Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Rules and Regulations 34775 

Dated: July 11, 2018. 

A.J. Tiongson, 

Rear Admiral, U.S. Coast Guard, Commander, 

First Coast Guard District. 

[FR Doc. 2018–15711 Filed 7–20–18; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0224; FRL–9977–82] 

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 that are 

identified and discussed later in this 

document as well as tolerances with 

regional registrations on clover, forage 

and clover, hay. In addition, this 

regulation removes certain previously 

established tolerances that are 

superseded by this final rule. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective July 

23, 2018. Objections and requests for 

hearings must be received on or before 

September 21, 2018, 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–2017–0224, 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: 

Michael L. Goodis, 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 e-CFR site at http://www.ecfr.gov/ 

cgi-bin/text-idx?&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–2017–0224 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 September 21, 2018. 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– 

2017–0224, 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 January 26, 

2018 (83 FR 3658) (FRL–9971–46), 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 7E8556) by IR–4 Project 

Headquarters, 500 College Road East, 

Suite 201W, Princeton, New Jersey, 

08540. 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- 

trifluoromethylnicotinic acid), TFNAAM (4-trifluoromethylnicotinamide), 

and TFNG (N-(4- 

trifluoromethylnicotinoyl)glycine), 

calculated as the stoichiometric 

equivalent of flonicamid as follows: 

1. Amend § 180.613(a)(1) by establishing a 

tolerance in or on Celtuce at 4.0 ppm; 

Florence fennel at 4.0 ppm; Kohlrabi at 1.5 

ppm; and Crop Group Expansions/ 

Conversions for Brassica, leafy greens, 

subgroup 4–16B at 16 ppm; Cottonseed 

subgroup 20C at 0.60 ppm; Leaf petiole 

vegetable subgroup 22B at 4.0 ppm; Leafy 

greens subgroup 4–16A, except spinach at 4.0 

ppm; and Vegetable, brassica, head and stem, 

group 5–16 at 1.5 ppm; and 

2. Amend § 180.613(c), Tolerances with 

regional registrations, by establishing a 

tolerance for Clover, forage at 0.9 ppm and 

Clover, hay at 4.0 ppm. 

In addition, upon establishing the 

above tolerances, the petitioner requests 

to remove existing tolerances in 40 CFR 

180.613(a) including Vegetable, leafy, 

except brassica, group 4, except spinach 

at 4.0 ppm; Brassica, head and stem, 

subgroup 5A at 1.5 ppm; Brassica, leafy 

greens, subgroup 5B at 16 ppm; Radish, 

tops, at 16 ppm; Turnip, greens at 16 


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ppm; and Cotton, undelinted seed at 

0.50 ppm. 

That document referenced a summary 

of the petition prepared by ISK 

Bioscience Corporation, the registrant, 

which is available in the docket, http:// 

www.regulations.gov. One comment was 

received on the petition notice of filing 

as outlined and responded to in Unit 

IV.C. 

Consistent with the authority in 

FFDCA 408(d)(4)(A)(i), EPA is issuing 

tolerances that vary from what the 

petitioner sought. The reason for these 

changes is explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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 their 

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. 

Flonicamid and its metabolites of 

concern, TFNA, TFNA–AM, TFNG, 

TFNG–AM (N-(4- 

trifluoromethylnicotinoyl)glycinamide), 

and TFNA–OH (6-hydro-4- 

trifluoromethylnicotinic acid), 

demonstrated low toxicity in acute oral 

toxicity studies. Flonicamid showed no 

systemic toxicity in a 28-day dermal 

study at the limit dose. 

Feeding studies in rats and dogs show 

the kidney and liver are the target 

organs for flonicamid toxicity. In repeatdose subchronic and chronic oral 

toxicity studies, the consistently 

observed adverse effect in rats and mice 

were kidney toxicity (i.e., hyaline 

deposition and nephritis); in dogs, 

vomiting and increased percentage of 

reticulocytes (an indicator for potential 

anemia). 

