75262 Federal Register / Vol. 78, No. 238 / Wednesday, December 11, 2013 / Rules and Regulations 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.629, in the table in 

paragraph (a), add alphabetically entries 

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

instant,’’ and revise footnote 1 to read as 

follows: 

§ 180.629 Flutriafol; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

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

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

* * * * * 

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

* * * * * 

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

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0038; FRL–9902–07] 

Flonicamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flonicamid in 

or on multiple commodities which are 

identified and discussed later in this 

document. In two separate petitions, 

Interregional Research Project No. 4 (IR– 

4) and ISK Biosciences Corporation 

(ISK) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 11, 2013. Objections and 

requests for hearings must be received 

on or before February 10, 2014, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0038, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION:

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0038 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before February 10, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0038, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of June 5, 2013 

(78 FR 33785) (FRL–9386–2), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 2E8137) by IR–4, 500 

College Rd. East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.613 be 

amended by establishing tolerances for 

residues of the insecticide flonicamid 

and its metabolites and degradates 

determined by measuring flonicamid 

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

pyridinecarboxamide) and its 

metabolites TFNA (4- 

trifluoromethylnicotinic acid), TFNA– 

AM (4-trifluoromethylnicotinamide), 

and TFNG (N-(4- 

trifluoromethylnicotinoyl)glycine), 

calculated as the stoichiometric 

equivalent of flonicamid, in or on 

alfalfa, forage at 7.0 parts per million 

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

seed at 1.5 ppm; clover, forage at 7.0 

ppm; clover, hay at 4.0 ppm; 


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peppermint, tops at 7.0 ppm; spearmint, 

tops at 7.0 ppm; vegetable, fruiting, 

group 8–10 at 0.40 ppm; vegetable, 

cucurbit, group 9 at 1.5 ppm; fruit, 

pome, group 11–10 at 0.20 ppm; and 

fruit, stone, group 12–12 at 0.60 ppm. 

The petition also requested, upon the 

approval of the aforementioned 

tolerances, removal of the established 

tolerances for residues of the flonicamid 

in or on the following crop groups: 

Vegetable, fruiting, group 8; fruit, pome, 

group 11; fruit, stone, group 12; 

cucumber; and vegetable, cucurbit, 

group 9, except cucumber. That 

document referenced a summary of the 

petition prepared by ISK Biosciences 

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. 

In addition, in the Federal Register of 

February 27, 2013 (78 FR 13295) (FRL– 

9380–2), 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 2F8088) by 

ISK Biosciences Corporation, 7470 

Auburn Rd., Suite A, Concord, OH 

44077. The petition requested that 40 

CFR 180.613 be amended by 

establishing tolerances for residues of 

the insecticide, flonicamid (N- 

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

pyridinecarboxamide) and its 

metabolites, TFNA (4-trifluoromethyl 

nicotinic acid), TFNA–AM (4- 

trifluoromethylnicotinamide), and 

TFNG (N-(4-trifluoro 

methylnicotinoyl)glycine), calculated as 

the stoichiometric equivalent of 

flonicamid, in or on tree, nuts, crop 

group 14–12 at 0.09 ppm; almond at 

0.09 ppm; pecan at 0.04 ppm; and 

almond, hulls at 10.0 ppm. That 

document referenced a summary of the 

petition prepared by ISK Biosciences 

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 has 

modified the levels at which tolerances 

are being established for some 

commodities and has determined not to 

establish tolerances for some of the 

requested commodities. The reason for 

these changes is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for flonicamid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with flonicamid 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. 

In the 28-day dermal study with 

flonicamid technical, no dermal or 

systemic toxicity was seen at the limit 

dose. In oral studies using rats and dogs, 

the kidney and liver are the target 

organs for flonicamid toxicity. Increased 

kidney weight and hyaline droplet 

deposition were observed as well as 

liver centrilobular hypertrophy in the 

rat 28-day oral range-finding, 90-day 

oral, developmental, and reproductive 

studies. The 90-day dog study showed 

kidney tubular vacuolation as well as 

increased adrenal weights, increased 

reticulocytes and decreased thymus 

weights. Increased reticulocyte count 

was noted in both the subchronic and 

chronic dog studies. 

In rats, developmental effects 

including increased incidence of 

cervical ribs were observed at 

maternally toxic (liver and kidney gross 

and histopathological effects) dose 

levels. In rabbits, developmental effects 

were not observed at any dose level 

including maternally toxic doses. 

