Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations 3481 

Dated: January 16, 2015. 

J.C. Burton, 

Captain, U.S. Coast Guard, Director of 

Inspections and Compliance. 

[FR Doc. 2015–01045 Filed 1–22–15; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0226; FRL–9914–77] 

Flupyradifurone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

flupyradifurone in or on multiple 

commodities which are identified and 

discussed later in this document. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 23, 2015. Objections and 

requests for hearings must be received 

on or before March 24, 2015, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0226, 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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2013–0226 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 March 24, 2015. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0226, 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 2F8101) by Bayer 

CropScience LP, 2 T.W. Alexander Dr., 

P.O. Box 12014, Research Triangle Park, 

NC 27709. The petition requested that 

40 CFR part 180 be amended by 

establishing tolerances for residues of 

flupyradifurone, 4-[[(6-chloro-3- 

pyridinyl)methyl](2,2- 

difluoroethyl)amino]-2(5H)-furanone, 

and its metabolites, difluoro acetic acid 

(DFA) and 4-[(2,2- 

difluoroethyl)amino]furan-2(5H)-one 

(DFEAF), in or on the following 

commodities: Aspirated grains fractions 

at 40 parts per million (ppm); root 

vegetables except sugar beets (crop 

subgroup 1B) at 1.5 ppm; tuberous and 

corm vegetables (crop subgroup 1C) at 

0.5 ppm; onion, bulb, subgroup, (crop 

subgroup 3–07A) at 0.3 ppm; onion, 

green, subgroup, (crop subgroup 3–07B) 

at 3 ppm; leafy vegetable, except 

Brassica vegetables (crop group 4) at 40 

ppm; taro leaves at 40 ppm; head and 

stem Brassica (crop subgroup 5A) at 6 

ppm; leafy Brassica greens (crop 

subgroup 5B) at 40 ppm; turnip greens 

at 40 ppm; edible-podded legume 

vegetables (crop subgroup 6A) at 5 ppm; 

succulent, shelled pea and bean (crop 

subgroup 6B) at 4 ppm; dried, shelled 

pea and bean (except soybean) (crop 

subgroups 6C) at 6 ppm; foliage of 

legume vegetables, including soybeans 

(crop group 7), forage, green vines at 40 

ppm; foliage of legume vegetables, 

including soybeans (crop group 7), hay 

at 50 ppm; soybean, seed at 4 ppm; 


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fruiting vegetables, except cucurbits 

(crop group 8–10), fruit at 3 ppm; 

tomato, paste at 4 ppm; cucurbit 

vegetables (crop group 9), fruit at 2 ppm, 

citrus fruits (crop group 10–10), fruit at 

3 ppm; citrus, pulp, dried at 15 ppm; 

pome fruits (crop group 11–10), fruit at 

1.5 ppm; bushberry subgroup (crop 

subgroup 13–07B) at 4 ppm; small fruit 

vine climbing subgroup, except fuzzy 

kiwifruit (crop subgroup 13–07F) at 3 

ppm; grapes, raisin at 6 ppm; low 

growing berry subgroup (crop subgroup 

13–07G) at 1.5 ppm; tree nuts (crop 

group 14), nutmeat at 0.15 ppm; 

pistachio at 0.15 ppm; tree nuts (crop 

group 14), hulls at 15 ppm; grain, cereal, 

(crop group 15), except rice; grain at 4 

ppm; sweet corn, kernels plus cobs with 

husks removed (k+cwhr) at 0.4 ppm; 

wheat, bran at 5 ppm; rice, grain 

(rotational crop) at 4 ppm; grain, cereal, 

forage, fodder and straw, group 16, 

forage at 20 ppm; grain, cereal, forage, 

fodder and straw, group 16, hay at 40 

ppm; grain, cereal, forage, fodder and 

straw, group 16, straw at 30 ppm; grain, 

cereal, forage, fodder and straw, group 

16, stover at 15 ppm; cotton, undelinted 

seed, (crop subgroup 20C) at 0.9 ppm; 

cotton, gin by-products at 40 ppm; 

nongrass animal feeds, forage, (crop 

group 18) at 20 ppm; nongrass animal 

feeds, hay, (crop group 18) at 40 ppm; 

coffee, bean, green at 2 ppm; coffee, 

bean, roasted; instant at 3 ppm; hops at 

20 ppm; peanut, hay at 30 ppm; peanut, 

nutmeat at 0.15 ppm; prickly pear 

cactus, fruit; at 0.5 ppm; pitaya, fruit at 

0.5 ppm; prickly pear cactus, pads at 0.9 

ppm; cattle, goat, hog, horse, sheep fat 

at 0.5 ppm; cattle, goat, hog, horse, 

sheep meat at 1 ppm; cattle, goat, hog, 

horse, sheep, meat byproducts at 2 ppm; 

milk at 0.3 ppm, poultry, eggs at 0.3 

ppm, poultry, meat at 0.5 ppm; poultry, 

meat byproducts at 0.5 ppm. 

