5946 Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 

would not be adequate to cover residues 

expected from the proposed use in the 

U.S., therefore, harmonization with 

Codex is not possible at this time. 

There is no Codex MRLs for 

difenoconazole in/on dragonfruit. 

C. Response to Comments 

EPA received one comment to the 

republished Notice of Filing for the 

petition requesting that EPA establish a 

rapeseed subgroup 20A tolerance that 

stated, in part, that no residue should be 

allowed for difenoconazole. 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 

section 408 of the FFDCA states that 

tolerances may be set when the Agency 

determines 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. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has changed the requested 

rapeseed subgroup 20A tolerance from 

0.1 to 0.10 ppm to be consistent with 

the tolerance setting procedures which 

involve using two significant numbers 

after the decimal point. EPA is also 

removing the current tolerance for 

canola, seed at 0.01 ppm because canola 

is included in the Rapeseed subgroup 

20A crops and the tolerance being 

established for this group at 0.10 ppm 

will supersede the lower tolerance for 

canola seed treatment. 

V. Conclusion 

Therefore, tolerances are established 

for residues of difenoconazole, [1-[2-[2- 

chloro-4-(4-chloro-phenoxy)-phenyl]- 

4methyll-[1,3]dioxolan-2-ylmethyl]-1H- 

[1,2,4]triazole, in or on rapeseed 

subgroup 20A at 0.10 ppm, and 

dragonfruit which is imported, at 1.5 

ppm. Also, the current tolerance for 

canola, seed is being removed. 

VI. Statutory and Executive Order 

Reviews 

This action 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

(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: January 28, 2015. 

Susan Lewis, 

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 Section 180.475: 

■ a. Remove the entry for ‘‘Canola, 

seed’’. 

■ b. Add alphabetically the following 

commodities to the table to paragraph 

(a)(1). 

§ 180.475 Difenoconazole; Tolerance for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

* * * * * 

Dragonfruit 1 .......................... 1.5 

* * * * * 

Rapeseed subgroup 20A ...... 0.10 

* * * * * 

1There are no U.S. registrations. 

* * * * * 

[FR Doc. 2015–02170 Filed 2–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0482; FRL–9922–06] 

Flutriafol; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 


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Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 5947 

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 

February 4, 2015. Objections and 

requests for hearings must be received 

on or before April 6, 2015, 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–2014–0482, 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 

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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0482 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 6, 2015. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0482, 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 December 

17, 2014 (79 FR 75107) (FRL–9918–90), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 3F8199) by 

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

1600 Wilson Blvd., Suite 700, Arlington, 

VA 22209–2510. The petition requested 

that 40 CFR 180.629 be amended by 

establishing tolerances for residues of 

the fungicide flutriafol, in or on 

Brassica, head and stem, subgroup 5A at 

1.5 parts per million (ppm); Brassica, 

head and stem, subgroup 5A, at 1.5 

ppm; Brassica, leafy greens, subgroup 

5B at 7.0 ppm; egg at 0.01 ppm; hog, 

liver at 0.05 ppm; hog, meat by 

products, except liver at 0.02 ppm; hog, 

muscle at 0.01 ppm; leaf petioles, 

subgroup 4B at 3.0 ppm; leafy greens, 

subgroup 4A except head lettuce at 10 

ppm; lettuce, head at 1.5 ppm; poultry, 

meat byproducts at 0.02 ppm; radicchio 

at 1.5 ppm; sorghum, grain, forage at 2.0 

ppm; sorghum, grain, grain at 1.5 ppm 

and sorghum, grain, stover at 6.0 ppm. 

The petition requested that 40 CFR 

180.629 amend the current established 

tolerances for residues of the fungicide 

flutriafol in or on cotton, gin byproducts 

from 0.5 ppm to 5.0 ppm; cotton, 

undelinted seed from 0.35 ppm to 0.5 

ppm; grain, aspirated fractions from 2.2 

ppm to 6.0 ppm. The petition also 

requested that 40 CFR 180.629 delete 

the current established tolerances for 

residues of the fungicide flutriafol in or 

on cotton, meal at 0.5 ppm; cotton, 

refined oil at 0.5 ppm; and hog, meat 

byproducts at 0.02 ppm. That document 

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. One comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA is issuing 

some tolerances that vary from what the 

petitioner requested. The reason for 

these changes are explained in Unit 

IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 


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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 is categorized as having 

high oral acute toxicity in the mouse. It 

is categorized as having 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 all 

species. After over one year of exposure, 

hepatotoxicity in rats, dogs, and mice 

took the form of minimal to severe fatty 

changes; bile duct proliferation/

cholangiolar fibrosis; 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 are 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. 

