[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)] [Rules and Regulations] [Pages 34775-34780] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2018-15449] ======================================================================= ----------------------------------------------------------------------- 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 In addition, this regulation removes certain previously established tolerances that are superseded by this final rule.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