That document referenced a summary 

of the petition prepared by Bayer 

CropScience, 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 has revised 

the proposed commodity definitions 

and altered tolerance levels for different 

commodities. EPA has reviewed the 

available residue data and has 

determined the appropriate tolerance 

levels for residues of flupyradifurone. 

The reasons for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . ..’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for flupyradifurone, 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with flupyradifurone, 

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. 

Flupyradifurone (BYI 02960) is a new 

butenolide insecticide. The most 

sensitive effects seen in the 

flupyradifurone database were skeletal 

muscle atrophy/degeneration in dogs. 

With repeated dosing, reductions in 

body weight and food consumption 

were commonly seen in various studies 

and in all species of test animals (rats, 

mice, dogs, and rabbits). The liver and 

thyroid were shown to be the common 

findings of flupyradifurone toxicity. The 

database appears to suggest that dogs are 

more sensitive to the effects of 

flupyradifurone; however, with body 

weight adjustments (based on a 3⁄4

scaling factor), the dog and rat are 

almost equally as sensitive in response 

to flupyradifurone toxicity. The skeletal 

muscle atrophy/degeneration seen in 

the 90-day and 1-year dog studies 

formed the basis for chronic dietary 

exposure toxicity endpoints. 

The developmental toxicity study in 

rats demonstrated no evidence of 

susceptibility in developing animals. In 

the rabbit developmental toxicity study, 

there was an increase in the incidence 

of fetal death at 80 milligram/kilogram/ 

day (mg/kg/day) (the highest dose 

tested), a dose that did not produce 

adverse effects in the maternal animals. 

Therefore, a quantitative increase in 

susceptibility was demonstrated in the 

rabbit developmental toxicity study. In 

the 2-generation reproduction study in 

rats, decreased parental body weights 

(≥10%) were seen at the LOAEL of 137 

mg/kg/day (parental NOAEL = 37.8 mg/ 

kg/day). In contrast, body weight 

decreases that were considered adverse 

were seen in F2 pups at 37.8 mg/kg/day 

(the parental NOAEL and the offspring 

LOAEL; offspring NOAEL = 7.7 mg/kg/ 

day). These findings suggest 

quantitative susceptibility for 

developing young animals. 

The acute neurotoxicity study (dosing 

by gavage) showed that at the time of 

peak-effect, flupyradifurone caused 

increases in the incidence of 

piloerection and dilated pupils at 50 

mg/kg. At the next higher dose level 

(200 mg/kg) and above, it produced a 

large host of clinical signs, which were 

related to neurotoxicity. The clinical 

signs included dilated pupils, lower 

muscle tone, low arousal, tremors, 

myoclonic jerks, chewing, repetitive 

licking of lips, gait incoordination, 

flattened or hunched posture, and 

impaired righting reflex. In the 90-day 

neurotoxicity study, no neurotoxicity or 

other adverse effects were seen at dose 

levels as high as 174 mg/kg/day. The 

developmental neurotoxicity study at 

102 mg/kg/day yielded an increased 

incidence of increased amplitude in 

startle response. 

Flupyradifurone is classified as ‘‘not 

likely to be carcinogenic to humans.’’ 

Carcinogenicity studies in rats and mice 

did not yield a compound-related 

increase in tumor incidence, and the 

genotoxicity battery did not show 

flupyradifurone to produce any 

genotoxicity. Flupyradifurone did not 

demonstrate any immunotoxic effects. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by flupyradifurone as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Flupyradifurone: Human Health Risk 

Assessment for The First Food Use’’ in 


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docket ID number EPA–HQ–OPP–2013– 

0226. 

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 (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for flupyradifurone used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUPYRADIFURONE, FOR USE IN HUMAN HEALTH

RISK ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (All populations) ............... NOAEL = 35 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = .35 

mg/kg/day.

Acute neurotoxicity study—rat. 

LOAEL = 50 mg/kg/day based on increased incidences of 

piloerection in both sexes and pupil dilation in females 

on day 1. At the next higher dose level (200 mg/kg) or 

above, lower muscle tone, rapid respiration, low arousal, tremors, myoclonic jerks, chewing, repetitive licking 

of lips, gait incoordination, flattened or hunched posture, 

dilated pupils, impaired (uncoordinated or slow) righting 

reflex, impaired flexor and tail pinch responses, and reduced rectal temperature. Automated measures of 

motor activity were also reduced in both sexes, compared to controls. 

