–2013–0655, for the pesticide 

petition of interest 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 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), announcing the filing of 

pesticide petitions (PP 3F8156; EPA– 

HQ–OPP–2013–0654) and (PP 3F8174; 

EPA–HQ–OPP–2013–0655) by 

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

1600 Wilson Blvd., Suite 700, Arlington, 

VA 22209–2510. The petitions 

requested that 40 CFR 180.629 amend 

the current established tolerances for 

residues of the fungicide flutriafol, 

including its metabolites and 

degradates, in or on corn, field, forage 

to 5 parts per million (ppm); corn, field, 

stover to 15 ppm; corn, pop, stover to 

15 ppm (PP 3F8156). The petitions also 

requested that the 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide flutriafol, 

including its metabolites and 

degradates, in or on cattle, liver at 1.0 

ppm; cattle, meat byproducts, except 

liver at 0. 10 ppm; cattle, muscle at 0.03 

ppm; goat, liver at 1.0 ppm; goat, meat 

byproducts, except liver at 0.10 ppm; 

goat, muscle at 0.03 ppm; horse, liver at 

1.0 ppm; horse, meat byproducts, except 

liver at 0.10 ppm; horse, muscle at 0.03 

ppm; milk at 0.01 ppm; sheep, liver at 

1.0 ppm; sheep, meat byproducts, 

except liver at 0.10 ppm; sheep, muscle 

at 0.03 ppm (PP 3F8156); african tree 

nut at 0.015 ppm; almond, nutmeat at 

0.6 ppm; almond, hulls at 15 ppm; 

brazil nut at 0.015 ppm; bur oak at 0.015 

ppm; butternut at 0.015 ppm; cajon at 

0.015 ppm; cashew at 0.015 ppm; 

castanha-do-maranhao at 0.015 ppm; 

coconut at 0.015 ppm; coquito nut at 

0.015 ppm; dika nut at 0.015 ppm; 

guiana chestnut at 0.015 ppm; hazelnut 

at 0.015 ppm; heartnut at 0.015 ppm; 

hickory nut at 0.015 ppm; Japanese 

horse-chestnut at 0.015 ppm; 

macadamia nut at 0.015 ppm; mongongo 

nut at 0.015 ppm; monkey-pot at 0.015 

ppm; pachira nut at 0.015 ppm; peanut, 

hay at 15 ppm; pecan at 0.015 ppm; 

sapucaia nut at 0.015 ppm; strawberry at 

1.5 ppm; tomato, paste at 1.5 ppm; 

triticale, grain at 0.10 ppm; vegetable, 

cucurbit, Group 9 at 0.20 ppm; 

vegetable, fruiting, Group 8–10 at 0.60 

ppm; walnut, black at 0.015 ppm; 

walnut, English at 0.015 ppm; wheat, 

forage at 30 ppm; wheat, grain at 0.10 

ppm; wheat, hay at 15 ppm; and wheat, 

straw at 9 ppm (PP 3F8174). The 

documents referenced a summary of the 

petitions prepared by Cheminova, Inc., 

the registrant, which is available in the 

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

There was one comment received in 

response to the notice of filings and is 

discussed in Unit IV.D. 

Based upon review of the data 

supporting the petitions, proposed 

tolerances for cattle, liver; cattle, meat 

by products, except liver; goat, liver; 

goat, meat by products, except liver; 

horse, liver; horse, meat by products, 

except liver; sheep, liver; and sheep, 

meat by products, except liver were 

lowered. The proposed tolerances for 

wheat, grain; pecan; african tree nut; 

brazil nut; bur oak, butternut, cajou; 

cashew; castanha-do-maranhao; 

coconut; coquito nut; dika nut; guiana 

chestnut; hazelnut; heartnut; hickory 

nut; japanese horse-chestnut; 

macadamia nut; mongongo nut; 

monkey-pot; pachira nut; sapucaia nut; 

walnut, black; walnut, english; 

vegetable, cucurbit, group 9; vegetable, 

fruiting, group 8–10; cattle, muscle; 

goat, muscle; horse, muscle; and sheep, 

muscle were increased. A tolerance for 

triticale, grain is not needed and so is 

not being established. On the other 

hand, EPA has determined that 

tolerances are needed for hog, fat and 

hog, muscle and accordingly are being 

established. The established tolerances 

for cattle, meat by products; goat, meat 

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32668 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 

by products; horse, meat by products; 

and sheep, meat by products are being 

removed. 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), and 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 are discussed in the 

most recent risk assessment, ‘‘Flutriafol: 

Human-Health Risk Assessment for 

Tolerances in/on Field Corn, Popcorn, 

Peanut, Wheat, Strawberries, Cucurbit, 

Vegetables, Fruiting Vegetables, and 

Tree Nuts,’’ which can be found at 

http://www.regulations.gov, under 

document ID number EPA–HQ–OPP– 

2013–0654–0005 and EPA–HQ–2013– 

0655–0007. 

