Federal Register / Vol. 79, No. 98 / Wednesday, May 21, 2014 / Rules and Regulations 29103 

DATES: The regulations in 33 CFR 

165.1312 will be enforced from 11:00 

a.m. on June 4, 2014 until 11:00 a.m. on 

June 9, 2014. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, call 

or email LTJG Ian McPhillips, 

Waterways Management Division, MSU 

Portland, Oregon, Coast Guard; 

telephone 503–240–9319, email 

MSUPDXWWM@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the security zone for 

the Portland Rose Festival detailed in 33 

CFR 165.1312 from 11:00 a.m. on June 

4, 2014 until 11:00 a.m. on June 9, 2014. 

Under the provisions of 33 CFR 

165.1312 and 33 CFR 165 Subpart D, no 

person or vessel may enter or remain in 

the security zone, consisting of all 

waters of the Willamette River, from 

surface to bottom, encompassed by the 

Hawthorne and Steel Bridges, without 

permission from the Sector Columbia 

River Captain of the Port. Persons or 

vessels wishing to enter the security 

zone may request permission to do so 

from the on scene Captain of the Port 

representative via VHF Channel 16 or 

13. The Coast Guard may be assisted by 

other Federal, State, or local 

enforcement agencies in enforcing this 

regulation. 

This notice is issued under authority 

of 33 CFR 165.1312 and 5 U.S.C. 552(a). 

In addition to this notice in the Federal 

Register, the Coast Guard will provide 

the maritime community with 

notification of this enforcement period 

via the Local Notice to Mariners. 

Dated: April 29, 2014. 

B.C. Jones, 

Captain, U.S. Coast Guard, Captain of the 

Port, Sector Columbia River. 

[FR Doc. 2014–11793 Filed 5–20–14; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0269; FRL–9905–80] 

Cyflumetofen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cyflumetofen 

in or on multiple commodities which 

are identified and discussed later in this 

document. BASF Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

21, 2014. Objections and requests for 

hearings must be received on or before 

July 21, 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–2012–0269, 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, 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–2012–0269 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 July 21, 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– 

2012–0269, 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 May 23, 

2012 (77 FR 30481) (FRL–9347–8), 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 2F7973) by BASF 

Corporation, P.O. Box 13528, Research 

Triangle Park, NC 27709. The petition 

requested that 40 CFR part 180 be 


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amended by establishing tolerances for 

residues of the insecticide cyflumetofen 

(2-methoxyethyl a-cyano-a-[4-(1,1- 

dimethylethyl)phenyl]-b-oxo-2- 

(trifluoromethyl)benzenepropanoate), in 

or on almond, hulls at 4.0 parts per 

million (ppm); citrus, oil at 16 ppm; 

fruit, citrus, group 10 at 0.3 ppm; fruit, 

pome, group 11 at 0.3 ppm; grape at 0.6 

ppm; grape, raisin at 0.9 ppm; nut, tree, 

group 14 at 0.01 ppm; strawberry at 0.6 

ppm; and tomato at 0.2 ppm. That 

document referenced a summary of the 

petition prepared by BASF Corporation, 

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, EPA modified 

some of the tolerance levels and 

commodity names requested by the 

applicant. The reasons 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 

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 including 

exposure resulting from the tolerances 

established by this action. EPA’s 

assessment of exposures and risks 

associated with 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 major target 

organ in rats, mice, and dogs following 

short-term and long-term oral 

administration of cyflumetofen is the 

adrenal glands characterized by 

increased organ weight and 

histopathology (vacuolation and 

hypertrophy of the adrenal cortical 

cells). 

Cyflumetofen has low acute toxicity 

by oral, dermal, and inhalation routes of 

exposure. It is minimally irritating to 

the eyes but not to the skin. It is a skin 

sensitizer. 

Decreased serum hormone 

concentrations (FSH, progesterone, and 

17 b-estradiol) were observed in the 

mid- and high-dose F1 females in a rat 

reproduction study while no hormonal 

effect was observed in the F1 male rats 

at any dose level. However, there were 

no corresponding changes in 

reproductive performance at any dose 

level. In the developmental toxicity 

study in rats, an increased incidence of 

wavy ribs was noted at the high-dose 

(1,000 milligrams/kilogram/day (mg/kg/ 

day)), while an increased incidence of 

incompletely ossified sternal centra was 

observed at the mid- and high-dose 

levels. These incidences occurred in the 

presence of maternal toxicity. In the 

developmental toxicity study in rabbits, 

a downward flexion of the forepaws 

and/or hind paws was observed in the 

high-dose (1,000 mg/kg/day) group pups 

and delays in skeletal ossification were 

observed in pups at the mid- and highdoses. Maternal toxicity (adrenal effects) 

was also observed at the mid- and highdoses. 