Chronic dietary (All populations) ............ NOAEL = 7.8 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = .078 

mg/kg/day.

cPAD = .078 mg/

kg/day. 

1-year oral toxicity study—dog. 

LOAEL = 28 mg/kg/day based on minimal to slight, focal 

to multifocal areas of skeletal muscle degeneration in 

grastrocnemius and/or biceps femoris muscle. 

Cancer (Oral, dermal, inhalation) ........... Flupyradifurone is classified as ‘‘not likely to be carcinogenic to humans’’ based on data showing no 

treatment related increase in tumor incidence in rat and mouse carcinogenicity studies. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

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

of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flupyradifurone, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from flupyradifurone, 

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 flupyradifurone. Exposure and risk 

assessments were conducted using the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM–FCID). This 

software uses 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). As to 

residue levels in food, EPA assumed 

that flupyradifurone residues were 

present at recommended tolerance 

levels in all commodities and that 100% 

of these crops were treated with 

flupyradifurone. DEEM default 

processing factors were used for 

cranberry juice, dried apple, dried beef, 

and dried pear; empirical processing 

factors were used for processed 

commodities of apple (sauce and juice), 

citrus oil, coffee, corn (bran, flour, meal, 

starch, oil), cotton (oil), grape (wine, 

juice), grapefruit (juice), hops (dried 

cones), lemons (juice), limes (juice), 

oranges (juice and peel), peanut (butter, 

oil), pears (juice), potatoes (chips, 

flakes, cooked), soybeans (oil, milk, 

flour), tomatoes (juice, puree, paste), 

and wheat (bran, germ, flour). 

ii. Chronic exposure. Exposure and 

risk assessments were conducted using 

the DEEM–FCID. This software uses 

2003–2008 food consumption data from 

the USDA’s NHANES/WWEIA. EPA 

assumed that flupyradifurone residues 

were present at recommended tolerance 

levels in all commodities and that 100% 

of these crops were treated with 

flupyradifurone. DEEM default 

processing factors were used for 

cranberry juice, dried apple, dried beef, 

and dried pear; empirical processing 

factors were used for processed 

commodities of apple (sauce and juice), 

citrus oil, coffee, corn (bran, flour, meal, 

starch, oil), cotton (oil), grape (wine, 

juice), grapefruit (juice), hops (dried 

cones), lemons (juice), limes (juice), 

oranges (juice and peel), peanut (butter, 


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oil), pears (juice), potatoes (chips, 

flakes, cooked), soybeans (oil, milk, 

flour), tomatoes (juice, puree, paste), 

and wheat (bran, germ, flour). 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that flupyradifurone 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 flupyradifurone. 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 flupyradifurone, in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

flupyradifurone. 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) the estimated 

drinking water concentrations (EDWCs) 

of flupyradifurone for acute exposures is 

estimated to be 52.5 parts per billion 

(ppb) for surface water. Based on the 

Pesticide Root Zone Model Ground 

Water (PRZM GW), the EDWCs of 

flupyradifurone for acute exposures are 

estimated to 352 ppb for ground water. 

Based on the PRZM/EXAMS the 

EDWCs of flupyradifurone for chronic 

exposures for non-cancer assessments 

are estimated to be 22.3 ppb for surface 

water and based on the PRZM GW the 

EDWCs are estimated to be 307 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 352 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 307 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). 

Flupyradifurone 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.’’ 

EPA has not found flupyradifurone to 

share a common mechanism of toxicity 

with any other substances, and 

flupyradifurone does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that flupyradifurone 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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

The developmental toxicity study in rats 

demonstrated no evidence of 

susceptibility in developing animals. In 

the rabbit developmental toxicity study, 

there was an increase in the incidence 

of fetal death at 80 mg/kg/day, a dose 

that did not produce adverse effects in 

the maternal animals. Therefore, a 

quantitative increase in susceptibility 

was demonstrated in the rabbit 

developmental toxicity study; however, 

the deaths occurred only at the highest 

tested dose. In the 2-generation 

reproduction study in rats, decreased 

parental body weights (≥10%) were seen 

at the LOAEL of 137 mg/kg/day 

(parental NOAEL = 37.8 mg/kg/day). In 

contrast, body weight decreases that 

were considered adverse were seen in F2

pups at 37.8 mg/kg/day (the parental 

NOAEL and the offspring LOAEL; 

offspring NOAEL = 7.7 mg/kg/day). 

