Flonicamid; Pesticide Tolerances, 13805-13809 [2019-06690]

Download as PDF Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2018–0273; FRL–9990–52] Flonicamid; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes a crop group tolerance for residues of flonicamid in or on the commodities in sunflower subgroup 20B. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: This regulation is effective April 8, 2019. Objections and requests for hearings must be received on or before June 7, 2019, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2018–0273, is available at https://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 https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: I. General Information jbell on DSK30RV082PROD with RULES 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 VerDate Sep<11>2014 16:38 Apr 05, 2019 Jkt 247001 13805 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). • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.html. B. How can I get electronic access to other related information? II. Summary of Petitioned-For Tolerance You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. In the Federal Register of July 24, 2018 (83 FR 34968) (FRL–9980–31), 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 8E8667) by Interregional Research Project Number 4 (IR–4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requests to establish a tolerance in 40 CFR part 180 for residues of the insecticide flonicamid, including its metabolites and degradates, determined by measuring only the sum of flonicamid, N-(cyanomethyl)-4(trifluoromethyl)-3pyridinecarboxamide, and its metabolites, TFNA (4trifluoromethylnicotinic acid), TFNAAM (4-trifluoromethylnicotinamide), and TFNG N-(4trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric equivalent of flonicamid, in or on the commodities in sunflower subgroup 20B at 0.70 parts per million (ppm). That document referenced a summary of the petition prepared by ISK Bioscience Corporation, the registrant, which is available in the docket, https:// www.regulations.gov. There were no comments received in response to the notice of filing. 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–2018–0273 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 June 7, 2019. 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– 2018–0273, by one of the following methods: • Federal eRulemaking Portal: https:// 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. PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/ dockets. 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 E:\FR\FM\08APR1.SGM 08APR1 13806 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Rules and Regulations jbell on DSK30RV082PROD with RULES 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 database and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Flonicamid and its metabolites of concern 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). Further detail of the toxicological profile for flonicamid is discussed in Unit III.A. of the final rule published in the Federal Register of July 23, 2018 (83 FR 34775) (FRL–9977–82). Specific information on the studies received and the nature of the adverse effects caused by flonicamid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in document, ‘‘SUBJECT: Flonicamid. Human Health Risk Assessment for the Establishment of Permanent Tolerances in or on Sunflower Subgroup 20B’’ at pages 18– 19 in docket ID number EPA–HQ–OPP– 2018–0273. VerDate Sep<11>2014 15:49 Apr 05, 2019 Jkt 247001 B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. A summary of the toxicological endpoints for flonicamid used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of July 23, 2018 (83 FR 34775) (FRL–9977–82). 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 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 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 (processing factor set to 1.0 for these commodities) and DEEM default processing factors were used for the other processed commodities. iii. Cancer. Flonicamid has been determined to have suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential. The Agency has determined that quantification of risk using a non-linear approach (i.e., using a chronic reference dose) adequately accounts for all chronic toxicity, including carcinogenicity that could result from exposure to flonicamid. Therefore, the chronic reference dose is considered protective for carcinogenic effects. iv. Anticipated residue and percent crop treated (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 https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. The drinking water assessment was conducted using a total toxic residue approach, which considers the parent compound and its major degradates of concern. Based on the Pesticide Root Zone Model Ground Water (PRZM GW), version 1.0, the estimated drinking water concentration (EDWC) of E:\FR\FM\08APR1.SGM 08APR1 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Rules and Regulations jbell on DSK30RV082PROD with RULES flonicamid for chronic exposure for non-cancer assessment is estimated to be 9.92 parts per billion (ppb) for ground water. The EDWC for surface water chronic exposure, derived using the Pesticide in Water Calculator (PWC version 1.52), is 0.94 ppb. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 9.92 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Flonicamid is not registered for any specific use patterns that would result in residential exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found flonicamid to share a common mechanism of toxicity with any other substances, and flonicamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that flonicamid does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the VerDate Sep<11>2014 15:49 Apr 05, 2019 Jkt 247001 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 FQPA Safety Factor (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. of the final rule published in the Federal Register of July 23, 2018 (83 FR 34775) (FRL–9977– 82), 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. PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 13807 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 64% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure. There are no residential uses for flonicamid. 3. Short- and Intermediate-term risks. Short- and intermediate-term aggregate exposures take into account short- and intermediate-term residential exposures plus chronic exposure to food and water (considered to be a background exposure level). Flonicamid is not registered for any use patterns that would result in short- and intermediateterm residential exposures. 4. Aggregate cancer risk for U.S. population. Based on the information referenced in Unit III.A., EPA has concluded that the cPAD is protective of possible cancer effects from flonicamid, and as evidenced in Unit III.E.2, E:\FR\FM\08APR1.SGM 08APR1 13808 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Rules and Regulations aggregate exposure to flonicamid is below the cPAD. As a result, EPA concludes that there is not an aggregate cancer risk from exposures to flonicamid. 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. The limit of quantitation (LOQ) is 0.01 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; telephone number: (410) 305–2905; email address: residuemethods@ epa.gov. jbell on DSK30RV082PROD with RULES 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 no Codex maximum residue limits (MRLs) for flonicamid and its metabolites in/on sunflower subgroup 20B. VerDate Sep<11>2014 15:49 Apr 05, 2019 Jkt 247001 V. Conclusion Therefore, tolerances are established for residues of flonicamid, N(cyanomethyl)-4-(trifluoromethyl)-3pyridinecarboxamide, and its metabolites, TFNA (4trifluoromethylnicotinic acid), TFNAAM (4-trifluoromethylnicotinamide), and TFNG, N-(4trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric equivalent of flonicamid, in or on sunflower subgroup 20B at 0.70 ppm. 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) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997),), nor is it considered a regulatory action under 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 tolerances 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 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 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: March 26, 2019. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.613, add alphabetically the entry ‘‘Sunflower subgroup 20B’’ to the table in paragraph (a)(1) to read as follows: ■ § 180.613 Flonicamid; tolerances for residues. (a) * * * (1) * * * E:\FR\FM\08APR1.SGM 08APR1 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Rules and Regulations recordings), please send an email to FCC504@fcc.gov or call the Consumer & Government Affairs Bureau at (202) 418–0530 (VOICE), (202) 418–0432 * * * * * Sunflower subgroup 20B ...... 0.70 (TTY). This document does not contain * * * * * information collection requirements subject to the Paperwork Reduction Act * * * * * of 1995, Public Law 104–13. In addition, [FR Doc. 2019–06690 Filed 4–5–19; 8:45 am] therefore, it does not contain any BILLING CODE 6560–50–P proposed information collection burden ‘‘for small business concerns with fewer than 25 employees,’’ pursuant to the FEDERAL COMMUNICATIONS Small Business Paperwork Relief Act of COMMISSION 2002, Public Law 107–198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory 47 CFR Part 73 Flexibility Act of 1980, 5 U.S.C. 601– [MB Docket No. 19–18; RM–11823; DA 19– 612, do not apply to this proceeding. 