83_FR_34916 83 FR 34775 - Flonicamid; Pesticide Tolerances

83 FR 34775 - Flonicamid; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 141 (July 23, 2018)

Page Range34775-34780
FR Document2018-15449

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 In addition, this regulation removes certain previously established tolerances that are superseded by this final rule.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).

Federal Register, Volume 83 Issue 141 (Monday, July 23, 2018)
[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Rules and Regulations]
[Pages 34775-34780]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15449]


=======================================================================
-----------------------------------------------------------------------

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superseded by this final rule.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: 
[email protected].

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), 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 
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 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 
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-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 
toxicity.

[[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 
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 
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 
20755-5350;

[[Page 34779]]

telephone number: (410) 305-2905; email address: 
[email protected].

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:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  180.613:
0
a. In the table in paragraph (a)(1):
0
i. Remove the entry ``Brassica, head and stem, subgroup 5A'';
0
ii. Add alphabetically the commodity ``Brassica, leafy greens, subgroup 
4-16B, except radish, tops'';
0
iii. Remove the entry ``Brassica, leafy greens, subgroup 5B'';
0
iv. Add alphabetically the commodities ``Celtuce'' and ``Cottonseed 
subgroup 20C'';
0
v. Remove the entry ``Cotton, undelinted seed'';
0
vi. Add alphabetically the commodities ``Florence fennel''; 
``Kohlrabi''; ``Leaf petiole vegetable subgroup 22B''; and ``Leafy 
greens subgroup 4-16A, except spinach'';
0
vii. Revise the entry for ``Radish, tops'';
0
viii. Remove the entry ``Turnip, greens'';
0
ix. Add alphabetically the commodity ``Vegetable, brassica, head and 
stem, group 5-16''; and
0
x. Remove the entry ``Vegetable, leafy, except brassica, group 4, 
except spinach''.
0
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
 tops...................................................
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]
 BILLING CODE 6560-50-P



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

                                             Dated: July 11, 2018.                                  (703) 305–7090; email address:                          • Federal eRulemaking Portal: http://
                                           A.J. Tiongson,                                           RDFRNotices@epa.gov.                                  www.regulations.gov. Follow the online
                                           Rear Admiral, U.S. Coast Guard, Commander,               SUPPLEMENTARY INFORMATION:                            instructions for submitting comments.
                                           First Coast Guard District.                                                                                    Do not submit electronically any
                                                                                                    I. General Information                                information you consider to be CBI or
                                           [FR Doc. 2018–15711 Filed 7–20–18; 8:45 am]
                                           BILLING CODE 9110–04–P                                   A. Does this action apply to me?                      other information whose disclosure is
                                                                                                       You may be potentially affected by                 restricted by statute.
                                                                                                    this action if you are an agricultural                  • Mail: OPP Docket, Environmental
                                           ENVIRONMENTAL PROTECTION                                 producer, food manufacturer, or                       Protection Agency Docket Center (EPA/
                                           AGENCY                                                   pesticide manufacturer. The following                 DC), (28221T), 1200 Pennsylvania Ave.
                                                                                                    list of North American Industrial                     NW, Washington, DC 20460–0001.
                                           40 CFR Part 180                                          Classification System (NAICS) codes is                  • Hand Delivery: To make special
                                                                                                    not intended to be exhaustive, but rather             arrangements for hand delivery or
                                           [EPA–HQ–OPP–2017–0224; FRL–9977–82]
                                                                                                    provides a guide to help readers                      delivery of boxed information, please
                                           Flonicamid; Pesticide Tolerances                         determine whether this document                       follow the instructions at http://
                                                                                                    applies to them. Potentially affected                 www.epa.gov/dockets/contacts.html.
                                           AGENCY:  Environmental Protection                        entities may include:                                   Additional instructions on
                                           Agency (EPA).                                               • Crop production (NAICS code 111).                commenting or visiting the docket,
                                           ACTION: Final rule.                                         • Animal production (NAICS code                    along with more information about
                                                                                                    112).                                                 dockets generally, is available at http://
                                           SUMMARY:   This regulation establishes                      • Food manufacturing (NAICS code                   www.epa.gov/dockets.
                                           tolerances for residues of flonicamid in                 311).
                                           or on multiple commodities that are                                                                            II. Summary of Petitioned-For
                                                                                                       • Pesticide manufacturing (NAICS
                                           identified and discussed later in this                   code 32532).                                          Tolerance
                                           document as well as tolerances with                                                                               In the Federal Register of January 26,
                                           regional registrations on clover, forage                 B. How can I get electronic access to
                                                                                                                                                          2018 (83 FR 3658) (FRL–9971–46), EPA
                                           and clover, hay. In addition, this                       other related information?
                                                                                                                                                          issued a document pursuant to FFDCA