These findings suggest quantitative 

susceptibility for developing young 

animals. However, the effects seen in 

the rabbit developmental study and in 

the rat reproductive study occurred at 

doses higher than the toxicity POD for 

risk assessment, which was selected 

from the 1-year dog study (28 mg/kg/

day, LOAEL) with a NOAEL of 7.8 mg/ 

kg/day. The NOAEL (7.8 mg/kg/day) 

selected as the POD for chronic dietary 

risk assessment is protective of the 

effects seen in the rat F2 pups and the 

increased incidence of fetal death in the 

developmental rabbit study. Therefore, 

there are no concerns for the observed 

increased susceptibility. 

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 

flupyradifurone is complete. 

ii. Although there is evidence that 

flupyradifurone has neurotoxic effects, 

EPA has a complete set of neurotoxicity 

studies (acute, subchronic, and 

developmental). The effects of those 

studies are well-characterized and 

indicate neurotoxic effects that occur at 

levels above the chronic POD that was 

selected for risk assessment. The 

NOAEL for the acute neurotoxicity 

study is being used for the acute POD. 

Therefore, there is no need to retain the 

10X FQPA SF to account for any 

uncertainty concerning these effects. 

iii. There is no evidence that 

flupyradifurone results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. There is 

quantitative susceptibility in rabbit 

developmental study and in the pup of 

the reproduction study, but the PODs 

are protective of this increased 

susceptibility. 

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 

flupyradifurone in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by flupyradifurone. 


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Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations 3485 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

flupyradifurone will occupy 38% of the 

aPAD for children 1–2 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 

flupyradifurone from food and water 

will utilize 84% of the cPAD for 

children 1–2 years old the population 

group receiving the greatest exposure. 

3. Short-term and Intermediate-term 

risk. Short-term and Intermediate-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). A short-term/

intermediate-term adverse effect was 

identified; however, flupyradifurone is 

not registered for any use patterns that 

would result in short-term or 

intermediate-term residential exposure. 

Because there is no short-term or 

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 short-term risk is 

necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for 

flupyradifurone. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

flupyradifurone is not expected to pose 

a cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

flupyradifurone residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography with tandem mass 

spectrometry (HPLC/MS–MS)) is 

available to enforce the tolerance 

expression. The validated limit of 

quantification (LOQ) is 0.01 mg/kg for 

flupyradifurone in most commodities. 

An HPLC/MS–MS method, Method 

RV–004–A11–05 (latest revision of the 

data collection method RV–004–A11– 

04), is adequate as the enforcement 

method for determination of residues of 

flupyradifurone in livestock 

commodities. The validated LOQ for 

flupyradifurone is 0.01 mg/kg in all 

matrices. 

The Food and Drug Administration 

(FDA) multi-residue methods (MRMs) 

are suitable for flupyradifurone only in 

non-fatty matrices. The methods are not 

suitable for fatty matrices or matrices 

that require further clean-up. 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 MRLs for flupyradifurone. 

C. Revisions to Petitioned-For 

Tolerances 

The Petitioner requested a definition 

for enforcement of tolerance as the sum 

of flupyradifurone and DFA and 

DFEAF, expressed as flupyradifurone, 

which significantly inflated the field 

trial residue values and resulted in 

higher tolerance values. EPA, consistent 

with its global review partners, has 

selected parent flupyradifurone only as 

the residue definition for tolerance 

enforcement. Flupyradifurone is the 

major portion of the residue in plant 

commodities and in some livestock 

commodities. In other livestock 

commodities, it is present at the same 

approximate concentration as some 

metabolites. Moreover, the significant 

metabolite DFA is not suitable for 

enforcement purposes, as its 

concentration is erratic with time. The 

harmonized enforcement definition, 

flupyradifurone only, will facilitate 

trade and is predicted to be the residue 

definition adopted by Codex in the 

future based on application of their 

policy. Therefore, EPA is reducing the 

tolerance values for the petitioned-for 

tolerances for the following commodity 

groups/subgroups or commodities: 

Cattle, goat, hog, horse, and sheep meat 

and meat byproducts; hog fat; milk; 

poultry eggs; root vegetables subgroup 

1B; tuberous and corm vegetables 

subgroup 1C; bulb onion subgroup 3– 

07A; leafy vegetable group 4; legume 

vegetables subgroups 6A, 6B, 6C; 

soybean; foliage of legume vegetables 

group 7; fruiting vegetables group 8–10; 

cucurbit vegetables group 9; citrus pulp; 

pome fruits group 11–10; grape raisins; 

bushberry subgroup 13B except 

cranberry; tree nut group 14; cereal 

grain group 15 except rice and except 

corn; sweet corn, cereal grain forage, 

fodder, and straw group 16; nongrass 

animal feeds crop group 18; cotton 

undelinted seed; coffee bean; hops; 

peanut hay; peanut; prickly pear cactus 

fruit and pad. 