Offspring effects (decreased body weight 

and delayed sexual maturation) in the 

multi-generation study were seen only 

in the presence of parental toxicity 

(kidney effects in males, blood effects in 

females). Thus, there is no evidence that 

flonicamid results in increased 

susceptibility (qualitative or 

quantitative) in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

There are no concerns for flonicamid 

neurotoxicity. Although clinical signs 

suggesting potential neurotoxic effects 

(e.g., decreased motor activity, tremors) 

were seen in the acute and subchronic 

neurotoxicity studies; other effects in 

these studies (e.g., increased mortality, 

and significant decreases in food 

consumption and body weight) 

indicated that the clinical signs were a 

result of the animals being in an 

extreme condition or otherwise 

compromised and in a state of general 

malaise. Also, these types of effects 

were not observed in the other 

subchronic or chronic studies in mice, 

rats or dogs. Thus, there is not clear 

evidence of neurotoxicity. Lastly, clear 

no-observed-adverse-effect-levels 

(NOAELs) and lowest-observed-adverse 

effect-levels (LOAELs) were defined for 

the clinical signs, which are above the 

levels currently used for risk assessment 

purposes. 

A 28-day oral (dietary) 

immunotoxicity study of technical 

flonicamid in female CD–1 mice 

demonstrated that flonicamid is not an 

immuno-suppressant, either structurally 

or functionally up to and including dose 

levels exceeding the limit dose. 

Although there is some limited 

evidence suggesting that flonicamid has 

a potential for carcinogenic effects, EPA 

determined that quantification of risk 

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

a chronic reference dose (cRfD)) 

adequately accounts for all chronic 

toxicity, including carcinogenicity that 

could result from exposure to 

flonicamid. The following 

considerations support that 

determination. First, mutagenicity 

studies were negative for the parent 

chemical, flonicamid, and its 

metabolites, TFNA, TFNA–AM, TFNG, 

TFNG–AM, and TFNA–OH. Second, 

although flonicamid is carcinogenic in 

CD–1 mice, based on increased 

incidences of lung tumors associated 

with Clara cell activation, this tumor 

type is associated with species and 

strain sensitivity and is not directly 

correlated with cancer risks in humans. 

Third, nasal cavity tumors seen in male 


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Wistar rats were linked to incisor 

inflammation and not considered to be 

treatment related. These tumor findings 

were confounded by the lack of a dose 

response and the biological significance 

is questionable. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by flonicamid as well as 

the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

entitled ‘‘Flonicamid—Human Health 

Risk Assessment for a Section 3 

Registration of New Uses on Alfalfa and 

Clover Grown for Seed, Mint, 

Greenhouse Grown Tomatoes, and Tree 

Nuts,’’ pp. 33–39 in docket ID number 

EPA–HQ–OPP–2013–0038. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for flonicamid used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of November 14, 

2012 (77 FR 67771) (FRL–9368–7). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flonicamid, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

flonicamid tolerances in 40 CFR 

180.613. EPA assessed dietary 

exposures from flonicamid 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 flonicamid; 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 U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). As 

to residue levels in food, the chronic 

dietary exposure assessment was a 

conservative assessment, conducted 

using tolerance-level residues and 100 

percent crop treated (PCT). 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to flonicamid. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/;or PCT 

information in the dietary assessment 

for flonicamid. Tolerance level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for flonicamid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

;transport characteristics of flonicamid. 

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. 

The drinking water assessment was 

conducted using a parent only and total 

toxic residues of flonicamid (TTR) 

approach. Total toxic residues include 

TFNA, TFNA–AM, TFNA–OH, TFNG, 

and TFNG–AM. 

Based on the Pesticide Root Zone 

Model/;Exposure Analysis Modeling 

System (PRZM/;EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of total 

toxic residues of flonicamid for chronic 

exposures for non-cancer assessments 

are estimated to be 0.94 parts per billion 

(ppb) for surface water and 9.92 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 9.92 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). 

Flonicamid 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 flonicamid to 

share a common mechanism of toxicity 

with any other substances, and 

flonicamid does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that flonicamid 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 


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Federal Register / Vol. 78, No. 238 / Wednesday, December 11, 2013 / Rules and Regulations 75265 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicity 

database for flonicamid includes 

prenatal developmental toxicity studies 

in rats and rabbits and a multigeneration reproduction toxicity study 

in rats. There is no evidence that 

flonicamid results in increased 

susceptibility (qualitative or 

quantitative) in rats or rabbits exposed 

in utero in the prenatal developmental 

studies or in young rats in the multigeneration reproduction study. No 

developmental effects were seen in 

rabbits. In the multi-generation 

reproduction study, developmental 

delays in the offspring (decreased body 

weights, delayed sexual maturation) 

were seen only in the presence of 

parental toxicity (kidney and blood 

effects). Also, there are clear NOAELs 

and LOAELs for all effects. The degree 

of concern for prenatal and/;or postnatal susceptibility is, therefore, low 

due to the lack of evidence of qualitative 

and quantitative 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 for chronic dietary 

and other exposures, except as noted 

below. That decision is based on the 

following findings: 

i. The toxicity database for flonicamid 

is complete except for a subchronic 

inhalation study. In the absence of a 

route specific inhalation study, EPA has 

retained a 10X FQPA SF to assess risks 

for inhalation exposure scenarios. 

However, residential inhalation 

exposures are not expected. 

ii. The available data base includes 

acute and subchronic neurotoxicity 

studies. As discussed in Unit III.A., EPA 

has concluded that the clinical signs 

observed in those studies were not the 

result of a neurotoxic mechanism and 

that therefore a developmental 

neurotoxicity study is not required. 

iii. There was no evidence for 

quantitative or qualitative susceptibility 

following oral exposures to rats in utero 

or oral exposure to rabbits in utero. 

iv. There are no residual uncertainties 

identified in the exposure databases. An 

unrefined conservative chronic dietary 

exposure assessment for food and 

drinking water was conducted, 

assuming tolerance level residues for all 

existing and proposed commodities and 

100 PCT of registered and proposed 

crops. The drinking water assessment 

utilized water concentration values 

generated by models and associated 

modeling parameters which are 

designed to produce conservative, 

health protective, high-end estimates of 

water concentrations which are not 

likely to be exceeded. The dietary (food 

and drinking water) exposure 

assessment does not underestimate the 

potential exposure for infants, children, 

or women of child bearing age. 

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. Shortterm, intermediate-term, and chronicterm 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, flonicamid 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 flonicamid 

from food and water will utilize 30% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for flonicamid. 

3. Short-term and intermediate-term 

risk. Short- term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Short-term and intermediate-term 

adverse effects were identified; 

however, flonicamid is not registered for 

any use patterns that would result in 

short-term or intermediate-term 

residential exposure. Short-term and 

intermediate-term risk is assessed based 

on short-term and intermediate-term 

residential exposure plus chronic 

dietary 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 or 

intermediate-term risk), no further 

assessment of short-term or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short-term 

and intermediate-term risk for 

flonicamid. 

4. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A., EPA has concluded that the 

cPAD is protective of possible cancer 

effects from flonicamid, and as 

evidenced in Unit III.E.2, aggregate 

exposure to flonicamid is below the 

cPAD. 

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 flonicamid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methods are 

available to enforce the tolerances for 

flonicamid and the major metabolites in 

plants and livestock. The proposed 

method for plants uses liquid 

chromatography with tandem mass 

spectrometry (LC/MS/MS) (FMC No. P– 

3561M) to determine the residues of 

flonicamid and its major metabolites, 

TFNA–AM, TFNA, and TFNG. Three 

enforcement methods are used for 

livestock commodities: 

1. An LC/MS/MS method RCC No. 

844743 for determination of residues in 

eggs, poultry tissues, and fat of cattle, 

goat, hog, horse, and sheep; 

2. LC/MS method RCC No. 842993 for 

determination of residues in milk; and 

3. LC/MS/MS method FMC No. P– 

3580, which includes an acid hydrolysis 

step, for determination of residues in 

meat and meat products (kidney and 

liver) of cattle, goat, hog, horse, and 

sheep. All three methods determine 

flonicamid and the metabolites OH– 

TFNA–AM, TFNA–AM, TFNG, and 

TFNA 

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 


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75266 Federal Register / Vol. 78, No. 238 / Wednesday, December 11, 2013 / Rules and Regulations 

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 any 

MRLs for flonicamid. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the review of the residue 

data, EPA is modifying the proposed 

tolerance on alfalfa forage from 7.0 ppm 

to 10.0 ppm; alfalfa hay from 0.20 ppm 

to 1.0 ppm; almond hulls from 10.0 ppm 

to 9.0 ppm; and the tree nut group 14– 

12 from 0.09 ppm to 0.15 ppm. For 

alfalfa forage, the tolerance was 

calculated using 5x the mean of the field 

trial data instead of using the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures because there are 

only two field trials reflecting the 

proposed application rate and preharvest interval. For alfalfa hay, the 

level of quantitation (LOQ) was used 

since all residues were <LOQ. The 

tolerances for the almond hulls and tree 

nuts were calculated using the OECD 

tolerance calculation procedures 

including using average field trial 

residues. 

Second, due to the need for additional 

field trials, the Agency is not 

establishing the tolerances requested for 

clover forage and clover hay at this time. 

Additionally, because ‘‘almond’’ and 

‘‘pecan’’ are part of the tree nut group 

14–12, the Agency is not establishing 

separate tolerances on these 

commodities. 

And lastly, EPA is increasing the 

established tolerance on milk and 

establishing new tolerances for hog 

commodities based on the maximum 

reasonably balanced diets (MRBD), 

calculated using ‘‘Table 1 Feedstuffs’’ 

(June 2008), and additional livestock 

feed items associated with the proposed 

uses in both PPs 2E8137 and 2F8088. 

V. Conclusion 

Therefore, tolerances are established 

for residues of flonicamid and its 

metabolites and degradates determined 

by measuring flonicamid (N- 

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

pyridinecarboxamide) and its 

metabolites TFNA (4- 

trifluoromethylnicotinic acid), TFNA– 

AM (4-trifluoromethyl-nicotinamide), 

and TFNG (N-(4- 

trifluoromethylnicotinoyl) glycine), 

calculated as the stoichiometric 

equivalent of flonicamid, in or on 

alfalfa, forage at 10.0 ppm; alfalfa, hay 

at 1.0 ppm; alfalfa, seed at 1.5 ppm; 

peppermint, tops at 7.0 ppm; spearmint, 

tops at 7.0 ppm; vegetable, fruiting, 

group 8–10 at 0.40 ppm; vegetable, 

cucurbit, group 9 at 1.5 ppm; fruit, 

pome, group 11–10 at 0.20 ppm; fruit, 

stone, group 12–12 at 0.60 ppm; 

almond, hulls at 9.0 ppm; nut, tree, 

group 14–12 at 0.15; hog, fat at 0.03 

ppm; hog, meat at 0.03 ppm; and hog, 

meat byproducts at 0.03 ppm. The 

existing tolerance for milk is revised 

from 0.03 ppm to 0.05 ppm. Lastly, as 

a result of the establishment of the 

above tolerances, the following existing 

tolerances are removed as unnecessary: 

Fruit, pome, group 11; fruit, stone, 

group 12; vegetable, fruiting, group 8; 

cucumber; vegetable, cucurbit, group 9, 

except cucumber. 

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: November 12, 2013. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.613: 


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Federal Register / Vol. 78, No. 238 / Wednesday, December 11, 2013 / Rules and Regulations 75267 

■ a. Remove from the table in paragraph 

(a)(1) the entries for ‘‘Fruit, pome, group 

11,’’ ‘‘Fruit, stone, group 12,’’ 

‘‘Vegetable, cucurbit, group 9, except 

cucumber’’ and ‘‘Vegetable, fruiting, 

group 8’’. 

■ b. Add alphabetically to the table in 

paragraph (a)(1) the following entries. 

■ c. Add alphabetically to the table in 

paragraph (a)(2) the entries for ‘‘Hog, 

fat,’’ ‘‘Hog, meat,’’ and ‘‘Hog, meat 

byproducts.’’ 

■ d. Revise the entry for ‘‘Milk’’ in the 

table in paragraph (a)(2). 

The amendments read as follows: 

§ 180.613 Flonicamid; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Alfalfa, forage ....................... 10.0 

Alfalfa, hay ............................ 1.0 

Alfalfa, seed .......................... 1.5 

Almond, hulls ........................ 9.0 

* * * * * 

Fruit, pome, group 11–10 ..... 0.20 

Fruit, stone, group 12–12 ..... 0.60 

* * * * * 

Nut, tree, group 14–12 ......... 0.15 

* * * * * 

Peppermint, tops .................. 7.0 

* * * * * 

Spearmint, tops .................... 7.0 

* * * * * 

Vegetable, cucurbit, group 9 1.5 

Vegetable, fruiting, group 8– 

10 ...................................... 0.40 

* * * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Hog, fat ................................. 0.03 

Hog, meat ............................. 0.03 

Hog, meat byproducts .......... 0.03 

* * * * * 

Milk ....................................... 0.05 

* * * * * 

* * * * * 

[FR Doc. 2013–29576 Filed 12–10–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 111220786–1781–01] 

RIN 0648–XD012 

Fisheries of the Northeastern United 

States; Summer Flounder Fishery; 

Commercial Quota Available for the 

State of New Jersey 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule. 

SUMMARY: NMFS announces that the 

2013 summer flounder commercial 

fishery in the State of New Jersey will 

be reopened to provide the opportunity 

for the fishery to fully harvest the 

available quota. Vessels issued a 

commercial Federal fisheries permit for 

the summer flounder fishery may land 

summer flounder in New Jersey until 

the quota is fully harvested. Regulations 

governing the summer flounder fishery 

require publication of this notification 

to advise New Jersey that quota remains 

available, and the summer flounder 

fishery is open to vessel permit holders 

for landing summer flounder in New 

Jersey, and to inform dealer permit 

holders in New Jersey that they may 

purchase summer flounder. 

DATES: Effective December 6, 2013, 

through December 31, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Carly Bari, (978) 281–9224, or 

Carly.Bari@noaa.gov. 

SUPPLEMENTARY INFORMATION: 

Regulations governing the summer 

flounder fishery are found at 50 CFR 

part 648. The regulations require annual 

specification of a commercial quota that 

is apportioned on a percentage basis 

among the coastal states from North 

Carolina through Maine. The process to 

set the annual commercial quota and the 

percent allocated to each state is 

described in § 648.102. 

The initial total commercial quota for 

summer flounder for the 2013 fishing 

year is 11,793,596 lb (5,349,575 kg) (77 

FR 76942, December 31, 2012). The 

percent allocated to vessels landing 

summer flounder in New Jersey is 

16.72499 percent, resulting in a 

commercial quota of 1,972,478 lb 

(894,716 kg). The 2013 allocation was 

adjusted to 1,972,066 lb (894,514 kg) 

after deduction of research set-aside, 

adjustment for 2012 quota overages, and 

adjustments for quota transfers between 

states. On November 27, 2013, NMFS 

closed the 2013 commercial summer 

flounder fishery in New Jersey 

prematurely, quota remains available for 

harvest. 

The Administrator, Northeast Region, 

NMFS (Regional Administrator), 

monitors the state commercial landings 

and has determined that, due to an 

error, there is still commercial summer 

flounder quota available for harvest in 

New Jersey. NMFS is required to 

publish notification in the Federal 

Register advising and notifying 

commercial vessels and dealer permit 

holders that, effective upon a specific 

date, there is commercial quota 

available for landing summer flounder 

in that state. 

Therefore, effective December 6, 2013, 

vessels holding summer flounder 

commercial Federal fisheries permits 

can land summer flounder in New 

Jersey until the commercial state quota 

is fully harvested. Effective December 6, 

2013, federally permitted dealers can 

also purchase summer flounder from 

federally permitted vessels that land in 

New Jersey until the commercial state 

quota is fully harvested. 

Classification 

This action is required by 50 CFR part 

648 and is exempt from review under 

Executive Order 12866. 

The Assistant Administrator for 

Fisheries, NOAA (AA), finds good cause 

pursuant to 5 U.S.C. 553(b)(B) to waive 

prior notice and the opportunity for 

public comment because it would be 

contrary to the public interest. This 

action reopens the summer flounder 

fishery for New Jersey until the state 

commercial summer flounder quota is 

fully harvested, under current 

regulations. If implementation of this 

reopening was delayed to solicit prior 

public comment, the quota for this 

fishing year would not be fully 

harvested, thereby undermining the 

conservation objectives of the Summer 

Flounder Fishery Management Plan. 

The AA further finds, pursuant to 5 

U.S.C. 553(d)(3), good cause to waive 

the 30-day delayed effectiveness period 

for the reason stated above. 

Authority: 16 U.S.C. 1801 et seq. 

Dated: December 6, 2013. 

Sean F. Corson, 

Acting Deputy Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service. 

[FR Doc. 2013–29525 Filed 12–6–13; 4:15 pm] 

BILLING CODE 3510–22–P 


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