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 

final rule published in the Federal 

Register of June 6, 2014 (79 FR 32666) 

(FRL–9910–38) under the docket ID 

numbers EPA–HQ–OPP–2013–0654– 

0005 and EPA–HQ–OPP–2013–0655– 

0008. 

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 discussed in Unit 

III.B. of the final rule published in the 

Federal Register of June 6, 2014. 

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) 

Nationwide 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 raisins and tomato paste 

are established, the Dietary Exposure 

Evaluation Model (DEEM) (ver. 7.81) 

default processing factors for these 

commodities were reduced to 1. The 

DEEM (ver. 7.81) 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 residue levels in food, EPA made the 

follow assumptions for the chronic 

exposure assessment: Tolerance-level 

residues or tolerance-level residues 

adjusted to account for the residues of 

concern for risk assessment and 100 

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 raisins and 

tomato paste are established, the DEEM 

(ver. 7.81) default processing factors for 

these commodities were reduced to 1. 

The DEEM (ver. 7.81) default processing 

factors were retained for the remaining 

relevant commodities. 


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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 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 dietary 

exposure analysis and risk assessment 

for flutriafol. 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) and the 

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 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 dietary risk assessment, the water 

concentration value of 310 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 202 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 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) 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 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–2013–0653–0006 entitled 

‘‘Common Triazole Metabolites: 

Updated Aggregate Human Health Risk 

Assessment to Address The New 

Section 3 Registrations For Use of 

Propiconazole on Rapeseed Crop 

Subgroup 20 A; Use of Difenoconazole 

on Rapeseed Crop Subgroup 20 A; and 

Use of Tebuconazole on Imported 

Oranges.’’ 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The potential impact of in utero and 

perinatal flutriafol exposure was 

investigated in three developmental 

toxicity studies (two in rats, one in 

rabbits) and 2 multi-generation 

reproduction toxicity studies in rats. In 

the first of two rat developmental 

toxicity studies, increased quantitative 

susceptibility was observed with 

developmental effects (delayed 

ossification or non-ossification of the 

skeleton in the fetuses) seen 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 body-weight gains observed in the 

dams. For rabbits, there was in 

increased qualitative fetal susceptibly. 


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5950 Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 

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 or long-term 

toxicity studies in rats, mice, and dogs. 

iii. There are no concerns or 

residential 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 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 44% 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 74% 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 and intermediate-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 intermediateterm aggregate risk is the sum of the 

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. 

5. 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 chromotography/nitrogen/

phosphorus detector (GC/NPD) for the 

proposed tolerances is available to 

enforce the tolerances recommended 

herein. 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 Codex MRLs for 

flutriafol in/on the proposed 

commodities. 

C. Response to Comments 

EPA received one comment to the 

Notice of Filing that stated, in part, that 

no residue should be allowed for 

flutriafol. 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. 


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Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 5951 

D. Revisions to Petitioned-for 

Tolerances 

Based on the analysis of available 

field trial data and the Organisation for 

Economic Co-operation and 

Development (OECD) tolerance 

calculation procedure, EPA established 

a higher tolerance for cotton, gin 

byproducts than requested. For the same 

reason, EPA is granting a tolerance for 

vegetable, leafy, except Brassica, crop 

group 4, except head lettuce and 

radicchio and is not granting separate 

subgroup tolerances for leafy greens 

(subgroup 4A) except head lettuce and 

leaf petioles (subgroup 4B). Based on 

the proposed uses and the resulting 

livestock dietary burdens, EPA is setting 

a poultry, fat tolerance and is increasing 

tolerances for cattle, liver; goat, liver; 

horse, liver; sheep, liver; and milk. 

Based upon the previous explanation, 

EPA is establishing tolerances for 

poultry, meat byproducts below the 

level requested. Since residues in hog 

tissue were near the Limit of 

Quantification (LOQ), EPA determined 

that separate tolerances in or on hog 

liver and hog meat byproducts except 

liver were unnecessary and is 

establishing a tolerance in or on hog 

meat byproducts only. Although the 

petition requested that EPA remove a 

tolerance for hog meat byproducts, no 

such tolerance existed before this rule, 

so EPA could not remove it. A tolerance 

in or on hog, muscle was not established 

as it was granted as part of a previous 

tolerance petition (PP 3F8174) under 

docket ID numbers EPA–HQ–OPP– 

2013–0654 and EPA–HQ–OPP–2013– 

0655. 