The petition requested a tolerance for 

root vegetables, except sugar beets 

subgroup 1B at 1.5 ppm. The ratio of 

highest average field trials (HAFTs) of 

the representative commodities (carrot/ 

radish, 0.603/0.046 ppm) was 13, but 

the ratio of the median residue value 

was 1.8. The small median ratio 

indicates that the central tendency of 

both carrot and radish residue values 

are similar and that a single tolerance 

would be appropriate for the subgroup, 

represented by carrot and radish. The 

higher tolerance estimate from carrot 

(0.90 ppm) will cover all members of the 

subgroup. 

The petition requested a tolerance for 

the leafy vegetable, except Brassica 

vegetables, group 4 at 40 ppm. Based on 

the available residue data, EPA is 

establishing separate tolerances for each 

of the subgroups of group 4, instead of 

a single tolerance for the whole group. 

For subgroup 4A (leafy greens), EPA is 


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3486 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations 

establishing a tolerance at 30 ppm, 

based on the highest residues, which 

were found on the representative crop 

spinach. For subgroup 4B (leafy 

petioles), EPA is establishing a separate 

tolerance at 9.0 ppm based on the celery 

residues. The leafy greens subgroup 

tolerance was translated to cover taro 

leaves; therefore, EPA is establishing a 

tolerance for taro leaves at 30 ppm, 

rather than the 40 ppm requested. 

The petitioned-for tolerance for the 

shelled pea and bean subgroup 6B at 4 

ppm was not possible because the 

residues on the garden pea and lima 

bean were substantially different. 

Residues differ by more than 5X 

between succulent peas and succulent 

beans. In accordance with 40 CFR 

180.40(g), a subgroup tolerance is not 

normally appropriate; rather, EPA may 

establish individual crop tolerances. 

Therefore, EPA is establishing 

individual tolerances for succulent peas 

and succulent beans. 

The petition requested a tolerance for 

cereal grains, grain, group 15 except rice 

at 4 ppm. The residues on sweet corn 

and field corn grain were much lower 

than those on sorghum, wheat, and 

barley grains; therefore, EPA is 

excluding corn (field corn, popcorn, and 

sweet corn) grain from that group 15 

tolerance, as well as rice. Based on 

available residue data, EPA is 

establishing separate tolerances for 

popcorn, grain, field corn, grain, and 

sweet corn (kernels plus cobs with 

husks removed) at 0.05 ppm. Under 

180.40(h), EPA may exclude some 

commodities from a group tolerance 

where the residue levels are 

significantly higher or lower than the 

other commodities in the group. Corn, 

unlike the other cereal grains, has a 

protective husk and this difference is 

often reflected in lower residues for late 

season foliar applications. Therefore, 

EPA is excluding corn grain and rice 

from the crop group 15 tolerance and 

establishing separate tolerances for corn. 

The remaining cereal grains, 

represented by grain sorghum, barley, 

and wheat, are quite similar. 

The petition requested a tolerance on 

nongrass animal feeds group 18, forage 

at 20 ppm and hay at 40 ppm. EPA is 

unable to establish group 18 tolerances 

at this time for forage and hay because 

data from only four field trials on clover 

(one of the representative crops) was 

available. Based on the available data, 

EPA is establishing tolerances for alfafa 

and regional tolerances for clover (since 

use on clover is restricted to 

Washington, Oregon, and Idaho, the 

area where the field trials were 

conducted). A group tolerance could be 

considered if additional field trials for 

clover from diverse areas of the U.S. 

were supplied. 

The petition requested a tolerance for 

rice grain at 4 ppm as a rotational crop. 

EPA cannot establish this tolerance at 

this time because no data were provided 

to support this request. Rice field trial 

data are required to establish a 

tolerance. 

The proposed wheat bran tolerance of 

5 ppm is not necessary. The cereal grain 

group tolerance covers wheat bran. The 

highest average field trial (HAFT) 

residue for wheat grain was 0.73 ppm 

and the experimentally determined 

processing factor for the conversion of 

grain to bran was 2.4. Therefore, the 

tolerance estimate for wheat bran is 1.8 

ppm (0.73 × 2.4). As 1.8 ppm is less than 

the 3 ppm cereal group tolerance, a 

separate tolerance for wheat bran is not 

needed. 

EPA was petitioned for tolerances on 

tree nut group 14 and pistachio. In the 

Federal Register of August 22, 2012 (77 

FR 50617) (FRL–9354–3), EPA issued a 

final rule that revised the crop grouping 

regulations. As part of this action, EPA 

expanded and revised the existing tree 

nut group 14. Changes to crop group 14 

included adding the specialty 

commodities African nut tree, Brazilian 

pine, bunya, bur oak, cajou nut, 

candlenut, coconut, coquito nut, dika 

nut, ginkgo, guiana chestnut, heartnut, 

Japanese horse-chestnut, mongongo nut, 

monkey-pot, monkey puzzle nut, okari 

nut, pachira nut, peach palm nut, pequi, 

pili nut, pine nut, pistachio, tropical 

almond and yellowhorn including 

cultivars, varieties, and/or hybrids of 

these; and naming the new crop group 

tree nut group 14–12. EPA indicated in 

the August 22, 2012 final rule as well as 

the earlier proposed rule published in 

the Federal Register of November 9, 

2011 (76 FR 69693) (FRL–8887–8) that, 

for petitions for which a Notice of Filing 

had been published, the Agency would 

attempt to conform these petitions to the 

final rule. Therefore, consistent with 

this final rule, EPA has assessed 

exposure to the, insecticide 

flupyradifurone, assuming use under 

the revised tree nut group 14–12. 

Because revising the requested crop 

group to the updated crop group did not 

result in a risk of concern, EPA is 

establishing tolerances for 

flupyradifurone residues on tree nut 

group 14–12. 

Cranberry was removed from 

subgroups 13–07B and 13–07G at the 

request of the petitioner as a 

modification to the original request. 

Tolerances are not needed for the 

processed commodities instant coffee, 

roasted coffee, and tomato paste. The 

recommended tolerances for the raw 

agricultural commodities, tomato and 

green coffee bean cover the respective 

processed commodities. The highest 

average field trial (HAFT) result for 

coffee was 0.55 ppm, and the processing 

factors for instant coffee and roasted 

coffee were 0.59 and 1.9, respectively. 

Tolerance estimate (HAFT × processing 

factor; 0.55 × 0.59 = 0.32 ppm roasted 

bean; 0.55 × 1.9 = 1.0 ppm instant 

coffee) are less than the recommended 

green coffee bean tolerance (1.5 ppm). 

The HAFT for the tomato field trials was 

0.57 ppm and the processing factor for 

conversion to paste was 2.0, and the 

product (0.57 × 2.0) is less than the 

recommended fruiting vegetable group 

tolerance (1.5 ppm). 

Tolerances are not required for 

poultry meat and poultry meat 

byproducts, as the projected diet for 

poultry and the results of the poultry 

feeding study indicate that residues are 

not likely in poultry meat and poultry 

meat byproducts. 

V. Conclusion 

Therefore, tolerances are established 

for residues of flupyradifurone, 4-[[(6- 

chloro-3-pyridinyl)methyl](2,2- 

difluoroethyl)amino]- 2(5H)-furanone, 

are: Alfalfa, forage at 9.0 ppm; alfalfa, 

hay at 20 ppm; almond, hulls at 15 ppm; 

bean, succulent at 0.2 ppm; berry, low 

growing, subgroup 13–07G, except 

cranberry at 1.5 ppm; Brassica, head 

and stem, subgroup 5A at 6.0 ppm; 

Brassica, leafy greens, subgroup 5B at 40 

ppm; bushberry subgroup 13–07B, 

except cranberry at 4.0 ppm; cactus, 

fruit at 0.30 ppm; cactus, pads at 0.70 

ppm; cattle, fat at 0.20 ppm; cattle, meat 

at 0.30 ppm; cattle, meat byproducts at 

1.0 ppm; clover, forage at 20 ppm; 

clover, hay at 30 ppm; coffee, green 

bean at 1.5 ppm; corn, field, grain at 

0.05 ppm; corn, pop, grain at 0.05 ppm; 

corn, sweet, kernels plus cobs with 

husks removed at 0.05 ppm; cotton, gin 

byproducts at 40 ppm; cottonseed 

subgroup 20C at 0.80 ppm; egg at 0.01 

ppm; fruit, citrus, group 10–10 at 3.0 

ppm; fruit, citrus, dried pulp, at 10 

ppm; fruit, pome, group 11–10 at 0.70 

ppm; fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F at 3.0 

ppm; goat, fat at 0.20 ppm; goat, meat 

at 0.30 ppm; goat, meat byproducts at 

1.0 ppm; grain, aspirated grains 

fractions at 40 ppm; grain, cereal, except 

rice and corn, group 15 at 3.0 ppm; 