225] The Commission will send a copy of Television Broadcasting Services this Report and Order in a report to be Gadsden and Hoover, Alabama sent to Congress and the Government Accountability Office pursuant to the AGENCY: Federal Communications Congressional review Act, see 5 U.S.C. Commission. 801(a)(1)(A). ACTION: Final rule. List of Subjects in 47 CFR Part 73 SUMMARY: At the request of ION Media License Company, LLC. (ION), licensee Television. of television station WPXH–TV, channel Federal Communications Commission. 45, Gadsden, Alabama (WPXH), the Commission has before it an unopposed Thomas Horan, Chief of Staff, Media Bureau. Notice of Proposed Rulemaking to amend the Post-Transition Table of DTV Final Rule Allotments by changing WPXH’s community of license from Gadsden to For the reasons discussed in the Hoover, Alabama. The Commission preamble, the Federal Communications believes that the proposed reallotment is Commission amends 47 CFR part 73 as consistent with the Commission’s follows: second allotment priority by providing Hoover with its first local transmission PART 73—RADIO BROADCAST service. The Commission also notes that SERVICE the proposed reallotment will not deprive Gadsden of its sole broadcast ■ 1. The authority citation for part 73 station because it will continue to be continues to read as follows: served by station WTJP–TV, licensed to Authority: 47 U.S.C. 154, 303, 334, 336, Trinity Christian Center of Santa Ana, and 339. Inc. on channel 26 at Gadsden. We also grant ION’s requested waiver of the § 73.622 [Amended] Commission’s rules. ■ 2. Section 73.622(i), the PostDATES: Effective April 8, 2019. Transition Table of DTV Allotments FOR FURTHER INFORMATION CONTACT: under Alabama, is amended by Joyce Bernstein, Media Bureau, at removing Gadsden, channel 45, and Joyce.Bernstein@fcc.gov. adding, in alphabetical order, Hoover, SUPPLEMENTARY INFORMATION: This is a channel 45. synopsis of the Commission’s Report and Order, MB Docket No. 19–18; RM– [FR Doc. 2019–06674 Filed 4–5–19; 8:45 am] 11823; DA 19–225, adopted March 28, BILLING CODE 6712–01–P 2019, and released March 28, 2019. The full text of this document is available for public inspection and copying during normal business hours in the FCC’s Reference Information Center at Portals II, CY–A257, 445 12th Street SW, Washington, DC, 20554, or online at https://apps.fcc.gov/ecfs/. To request materials in accessible formats (braille, large print, computer diskettes, or audio jbell on DSK30RV082PROD with RULES Commodity VerDate Sep<11>2014 15:49 Apr 05, 2019 Parts per million Jkt 247001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 13809 DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS–HQ–ES–2018–0096; 4500030113] RIN 1018–BD72 Endangered and Threatened Wildlife and Plants; Adding 16 Species, Removing One Species, and Updating Entries for 17 Species on the List of Endangered and Threatened Wildlife Fish and Wildlife Service, Interior. ACTION: Final rule; correcting amendments. AGENCY: We, the U.S. Fish and Wildlife Service (Service), are amending the List of Endangered and Threatened Wildlife (List) by adding 16 species (gulf grouper, island grouper, common guitarfish, blackchin guitarfish, daggernose shark, Brazilian guitarfish, striped smoothhound shark, spiny angelshark, Argentine angelshark, narrownose smoothhound shark, Maui dolphin, Hector’s dolphin, giant manta ray, oceanic whitetip shark, Taiwanese humpback dolphin, and chambered nautilus) and by removing one species (Puget Sound-Georgia Basin distinct population segment (DPS) of canary rockfish). We are also updating the entries for the following six species by adding critical habitat designation citations: Gulf of Maine DPS of Atlantic sturgeon, New York Bight DPS of Atlantic sturgeon, Chesapeake Bay DPS of Atlantic sturgeon, South Atlantic DPS of Atlantic sturgeon, Carolina DPS of Atlantic sturgeon, and Main Hawaiian Islands Insular DPS of false killer whale. Lastly, we are updating the genus name for the Saimaa subspecies of ringed seal. The above amendments are based on previously published determinations by the National Marine Fisheries Service (NMFS) of the National Oceanic and Atmospheric Administration, Department of Commerce, which has jurisdiction for these species. We are also adding nonsubstantive corrections to entries for 10 other species on the List: Three foreign coral species, dusky sea snake, Banggai cardinalfish, the Tanzanian DPS of African coelacanth, Nassau grouper, and three angelshark species. We added these 10 species to the List in 2016, but the entries did not include the Federal Register citations for the final listing rule, as is our standard practice when we add new entries to the List. The changes being made via this rule simply provide SUMMARY: E:\FR\FM\08APR1.SGM 08APR1

