Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Rules and Regulations 71947 

12(d) of the National Technology 

Transfer and Advancement Act 

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

XI. 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: November 9, 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 § 180.960, add alphabetically the 

following polymer to the table to read as 

follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

* * * * * 

2-Propenoic acid, polymer 

with ethenylbenzene and 

(1-methylethenyl)benzene, 

minimum number average 

molecular weight (in amu), 

2,000 ................................. 52831–04–6. 

*****

[FR Doc. 2015–29466 Filed 11–17–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0179; FRL–9933–61] 

Flutriafol; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerances for residues of flutriafol in or 

on hop, dried cones. Cheminova A/S, 

c/o Cheminova, Inc. requested this 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

Additionally, tolerances are being 

removed that were inadvertently 

returned from an earlier Final rule. 

DATES: This regulation is effective 

November 18, 2015. Objections and 

requests for hearings must be received 

on or before January 19, 2016, 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–2015–0179, 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–2015–0179 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 January 19, 2016. 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– 

2015–0179, 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. 


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71948 Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Rules and Regulations 

II. Summary of Petitioned-for Tolerance 

and This Action 

In the Federal Register of April 22, 

2015 (80 FR 22466) (FRL–9925–79), 

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 4F8294) by 

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

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, ((±)-a-(2- 

fluorophenyl)-a-(4-fluorophenyl)-1H– 

1,2,4-triazole-1-ethanol), in or on hops, 

dried cones at 20 parts per million 

(ppm). That document referenced a 

summary of the petition prepared by 

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

the registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. For 

purposes of accuracy, the Agency notes 

that a harmless error was made in the 

notice of filing publication and is 

correcting that misstatement here: The 

petition was actually filed by 

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

Additionally, in the Federal Register 

of February 4, 2015 (80 FR 5946) (FRL– 

9922–06) EPA established tolerances for 

residues of flutriafol, in or on several 

commodities, including cotton, gin 

byproducts at 6.0 ppm and cotton, 

undelinted seed at 0.50 ppm. When 

establishing the general tolerances in 

paragraph (a) for cotton, gin byproducts 

at 6.0 ppm and cotton, undelinted seed 

at 0.50 ppm, EPA inadvertently forgot to 

remove the existing tolerances for 

cotton, gin byproducts at 0.02 ppm and 

cotton, undelinted seed at 0.01 ppm 

from the table in paragraph (d) for 

Indirect or inadvertent residues. These 

indirect tolerances were made 

redundant by the establishment of the 

tolerances in the General section at a 

higher level for the same commodities. 

Therefore, EPA is removing the cotton, 

gin byproducts and cotton, undelinted 

seed tolerances established in 

§ 180.629(d). 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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. Consistent with 

the mammalian toxicity profiles of the 

other triazole fungicides, the prevalent 

adverse effects following oral exposure 

to flutriafol were in the liver. Effects 

consisted of increases in liver enzyme 

release (alkaline phosphatase), liver 

weights, and histopathology findings 

(hepatocyte vacuolization to 

centrilobular hypertrophy and slight 

increases in hemosiderin-laden Kupffer 

cells, minimal to severe fatty changes, 

and bile duct proliferation/cholangiolar 

fibrosis). Progression of toxicity 

occurred with time as some effects were 

only observed at chronic durations. 

Slight indications of effects in the 

hematopoietic system were sporadically 

seen in all species consisting of slight 

anemia, increased platelets, white blood 

cells, neutrophils, and lymphocytes. 

The effects in the neurotoxicity 

screening batteries were observed only 

at higher doses and were considered 

secondary effects (decreased motor 

activity and hindlimb grip strength, 

ptosis, lost righting reflex, hunched 

posture, and ataxia). Flutriafol showed 

no evidence of dermal toxicity, or 

immunotoxicity. Flutriafol showed no 

evidence of carcinogenicity in rodents 

or in vitro. 

There is evidence of increased 

quantitative and qualitative pre- and 

postnatal susceptibility for flutriafol in 

rats and rabbits. In the first of two rat 

developmental toxicity studies, 

developmental effects (delayed 

ossification or non-ossification of the 

skeleton in the fetuses) were observed at 

a lower dose than that where maternal 

effects were observed. In the second rat 

developmental study, developmental 

effects (external, visceral, and skeletal 

malformations; embryo lethality; 

skeletal variations; a generalized delay 

in fetal development; and fewer live 

fetuses) were more severe than the 

decreased food consumption and bodyweight gains observed in the dams at the 

same dose. For rabbits, intrauterine 

deaths occurred at a dose level that also 

caused adverse effects in maternal 

animals. In the 2-generation 

reproduction studies, 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) observed at the same dose. 

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. 

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 

final rule published in the Federal 

Register of June 6, 2014 (79 FR 32666) 

(FRL–9910–38). 

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 


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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 the NOAEL and the 

LOAEL are identified. 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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

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 raisin and tomato paste 

tolerances 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. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA NHANES/WWEIA 

conducted from 2003–2008. As to 

residue levels in food, EPA made the 

following 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 raisin and 

tomato paste tolerances 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. 