No evidence of neurotoxicity or 

immunotoxicity was observed in any of 

the submitted studies for cyflumetofen. 

Although there is some evidence of 

thyroid tumors in rats, the Agency has 

determined that quantification of risk 

using a non-linear approach (i.e., 

reference dose (RfD)) will adequately 

account for all chronic toxicity, 

including carcinogenicity, that could 

result from exposure to cyflumetofen. 

This conclusion is based on the 

following reasons. The single tumor 

type (thyroid c-cell) occurred in only 

one sex (male) and one species (rat). 

This tumor effect was seen only at high 

doses (250 mg/kg/day), which far 

exceeds the chronic no-observedadverse-effect-level (NOAEL) the 

Agency is using for its risk assessment 

(16.5 mg/kg/day). And there is no 

concern for mutagenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by cyflumetofen as well 

as the NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Cyflumetofen: New Active Ingredient 

Human Health Risk Assessment to 

Support Uses on Citrus (Crop Group 10– 

10), Pome Fruits Crop Group 11–10), 

Tree Nuts (Crop Group 14–12), Grape, 

Strawberry, and Tomato’’ section IV, pg. 

12 in docket ID number EPA–HQ–OPP– 

2012–0269. 

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 

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 Cyflumetofen used for 

human risk assessment is shown in the 

following Table 1 of this unit. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CYFLUMETOFEN FOR USE IN FFDCA HUMAN

HEALTH RISK ASSESSMENT

Exposure/scenario Point of departure Uncertainty/FQPA 

safety factors 

RfD, PAD, level of 

concern for risk 

assessment 

Study and toxicological effects 

Acute Dietary (All 

populations).

An acute reference dose has not been established for either the general population or for Females 13–49 years of age 

since there were no appropriate studies that demonstrated evidence of toxicity attributable to a single dose for these 

populations. 

Chronic Dietary (All 

Populations).

NOAEL = 16.5 mg/

kg/day.

UFA = 10x ............

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 

0.17 mg/kg/day.

cPAD = 0.17 mg/

kg/day 

Three co-critical studies: 

90-day feeding study in rats: 

LOAEL = 54.5/62.8 mg/kg/day (M/F) based on hematology and organ weight changes in the liver, adrenal, 

kidney and ovaries; and histopathology effects in the 

adrenals and the ovaries. NOAEL = 16.5/19 mg/kg/day 

(M/F). 

Chronic toxicity/carcinogenicity study in rats: 

LOAEL = 49.5/61.9 mg/kg/day in (M/F) based on increased adrenal weights and histopathology. NOAEL = 

16.5/20.3 mg/kg/day (M/F). 

Two generation reproduction study in rats: 

Parental: LOAEL = 30.6/46.6 mg/kg/day (M/F) based on 

increased organ weight and histopathology in adrenals. 

NOAEL = 9.2/13.8 mg/kg/day (M/F). 

Inhalation (Short-, 

Intermediate- and 

Long-Term).

NOAEL = 16.5 mg/

kg/day.

UFA = 10x ............

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

100.

Same as chronic dietary endpoint. 

Cancer (oral, dermal, inhalation).The quantification of risk using a non-linear approach (i.e., cRfD) will adequately account for all chronic toxicity, including 

carcinogenicity. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to cyflumetofen, EPA 

considered exposure under the 

petitioned-for tolerances in 40 CFR 180. 

EPA assessed dietary exposures from 

cyflumetofen 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. No such effects were 

identified in the toxicological studies 

for cyflumetofen; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 2003– 

2008 food consumption data from the 

U.S. Department of Agriculture’s 

(USDA’s) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). The 

partially refined chronic analysis 

conducted was based on tolerance-level 

residues, 100% percent crop treated 

(PCT) assumptions, and both 

empirically derived and default 

processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., the Agency 

has determined that quantification of 

risk using a nonlinear approach (i.e., 

RfD) would adequately account for all 

chronic toxicity, including 

carcinogenicity, that could result from 

exposure to cyflumetofen. Therefore, a 

separate cancer dietary exposure 

analysis was not performed. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for cyflumetofen. 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 cyflumetofen in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

cyflumetofen. 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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentrations in Ground Water Model 

as well as Pesticide Root Zone Model— 

Groundwater, the estimated drinking 

water concentrations (EDWCs) of 

cyflumetofen for chronic exposure 

assessments are estimated to be 0.33 

parts per billion (ppb) for surface water 

and 0.0024 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 0.33 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). EPA 

assessed residential exposure using the 

following assumptions: The use of 

cyflumetofen on ornamentals in 

residential landscapes may result in 

residential handler exposure. 

Residential handler exposure is 

expected to be short-term in duration as 


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intermediate- or long-term exposures are 

not likely because of the intermittent 

nature of applications by homeowners. 

The quantitative exposure/risk 

assessment developed for residential 

handlers is based on the following 

scenarios: 

• Mixing/loading/applying liquid to 

ornamentals with hose-end sprayer. 

• Mixing/loading/applying liquid to 

ornamentals with manually-pressurized 

handwand. 

• Mixing/loading/applying liquid to 

ornamentals with backpack. 

• Mixing/loading/applying liquid to 

ornamentals with a sprinkler can. 

Since no dermal hazard was 

identified for cyflumetofen in the 

toxicological database, only inhalation 

exposure assessments were conducted 

for residential handlers. EPA did not 

assess post-application exposure from 

the use of cyflumetofen in residential 

settings because: 

1. No dermal hazard was identified in 

the toxicity database for cyflumetofen, 

so a quantitative residential postapplication dermal risk assessment is 

not required; 

2. Post-application inhalation 

exposure while performing activities in 

previously treated gardens was not 

assessed due to the low vapor pressure 

and the expected dilution in outdoor air 

after an application has occurred; 

3. The potential for post-application 

non-dietary ingestion exposure for 

children (1 < 2 years old) is greatly 

diminished since young children are not 

expected to engage in the types of 

activities associated with these areas 

(e.g., gardening) or utilize these areas for 

prolonged periods of play. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

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.’’ 

EPA has not found cyflumetofen to 

share a common mechanism of toxicity 

with any other substances, and 

cyflumetofen does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that cyflumetofen does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/

cumulative. 

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. 

There is no evidence of increased 

qualitative or quantitative susceptibility 

in the rat 2-generation reproduction 

study; however, the rat and rabbit 

developmental studies indicate 

susceptibility in the pups. There is 

evidence of increased quantitative 

susceptibility in the rabbit 

developmental toxicity study, since 

developmental effects (changes in 

ossicification, paw flexion, and 

decreased fetal body weights) at the 

limit dose were observed where no 

maternal toxicity was present. There is 

evidence of increased qualitative 

susceptibility in the rat developmental 

toxicity study as developmental effects 

(increased incidence of incompletely 

ossified sternal centra) were seen at the 

same dose that caused an increase in 

adrenal weights and organ-to-body 

weight ratio in the maternal animals. 

Notwithstanding, the degree of concern 

for these effects in infants and children 

is low because the rat and rabbit 

developmental effects have clearly 

defined NOAEL/LOAELs and the dose 

selected for chronic risk assessment is 

protective of these effects. Therefore, the 

PODs based on adrenal effects in rat are 

health protective of all lifestages. 

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 

cyflumetofen is complete. 

ii. There is no indication that 

cyflumetofen is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is some evidence that 

cyflumetofen results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies. 

However, as described in Unit III.D.2., 

because of the low degree of concern for 

these effects, it is not necessary to retain 

the 10X FQPA factor to adequately 

protect infants and children. 

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 cyflumetofen 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by cyflumetofen. 

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. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, cyflumetofen is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to cyflumetofen 

from food and water will utilize 2.3% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of cyflumetofen is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 


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(considered to be a background 

exposure level). 

Cyflumetofen is currently proposed 

for uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to cyflumetofen. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures are above the 

Level of Concern (LOC) of 100 and are 

not of concern (MOEs ≥ 100). 

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 no intermediate-term adverse 

effect was identified, cyflumetofen is 

not expected to pose an intermediateterm risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized in Unit III.A., EPA has 

concluded that the cPAD is protective of 

potential cancer effects. Given the 

results of the chronic risk assessment, 

cyflumetofen is not expected 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 cyflumetofen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography) 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 cyflumetofen. 

C. Revisions to Petitioned-For 

Tolerances 

EPA revised the commodity names for 

the requested tolerances consistent with 

its policy to establish crop group 

tolerances using the most recently 

established crop groups. This policy 

was explained in the most recent 

rulemaking establishing crop groups in 

the Federal Register on August 22, 2012 

(77 FR 50617) (FRL–9354–3). Under this 

policy, rather than establish new 

tolerances under the pre-existing crop 

groups, EPA intends to conform 

petitions seeking tolerances for crop 

groups to the newer established crop 

groups, as part of its effort to eventually 

convert tolerances for any pre-existing 

crop group to tolerances with coverage 

under the revised crop group. Therefore, 

although the petitioner had requested 

tolerances on fruit, citrus, group 10; 

fruit, pome, group 11; and nut, tree, 

group 14. EPA evaluated and is 

establishing tolerances for fruit, citrus, 

group 10–10; fruit, pome, group 11–10; 

and nut, tree, group 14–12, respectively. 