                                           regulation removes certain previously                      You may access a frequently updated                 section 408(d)(3), 21 U.S.C. 346a(d)(3),
                                           established tolerances that are                          electronic version of EPA’s tolerance                 announcing the filing of a pesticide
                                           superseded by this final rule.                           regulations at 40 CFR part 180 through                petition (PP 7E8556) by IR–4 Project
                                           Interregional Research Project Number 4                  the e-CFR site at http://www.ecfr.gov/                Headquarters, 500 College Road East,
                                           (IR–4) requested these tolerances under                  cgi-bin/text-idx?&c=ecfr&tpl=/                        Suite 201W, Princeton, New Jersey,
                                           the Federal Food, Drug, and Cosmetic                     ecfrbrowse/Title40/40tab_02.tpl.                      08540. The petition requested that 40
                                           Act (FFDCA).                                                                                                   CFR 180.613 be amended by
                                                                                                    C. How can I file an objection or hearing
                                           DATES: This regulation is effective July                                                                       establishing tolerances for residues of
                                                                                                    request?
                                           23, 2018. Objections and requests for                                                                          the insecticide flonicamid, N-
                                           hearings must be received on or before                     Under FFDCA section 408(g), 21                      (cyanomethyl)-4-(trifluoromethyl)-3-
                                           September 21, 2018, and must be filed                    U.S.C. 346a, any person may file an                   pyridinecarboxamide, and its
                                           in accordance with the instructions                      objection to any aspect of this regulation            metabolites, TFNA (4-
                                           provided in 40 CFR part 178 (see also                    and may also request a hearing on those
                                                                                                                                                          trifluoromethylnicotinic acid), TFNA-
                                           Unit I.C. of the SUPPLEMENTARY                           objections. You must file your objection
                                                                                                                                                          AM (4-trifluoromethylnicotinamide),
                                           INFORMATION).                                            or request a hearing on this regulation
                                                                                                                                                          and TFNG (N-(4-
                                                                                                    in accordance with the instructions
                                           ADDRESSES: The docket for this action,                                                                         trifluoromethylnicotinoyl)glycine),
                                                                                                    provided in 40 CFR part 178. To ensure
                                           identified by docket identification (ID)                                                                       calculated as the stoichiometric
                                                                                                    proper receipt by EPA, you must
                                           number EPA–HQ–OPP–2017–0224, is                                                                                equivalent of flonicamid as follows:
                                                                                                    identify docket ID number EPA–HQ–
                                           available at http://www.regulations.gov                  OPP–2017–0224 in the subject line on                    1. Amend § 180.613(a)(1) by establishing a
                                           or at the Office of Pesticide Programs                   the first page of your submission. All                tolerance in or on Celtuce at 4.0 ppm;
                                           Regulatory Public Docket (OPP Docket)                    objections and requests for a hearing                 Florence fennel at 4.0 ppm; Kohlrabi at 1.5
                                           in the Environmental Protection Agency                                                                         ppm; and Crop Group Expansions/
                                                                                                    must be in writing, and must be
                                           Docket Center (EPA/DC), West William                                                                           Conversions for Brassica, leafy greens,
                                                                                                    received by the Hearing Clerk on or                   subgroup 4–16B at 16 ppm; Cottonseed
                                           Jefferson Clinton Bldg., Rm. 3334, 1301                  before September 21, 2018. Addresses                  subgroup 20C at 0.60 ppm; Leaf petiole
                                           Constitution Ave. NW, Washington, DC                     for mail and hand delivery of objections              vegetable subgroup 22B at 4.0 ppm; Leafy
                                           20460–0001. The Public Reading Room                      and hearing requests are provided in 40               greens subgroup 4–16A, except spinach at 4.0
                                           is open from 8:30 a.m. to 4:30 p.m.,                     CFR 178.25(b).                                        ppm; and Vegetable, brassica, head and stem,
                                           Monday through Friday, excluding legal                     In addition to filing an objection or               group 5–16 at 1.5 ppm; and
                                           holidays. The telephone number for the                   hearing request with the Hearing Clerk                  2. Amend § 180.613(c), Tolerances with
                                           Public Reading Room is (202) 566–1744,                   as described in 40 CFR part 178, please               regional registrations, by establishing a
                                           and the telephone number for the OPP                     submit a copy of the filing (excluding                tolerance for Clover, forage at 0.9 ppm and
                                           Docket is (703) 305–5805. Please review                  any Confidential Business Information                 Clover, hay at 4.0 ppm.
                                           the visitor instructions and additional                  (CBI)) for inclusion in the public docket.               In addition, upon establishing the
                                           information about the docket available                   Information not marked confidential                   above tolerances, the petitioner requests
                                           at http://www.epa.gov/dockets.                           pursuant to 40 CFR part 2 may be                      to remove existing tolerances in 40 CFR
amozie on DSK3GDR082PROD with RULES