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 percent 

crop treated (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 dietary 

exposure analysis and risk assessment 

for flutriafol in drinking water. 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://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the First Index Reservoir 

Screening Tool (FIRST), and Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of flutriafol for 

acute exposures are estimated to be 15.9 

parts per billion (ppb) for surface water 

and 193 ppb for ground water. 

For chronic exposures assessments 

the EDWC’s are estimated to be 5.39 ppb 

for surface water and 165 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 193 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 165 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 


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from substances found to have a 

common mechanism of toxicity, see 

EPA’s Web site at http://www2.epa.gov/ 

pesticide-science-and-assessingpesticide-risks/cumulative-assessmentrisk-pesticides. 

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 risk 

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. 

The most recent update to that 

aggregate human health risk assessment 

for free traizoles and its conjugates was 

conducted on April 9, 2015. This 

assessment considered all proposed/

registered triazole derived pesticides 

uses with the resulting risk less than the 

Agency’s level of concern. 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–2015–0179–0014 entitled, 

‘‘Common Triazole Metabolites: 

Updated Aggregate Human Health Risk 

Assessment to Address The New 

Section 3 Registrations for Use of 

Propiconazole on Tea, Dill, Mustard 

Greens, Radish, and Watercress; Use of 

Difenoconazole on Globe Artichoke, 

Ginseng and Greenhouse Grown 

Cucumbers and Conversation of the 

Established Foliar Uses/Tolerances for 

Stone Fruit and Tree Nut Crop Groups 

to Fruit, Stone, Group 12–12 and the 

Nut, Tree, Group 14–12.; and Use of 

Flutriafol on Hops.’’ 

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 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. 

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 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 rats, 

there are no concerns for the offspring 

toxicity observed in the developmental 

and reproductive toxicity studies for the 

following reasons: (1) clear NOAELs and 

LOAELs were established in the fetuses/ 

offspring for each of these studies; (2) 

the dose-response for these effects are 

well-defined and characterized; (3) 

developmental endpoints are used for 

assessing acute dietary risks to the most 

sensitive population (females 13–49 

years old) as well as all other short and 

intermediate-term exposure scenarios; 

(4) the acute reference dose for females 

13–49 is 1,000 fold lower than the dose 

at which quantitative susceptibility in 

the first developmental rat study was 

observed; and (5) 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. 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. 


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Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Rules and Regulations 71951 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

flutriafol will occupy 39% of the aPAD 

for females 13–49 years, the population 

group receiving the greatest % aPAD. 

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 96% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for flutriafol. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Because there is no 

short-term residential exposure, and 

chronic dietary exposure has already 

been assessed under the appropriately 

protective cPAD (which is at least as 

protective as the POD used to assess 

short-term risk), no further assessment 

of short-term risk is necessary, and EPA 

relies on the chronic dietary risk 

assessment for evaluating short-term 

risk for flutriafol. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because there is no intermediate-term 

residential exposure, and chronic 

dietary exposure has already been 

assessed under the appropriately 

protective cPAD (which is at least as 

protective as the POD used to assess 

short-term risk), no further assessment 

of intermediate-term risk is necessary, 

and EPA relies on the chronic dietary 

risk assessment for evaluating 

intermediate-term risk for flutriafol. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

flutriafol is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to flutriafol 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

gas chromotography/nitrogenphosphorus detector (GC/NPD) for the 

proposed tolerances is available to 

enforce the tolerances recommended 

herein is available to enforce the 

tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for flutriafol. 

V. Conclusion 

Therefore, tolerances are established 

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

fluorophenyl)-a-(4-fluorophenyl)-1H1,2,4-triazole-1-ethanol), in or on hop, 

dried cones at 20 ppm. Additionally, the 

tolerances for cotton, gin byproducts, 

and cotton, undelinted seed established 

in 180.629(d) are 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 


wgreen on DSK2VPTVN1PROD with RULES
71952 Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Rules and Regulations 

1All references to sections of the regulations in 

this document refer to title 49 CFR. 

2HHFT ‘‘means a single train transporting 20 or 

more loaded tank cars of a Class 3 flammable liquid 

in a continuous block or a single train carrying 35 

or more loaded tank cars of a Class 3 flammable 

liquid throughout the train consist.’’ § 171.8. 

3http://www.phmsa.dot.gov/pv_obj_cache/pv_

obj_id_79961459E55D0ADB8FF510CF4A

93EC93E3A00000/filename/Notice_No_15_14_

Delay_in_Appeals.pdf 

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: November 10, 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 § 180.629: 

■ a. Add alphabetically the commodity 

‘‘Hop, dried cones’’ to the table in 

paragraph (a). 

■ b. Remove the commodities ‘‘Cotton, 

gin byproducts,’’ and ‘‘Cotton, 

undelinted seed’’ from the table in 

paragraph (d). 