There is no evidence that flonicamid 

results in increased susceptibility 

(qualitative or quantitative) in utero in 

rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

In the rat prenatal developmental 

toxicity study, maternal toxicity 

consisted of kidney toxicity (i.e., 

nephritis) in the absence of 

developmental toxicity at the highestdose tested (HDT); in the rabbit, 

maternal toxicity consisted of decreased 

food consumption in the absence of 

developmental toxicity at the HDT. In 

the rat reproduction and fertility effects 

study, parental toxicity (i.e., kidney 

hyaline deposition and luteinizing 

hormone level increases) occurred at 

doses much lower than doses causing 

offspring effects (i.e., decreased body 

weight and delayed sexual maturation). 

There are no concerns for flonicamid 

neurotoxicity. In the acute neurotoxicity 

study in rats, signs of toxicity such as 

decreased motor activity, tremors, 

impaired gait, and impaired respiration 

were observed at lethal dose levels 

(1,000 mg/kg). In the subchronic 

neurotoxicity study, decreased body 

weight, food consumption, foot splay, 

and motor activity were observed in 

males at doses greater than 67 mg/kg/ 

day, and in females at 722 mg/kg/day. 

In the immunotoxicity study in mice, 

there were no indications of increased 

immunotoxic potential in the T-cell 

dependent antibody response (TDAR) 

assay at the limit dose. 

Mutagenicity studies were negative 

for flonicamid and its metabolites of 

concern. Treatment-related lung tumors 

were observed in CD–1 mice. This 

tumor type, however, is associated with 

species and strain sensitivity and is not 

directly correlated with cancer risks in 

humans. Nasal cavity tumors in male 

Wistar rats were linked to incisor 

inflammation. Nasolacrimal duct tumor 

findings for females were confounded 

by the lack of a dose-response, and the 

biological significance of these tumors is 

questionable. The determination of 

carcinogenicity potential for flonicamid 

was based on the weight of the evidence 

approach and resulted in the 

classification of ‘‘suggestive evidence of 

carcinogenicity, but not sufficient to 

assess human carcinogenic potential.’’ 

The Agency 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. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by flonicamid as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘SUBJECT: Flonicamid. Human Health 

Risk Assessment for the Petition for the 

Establishment of Permanent Tolerances 

for Clover, Crop Group Conversions to 

Brassica, Head and Stem Vegetable, 

Group 5–16; Brassica, Leafy Greens, 

Subgroup 4–16B; Leaf Petiole Vegetable, 

Subgroup 22B; Leafy Greens, Subgroup 

4–16A, Except Spinach; Celtuce; 

Florence Fennel; and Kohlrabi 

(DP439902); Expansion of Cottonseed 

Tolerances to Cottonseed Subgroup 20C, 

and Revised Use Directions for Citrus 

(DP441385),’’ at pages 20–21 in docket 

ID number EPA–HQ–OPP–2017–0224. 

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 


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degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

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

A summary of the toxicological 

endpoints for flonicamid used for 

human risk assessment is presented in 

the following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLONICAMID 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 

Chronic dietary (All populations) NOAEL = 3.7 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.04 

mg/kg/day.

cPAD = 0.04 mg/kg/ 

day 

Reproduction and Fertility Effects Study in Rats 

Parental LOAEL = 22 mg/kg/day based on increased kidney 

weights, kidney hyaline deposition, increased blood serum 

LH (F1 females). 

Cancer (Oral, dermal, inhalation).Classification; ‘‘Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential’’ based on the results of carcinogenicity studies in rats and mice. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. 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 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 United States Department of 

Agriculture (USDA) 2003–2008 National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). The chronic 

dietary (food and drinking water) 

exposure assessment was conducted 

using the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCID), Version 3.16. As to residue levels 

in food, an unrefined chronic dietary 

exposure assessment was conducted for 

all proposed and established food uses 

of flonicamid. Tolerance-level residues 

were combined with 100 percent crop 

treated (PCT) estimates. Separate 

tolerances established for potato 

granules/flakes, tomato paste, and 

tomato puree were based on processing 

studies and DEEM default processing 

factors were used for the other 

processed commodities. 

