Federal Register / Vol. 78, No. 238 / Wednesday, December 11, 2013 / Rules and Regulations 75257 

tolerance without any numerical 

limitation. 

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 PDJ. 

VIII. Conclusion 

EPA concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of PDJ. EPA is 

therefore establishing an exemption 

from the requirement of a tolerance for 

residues of PDJ when used as a plant 

growth regulator in or on apple and 

grape pre-harvest, in accordance with 

label directions and good agricultural 

practices. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance exemption 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). 

X. 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: October 25, 2013. 

Steven Bradbury, 

Director, 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. Revise § 180.1299 to read as 

follows: 

§ 180.1299 Prohydrojasmon; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the biochemical pesticide 

prohydrojasmon (PDJ), propyl-3-oxo-2- 

pentylcyclo-pentylacetate, when used as 

a plant growth regulator in or on apple 

and grape pre-harvest, in accordance 

with label directions and good 

agricultural practices. 

[FR Doc. 2013–29561 Filed 12–10–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0295; FRL–9902–17] 

Flutriafol; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flutriafol in or 

on coffee, bean, green and coffee, 

instant. Cheminova A/S, c/o Cheminova 

Inc. requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 11, 2013. Objections and 

requests for hearings must be received 

on or before February 10, 2014, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0295, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 


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Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can i get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0295 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 February 10, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0295, 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.htm. 

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 June 5, 2013 

(78 FR 33785) (FRL–9386–2), 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 2E8074) by Cheminova 

A/S, c/o Cheminova, Inc., 1600 Wilson 

Blvd., Suite 700, Arlington, VA 22209– 

2510. The petition requested that EPA 

establish import tolerances for residues 

of the fungicide flutriafol, in or on 

coffee, bean, green at 0.20 parts per 

million (ppm) and coffee, instant at 0.30 

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. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, tolerances for 

coffee, green bean have been revised 

from 0.20 to 0.15 ppm. The reason for 

this change is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for flutriafol 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with flutriafol follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The hazard characterization and 

toxicity endpoints for risk assessment 

remain unchanged from the assessment 

upon which the final rule published in 

the Federal Register on August 8, 2012 

(77 FR 47296) (FRL–9348–8) is based. 

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 


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preamble to that final rule and its 

supporting documents as well as in the 

most recent human health risk 

assessment, Flutriafol: Human-Health 

Risk Assessment for Tolerances in/on 

Imported Coffee, which can be found in 

www.regulations.gov, under docket ID 

number EPA–HQ–OPP–2013–0295– 

0004. 

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 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://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for flutriafol used for human 

risk assessment is shown in the table 

contained in Unit III.B. of the preamble 

to the final rule published in the 

Federal Register issue of August 8, 2012 

(77 FR 47296) (FRL–9348–8). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flutriafol, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

flutriafol tolerances in 40 CFR 180.629. 

EPA assessed dietary exposures from 

flutriafol in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for flutriafol. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture’s (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat In 

America (NHANES/WWEIA) conducted 

from 2003–2008. As to residue levels in 

food, EPA made the following 

assumptions for the acute exposure 

assessment: tolerance-level residues or 

tolerance-level residues adjusted to 

account for the residues of concern for 

risk assessment, 100 percent crop 

treated (PCT), modeled drinking water 

estimates, and DEEMTM ver. 7.81 default 

processing factors. 

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 

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, 100 PCT, 

modeled drinking water estimates, and 

DEEMTM ver. 7.81 default processing 

factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that flutriafol does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for flutriafol. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. The proposed tolerance in or on 

imported coffee will not impact residues 

in the U.S. drinking water. However, 

there are registered uses for application 

of flutriafol in the U.S.A and the Agency 

used screening level water exposure 

models to estimate residues in drinking 

water. These estimates were then 

incorporated in the dietary exposure 

analysis and risk assessment for 

flutriafol. The simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of flutriafol. 

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 48.8 

parts per billion (ppb) for surface water 

and 310 ppb for ground water. 

For chronic exposures for non-cancer 

assessments the EDWC’s are estimated 

to be 5.70 ppb for surface water and 202 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 310 ppb was 

used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 202] 

ppb was used to assess the contribution 

to drinking water. The drinking water 

models and their descriptions are 

available at the EPA internet site: 

http://www.epa.gov/oppefed1/models/

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 


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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 

Identification (ID) Number EPA–HQ– 

OPP–2005–0497 and an update to the 

aggregate human health risk assessment 

for free triazoles and its conjugates may 

be found in this current docket, Docket 

ID Number EPA–HQ–OPP–2013–0295 

entitled ‘‘Common Triazole Metabolites: 

Updated Dietary (Food + Water) 

Exposure and Risk Assessment to 

Address the Revised Tolerance for 

Residues of Fenbuconazole in Peppers.’’ 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

The potential impact of in utero and 

perinatal flutriafol exposure was 

investigated in three developmental 

toxicity studies (two in rats, one in 

rabbits) and two multi-generation 

reproduction toxicity studies in rats. In 

the first of two rat developmental 

toxicity studies, a quantitative 

susceptibility was observed (delayed 

ossification or non-ossification of the 

skeleton in the fetuses) at a lower dose 

than maternal effects. In the second rat 

developmental study, a qualitative 

susceptibility was noted. Although 

developmental toxicity occurred at the 

same dose level that elicited maternal 

toxicity, the developmental effects 

(external, visceral, and skeletal 

malformations; embryo lethality; 

skeletal variations; a generalized delay 

in fetal development; and fewer live 

fetuses) were more severe than the 

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

rabbits, intrauterine deaths occurred at 

a dose level that also caused adverse 

effects in maternal animals. In the twogeneration reproduction studies, a 

qualitative susceptibility was also seen. 