                                           FOR FURTHER INFORMATION CONTACT:                         disclosed publicly by EPA without prior               180.613(a) including Vegetable, leafy,
                                           Michael L. Goodis, Registration Division                 notice. Submit the non-CBI copy of your               except brassica, group 4, except spinach
                                           (7505P), Office of Pesticide Programs,                   objection or hearing request, identified              at 4.0 ppm; Brassica, head and stem,
                                           Environmental Protection Agency, 1200                    by docket ID number EPA–HQ–OPP–                       subgroup 5A at 1.5 ppm; Brassica, leafy
                                           Pennsylvania Ave. NW, Washington, DC                     2017–0224, by one of the following                    greens, subgroup 5B at 16 ppm; Radish,
                                           20460–0001; main telephone number:                       methods:                                              tops, at 16 ppm; Turnip, greens at 16


                                      VerDate Sep<11>2014   16:12 Jul 20, 2018   Jkt 244001   PO 00000   Frm 00023   Fmt 4700   Sfmt 4700   E:\FR\FM\23JYR1.SGM   23JYR1


                                           34776               Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Rules and Regulations

                                           ppm; and Cotton, undelinted seed at                         Flonicamid and its metabolites of                  inflammation. Nasolacrimal duct tumor
                                           0.50 ppm.                                                concern, TFNA, TFNA–AM, TFNG,                         findings for females were confounded
                                             That document referenced a summary                     TFNG–AM (N-(4-                                        by the lack of a dose-response, and the
                                           of the petition prepared by ISK                          trifluoromethylnicotinoyl)glycinamide),               biological significance of these tumors is
                                           Bioscience Corporation, the registrant,                  and TFNA–OH (6-hydro-4-                               questionable. The determination of
                                           which is available in the docket, http://                trifluoromethylnicotinic acid),                       carcinogenicity potential for flonicamid
                                           www.regulations.gov. One comment was                     demonstrated low toxicity in acute oral               was based on the weight of the evidence
                                           received on the petition notice of filing                toxicity studies. Flonicamid showed no                approach and resulted in the
                                           as outlined and responded to in Unit                     systemic toxicity in a 28-day dermal                  classification of ‘‘suggestive evidence of
                                           IV.C.                                                    study at the limit dose.                              carcinogenicity, but not sufficient to
                                             Consistent with the authority in                          Feeding studies in rats and dogs show              assess human carcinogenic potential.’’
                                           FFDCA 408(d)(4)(A)(i), EPA is issuing                    the kidney and liver are the target                   The Agency determined that
                                           tolerances that vary from what the                       organs for flonicamid toxicity. In repeat-            quantification of risk using a non-linear
                                           petitioner sought. The reason for these                  dose subchronic and chronic oral                      approach (i.e., using a chronic reference
                                           changes is explained in Unit IV.D.                       toxicity studies, the consistently                    dose (cRfD)) adequately accounts for all
                                                                                                    observed adverse effect in rats and mice              chronic toxicity, including
                                           III. Aggregate Risk Assessment and                       were kidney toxicity (i.e., hyaline                   carcinogenicity that could result from
                                           Determination of Safety                                  deposition and nephritis); in dogs,                   exposure to flonicamid.
                                              Section 408(b)(2)(A)(i) of FFDCA                      vomiting and increased percentage of                     Specific information on the studies
                                           allows EPA to establish a tolerance (the                 reticulocytes (an indicator for potential             received and the nature of the adverse
                                           legal limit for a pesticide chemical                     anemia).                                              effects caused by flonicamid as well as
                                                                                                       There is no evidence that flonicamid               the no-observed-adverse-effect-level
                                           residue in or on a food) only if EPA
                                                                                                    results in increased susceptibility                   (NOAEL) and the lowest-observed-
                                           determines that the tolerance is ‘‘safe.’’
                                                                                                    (qualitative or quantitative) in utero in             adverse-effect-level (LOAEL) from the
                                           Section 408(b)(2)(A)(ii) of FFDCA
                                                                                                    rats or rabbits in the prenatal                       toxicity studies can be found at http://
                                           defines ‘‘safe’’ to mean that ‘‘there is a
                                                                                                    developmental studies or in young rats                www.regulations.gov in document
                                           reasonable certainty that no harm will
                                                                                                    in the 2-generation reproduction study.               ‘‘SUBJECT: Flonicamid. Human Health
                                           result from aggregate exposure to the                    In the rat prenatal developmental                     Risk Assessment for the Petition for the
                                           pesticide chemical residue, including                    toxicity study, maternal toxicity                     Establishment of Permanent Tolerances
                                           all anticipated dietary exposures and all                consisted of kidney toxicity (i.e.,                   for Clover, Crop Group Conversions to
                                           other exposures for which there is                       nephritis) in the absence of                          Brassica, Head and Stem Vegetable,
                                           reliable information.’’ This includes                    developmental toxicity at the highest-                Group 5–16; Brassica, Leafy Greens,
                                           exposure through drinking water and in                   dose tested (HDT); in the rabbit,                     Subgroup 4–16B; Leaf Petiole Vegetable,
                                           residential settings, but does not include               maternal toxicity consisted of decreased              Subgroup 22B; Leafy Greens, Subgroup
                                           occupational exposure. Section                           food consumption in the absence of                    4–16A, Except Spinach; Celtuce;
                                           408(b)(2)(C) of FFDCA requires EPA to                    developmental toxicity at the HDT. In                 Florence Fennel; and Kohlrabi
                                           give special consideration to exposure                   the rat reproduction and fertility effects            (DP439902); Expansion of Cottonseed
                                           of infants and children to the pesticide                 study, parental toxicity (i.e., kidney                Tolerances to Cottonseed Subgroup 20C,
                                           chemical residue in establishing a                       hyaline deposition and luteinizing                    and Revised Use Directions for Citrus
                                           tolerance and to ‘‘ensure that there is a                hormone level increases) occurred at                  (DP441385),’’ at pages 20–21 in docket
                                           reasonable certainty that no harm will                   doses much lower than doses causing                   ID number EPA–HQ–OPP–2017–0224.
                                           result to infants and children from                      offspring effects (i.e., decreased body
                                           aggregate exposure to the pesticide                      weight and delayed sexual maturation).                B. Toxicological Points of Departure/
                                           chemical residue. . . .’’                                   There are no concerns for flonicamid               Levels of Concern
                                              Consistent with FFDCA section                         neurotoxicity. In the acute neurotoxicity                Once a pesticide’s toxicological
                                           408(b)(2)(D), and the factors specified in               study in rats, signs of toxicity such as              profile is determined, EPA identifies
                                           FFDCA section 408(b)(2)(D), EPA has                      decreased motor activity, tremors,                    toxicological points of departure (POD)
                                           reviewed the available scientific data                   impaired gait, and impaired respiration               and levels of concern to use in
                                           and other relevant information in                        were observed at lethal dose levels                   evaluating the risk posed by human
                                           support of this action. EPA has                          (1,000 mg/kg). In the subchronic                      exposure to the pesticide. For hazards
                                           sufficient data to assess the hazards of                 neurotoxicity study, decreased body                   that have a threshold below which there
                                           and to make a determination on                           weight, food consumption, foot splay,                 is no appreciable risk, the toxicological
                                           aggregate exposure for flonicamid                        and motor activity were observed in                   POD is used as the basis for derivation
                                           including exposure resulting from the                    males at doses greater than 67 mg/kg/                 of reference values for risk assessment.
                                           tolerances established by this action.                   day, and in females at 722 mg/kg/day.                 PODs are developed based on a careful
                                           EPA’s assessment of exposures and risks                  In the immunotoxicity study in mice,                  analysis of the doses in each
                                           associated with flonicamid follows.                      there were no indications of increased                toxicological study to determine the
                                                                                                    immunotoxic potential in the T-cell                   dose at which no adverse effects are
                                           A. Toxicological Profile
                                                                                                    dependent antibody response (TDAR)                    observed (the NOAEL) and the lowest
                                             EPA has evaluated the available                        assay at the limit dose.                              dose at which adverse effects of concern
                                           toxicity data and considered their                          Mutagenicity studies were negative                 are identified (the LOAEL). Uncertainty/
                                           validity, completeness, and reliability as               for flonicamid and its metabolites of                 safety factors are used in conjunction
                                           well as the relationship of the results of               concern. Treatment-related lung tumors                with the POD to calculate a safe
amozie on DSK3GDR082PROD with RULES




                                           the studies to human risk. EPA has also                  were observed in CD–1 mice. This                      exposure level—generally referred to as
                                           considered available information                         tumor type, however, is associated with               a population-adjusted dose (PAD) or a
                                           concerning the variability of the                        species and strain sensitivity and is not             reference dose (RfD)—and a safe margin
                                           sensitivities of major identifiable                      directly correlated with cancer risks in              of exposure (MOE). For non-threshold
                                           subgroups of consumers, including                        humans. Nasal cavity tumors in male                   risks, the Agency assumes that any
                                           infants and children.                                    Wistar rats were linked to incisor                    amount of exposure will lead to some


                                      VerDate Sep<11>2014   16:12 Jul 20, 2018   Jkt 244001   PO 00000   Frm 00024   Fmt 4700   Sfmt 4700   E:\FR\FM\23JYR1.SGM   23JYR1