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., 

chronic exposure. 

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/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 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://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

The drinking water assessment was 

conducted using both a parent only 

exposure, and a total toxic residue 

approach, which considers the parent 

compound and its major degradates of 

concern. Total toxic residues include 

4-trifluoromethylnicotinic acid (TFNA), 

4-trifluoromethylnictinamide (TFNA– 

AM), 6-hydro-4-trifluoromethylnicotinic 

acid (TFNA–OH), N-(4- 

trifluoromethylnicotinoyl)glycine 

(TFNG), and N-(4- 

trifluoromethylnicotinoyl)glycinamide 

(TFNG–AM). 

Based on the Pesticide Root Zone 

Model Ground Water (PRZM GW), 

version 1.0, the estimated drinking 

water concentrations (EDWCs) 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 exposure assessment, 

the water concentration value of 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. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 


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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 website at http:// 

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

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 safety factor when reliable 

data 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 utero in 

rats or rabbits in the prenatal 

developmental studies or in young rats 

in the multi-generation 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 post-natal 

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, except where 

assessing risks from inhalation exposure 

as discussed below. Those decisions are 

based on the following findings: 

i. The toxicity database for flonicamid 

is essentially complete, except for an 

outstanding subchronic 28-day 

inhalation study. In the absence of a 

subchronic inhalation study, EPA has 

retained a 10X FQPA SF to assess risks 

from inhalation exposure, although at 

present, residential inhalation exposure 

is not expected from existing or pending 

uses of flonicamid. 

ii. There is no indication that 

flonicamid is a neurotoxic chemical. As 

discussed in Unit III.A., EPA has 

concluded that the clinical signs 

observed from available acute and 

subchronic neurotoxicity studies were 

not the result of a neurotoxic 

mechanism. Therefore, there is no need 

for a developmental neurotoxicity study 

or additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

flonicamid 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. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic dietary food exposure 

assessment was based on 100 PCT, 

tolerance-level residues and where 

applicable, default processing factors. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to flonicamid in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by flonicamid. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, 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 60% 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- and Intermediate-term risks. 

Short- and intermediate-term aggregate 

exposures take into account short- and 

intermediate-term residential exposures 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Flonicamid is not 

registered for any use patterns that 

would result in short- and intermediateterm residential exposures. 

4. Aggregate cancer risk for U.S. 

population. Based on the information 

referenced 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. Aggregate cancer risk 

from existing and proposed food uses is 

below EPA’s level of concern. 

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 flonicamid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. FMC Method No. P–3561M, 

a liquid chromatography-tandem mass 

spectrometry (LC/MS/MS) method, is an 

acceptable enforcement method for 

flonicamid and its metabolites in plant 

commodities. The method determines 

residues of flonicamid and its 

metabolites TFNA–AM, TFNA, and 

TFNG. The method has been sufficiently 

validated in five diverse crops. 

Depending on the matrix, the limit of 

quantitation (LOQ) is 0.01 or 0.02 ppm. 

The limit of detection (LOD) can be 

estimated as one-third the LOQ. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 


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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. 

There are Codex MRLs for residues of 

flonicamid in or on celery at 1.5 ppm, 

head lettuce at 1.5 ppm, leaf lettuce at 

8.0 ppm, radish tops at 20 ppm, and 

cottonseed at 0.60 ppm. The Codex MRL 

and U.S. tolerance on cottonseed are 

harmonized. The petitioned-for 

tolerance on Brasssica, leafy greens 

subgroup 4–16B which includes radish 

tops is being established for Brasssica, 

leafy greens subgroup 4–16B, except 

radish tops at 16 ppm. An existing 

radish, tops tolerance at 16 ppm is being 

revised to 20 ppm to harmonize with 

the established Codex MRL. EPA is not 

harmonizing the relevant U.S. 

tolerances with the other established 

Codex MRLs for the following reasons. 