Effects in the offspring (decreased litter 

size and percentage of live births, 

increased pup mortality, and liver 

toxicity) can be attributed to the 

systemic toxicity of the parental animals 

(decreased body weight and food 

consumption and liver toxicity). 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for flutriafol is 

complete. 

ii. There is no indication that 

flutriafol is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. Signs of 

neurotoxicity were reported in the acute 

and subchronic neurotoxicity studies at 

the highest dose only; however, these 

effects were primarily seen in animals 

that were agonal (at the point of death) 

and, thus, are not indicative of 

neurotoxicity. In addition, there was no 

evidence of neurotoxicity in any 

additional short-term studies in rats, 

mice, and dogs, or in the long-term 

toxicity studies in rats, mice, and dogs. 

iii. There are no concerns or residual 

uncertainties for prenatal and/or 

postnatal toxicity. Although there is 

evidence for increased qualitative 

susceptibility in the prenatal study in 

rats and rabbits and the two-generation 

reproduction study in rats, there are no 

concerns for the offspring toxicity 

observed in the developmental and 

reproductive toxicity studies for the 

following reasons: 

• Clear NOAELs and LOAELs were 

established in the fetuses/offspring for 

each of these studies; 

• The dose-response for these effects 

are well-defined and characterized; 

• Developmental endpoints are used 

for assessing acute dietary risks to the 

most sensitive population (females 13– 

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

scenarios; and 

• The chronic reference dose is 

greater than 300-fold lower than the 

dose at which the offspring effects were 

observed in the two-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 27% 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 36% of the 

cPAD for all infants less than 1 year old, 

the population group receiving the 

greatest exposure. Because there are no 


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residential uses for flutriafol, the 

chronic aggregate risk includes food and 

drinking water only. 

3. Short- 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 intermediate-term aggregate 

risk is the sum of the risk from exposure 

to flutriafol through food and water and 

will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

flutriafol is classified as ‘‘not likely to be 

carcinogenic to humans’’. EPA does not 

expect flutriafol to pose a cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to flutriafol 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Gas Chromatography/Nitrogen/

Phosphorus detector (GC/NPD) for 

proposed tolerances) are available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

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 established MRLs for 

flutriafol in or on coffee, bean, green at 

0.15 ppm. These MRLs are the same as 

the tolerances established for flutriafol 

in the United States. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the analysis of the residue 

field trial data and application of the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculator procedure, a green coffee 

bean tolerance of 0.15 ppm for residues 

of flutriafol is appropriate. The 

tolerance for coffee, green bean is 

harmonized with the Codex MRL. The 

Agency determined that the tolerance 

level of 0.15 ppm would be appropriate 

so as to harmonize with the MRL. 

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 coffee, 

bean, green at 0.15 ppm and coffee, 

instant at 0.30 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerances 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: December 2, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 


rmajette on DSK2TPTVN1PROD with RULES
75262 Federal Register / Vol. 78, No. 238 / Wednesday, December 11, 2013 / Rules and Regulations 

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, in the table in 

paragraph (a), add alphabetically entries 

for ‘‘Coffee, green, bean’’ and ‘‘Coffee, 

instant,’’ and revise footnote 1 to read as 

follows: 

§ 180.629 Flutriafol; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Coffee, green, bean 1 ............ 0.15 

Coffee, instant 1 .................... 0.30 

* * * * * 

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

* * * * * 

[FR Doc. 2013–29556 Filed 12–10–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0038; FRL–9902–07] 

Flonicamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flonicamid in 

or on multiple commodities which are 

identified and discussed later in this 

document. In two separate petitions, 

Interregional Research Project No. 4 (IR– 

4) and ISK Biosciences Corporation 

(ISK) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 11, 2013. Objections and 

requests for hearings must be received 

on or before February 10, 2014, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0038, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION:

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0038 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 February 10, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0038, 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 June 5, 2013 

(78 FR 33785) (FRL–9386–2), 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 2E8137) by IR–4, 500 

College Rd. East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.613 be 

amended by establishing tolerances for 

residues of the insecticide flonicamid 

and its metabolites and degradates 

determined by measuring flonicamid 

(N-(cyanomethyl)-4-(trifluoromethyl)-3- 

pyridinecarboxamide) and its 

metabolites TFNA (4- 

trifluoromethylnicotinic acid), TFNA– 

AM (4-trifluoromethylnicotinamide), 

and TFNG (N-(4- 

trifluoromethylnicotinoyl)glycine), 

calculated as the stoichiometric 

equivalent of flonicamid, in or on 

alfalfa, forage at 7.0 parts per million 

(ppm); alfalfa, hay at 0.20 ppm; alfalfa, 

seed at 1.5 ppm; clover, forage at 7.0 

ppm; clover, hay at 4.0 ppm; 


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