                                                               Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Rules and Regulations                                             34777

                                           degree of risk. Thus, the Agency                         complete description of the risk                         A summary of the toxicological
                                           estimates risk in terms of the probability               assessment process, see http://                        endpoints for flonicamid used for
                                           of an occurrence of the adverse effect                   www2.epa.gov/pesticide-science-and-                    human risk assessment is presented in
                                           expected in a lifetime. For more                         assessing-pesticide-risks/assessing-                   the following Table.
                                           information on the general principles                    human-health-risk-pesticides.
                                           EPA uses in risk characterization and a

                                                TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLONICAMID FOR USE IN HUMAN HEALTH RISK
                                                                                        ASSESSMENT
                                                                                    Point of departure         RfD, PAD, LOC for
                                                  Exposure/scenario                and uncertainty/safe-                                                   Study and toxicological effects
                                                                                                                risk assessment
                                                                                        ty factors

                                           Chronic dietary (All populations)       NOAEL = 3.7 mg/kg/         Chronic RfD = 0.04            Reproduction and Fertility Effects Study in Rats
                                                                                    day.                        mg/kg/day.                  Parental LOAEL = 22 mg/kg/day based on increased kidney
                                                                                   UFA = 10x                  cPAD = 0.04 mg/kg/              weights, kidney hyaline deposition, increased blood serum
                                                                                   UFH = 10x                    day                           LH (F1 females).
                                                                                   FQPA SF = 1x

                                           Cancer (Oral, dermal, inhala-           Classification; ‘‘Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic poten-
                                             tion).                                tial’’ 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 begin-
                                           ning 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-ob-
                                           served-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = ex-
                                           trapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).


                                           C. Exposure Assessment                                   tolerances established for potato                      4-trifluoromethylnictinamide (TFNA–
                                              1. Dietary exposure from food and                     granules/flakes, tomato paste, and                     AM), 6-hydro-4-trifluoromethylnicotinic
                                           feed uses. In evaluating dietary                         tomato puree were based on processing                  acid (TFNA–OH), N-(4-
                                                                                                    studies and DEEM default processing                    trifluoromethylnicotinoyl)glycine
                                           exposure to flonicamid, EPA considered
                                                                                                    factors were used for the other                        (TFNG), and N-(4-
                                           exposure under the petitioned-for
                                                                                                    processed commodities.                                 trifluoromethylnicotinoyl)glycinamide
                                           tolerances as well as all existing                          iii. Cancer. Based on the data                      (TFNG–AM).
                                           flonicamid tolerances in 40 CFR                          summarized in Unit III.A., EPA has                        Based on the Pesticide Root Zone
                                           180.613. EPA assessed dietary                            concluded that a nonlinear RfD                         Model Ground Water (PRZM GW),
                                           exposures from flonicamid in food as                     approach is appropriate for assessing                  version 1.0, the estimated drinking
                                           follows:                                                 cancer risk to flonicamid. Cancer risk                 water concentrations (EDWCs) of
                                              i. Acute exposure. Quantitative acute                 was assessed using the same exposure                   flonicamid for chronic exposures for
                                           dietary exposure and risk assessments                    estimates as discussed in Unit III.C.1.ii.,            non-cancer assessments are estimated to
                                           are performed for a food-use pesticide,                  chronic exposure.                                      be 0.94 parts per billion (ppb) for
                                           if a toxicological study has indicated the                  iv. Anticipated residue and PCT                     surface water and 9.92 ppb for ground
                                           possibility of an effect of concern                      information. EPA did not use                           water.
                                           occurring as a result of a 1-day or single               anticipated residue and/or PCT                            Modeled estimates of drinking water
                                           exposure. No such effects were                           information in the dietary assessment                  concentrations were directly entered
                                           identified in the toxicological studies                  for flonicamid. Tolerance level residues               into the dietary exposure model. For
                                           for flonicamid; therefore, a quantitative                and/or 100 PCT were assumed for all                    chronic dietary exposure assessment,
                                           acute dietary exposure assessment is                     food commodities.                                      the water concentration value of 9.92
                                           unnecessary.                                                2. Dietary exposure from drinking                   ppb was used to assess the contribution
                                              ii. Chronic exposure. In conducting                   water. The Agency used screening level                 to drinking water.
                                           the chronic dietary exposure assessment                  water exposure models in the dietary                      3. From non-dietary exposure. The
                                           EPA used the food consumption data                       exposure analysis and risk assessment                  term ‘‘residential exposure’’ is used in
                                           from the United States Department of                     for flonicamid in drinking water. These                this document to refer to non-
                                           Agriculture (USDA) 2003–2008 National                    simulation models take into account                    occupational, non-dietary exposure
                                           Health and Nutrition Examination                         data on the physical, chemical, and fate/              (e.g., for lawn and garden pest control,
                                           Survey, What We Eat in America                           transport characteristics of flonicamid.               indoor pest control, termiticides, and
                                           (NHANES/WWEIA). The chronic                              Further information regarding EPA                      flea and tick control on pets).
                                           dietary (food and drinking water)                        drinking water models used in pesticide                   Flonicamid is not registered for any
                                           exposure assessment was conducted                        exposure assessment can be found at                    specific use patterns that would result
                                           using the Dietary Exposure Evaluation                    http://www2.epa.gov/pesticide-science-                 in residential exposure. Further
                                           Model software with the Food                             and-assessing-pesticide-risks/about-                   information regarding EPA standard
                                           Commodity Intake Database (DEEM–                         water-exposure-models-used-pesticide.                  assumptions and generic inputs for
                                           FCID), Version 3.16. As to residue levels                   The drinking water assessment was                   residential exposures may be found at
amozie on DSK3GDR082PROD with RULES




                                           in food, an unrefined chronic dietary                    conducted using both a parent only                     http://www2.epa.gov/pesticide-science-
                                           exposure assessment was conducted for                    exposure, and a total toxic residue                    and-assessing-pesticide-risks/standard-
                                           all proposed and established food uses                   approach, which considers the parent                   operating-procedures-residential-
                                           of flonicamid. Tolerance-level residues                  compound and its major degradates of                   pesticide.
                                           were combined with 100 percent crop                      concern. Total toxic residues include                     4. Cumulative effects from substances
                                           treated (PCT) estimates. Separate                        4-trifluoromethylnicotinic acid (TFNA),                with a common mechanism of toxicity.