The addition reads as follows: 

§ 180.629 Flutriafol; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Hop, dried cones .................. 20 

* * * * * 

* * * * * 

[FR Doc. 2015–29462 Filed 11–17–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Pipeline and Hazardous Materials 

Safety Administration 

49 CFR Parts 171, 172, 173, 174, and 

179 

[Docket No. PHMSA–2012–0082 (HM–251)] 

RIN 2137–AE91 

Hazardous Materials: Enhanced Tank 

Car Standards and Operational 

Controls for High-Hazard Flammable 

Trains 

AGENCY: Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA), Department of Transportation 

(DOT). 

ACTION: Response to appeals. 

SUMMARY: On May 8, 2015, the Pipeline 

and Hazardous Materials Safety 

Administration, in coordination with 

the Federal Railroad Administration 

(FRA), published a final rule entitled 

‘‘Hazardous Materials: Enhanced Tank 

Car Standards and Operational Controls 

for High-Hazard Flammable Trains,’’ 

which adopted requirements designed 

to reduce the consequences and, in 

some instances, reduce the probability 

of accidents involving trains 

transporting large quantities of Class 3 

flammable liquids. The Hazardous 

Materials Regulations provide a person 

the opportunity to appeal a PHMSA 

action, including a final rule. PHMSA 

received six appeals regarding the final 

rule, one of which was withdrawn. This 

document responds to the five 

remaining appeals submitted by the 

Dangerous Goods Advisory Council 

(DGAC), American Chemistry Council 

(ACC), Association of American 

Railroads (AAR), American Fuel & 

Petrochemical Manufacturers (AFPM), 

and jointly the Umatilla, Yakama, Warm 

Springs, and Nez Perce tribes (Columbia 

River Treaty Tribes) and the Quinault 

Indian Nation (Northwest Treaty 

Tribes). 

DATES: November 18, 2015. 

ADDRESSES: You may find information 

on this rulemaking and the associated 

appeals (Docket No. PHMSA–2012– 

0082) at the Federal eRulemaking Portal: 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Ben 

Supko, (202) 366–8553, Standards and 

Rulemaking Division, Pipeline and 

Hazardous Materials Safety 

Administration or Karl Alexy, (202) 

493–6245, Office of Safety Assurance 

and Compliance, Federal Railroad 

Administration, 1200 New Jersey Ave. 

SE., Washington, DC 20590. 

SUPPLEMENTARY INFORMATION: 

Table of Contents of Supplementary 

Information 

I. Background 

II. Response to Appeals 

A. Scope of Rulemaking 

Dangerous Goods Advisory Council 

American Chemistry Council 

Association of American Railroads 

PHMSA and FRA Response 

B. Tribal Impacts and Consultation 

Columbia River Treaty Tribes and 

Northwest Treaty Tribes 

PHMSA and FRA Response 

C. Information Sharing/Notification 

Columbia River Treaty Tribes and 

Northwest Treaty Tribes 

PHMSA and FRA Response 

D. Testing and Sampling Program 

Dangerous Goods Advisory Council 

PHMSA and FRA Response 

E. Retrofit Timeline and Tank Car 

Reporting Requirements 

American Fuel & Petrochemical 

Manufacturers 

PHMSA and FRA Response 

F. Thermal Protection for Tank Cars 

Association of American Railroads 

PHMSA and FRA Response 

G. Advanced Brake Signal Propagation 

Systems 

Dangerous Goods Advisory Council 

PHMSA and FRA Response 

Association of American Railroads 

PHMSA and FRA Response 

III. Summary 

I. Background 

Under 49 CFR 106.110–106.130,1 a 

person may appeal a PHMSA action, 

including a final rule. Appeals must 

reach PHMSA no later than 30 days 

after the date PHMSA published the 

regulation. On May 8, 2015, PHMSA, in 

coordination with FRA, published a 

final rule entitled ‘‘Hazardous Materials: 

Enhanced Tank Car Standards and 

Operational Controls for High-Hazard 

Flammable Trains’’ (HM–251, 80 FR 

26644) (the final rule). The final rule 

adopted requirements designed to 

reduce the consequences and, in some 

instances, reduce the probability of, 

accidents involving trains transporting 

large quantities of flammable liquids. 

The final rule defines certain trains 

transporting large volumes of flammable 

liquids as ‘‘high-hazard flammable 

trains’’ (HHFT) 2 and regulates their 

operation in terms of enhanced tank car 

designs, speed restrictions, braking 

systems, and routing. In response to the 

final rule, PHMSA received six appeals, 

one of which was withdrawn. The five 

active appeals were submitted by the 

DGAC, ACC, AAR, AFPM, and jointly 

the Columbia River Treaty Tribes and 

the Northwest Treaty Tribes. 

Section 106.130 requires PHMSA to 

notify those who appeal, in writing, of 

the action on the appeal, within 90 days 

after the date that PHMSA published the 

action being appealed. Based on the 

final rule’s publication date of May 8, 

2015, PHMSA was required to provide 

a response or notice of delay by August 

6, 2015. On August 6, 2015, PHMSA 

posted a notice of delay on its Web site 

and subsequently published that notice 

in the Federal Register on August 10, 

2015 (Notice 15–14; 80 FR 47987).3

This document summarizes and 

responds to the appeals of the DGAC, 


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