Agencies

[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Rules and Regulations]
[Pages 13805-13809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06690]



[[Page 13805]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0273; FRL-9990-52]


Flonicamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a crop group tolerance for 
residues of flonicamid in or on the commodities in sunflower subgroup 
20B. Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 8, 2019. Objections and 
requests for hearings must be received on or before June 7, 2019, 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-2018-0273, is available at https://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 https://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 Government 
Printing Office's e-CFR site at https://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-2018-0273 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 
June 7, 2019. 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-2018-0273, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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 
8E8667) by Interregional Research Project Number 4 (IR-4), Rutgers, The 
State University of New Jersey, 500 College Road East, Suite 201W, 
Princeton, NJ 08540. The petition requests to establish a tolerance in 
40 CFR part 180 for residues of the insecticide flonicamid, including 
its metabolites and degradates, 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 commodities in sunflower 
subgroup 20B at 0.70 parts per million (ppm). That document referenced 
a summary of the petition prepared by ISK Bioscience Corporation, the 
registrant, which is available in the docket, https://www.regulations.gov.
    There were no comments received in response to the notice of 
filing.

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

[[Page 13806]]

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 database and considered 
its validity, completeness, and reliability as well as the relationship 
of the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Flonicamid and its metabolites of concern 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).
    Further detail of the toxicological profile for flonicamid is 
discussed in Unit III.A. of the final rule published in the Federal 
Register of July 23, 2018 (83 FR 34775) (FRL-9977-82).
    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 https://www.regulations.gov in document, ``SUBJECT: Flonicamid. Human Health 
Risk Assessment for the Establishment of Permanent Tolerances in or on 
Sunflower Subgroup 20B'' at pages 18-19 in docket ID number EPA-HQ-OPP-
2018-0273.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://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 discussed in Unit III.B. of the final rule 
published in the Federal Register of July 23, 2018 (83 FR 34775) (FRL-
9977-82).

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 
(processing factor set to 1.0 for these commodities) and DEEM default 
processing factors were used for the other processed commodities.
    iii. Cancer. Flonicamid has been determined to have suggestive 
evidence of carcinogenicity, but not sufficient to assess human 
carcinogenic potential. The Agency has determined that quantification 
of risk using a non-linear approach (i.e., using a chronic reference 
dose) adequately accounts for all chronic toxicity, including 
carcinogenicity that could result from exposure to flonicamid. 
Therefore, the chronic reference dose is considered protective for 
carcinogenic effects.
    iv. Anticipated residue and percent crop treated (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 https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    The drinking water assessment was conducted using a total toxic 
residue approach, which considers the parent compound and its major 
degradates of concern.
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW), 
version 1.0, the estimated drinking water concentration (EDWC) of

[[Page 13807]]

flonicamid for chronic exposure for non-cancer assessment is estimated 
to be 9.92 parts per billion (ppb) for ground water. The EDWC for 
surface water chronic exposure, derived using the Pesticide in Water 
Calculator (PWC version 1.52), is 0.94 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 9.92 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to 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 https://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. 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 https://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 FQPA Safety 
Factor (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. of the final rule published in 
the Federal Register of July 23, 2018 (83 FR 34775) (FRL-9977-82), 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 64% 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,

[[Page 13808]]

aggregate exposure to flonicamid is below the cPAD. As a result, EPA 
concludes that there is not an aggregate cancer risk from exposures to 
flonicamid.
    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. The limit of quantitation (LOQ) is 
0.01 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; 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 no Codex maximum residue limits (MRLs) for flonicamid and 
its metabolites in/on sunflower subgroup 20B.

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 sunflower subgroup 20B at 0.70 ppm.

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) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997),), nor is it considered a 
regulatory action under 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 tolerances 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 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: March 26, 2019.
Michael 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, add alphabetically the entry ``Sunflower subgroup 
20B'' to the table in paragraph (a)(1) to read as follows:


Sec.  180.613  Flonicamid; tolerances for residues.

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

[[Page 13809]]



------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sunflower subgroup 20B..................................            0.70
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-06690 Filed 4-5-19; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.