                                      VerDate Sep<11>2014   16:12 Jul 20, 2018   Jkt 244001   PO 00000   Frm 00025   Fmt 4700   Sfmt 4700    E:\FR\FM\23JYR1.SGM   23JYR1


                                           34778               Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Rules and Regulations

                                           Section 408(b)(2)(D)(v) of FFDCA                         and LOAELs for all effects. The degree                   1. Acute risk. An acute aggregate risk
                                           requires that, when considering whether                  of concern for prenatal and/or post-natal             assessment takes into account acute
                                           to establish, modify, or revoke a                        susceptibility is, therefore, low due to              exposure estimates from dietary
                                           tolerance, the Agency consider                           the lack of evidence of qualitative and               consumption of food and drinking
                                           ‘‘available information’’ concerning the                 quantitative susceptibility.                          water. No adverse effect resulting from
                                           cumulative effects of a particular                          3. Conclusion. EPA has determined                  a single oral exposure was identified
                                           pesticide’s residues and ‘‘other                         that reliable data show the safety of                 and no acute dietary endpoint was
                                           substances that have a common                            infants and children would be                         selected. Therefore, flonicamid is not
                                           mechanism of toxicity.’’                                 adequately protected if the FQPA SF                   expected to pose an acute risk.
                                              EPA has not found flonicamid to                       were reduced to 1x, except where                         2. Chronic risk. Using the exposure
                                           share a common mechanism of toxicity                     assessing risks from inhalation exposure              assumptions described in this unit for
                                           with any other substances, and                           as discussed below. Those decisions are               chronic exposure, EPA has concluded
                                           flonicamid does not appear to produce                    based on the following findings:                      that chronic exposure to flonicamid
                                           a toxic metabolite produced by other                        i. The toxicity database for flonicamid            from food and water will utilize 60% of
                                           substances. For the purposes of this                     is essentially complete, except for an                the cPAD for children 1–2 years old, the
                                           tolerance action, therefore, EPA has                     outstanding subchronic 28-day                         population group receiving the greatest
                                           assumed that flonicamid does not have                    inhalation study. In the absence of a                 exposure. There are no residential uses
                                           a common mechanism of toxicity with                      subchronic inhalation study, EPA has                  for flonicamid.
                                           other substances. For information                        retained a 10X FQPA SF to assess risks                   3. Short- and Intermediate-term risks.
                                           regarding EPA’s efforts to determine                     from inhalation exposure, although at                 Short- and intermediate-term aggregate
                                           which chemicals have a common                            present, residential inhalation exposure              exposures take into account short- and
                                           mechanism of toxicity and to evaluate                    is not expected from existing or pending              intermediate-term residential exposures
                                           the cumulative effects of such                           uses of flonicamid.                                   plus chronic exposure to food and water
                                           chemicals, see EPA’s website at http://                     ii. There is no indication that                    (considered to be a background
                                           www2.epa.gov/pesticide-science-and-                      flonicamid is a neurotoxic chemical. As               exposure level). Flonicamid is not
                                           assessing-pesticide-risks/cumulative-                    discussed in Unit III.A., EPA has                     registered for any use patterns that
                                           assessment-risk-pesticides.                              concluded that the clinical signs                     would result in short- and intermediate-
                                                                                                    observed from available acute and                     term residential exposures.
                                           D. Safety Factor for Infants and                         subchronic neurotoxicity studies were
                                           Children                                                                                                          4. Aggregate cancer risk for U.S.
                                                                                                    not the result of a neurotoxic                        population. Based on the information
                                              1. In general. Section 408(b)(2)(C) of                mechanism. Therefore, there is no need                referenced in Unit III.A., EPA has
                                           FFDCA provides that EPA shall apply                      for a developmental neurotoxicity study               concluded that the cPAD is protective of
                                           an additional tenfold (10X) margin of                    or additional UFs to account for                      possible cancer effects from flonicamid,
                                           safety for infants and children in the                   neurotoxicity.                                        and as evidenced in Unit III.E.2,
                                           case of threshold effects to account for                    iii. There is no evidence that                     aggregate exposure to flonicamid is
                                           prenatal and postnatal toxicity and the                  flonicamid results in increased                       below the cPAD. Aggregate cancer risk
                                           completeness of the database on toxicity                 susceptibility in in utero rats or rabbits            from existing and proposed food uses is
                                           and exposure unless EPA determines                       in the prenatal developmental studies or              below EPA’s level of concern.
                                           based on reliable data that a different                  in young rats in the 2-generation                        5. Determination of safety. Based on
                                           margin of safety will be safe for infants                reproduction study.                                   these risk assessments, EPA concludes
                                           and children. This additional margin of                     iv. There are no residual uncertainties
                                                                                                                                                          that there is a reasonable certainty that
                                           safety is commonly referred to as the                    identified in the exposure databases.
                                                                                                                                                          no harm will result to the general
                                           Food Quality Protection Act Safety                       The chronic dietary food exposure
                                                                                                                                                          population, or to infants and children
                                           Factor (FQPA SF). In applying this                       assessment was based on 100 PCT,
                                                                                                                                                          from aggregate exposure to flonicamid
                                           provision, EPA either retains the default                tolerance-level residues and where
                                                                                                                                                          residues.
                                           value of 10X, or uses a different                        applicable, default processing factors.
                                           additional safety factor when reliable                   EPA made conservative (protective)                    IV. Other Considerations
                                           data available to EPA support the choice                 assumptions in the ground and surface
                                           of a different factor.                                                                                         A. Analytical Enforcement Methodology
                                                                                                    water modeling used to assess exposure
                                              2. Prenatal and postnatal sensitivity.                to flonicamid in drinking water. These                   Adequate enforcement methodology
                                           The prenatal and postnatal toxicity                      assessments will not underestimate the                is available to enforce the tolerance
                                           database for flonicamid includes                         exposure and risks posed by flonicamid.               expression. FMC Method No. P–3561M,
                                           prenatal developmental toxicity studies                                                                        a liquid chromatography-tandem mass
                                           in rats and rabbits and a multigeneration                E. Aggregate Risks and Determination of               spectrometry (LC/MS/MS) method, is an
                                           reproduction toxicity study in rats.                     Safety                                                acceptable enforcement method for
                                           There is no evidence that flonicamid                        EPA determines whether acute and                   flonicamid and its metabolites in plant
                                           results in increased susceptibility                      chronic dietary pesticide exposures are               commodities. The method determines
                                           (qualitative or quantitative) in utero in                safe by comparing aggregate exposure                  residues of flonicamid and its
                                           rats or rabbits in the prenatal                          estimates to the acute PAD (aPAD) and                 metabolites TFNA–AM, TFNA, and
                                           developmental studies or in young rats                   chronic PAD (cPAD). For linear cancer                 TFNG. The method has been sufficiently
                                           in the multi-generation reproduction                     risks, EPA calculates the lifetime                    validated in five diverse crops.
                                           study. No developmental effects were                     probability of acquiring cancer given the             Depending on the matrix, the limit of
                                           seen in rabbits. In the multi-generation                 estimated aggregate exposure. Short-,                 quantitation (LOQ) is 0.01 or 0.02 ppm.
amozie on DSK3GDR082PROD with RULES