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. 

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Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 32669 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUTRIAFOL 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 = 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. 

Dermal short (1 to 30 days) and 

Intermediate (1–6 months) 

Term.

NOAEL = 7.5 mg/kg/

day.

Dermal absorption 

factor = 21%1

UFA = 10x 

UFH = 10x 

Occupational LOC 

for MOE = 100.

Developmental toxicity—rabbit. 

Developmental LOAEL = 15 mg/kg/day based on decreased 

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

Inhalation short (1 to 30 days) 

and Intermediate (1–6 

months) Term.

NOAEL= 7.5 mg/kg/

day.

Inhalation toxicity assumed to be 

equivalent to oral 

toxicity 

Inhalation-absorption 

factor = 100% 2

UFA = 10x 

UFH = 10x 

Occupational LOC 

for MOE = 100.

Developmental toxicity—rabbit. 

Developmental LOAEL = 15 mg/kg/day based on decreased 

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

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

mice. 

1 Dermal absorption factor was derived from the dermal penetration study. 

2 Inhalation absorption factor is considered the worst-case scenario for inhalation exposure using an oral NOAEL. 

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

of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 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’s (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat In 

America (NHANES/WWEIA) conducted 

from 2003–2008. 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 and 100 percent crop 

treated (PCT). Since adequate 

processing studies have been submitted 

which indicate that tolerances for 

residues in/on apple juice, grape juice, 

dried prunes, and tomato puree are 

unnecessary and since tolerances for 

residues in/on raisin and tomato paste 

tolerances are established/

recommended, the default processing 

factors for these commodities were 

reduced to 1. The default processing 

factors were retained for the remaining 

relevant commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s (NHANES/WWEIA) 

conducted from 2003–2008 as well. As 

to the residue levels in food, EPA made 

the following assumptions for the 

chronic exposure assessment: 

Tolerance-level residues or tolerancelevel residues adjusted to account for 

the residues of concern for risk 

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32670 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 

assessment and 100 PCT. Since 

adequate processing studies have been 

submitted which indicate that 

tolerances for residues in/on apple 

juice, dried prunes, grape juice, and 

tomato puree are unnecessary and since 

tolerances for residues in/on raisin and 

tomato paste tolerances are established/ 

recommended, the default processing 

factors for these commodities were 

reduced to 1. The default processing 

factors were retained for the remaining 

relevant commodities. 

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 

and/or 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), First Index Reservoir 

Screening Tool (FIRST), Pesticide Root 

Zone Model/Ground Water (PRZM/GW), 

the estimated drinking water 

concentrations (EDWCs) of flutriafol for 

acute exposures are estimated to be 

40.55 parts per billion (ppb) for surface 

water and 310 ppb for ground water. 

For chronic exposures for cancer 

assessments the EDWC’s are estimated 

to be 4.03 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 and chronic dietary risk 

assessment, the water concentration 

value of 310 ppb and 202 ppb, 

respectively, were 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 triazolecontaining 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. 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 two 

triazole conjugates triazolylalanine (TA) 

and triazolylacetic acid (TAA). To 

support existing tolerances and to 

establish new tolerances for triazolederivative pesticides, EPA conducted an 

initial human-health risk assessment for 

exposure to T, TA, and TAA 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, 

screening-level evaluation in terms of 

hazards associated with common 

metabolites (e.g., use of a maximum 

combination of uncertainty factors 

(UFs)) and potential dietary and nondietary exposures (i.e., high-end 

estimates of both dietary and nondietary exposures). In addition, the 

Agency retained the additional 10X 

Food Quality Protection Act (FQPA) 

safety factor (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 ID number EPA–HQ–OPP–2005– 

0497 and an update to the aggregate 

human health risk assessment for free 

triazoles and its conjugates may be 

found in this current docket, docket ID 

number EPA–HQ–OPP–2013–0295 

entitled ‘‘Common Triazole Metabolites: 

Updated Dietary (Food + Water) 

Exposure and Risk Assessment to 

Address the Revised Tolerance for 

Residues of Fenbuconazole in Peppers.’’ 

Based on the triazole residue estimates 

resulting from the proposed uses for 

flutriafol, a revised triazole risk 

assessment is unnecessary. 

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 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. 

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 multi-generation 

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 the 

developmental toxicity occurred at the 

same dose level that elicited maternal 

toxicity, the developmental effects 

(external, visceral, and skeletal 

malformations; embryo lethality 

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Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 32671 

variations; a generalized delay in fetal 

development; and fewer live fetuses) 

were more severe than the decreased 

food consumption and body-weight 

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 indication that 

flutriafol is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 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. 

iii. There are no concerns or residual 

uncertainties for prenatal and/or 

postnatal toxicity. Although there is 

evidence for increased quantitative and 

qualitative susceptibility in the prenatal 

study 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: 

• Clear NOAELs and LOAELs were 

established in the fetuses/offspring for 

each of these studies. 

• The dose-response for these effects 

are well-defined and characterized. 

• Developmental endpoints are used 

for assessing acute dietary risks to the 

most sensitive population (females 13– 

49 years old) as well as all other shortand intermediate-term exposure 

scenarios. 

• 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 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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to flutriafol will 

occupy 31% 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 51% of the 

cPAD for children (1–2 years old the 

population group receiving the greatest 

exposure. Because there are no 

residential uses for flutriafol, the 

chronic aggregate risk includes food and 

drinking water only. 

3. Short-term risk. Short- and 

intermediate-term aggregate exposure 

takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Since flutriafol is not 

registered for any use patterns that 

would result in residential exposure, the 

short- and intermediate-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. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

flutriafol is classified as ‘‘not likely to be 

carcinogenic to humans.’’ EPA does not 

expect flutriafol to pose a cancer risk. 

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 (GC/NPD) for 

proposed tolerances) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

There are no Canadian or Mexican 

MRLs for flutriafol in/on the proposed 

commodities with the exception for 

peanut hay; dried chili peppers; sweet 

peppers; wheat straw; wheat grain and 

wheat bran. The Codex has established 

MRLs for flutriafol in or on dried chili 

peppers at 10 ppm; peanut, hay at 20 

ppm; sweet peppers at 1 ppm; wheat, 

bran at 0.3 ppm; wheat, grain at 0.15 

ppm; and wheat, straw at 8 ppm. Wheat, 

bran and wheat, grain MRLs are the 

same as the tolerances being established 

for flutriafol in the United States. The 

Agency is establishing tolerances for 

vegetable, fruiting, group 8–10 at 1.0 

ppm to harmonize with the Codex sweet 

pepper MRL. 

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32672 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 

Harmonization of the peanut, hay and 

wheat, straw tolerances were 

determined to be unnecessary as these 

commodities do not normally enter 

international commerce. 

C. Revisions to Petitioned-For 

Tolerances 

Based on an analysis of feeding 

studies and on the livestock maximum 

reasonable dietary burdens, EPA is 

establishing tolerances for hog, fat and 

hog, muscle and establishing lower 

tolerances than those proposed by the 

petitioner for cattle, liver; cattle, meat 

by products, except liver; goat, liver; 

goat, meat by products, except liver; 

horse, liver; horse, meat by products, 

except liver; sheep, liver; and sheep, 

meat by products, except liver. For the 

same reason EPA is establishing higher 

tolerance than those proposed by the 

petitioner for cattle, muscle; goat, 

muscle; horse, muscle; and sheep, 

muscle. 

EPA established higher tolerance than 

those proposed by the petitioner for 

African tree nut; brazil nut; bur oak, 

butternut, cajou; cashew; castanha-domaranhao; coconut; coquito nut; dika 

nut; guiana chestnut; hazelnut; heartnut; 

hickory nut; Japanese horse-chestnut; 

macadamia nut; mongongo nut; 

monkey-pot; pachira nut; sapucaia nut; 

vegetable, cucurbit, group 9; walnut, 

black; walnut, english and wheat, grain 

based upon the analysis of residue 

levels from crop field trial data and the 

Organization for Economic Cooperation 

Development (OECD) tolerance 

calculation procedure. The proposed 

tolerance for triticale is unnecessary 

because triticale is covered by the wheat 

tolerances. As the petitioned for 

tolerances for liver and meat byproducts 

of cattle, goat, horse, and sheep, replace 

meat byproducts tolerances for cattle, 

goat, horse, and sheep, the latter 

tolerances are being removed. 

D. Response to Comments 

EPA received one comment to the 

Notice of Filing that stated, in part, that 

no residues or increase in residues 

should be allowed for flutriafol. No 

additional data was provided by the 

commenter for Agency review. The 

Agency understands the commenter’s 

concerns and recognizes that some 

individuals believe that pesticides 

should be banned on agricultural crops. 

However, the existing legal framework 

provided by FFDCA section 408 states 

that tolerances may be set when persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. This citizen’s comment 

appears to be directed at the underlying 

statute and not EPA’s implementation of 

it; the citizen has made no contention 

that EPA has acted in violation of the 

statutory framework. As is the case with 

almost all conventional pesticides, 

numerous tests have been performed to 

study the toxicological effects of 

flutriafol. The various tests use doses 

that range from quite low to many times 

higher than virtually any member of the 

population of the United States could 

ever be exposed to. The highest doses 

are, in fact, deliberately chosen to try to 

elicit toxicological symptoms because a 

description of these symptoms and the 

dose levels at which they occur is one 

of the desired outcomes of the studies. 

Virtually any chemical (vitamins, for 

example) is toxic if taken in excessively 

large doses. Risk, however, is a function 

of the exposure levels that actually 

occur in the population in comparison 

to the threshold exposure level at which 

adverse symptoms begin to be elicited. 

For a toxicologically average person, if 

actual exposure is less than the adverse 

symptom exposure threshold, no such 

symptoms are expected to be seen. 

However, in order to make the 

reasonable certainty of no harm 

determination the Agency requires more 

assurance than this that the use of 

animals (instead of humans) for testing, 

variations in susceptibility among 

members of the U.S. population, greater 

sensitivity of infants and children, etc., 

has been accounted for in the risk 

assessment process. Therefore, safety 

factors are used in conjunction with 

dosing levels at which no or only the 

first symptoms of exposure to the 

pesticide were seen to provide a 

substantial additional margin of safety. 

This mechanism helps assure that 

toxicological symptoms will not be 

elicited in members of the U.S. 

population by beneficial, labeled uses of 

the pesticide. The fact that very high 

doses of a pesticide cause toxicological 

symptoms is not, by itself, enough to 

make approval of uses of that pesticide 

unreasonable. 

V. Conclusion 

Therefore, tolerances are established 

for residues of flutriafol, in or on 

African tree nut at 0.02 ppm; Almond at 

0.60 ppm; Almond hull at 15 ppm; 

Brazil nut at 0.02 ppm; Butternut at 0.02 

ppm; Bur oak at 0.02 ppm; Cajou at 0.02 

ppm; Cashew at 0.02 ppm; Castanha-DoMaranhao at 0.02 ppm; Cattle, fat at 0.05 

ppm; Cattle, liver at 0.80 ppm; Cattle, 

meat by products, except liver at 0.05 

ppm; Cattle, muscle at 0.05 ppm; 

Coconut at 0.02 ppm; Coquito nut at 

0.02 ppm; Corn, field, forage at 5.0 ppm; 

Corn, field, stover to 15 ppm; Corn, pop, 

stover to 15 ppm; Dika nut at 0.02 ppm; 

Guiana chestnut at 0.02 ppm; Goat, fat 

at 0.05 ppm; Goat liver at 0.80 ppm; 

Goat, meat byproducts, except liver at 

0.05 ppm; Goat, muscle at 0.05 ppm; 

Hazelnut at 0.02 ppm; Heartnut at 0.02 

ppm; Hickory nut at 0.02 ppm; Hog, fat 

at 0.01 ppm; Hog, muscle at 0.01 ppm; 

Horse, fat at 0.05 ppm; Horse, liver at 

0.80 ppm; Horse, meat byproducts, 

except liver at 0.05 ppm; Horse, muscle 

at 0.05 ppm; Japanese horse-chestnut at 

0.02 ppm; Macadamia nut at 0.02 ppm; 

Milk at 0.01 ppm; Mongongo nut at 0.02 

ppm; Monkey-pot at 0.02 ppm; Pachira 

nut at 0.02 ppm; Peanut, hay at 15 ppm; 

Pecan at 0.02 ppm; Sapucaia nut at 0.02 

ppm; Sheep, fat at 0.05 ppm; Sheep, 

liver at 0.80 ppm; Sheep, meat 

byproducts, except liver at 0.05 ppm; 

Sheep, muscle at 0.05 ppm; Strawberry 

at 1.5ppm; Tomato, paste at 1.5 ppm; 

Vegetable, cucurbit, group 9 at 0.30 

ppm; Vegetable, fruiting, group 8–10 at 

1.0 ppm; Walnut, black at 0.02 ppm; 

Walnut, English at 0.02 ppm; Wheat, 

bran at 0.30 ppm; Wheat, forage at 30 

ppm; Wheat, germ at 0.25 ppm; Wheat, 

grain at 0.15 ppm; Wheat, hay at 15 

ppm; and Wheat, straw at 9.0 ppm. 

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 

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Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 32673 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 2, 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 § 180.629, revise the table in 

paragraph (a) to read as follows: 

§ 180.629 Flutriafol; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

African tree nut ......................... 0 .02 

Almond ...................................... 0 .60 

Almond, hull .............................. 15 

Banana 1 ................................... 0 .30 

Beet sugar ................................ 0 .08 

Brazil nut ................................... 0 .02 

Bur oak ..................................... 0 .02 

Butternut ................................... 0 .02 

Cajou ........................................ 0 .02 

Cashew ..................................... 0 .02 

Castanha-do-maranhao ............ 0 .02 

Cattle, fat .................................. 0 .05 

Cattle, liver ................................ 0 .80 

Cattle, meat byproducts, except 

liver ........................................ 0 .05 

Cattle, muscle ........................... 0 .05 

Coconut .................................... 0 .02 

Coffee, green, bean 1 ............... 0 .15 

Coffee, instant 1 ........................ 0 .30 

Coquito nut ............................... 0 .02 

Corn, field, forage ..................... 5 .0 

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

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

Corn, field, stover ..................... 15 

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

Corn, pop, stover ...................... 15 

Dika nut .................................... 0 .02 

Fruit, pome, group 11–09 ......... 0 .40 

Fruit, stone, group 12–10 ......... 1 .5 

Goat, fat .................................... 0 .05 

Goat, liver ................................. 0 .80 

Goat, meat byproducts, except 

liver ........................................ 0 .05 

Goat, muscle ............................ 0 .05 

Grain, aspirated fractions ......... 2 .2 

Grape ........................................ 1 .5 

Grape, raisin ............................. 2 .4 

Guiana chestnut ....................... 0 .02 

Hazelnut .................................... 0 .02 

Heartnut .................................... 0 .02 

Hickory nut ................................ 0 .02 

Hog, fat ..................................... 0 .01 

Hog, muscle .............................. 0 .01 

Horse, fat .................................. 0 .05 

Horse, liver ............................... 0 .80 

Horse, meat byproducts, except 

liver ........................................ 0 .05 

Horse, muscle ........................... 0 .05 

Japanese horse-chestnut ......... 0 .02 

Macadamia nut ......................... 0 .02 

Milk ........................................... 0 .01 

Mongongo nut ........................... 0 .02 

Monkey-pot ............................... 0 .02 

Pachira nut ............................... 0 .02 

Peanut ...................................... 0 .09 

Peanut, hay .............................. 15 

Pecan ........................................ 0 .02 

Sapucaia nut ............................. 0 .02 

Sheep, fat ................................. 0 .05 

Sheep, liver ............................... 0 .80 

Sheep, meat byproducts, except liver ................................ 0 .05 

Sheep, muscle .......................... 0 .05 

Soybean, seed .......................... 0 .35 

Strawberry ................................ 1 .5 

Commodity Parts per 

million 

Tomato, paste ........................... 1 .5 

Vegetable, cucurbit, group 9 .... 0 .30 

Vegetable, fruiting, group 8–10 1 .0 

Walnut, black ............................ 0 .02 

Walnut, English ......................... 0 .02 

Wheat, bran .............................. 0 .30 

Wheat, forage ........................... 30 

Wheat, germ ............................. 0 .25 

Wheat, grain ............................. 0 .15 

Wheat, hay ............................... 15 

Wheat, straw ............................. 9 .0 

1There are no U.S. registrations as of October 22, 2013. 

* * * * * 

[FR Doc. 2014–13223 Filed 6–5–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1990–0011; FRL–9911– 

80–Region 4] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Deletion 

of the B&B Chemical Co., Inc. 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region 4 is publishing 

this direct final Notice of Deletion for 

the B&B Chemical Co., Inc. Superfund 

Site (Site), located in Miami-Dade 

County, Florida, from the National 

Priorities List (NPL) and requests public 

comments on this action. The NPL, 

promulgated pursuant to section 105 of 

the Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended, is 

an appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). The EPA and 

the State of Florida, through the Florida 

Department of Environmental Protection 

(FDEP), have determined that all 

appropriate response actions under 

CERCLA, other than operation, 

maintenance, and five year reviews, 

have been completed. However, this 

deletion does not preclude future 

actions under Superfund. 

DATES: This direct final deletion is 

effective August 5, 2014 unless EPA 

receives adverse comments by July 7, 

2014. If adverse comments are received, 

EPA will publish a timely withdrawal of 

the direct final deletion in the Federal 

Register informing the public that the 

deletion will not take effect. 

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