[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Rules and Regulations]
[Pages 34775-34780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15449]



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superseded by this final rule.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: 


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 

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 
     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), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG (N-(4-
trifluoromethylnicotinoyl)glycine), calculated as the stoichiometric 
equivalent of flonicamid as follows:

    1. Amend Sec.  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 Sec.  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

[[Page 34776]]

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 
    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 repeat-dose 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 highest-dose 
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-observed-adverse-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

[[Page 34777]]

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-and-assessing-pesticide-risks/assessing-human-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
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
Chronic dietary (All populations)  NOAEL = 3.7 mg/kg/    Chronic RfD = 0.04   Reproduction and Fertility Effects
                                    day.                  mg/kg/day.           Study in Rats
                                   UFA = 10x...........  cPAD = 0.04 mg/kg/   Parental LOAEL = 22 mg/kg/day
                                   UFH = 10x...........   day.                 based on increased kidney
                                   FQPA SF = 1x........                        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 
    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 
    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-science-and-assessing-pesticide-risks/about-water-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 non-occupational, 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-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 

[[Page 34778]]

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-and-assessing-pesticide-risks/cumulative-assessment-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 
    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 
intermediate-term 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 

[[Page 34779]]

telephone number: (410) 305-2905; email address: 

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 non-violative. 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

[[Page 34780]]

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:


1. The authority citation for part 180 continues to read as follows:

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

2. In Sec.  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:

Sec.  180.613  Flonicamid; tolerances for residues.

    (a) * * *
    (1) * * *

                                                             Parts per
                        Commodity                             million
                                * * * * *
Brassica, leafy greens, subgroup 4-16B, except radish,                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 Sec.  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:

                                                             Parts per
                        Commodity                             million
Clover, forage..........................................            0.90
Clover, hay.............................................             5.0

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