                                           reproduction study, developmental                        intermediate-, and chronic-term risks                 The limit of detection (LOD) can be
                                           delays in the offspring (decreased body                  are evaluated by comparing the                        estimated as one-third the LOQ.
                                           weights, delayed sexual maturation)                      estimated aggregate food, water, and                     The method may be requested from:
                                           were seen only in the presence of                        residential exposure to the appropriate               Chief, Analytical Chemistry Branch,
                                           parental toxicity (kidney and blood                      PODs to ensure that an adequate MOE                   Environmental Science Center, 701
                                           effects). Also, there are clear NOAELs                   exists.                                               Mapes Rd., Ft. Meade, MD 20755–5350;


                                      VerDate Sep<11>2014   16:12 Jul 20, 2018   Jkt 244001   PO 00000   Frm 00026   Fmt 4700   Sfmt 4700   E:\FR\FM\23JYR1.SGM   23JYR1


                                                               Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Rules and Regulations                                          34779

                                           telephone number: (410) 305–2905;                        which directs the Agency’s to assess                  ppm, and Vegetables, brassica, head and
                                           email address: residuemethods@                           certain information in determining                    stem, group 5–16 at 1.5 ppm. In
                                           epa.gov.                                                 whether tolerances are safe.                          addition, tolerances with regional
                                                                                                                                                          restrictions are established on Clover,
                                           B. International Residue Limits                          D. Revisions to Petitioned-For
                                                                                                                                                          forage at 0.90 ppm; and Clover, hay at
                                              In making its tolerance decisions, EPA                Tolerances
                                                                                                                                                          5.0 ppm. Lastly, certain established
                                           seeks to harmonize U.S. tolerances with                     The EPA-established tolerances are                 flonicamid tolerances are being removed
                                           international standards whenever                         identical to the proposed tolerance                   including entries for Vegetable, leafy,
                                           possible, consistent with U.S. food                      levels, except for the tolerances for                 except brassica, group 4, except
                                           safety standards and agricultural                        clover. First, EPA adjusted the number                spinach; Brassica, head and stem,
                                           practices. EPA considers the                             of significant figures in the tolerance               subgroup 5A; Brassica, leafy greens,
                                           international maximum residue limits                     levels clover, forage proposed at 0.9 was             subgroup 5B; Radish, tops; Turnip,
                                           (MRLs) established by the Codex                          revised to 0.90 ppm. In accordance with               greens; and Cotton, undelinted seed as
                                           Alimentarius Commission (Codex), as                      its standard practice to provide greater              they are superseded by this regulatory
                                           required by FFDCA section 408(b)(4).                     precision about the levels of residues                action.
                                           The Codex Alimentarius is a joint                        that are permitted by a tolerance, EPA
                                           United Nations Food and Agriculture                      is adding an additional significant figure            VI. Statutory and Executive Order
                                           Organization/World Health                                to the petitioned-for tolerance values.               Reviews
                                           Organization food standards program,                     This is intended to avoid the situation                  This action establishes tolerances
                                           and it is recognized as an international                 where residues may be higher than the                 under FFDCA section 408(d) in
                                           food safety standards-setting                            tolerance level, but as a result of                   response to a petition submitted to the
                                           organization in trade agreements to                      rounding would be considered non-                     Agency. The Office of Management and
                                           which the United States is a party. EPA                  violative. For example, Clover, forage                Budget (OMB) has exempted these types
                                           may establish a tolerance that is                        tolerance proposed at 0.9 ppm was                     of actions from review under Executive
                                           different from a Codex MRL; however,                     established at 0.90 ppm, to avoid an                  Order 12866, entitled ‘‘Regulatory
                                           FFDCA section 408(b)(4) requires that                    observed hypothetical tolerance at 0.94               Planning and Review’’ (58 FR 51735,
                                           EPA explain the reasons for departing                    ppm being rounded to 0.9 ppm.                         October 4, 1993). Because this action
                                           from the Codex level.                                       Also, EPA established a tolerance for              has been exempted from review under
                                              There are Codex MRLs for residues of                  clover, hay at 5.0 ppm, not at proposed               Executive Order 12866, this action is
                                           flonicamid in or on celery at 1.5 ppm,                   4.0 ppm because some of the residue                   not subject to Executive Order 13211,
                                           head lettuce at 1.5 ppm, leaf lettuce at                 data submitted by IR–4 were not                       entitled ‘‘Actions Concerning
                                           8.0 ppm, radish tops at 20 ppm, and                      converted to parent equivalents while                 Regulations That Significantly Affect
                                           cottonseed at 0.60 ppm. The Codex MRL                    all the residue data used by EPA were                 Energy Supply, Distribution, or Use’’ (66
                                           and U.S. tolerance on cottonseed are                     converted to parent equivalents.                      FR 28355, May 22, 2001); Executive
                                           harmonized. The petitioned-for                              EPA calculated tolerance levels using              Order 13045, entitled ‘‘Protection of
                                           tolerance on Brasssica, leafy greens                     the Organization for Economic                         Children from Environmental Health
                                           subgroup 4–16B which includes radish                     Cooperation and Development (OECD)                    Risks and Safety Risks’’ (62 FR 19885,
                                           tops is being established for Brasssica,                 tolerance calculation procedures and                  April 23, 1997); or Executive Order
                                           leafy greens subgroup 4–16B, except                      available field trial data residues.                  13771, entitled ‘‘Reducing Regulations
                                           radish tops at 16 ppm. An existing                       Additionally, the petitioned-for                      and Controlling Regulatory Costs’’ (82
                                           radish, tops tolerance at 16 ppm is being                tolerance on Brasssica, leafy greens                  FR 9339, February 3, 2017). This action
                                           revised to 20 ppm to harmonize with                      subgroup 4–16B which includes radish                  does not contain any information
                                           the established Codex MRL. EPA is not                    tops is being established for Brasssica,              collections subject to OMB approval
                                           harmonizing the relevant U.S.                            leafy greens subgroup 4–16B, except                   under the Paperwork Reduction Act
                                           tolerances with the other established                    radish tops at 16 ppm. Lastly, the                    (PRA) (44 U.S.C. 3501 et seq.), nor does
                                           Codex MRLs for the following reasons.                    existing radish, tops tolerance at 16 ppm             it require any special considerations
                                           The U.S. tolerance for celery is set at 4.0              is being revised to 20 ppm to harmonize               under Executive Order 12898, entitled
                                           ppm as part of the Leaf Petiole vegetable                with the established Codex MRL.                       ‘‘Federal Actions to Address
                                           subgroup 22B. The U.S. tolerance for                                                                           Environmental Justice in Minority
                                                                                                    V. Conclusion
                                           lettuce, head and lettuce, leaf is set at                                                                      Populations and Low-Income
                                           4.0 as part of the Leafy greens, subgroup                   Therefore, tolerances are established              Populations’’ (59 FR 7629, February 16,
                                           4–16A, is harmonized with Canada                         for residues of flonicamid, N-                        1994).
                                           since the greatest percentage of U.S.                    (cyanomethyl)-4-(trifluoromethyl)-3-                     Since tolerances and exemptions that
                                           exports are to Canada. This subgroup is                  pyridinecarboxamide, and its                          are established on the basis of a petition
                                           not harmonized with the Codex                            metabolites, TFNA (4-                                 under FFDCA section 408(d), such as
                                           tolerance at 8.0 ppm. In the case of                     trifluoromethylnicotinic acid), TFNA–                 the tolerance in this final rule, do not
                                           celery and head lettuce, lowering the                    AM (4-trifluoromethylnicotinamide),                   require the issuance of a proposed rule,
                                           tolerances could result in exceedances                   and TFNG (N-(4-                                       the requirements of the Regulatory
                                           when domestic growers apply                              trifluoromethylnicotinoyl)glycine),                   Flexibility Act (RFA) (5 U.S.C. 601 et
                                           flonicamid in accordance with label                      calculated as the stoichiometric                      seq.), do not apply.
                                           directions.                                              equivalent of flonicamid, in or on                       This action directly regulates growers,
                                                                                                    Brassica leafy greens, subgroup 4–16B,                food processors, food handlers, and food
                                           C. Response to Comments                                  except radish tops at 16 ppm; Celtuce at              retailers, not States or tribes, nor does
amozie on DSK3GDR082PROD with RULES