The U.S. tolerance for celery is set at 4.0 

ppm as part of the Leaf Petiole vegetable 

subgroup 22B. The U.S. tolerance for 

lettuce, head and lettuce, leaf is set at 

4.0 as part of the Leafy greens, subgroup 

4–16A, is harmonized with Canada 

since the greatest percentage of U.S. 

exports are to Canada. This subgroup is 

not harmonized with the Codex 

tolerance at 8.0 ppm. In the case of 

celery and head lettuce, lowering the 

tolerances could result in exceedances 

when domestic growers apply 

flonicamid in accordance with label 

directions. 

C. Response to Comments 

One anonymous public comment was 

received on the notice of filing raising 

concern about the need to assess 

impacts of regulations on the American 

people. This comment did not raise 

issues within the scope of the FFDCA, 

which directs the Agency’s to assess 

certain information in determining 

whether tolerances are safe. 

D. Revisions to Petitioned-For 

Tolerances 

The EPA-established tolerances are 

identical to the proposed tolerance 

levels, except for the tolerances for 

clover. First, EPA adjusted the number 

of significant figures in the tolerance 

levels clover, forage proposed at 0.9 was 

revised to 0.90 ppm. In accordance with 

its standard practice to provide greater 

precision about the levels of residues 

that are permitted by a tolerance, EPA 

is adding an additional significant figure 

to the petitioned-for tolerance values. 

This is intended to avoid the situation 

where residues may be higher than the 

tolerance level, but as a result of 

rounding would be considered nonviolative. For example, Clover, forage 

tolerance proposed at 0.9 ppm was 

established at 0.90 ppm, to avoid an 

observed hypothetical tolerance at 0.94 

ppm being rounded to 0.9 ppm. 

Also, EPA established a tolerance for 

clover, hay at 5.0 ppm, not at proposed 

4.0 ppm because some of the residue 

data submitted by IR–4 were not 

converted to parent equivalents while 

all the residue data used by EPA were 

converted to parent equivalents. 

EPA calculated tolerance levels using 

the Organization for Economic 

Cooperation and Development (OECD) 

tolerance calculation procedures and 

available field trial data residues. 

Additionally, the petitioned-for 

tolerance on Brasssica, leafy greens 

subgroup 4–16B which includes radish 

tops is being established for Brasssica, 

leafy greens subgroup 4–16B, except 

radish tops at 16 ppm. Lastly, the 

existing radish, tops tolerance at 16 ppm 

is being revised to 20 ppm to harmonize 

with the established Codex MRL. 

V. Conclusion 

Therefore, tolerances are established 

for residues of 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 

Brassica leafy greens, subgroup 4–16B, 

except radish tops at 16 ppm; Celtuce at 

4.0 ppm; Cottonseed subgroup 20C at 

0.60 ppm; Florence fennel at 4.0 ppm; 

Kohlrabi at 1.5 ppm; Leaf petiole 

vegetable subgroup 22B at 4.0 ppm; 

Leafy greens subgroup 4–16A, except 

spinach at 4.0 ppm; Radish, tops at 20 

ppm, and Vegetables, brassica, head and 

stem, group 5–16 at 1.5 ppm. In 

addition, tolerances with regional 

restrictions are established on Clover, 

forage at 0.90 ppm; and Clover, hay at 

5.0 ppm. Lastly, certain established 

flonicamid tolerances are being removed 

including entries for Vegetable, leafy, 

except brassica, group 4, except 

spinach; Brassica, head and stem, 

subgroup 5A; Brassica, leafy greens, 

subgroup 5B; Radish, tops; Turnip, 

greens; and Cotton, undelinted seed as 

they are superseded by this regulatory 

action. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001); Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997); or Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). This action 

does not contain any information 

collections subject to OMB approval 

under the Paperwork Reduction Act 

(PRA) (44 U.S.C. 3501 et seq.), nor does 

it require any special considerations 

under Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 


amozie on DSK3GDR082PROD with RULES
34780 Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Rules and Regulations 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

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: July 11, 2018. 

Michael L. Goodis, 

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: 

■ a. In the table in paragraph (a)(1): 

■ i. Remove the entry ‘‘Brassica, head 

and stem, subgroup 5A’’; 

■ ii. Add alphabetically the commodity 

‘‘Brassica, leafy greens, subgroup 4–16B, 

except radish, tops’’; 

■ iii. Remove the entry ‘‘Brassica, leafy 

greens, subgroup 5B’’; 

■ iv. Add alphabetically the 

commodities ‘‘Celtuce’’ and 

‘‘Cottonseed subgroup 20C’’; 

■ v. Remove the entry ‘‘Cotton, 

undelinted seed’’; 

■ vi. Add alphabetically the 

commodities ‘‘Florence fennel’’; 

‘‘Kohlrabi’’; ‘‘Leaf petiole vegetable 

subgroup 22B’’; and ‘‘Leafy greens 

subgroup 4–16A, except spinach’’; 

■ vii. Revise the entry for ‘‘Radish, 

tops’’; 

■ viii. Remove the entry ‘‘Turnip, 

greens’’; 

■ ix. Add alphabetically the commodity 

‘‘Vegetable, brassica, head and stem, 

group 5–16’’; and 

■ x. Remove the entry ‘‘Vegetable, leafy, 

except brassica, group 4, except 

spinach’’. 

■ b. Revise paragraph (c). 

The additions and revisions read as 

follows: 

§ 180.613 Flonicamid; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Brassica, leafy greens, subgroup 4–16B, except radish, tops ............................. 16 

Celtuce .................................. 4.0 

* * * * * 

Cottonseed subgroup 20C ... 0.60 

Florence fennel ..................... 4.0 

* * * * * 

Kohlrabi ................................. 1.5 

Leaf petiole vegetable subgroup 22B ......................... 4.0 

Leafy greens subgroup 4– 

16A, except spinach ......... 4.0 

* * * * * 

Radish, tops .......................... 20 

* * * * * 

Vegetable, brassica, head 

and stem, group 5–16 ....... 1.5 

* * * * * 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registration, as defined by § 180.1(1), are 

established for the residues of the 

insecticide flonicamid, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of 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 the 

following commodities: 

Commodity Parts per 

million 

Clover, forage ....................... 0.90 

Clover, hay ........................... 5.0 

* * * * * 

[FR Doc. 2018–15449 Filed 7–20–18; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL MARITIME COMMISSION 

46 CFR Parts 531 and 532 

[Docket No. 17–10] 

RIN 3072–AC68 

Amendments to Regulations 

Governing NVOCC Negotiated Rate 

Arrangements and NVOCC Service 

Arrangements 

AGENCY: Federal Maritime Commission. 

ACTION: Final rule. 

SUMMARY: The Federal Maritime 

Commission (FMC or Commission) 

amends its rules governing Non-VesselOperating Common Carrier (NVOCC) 

Negotiated Rate Arrangements and 

NVOCC Service Arrangements. The 

regulatory changes modernize, update, 

and reduce regulatory burdens. 

DATES: This final rule is effective August 

22, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Rachel E. Dickon, Secretary. Phone: 

(202) 523–5725. Email: secretary@

fmc.gov. For technical questions, 

contact Florence A. Carr, Director, 

Bureau of Trade Analysis. Phone: (202) 

523–5796. Email: tradeanalysis@

fmc.gov. For legal questions, contact 

Tyler J. Wood, General Counsel. Phone: 

(202) 523–5740. Email: generalcounsel@

fmc.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

II. Background 

A. NVOCC Service Arrangements (NSAs) 

B. NVOCC Negotiated Rate Arrangements 

(NRAs) 

C. Pre-Rulemaking Differences Between 

Tariffs; NSAs; NRAs 

D. NCBFAA Petition for Rulemaking and 

Overview of Comments 

E. Summary of November 29, 2017, Notice 

of Proposed Rulemaking 


amozie on DSK3GDR082PROD with RULES