V. Conclusion 

Therefore, tolerances are established 

for residues of flutriafol, in or on 

Brassica, head and stem (subgroup 5A) 

at 1.5 ppm; Brassica, leafy greens 

(subgroup 5B) at 7.0 ppm; cotton, gin 

byproducts at 6.0 ppm; cotton, 

undelinted seed at 0.50 ppm; egg at 0.01 

ppm; grain, aspirated fractions at 6.0 

ppm; hog, meat by products at 0.05 

ppm; lettuce, head at 1.5 ppm; liver 

(cattle, goat, horse, sheep) at 1.0 ppm; 

milk at 0.02 ppm; poultry, fat at 0.01 

ppm; poultry, meat byproducts at 0.01 

ppm; radicchio at 1.5 ppm; sorghum, 

grain forage at 2.0 ppm; sorghum, grain, 

grain at 1.5 ppm; sorghum, grain, stover 

at 6.0 ppm and vegetable, leafy, except 

Brassica, crop group 4, except head 

lettuce and radicchio at 10 ppm. 

Also, as a housekeeping measure, this 

regulation removes the entries for the 

tolerances contained in paragraph (b) of 

§ 180.629 as those tolerances expired on 

December 31, 2014. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 28, 2015. 

Susan T. Lewis, 

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: 

■ i. Add alphabetically the entries for 

‘‘Brassica, head and stem (subgroup 

5A)’’; ‘‘Brassica, leafy greens (subgroup 

5B)’’; ‘‘Cotton, gin byproducts’’; 

‘‘Cotton, undelinted seed’’; ‘‘Egg’’; ‘‘Hog, 

meat byproducts’’; ‘‘Lettuce, head’’; 

‘‘Poultry, fat’’; ‘‘Poultry, meat 

byproducts’’; ‘‘Radicchio’’; ‘‘Sorghum, 

grain, forage’’; ‘‘Sorghum, grain, grain’’; 

‘‘Sorghum, grain, stover’’ and 

‘‘Vegetable, leafy, except Brassica, crop 

group 4, except head lettuce and 

radicchio’’ to the table in paragraph (a). 

■ ii. Revise the entries for ‘‘Cattle, 

liver’’; ‘‘Goat, liver’’; ‘‘Grain, aspirated 

fractions’’; ‘‘Horse, liver’’; ‘‘Milk’’; and 

‘‘Sheep, liver’’ in the table in paragraph 

(a). 

■ iii. Revise paragraph (b). 

The amendments read as follows: 

§ 180.629 Flutriafol; tolerances for 

residues. 

(a) General. * * * 


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5952 Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 

Commodity Parts per 

million 

* * * * * 

Brassica, head and stem 

(subgroup 5A) ................. 1 .5 

Brassica, leafy greens (subgroup 5B) ........................ 7 .0 

* * * * * 

Cattle, liver .......................... 1 .0 

* * * * * 

Cotton, gin byproducts ....... 6 .0 

Cotton, undelinted seed ..... 0 .50 

* * * * * 

Egg ..................................... 0 .01 

* * * * * 

Goat, liver ........................... 1 .0 

* * * * * 

Grain, aspirated fractions ... 6 .0 

* * * * * 

Hog, meat byproducts ........ 0 .05 

* * * * * 

Horse, liver ......................... 1 .0 

* * * * * 

Lettuce, head ...................... 1 .5 

* * * * * 

Milk ..................................... 0 .02 

* * * * * 

Poultry, fat .......................... 0 .01 

Poultry, meat byproducts .... 0 .01 

Radicchio ............................ 1 .5 

* * * * * 

Sheep, liver ......................... 1 .0 

* * * * * 

Sorghum, grain, forage ....... 2 .0 

Sorghum, grain, grain ......... 1 .5 

Sorghum, grain, stover ....... 6 .0 

* * * * * 

Vegetable, leafy, except 

Brassica, crop group 4, 

except head lettuce and 

radicchio .......................... 10 

* * * * * 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2015–02177 Filed 2–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0514; FRL–9920–44] 

Poly(oxy-1,2-ethanediyl), α-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10– 

C16) -alkyl ethers, disodium salts; 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16) 

alkyl ethers, disodium salts when used 

as an inert ingredient (surfactant) in 

pesticide formulations applied to 

growing crops (seed treatment use only) 

under 40 CFR 180.920 at a 

concentration not to exceed 0.125% by 

weight. BASF submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting the 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of poly(oxy-1,2-ethanediyl), 

a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16) alkyl ethers, 

disodium salts. 

DATES: This regulation is effective 

February 4, 2015. Objections and 

requests for hearings must be received 

on or before April 6, 2015, 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–2014–0514, 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 

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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0514 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 6, 2015. 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 


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