                                              One anonymous public comment was                      4.0 ppm; Cottonseed subgroup 20C at                   this action alter the relationships or
                                           received on the notice of filing raising                 0.60 ppm; Florence fennel at 4.0 ppm;                 distribution of power and
                                           concern about the need to assess                         Kohlrabi at 1.5 ppm; Leaf petiole                     responsibilities established by Congress
                                           impacts of regulations on the American                   vegetable subgroup 22B at 4.0 ppm;                    in the preemption provisions of FFDCA
                                           people. This comment did not raise                       Leafy greens subgroup 4–16A, except                   section 408(n)(4). As such, the Agency
                                           issues within the scope of the FFDCA,                    spinach at 4.0 ppm; Radish, tops at 20                has determined that this action will not


                                      VerDate Sep<11>2014   16:12 Jul 20, 2018   Jkt 244001   PO 00000   Frm 00027   Fmt 4700   Sfmt 4700   E:\FR\FM\23JYR1.SGM   23JYR1


                                           34780               Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Rules and Regulations

                                           have a substantial direct effect on States               ■  iv. Add alphabetically the                                          metabolites, TFNA (4-
                                           or tribal governments, on the                            commodities ‘‘Celtuce’’ and                                            trifluoromethylnicotinic acid), TFNA–
                                           relationship between the national                        ‘‘Cottonseed subgroup 20C’’;                                           AM (4-trifluoromethylnicotinamide),
                                           government and the States or tribal                      ■ v. Remove the entry ‘‘Cotton,                                        and TFNG (N-(4-
                                           governments, or on the distribution of                   undelinted seed’’;                                                     trifluoromethylnicotinoyl)glycine),
                                           power and responsibilities among the                     ■ vi. Add alphabetically the                                           calculated as the stoichiometric
                                           various levels of government or between                  commodities ‘‘Florence fennel’’;                                       equivalent of flonicamid, in or on the
                                           the Federal Government and Indian                        ‘‘Kohlrabi’’; ‘‘Leaf petiole vegetable                                 following commodities:
                                           tribes. Thus, the Agency has determined                  subgroup 22B’’; and ‘‘Leafy greens
                                           that Executive Order 13132, entitled                     subgroup 4–16A, except spinach’’;                                                  Commodity                     Parts per
                                           ‘‘Federalism’’ (64 FR 43255, August 10,                  ■ vii. Revise the entry for ‘‘Radish,                                                                             million
                                           1999) and Executive Order 13175,                         tops’’;
                                                                                                                                                                           Clover, forage .......................           0.90
                                           entitled ‘‘Consultation and Coordination                 ■ viii. Remove the entry ‘‘Turnip,
                                                                                                                                                                           Clover, hay ...........................           5.0
                                           with Indian Tribal Governments’’ (65 FR                  greens’’;
                                           67249, November 9, 2000) do not apply                    ■ ix. Add alphabetically the commodity
                                                                                                                                                                           *       *       *        *       *
                                           to this action. In addition, this action                 ‘‘Vegetable, brassica, head and stem,                                  [FR Doc. 2018–15449 Filed 7–20–18; 8:45 am]
                                           does not impose any enforceable duty or                  group 5–16’’; and
                                                                                                                                                                           BILLING CODE 6560–50–P
                                           contain any unfunded mandate as                          ■ x. Remove the entry ‘‘Vegetable, leafy,
                                           described under Title II of the Unfunded                 except brassica, group 4, except
                                           Mandates Reform Act (UMRA) (2 U.S.C.                     spinach’’.
                                                                                                    ■ b. Revise paragraph (c).                                             FEDERAL MARITIME COMMISSION
                                           1501 et seq.).
                                              This action does not involve any                         The additions and revisions read as
                                                                                                    follows:                                                               46 CFR Parts 531 and 532
                                           technical standards that would require
                                           Agency consideration of voluntary                                                                                               [Docket No. 17–10]
                                                                                                    § 180.613 Flonicamid; tolerances for
                                           consensus standards pursuant to section                  residues.                                                              RIN 3072–AC68
                                           12(d) of the National Technology                              (a) * * *
                                           Transfer and Advancement Act                                  (1) * * *                                                         Amendments to Regulations
                                           (NTTAA) (15 U.S.C. 272 note).                                                                                                   Governing NVOCC Negotiated Rate
                                           VII. Congressional Review Act                                                                                 Parts per         Arrangements and NVOCC Service
                                                                                                                Commodity                                 million          Arrangements
                                             Pursuant to the Congressional Review
                                           Act (5 U.S.C. 801 et seq.), EPA will                                                                                            AGENCY:      Federal Maritime Commission.
                                           submit a report containing this rule and                     *           *              *                 *           *         ACTION:     Final rule.
                                           other required information to the U.S.                   Brassica, leafy greens, sub-
                                           Senate, the U.S. House of                                  group 4–16B, except rad-                                                  The Federal Maritime