grain, cereal, forage, fodder and straw, 

group 16 at 30 ppm; grape, raisin at 5.0 

ppm; hog, fat at 0.01 ppm; hog, meat at 

0.01 ppm; hog, meat byproducts at 0.04 

ppm; hops, dried cones 10 ppm; horse, 

fat at 0.20 ppm; horse, meat at 0.30 

ppm; horse, meat byproducts at 1.0 

ppm; leaf petioles, subgroup 4B at 9.0 


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Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations 3487 

ppm; leafy greens, subgroup 4A at 30 

ppm; milk at 0.15 ppm; nut, tree, group 

14–12 at 0.02 ppm; onion, bulb, 

subgroup 3–07A at 0.09 ppm; onion, 

green, subgroup 3–07B at 3.0 ppm; pea 

and bean, dried, shelled except soybean, 

subgroup 6C at 3.0 ppm; pea, succulent 

at 2.0 ppm; peanut at 0.04 ppm; peanut, 

hay at 20 ppm; pitaya at 0.30 ppm; 

sheep, fat at 0.2 ppm; sheep, meat at 

0.30 ppm; sheep, meat byproducts at 1.0 

ppm; soybean, seed at 1.5 ppm; taro 

leaves at 30 ppm; turnip greens at 40 

ppm; vegetable, cucurbit, group 9 at 

0.40 ppm; vegetable, fruiting, group 8– 

10 at 1.5 ppm; vegetable, legume, edible 

podded, subgroup 6A at 3.0 ppm; 

vegetable, root, except sugar beet, 

subgroup 1B at 0.9 ppm; vegetable, 

tuberous and corm, subgroup 1C at 0.05 

ppm; vegetable, foliage of legume, group 

7, at 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 tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 14, 2015. 

Jack E. 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. Add § 180.679 to read as follows: 

§ 180.679 Flupyradifurone; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide flupyradifurone, including 

its metabolites and degradates, in or on 

the commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

flupyradifurone, 4-[[(6-chloro-3- 

pyridinyl)methyl](2,2- 

difluoroethyl)amino]- 2(5H)-furanone. 

Commodity Parts per 

million 

Alfalfa, forage ........................... 9.0 

Alfalfa, hay ................................ 20 

Almond, hulls ............................ 15 

Bean, succulent ........................ 0.20 

Berry, low growing, except 

cranberry subgroup 13–07G 1.5 

Brassica, head and stem subgroup 5A ............................... 6.0 

Brassica, leafy greens subgroup 5B ............................... 40 

Bushberry, except cranberry 

subgroup 13–07B .................. 4.0 

Cactus, fruit .............................. 0.30 

Cactus, pads ............................. 0.70 

Cattle, fat .................................. 0.20 

Cattle, meat .............................. 0.30 

Cattle, meat byproducts ........... 1.0 

Coffee, green bean 1 ................ 1.5 

Corn, field, grain ....................... 0.05 

Corn, pop, grain ........................ 0.05 

Corn, sweet, kernels plus cobs 

with husks removed .............. 0.05 

Cotton, gin byproducts ............. 40 

Cottonseed, subgroup 20C ...... 0.80 

Egg ........................................... 0.01 

Fruit, citrus, dried pulp .............. 10 

Fruit, citrus, group 10–10 ......... 3.0 

Fruit, pome, group 11–10 ......... 0.70 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 

13–07F .................................. 3.0 

Goat, fat .................................... 0.20 

Goat, meat ................................ 0.30 

Goat, meat byproducts ............. 1.0 

Grain, aspirated grain fractions 40 

Grain, cereal, forage, fodder 

and straw, group 16 .............. 30 

Grain, cereal, group 15, except 

rice and corn ......................... 3.0 

Grape, raisin ............................. 5.0 

Hog, fat ..................................... 0.01 

Hog, meat ................................. 0.01 

Hog, meat byproducts .............. 0.04 

Hops, dried cones .................... 10 

Horse, fat .................................. 0.20 

Horse, meat .............................. 0.30 

Horse, meat byproducts ........... 1.0 

Leaf petioles, subgroup 4B ...... 9.0 

Leafy greens, subgroup 4A ...... 30 

Milk ........................................... 0.15 

Nut, tree, group 14–12 ............. 0.02 

Onion, bulb, subgroup 3–07A .. 0.09 

Onion, green, subgroup 3–07B 3.0 

Pea and bean, dried, shelled 

except soybean, subgroup 

6C .......................................... 3.0 

Pea, succulent .......................... 2.0 

Peanut ...................................... 0.04 


emcdonald on DSK67QTVN1PROD with RULES
3488 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations 

Commodity Parts per 

million 

Peanut, hay .............................. 20 

Pitaya ........................................ 0.30 

Sheep, fat ................................. 0.20 

Sheep, meat ............................. 0.30 

Sheep, meat byproducts .......... 1.0 

Soybean, seed .......................... 1.5 

Taro leaves ............................... 30 

Turnip greens ........................... 40 

Vegetable, cucurbit, group 9 .... 0.40 

Vegetable, foliage of legume, 

group 7 .................................. 30 

Vegetable, fruiting, group 8–10 1.5 

Vegetable, legume, edible podded, subgroup 6A ................. 3.0 

Vegetable, root, except sugar 

beet, subgroup 1B ................ 0.90 

Vegetable, tuberous and corm, 

subgroup 1C ......................... 0.05 

1 No U.S. registration. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

restrictions. Tolerances are established 

for residues of the insecticide 

flupyradifurone, including its 

metabolites and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

flupyradifurone, 4-[[(6-chloro-3- 

pyridinyl)methyl](2,2- 

difluoroethyl)amino]- 2(5H)-furanone. 

Commodity Parts per 

million 

Clover, forage ........................... 20 

Clover, hay ............................... 30 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2015–01013 Filed 1–22–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2014–0002; Internal 

Agency Docket No. FEMA–8369] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. Also, information 

identifying the current participation 

status of a community can be obtained 

from FEMA’s Community Status Book 

(CSB). The CSB is available at http://

www.fema.gov/fema/csb.shtm. 

DATES: Effective Dates: The effective 

date of each community’s scheduled 

suspension is the third date (‘‘Susp.’’) 

listed in the third column of the 

following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact Bret Gates, Federal 

Insurance and Mitigation 

Administration, Federal Emergency 

Management Agency, 500 C Street SW., 

Washington, DC 20472, (202) 646–4133. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

Federal flood insurance that is not 

otherwise generally available from 

private insurers. In return, communities 

agree to adopt and administer local 

floodplain management measures aimed 

at protecting lives and new construction 

from future flooding. Section 1315 of 

the National Flood Insurance Act of 

1968, as amended, 42 U.S.C. 4022, 

prohibits the sale of NFIP flood 

insurance unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed in this document no 

longer meet that statutory requirement 

for compliance with program 

regulations, 44 CFR part 59. 

Accordingly, the communities will be 

suspended on the effective date in the 

third column. As of that date, flood 

insurance will no longer be available in 

the community. We recognize that some 

of these communities may adopt and 

submit the required documentation of 

legally enforceable floodplain 

management measures after this rule is 

published but prior to the actual 

suspension date. These communities 

will not be suspended and will continue 

to be eligible for the sale of NFIP flood 

insurance. A notice withdrawing the 

suspension of such communities will be 

published in the Federal Register. 

In addition, FEMA publishes a Flood 

Insurance Rate Map (FIRM) that 

identifies the Special Flood Hazard 

Areas (SFHAs) in these communities. 

The date of the FIRM, if one has been 

published, is indicated in the fourth 

column of the table. No direct Federal 

financial assistance (except assistance 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act not in connection with a 

flood) may be provided for construction 

or acquisition of buildings in identified 

SFHAs for communities not 

participating in the NFIP and identified 

for more than a year on FEMA’s initial 

FIRM for the community as having 

flood-prone areas (section 202(a) of the 

Flood Disaster Protection Act of 1973, 

42 U.S.C. 4106(a), as amended). This 

prohibition against certain types of 

Federal assistance becomes effective for 

the communities listed on the date 

shown in the last column. The 

Administrator finds that notice and 

public comment procedures under 5 

U.S.C. 553(b), are impracticable and 

unnecessary because communities listed 

in this final rule have been adequately 

notified. 

Each community receives 6-month, 

90-day, and 30-day notification letters 

addressed to the Chief Executive Officer 

stating that the community will be 

suspended unless the required 

floodplain management measures are 

met prior to the effective suspension 

date. Since these notifications were 

made, this final rule may take effect 

within less than 30 days. 

National Environmental Policy Act. 

This rule is categorically excluded from 

the requirements of 44 CFR part 10, 

Environmental Considerations. No 

environmental impact assessment has 

been prepared. 

Regulatory Flexibility Act. The 

Administrator has determined that this 

rule is exempt from the requirements of 

the Regulatory Flexibility Act because 

the National Flood Insurance Act of 

1968, as amended, Section 1315, 42 

U.S.C. 4022, prohibits flood insurance 

coverage unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed no longer comply 

with the statutory requirements, and 

after the effective date, flood insurance 

will no longer be available in the 

communities unless remedial action 

takes place. 

Regulatory Classification. This final 

rule is not a significant regulatory action 

under the criteria of section 3(f) of 

Executive Order 12866 of September 30, 


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