The petitioner requested a tolerance 

of 0.2 ppm for tomato based on residues 

found in tomatoes that had been frozen 

and stored in accordance with OECD 

Guideline 506 (October 16, 2007) to 

account for residue loss that may have 

occurred during storage. EPA is 

establishing a tolerance for tomato at 

0.40 ppm. In addition, EPA is not 

establishing a separate tolerance for 

grape, raisin of 0.9 ppm, as requested, 

since the tolerance for the raw 

agricultural commodity grape at 0.60 

ppm is adequate to account for any 

residue concentration shown in the 

processed commodity. 

V. Conclusion 

Therefore, tolerances are established 

for residues of cyflumetofen, in or on 

almond, hulls at 4.0 ppm; citrus, oil at 

16 ppm; grape at 0.60 ppm; fruit, citrus, 

group 10–10 at 0.30 ppm; fruit, pome, 

group 11–10 at 0.30 ppm; nut, tree, 

group 14–12 at 0.01 ppm; strawberry at 

0.60 ppm; and tomato at 0.40 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 


emcdonald on DSK67QTVN1PROD with RULES
29108 Federal Register / Vol. 79, No. 98 / Wednesday, May 21, 2014 / Rules and Regulations 

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: May 9, 2014. 

Jack Housenger, 

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. Section 180.677 is added to subpart 

C to read as follows: 

§ 180.677 Cyflumetofen; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide cyflumetofen, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels for 

cyflumetofen is to be determined by 

measuring only cyflumetofen, 2- 

methoxyethyl a-cyano-a-[4-(1,1- 

dimethylethyl)phenyl]-b-oxo-2- 

(trifluoromethyl)benzenepropanoate, in 

or on the commodity. 

Commodity Parts per 

million 

Almond, hulls ............................ 4.0 

Citrus, oil ................................... 16 

Fruit, citrus, group 10–10 ......... 0.30 

Fruit, pome, group 11–10 ......... 0.30 

Grape ........................................ 0.60 

Nut, tree, group 14–12 ............. 0.01 

Strawberry ................................ 0.60 

Commodity Parts per 

million 

Tomato ...................................... 0.40 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2014–11496 Filed 5–20–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1989–0008; FRL–9911– 

19–Region 1] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Deletion 

of the Town Garage/Radio Beacon 

Superfund Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region 1 is publishing a 

direct final Notice of Deletion of the 

Town Garage/Radio Beacon, Superfund 

(Site), located in Londonderry, New 

Hampshire from the National Priorities 

List (NPL). The NPL, promulgated 

pursuant to section 105 of the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended, is 

an appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). This direct 

final deletion is being published by EPA 

with the concurrence of the State of 

New Hampshire, through the New 

Hampshire Department of 

Environmental Services (NHDES), 

because EPA has determined that all 

appropriate response actions under 

CERCLA, have been completed. 

However, this deletion does not 

preclude future actions under 

Superfund. 

DATES: This direct final deletion is 

effective July 21, 2014 unless EPA 

receives adverse comments by June 20, 

2014. If adverse comments are received, 

EPA will publish a timely withdrawal of 

the direct final deletion in the Federal 

Register informing the public that the 

deletion will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID no. EPA–HQ– 

SFUND–1989–0008, by one of the 

following methods: 

• http://www.regulations.gov. Follow 

on-line instructions for submitting 

comments. 

• Email: lovely.william@epa.gov or 

elliott.rodney@epa.gov. 

• Fax: 617–918–0240 or 617–918– 

0372. 

• Mail: William Lovely, EPA Region 

1—New England, 5 Post Office Square, 

Suite 100, Mail Code OSRR07–4, 

Boston, MA 02109–3912 or Rodney 

Elliott, EPA Region 1—New England, 5 

Post Office Square, Suite 100, Mail Code 

ORA01–1, Boston, MA 02109–3912. 

• Hand delivery: William Lovely, 

EPA Region 1—New England, 5 Post 

Office Square, Suite 100, Mail Code 

OSRR07–4, Boston, MA 02109–3912 or 

Rodney Elliott, EPA Region 1—New 

England, 5 Post Office Square, Suite 

100, Mail Code ORA01–1, Boston, MA 

02109–3912. Such deliveries are only 

accepted during the Docket’s normal 

hours of operation (9:00 a.m. to 5:00 

p.m.), and special arrangements should 

be made for deliveries of boxed 

information. 

Instructions: Direct your comments to 

Docket ID no. EPA–HQ–SFUND–1989– 

0008. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http://

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http://

www.regulations.gov or email. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through http://

www.regulations.gov, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 


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