                                                                                                                                                                           SUMMARY:
                                                                                                      ish, tops .............................                        16
                                                                                                                                                                      Commission (FMC or Commission)
                                           Representatives, and the Comptroller
                                                                                                    Celtuce ..................................                       4.0
                                           General of the United States prior to                                                                                      amends its rules governing Non-Vessel-
                                           publication of the rule in the Federal                      *        *             *                      *          *     Operating Common Carrier (NVOCC)
                                           Register. This action is not a ‘‘major                   Cottonseed subgroup 20C ...                                 0.60 Negotiated Rate Arrangements and
                                           rule’’ as defined by 5 U.S.C. 804(2).                    Florence fennel .....................                         4.0 NVOCC Service Arrangements. The
                                                                                                                                                                      regulatory changes modernize, update,
                                           List of Subjects in 40 CFR Part 180                         *            *              *                 *          *     and reduce regulatory burdens.
                                             Environmental protection,                              Kohlrabi .................................                    1.5 DATES: This final rule is effective August
                                           Administrative practice and procedure,                   Leaf petiole vegetable sub-
                                                                                                                                                                      22, 2018.
                                           Agricultural commodities, Pesticides                       group 22B .........................                         4.0
                                                                                                    Leafy greens subgroup 4–                                          FOR FURTHER INFORMATION CONTACT:
                                           and pests, Reporting and recordkeeping
                                                                                                      16A, except spinach .........                               4.0 Rachel E. Dickon, Secretary. Phone:
                                           requirements.
                                                                                                                                                                      (202) 523–5725. Email: secretary@
                                             Dated: July 11, 2018.                                    *          *              *                    *          *     fmc.gov. For technical questions,
                                           Michael L. Goodis,                                       Radish, tops ..........................                        20 contact Florence A. Carr, Director,
                                           Director, Registration Division, Office of                                                                                 Bureau of Trade Analysis. Phone: (202)
                                                                                                       *         *        *                          *          *
                                           Pesticide Programs.                                                                                                        523–5796. Email: tradeanalysis@
                                                                                                    Vegetable, brassica, head
                                             Therefore, 40 CFR chapter I is                           and stem, group 5–16 .......                                1.5 fmc.gov. For legal questions, contact
                                           amended as follows:                                                                                                        Tyler J. Wood, General Counsel. Phone:
                                                                                                         *            *              *               *          *     (202) 523–5740. Email: generalcounsel@
                                           PART 180—[AMENDED]                                                                                                         fmc.gov.
                                                                                               *    **     *    *                                                     SUPPLEMENTARY INFORMATION:
                                           ■ 1. The authority citation for part 180        (c) Tolerances with regional
                                           continues to read as follows:                 registrations. Tolerances with regional                                           Table of Contents
                                              Authority: 21 U.S.C. 321(q), 346a and 371. registration, as defined by § 180.1(1), are                                       I. Executive Summary
                                                                                         established for the residues of the                                               II. Background
                                           ■ 2. In § 180.613:
                                                                                         insecticide flonicamid, including its                                                A. NVOCC Service Arrangements (NSAs)
                                           ■ a. In the table in paragraph (a)(1):
                                                                                         metabolites and degradates, in or on the                                             B. NVOCC Negotiated Rate Arrangements
                                           ■ i. Remove the entry ‘‘Brassica, head
amozie on DSK3GDR082PROD with RULES




                                                                                         commodities in the table below.                                                        (NRAs)
                                           and stem, subgroup 5A’’;                                                                                                           C. Pre-Rulemaking Differences Between
                                           ■ ii. Add alphabetically the commodity        Compliance with the tolerance levels                                                   Tariffs; NSAs; NRAs
                                           ‘‘Brassica, leafy greens, subgroup 4–16B, specified below is to be determined by                                                   D. NCBFAA Petition for Rulemaking and
                                           except radish, tops’’;                        measuring only the sum of flonicamid,                                                  Overview of Comments
                                           ■ iii. Remove the entry ‘‘Brassica, leafy     N-(cyanomethyl)-4-(trifluoromethyl)-3-                                               E. Summary of November 29, 2017, Notice
                                           greens, subgroup 5B’’;                        pyridinecarboxamide, and its                                                           of Proposed Rulemaking



                                      VerDate Sep<11>2014   16:12 Jul 20, 2018   Jkt 244001   PO 00000    Frm 00028       Fmt 4700       Sfmt 4700       E:\FR\FM\23JYR1.SGM       23JYR1



Document Created: 2018-07-21 00:48:06
Document Modified: 2018-07-21 00:48:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation83 FR 34775 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR