Flonicamid; Pesticide Tolerances for Emergency Exemptions, 3610-3615 [2018-01480]

Download as PDF 3610 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations 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. The Codex has not established a MRL for chlorfenapyr in or on tea, dried. C. Revisions to Petitioned-for Tolerances EPA is establishing a tolerance for ‘‘tea, dried’’, as opposed to ‘‘tea’’ as requested by the petitioner, for consistency with the Agency’s food and feed commodity vocabulary. In addition, EPA is amending the introductory text of paragraph (a)(1) to be consistent with the Agency’s policy for drafting the tolerance expression. These revisions reflect the language in FFDCA section 408(a)(3), which includes metabolites and degradates of a pesticide chemical under the same tolerance unless otherwise excluded, as well as providing greater clarity for measuring residues to determine compliance. These revisions do not substantively change the existing tolerances in paragraph (a)(3). daltland on DSKBBV9HB2PROD with RULES V. Conclusion Therefore, a tolerance is established without U.S. registrations for residues of chlorfenapyr, 4-bromo-2-(4-chloro phenyl)-1-(ethoxymethyl)-5-(trifluro methyl)-1H-pyrrole-3-carbonitrile, in or on tea, dried at 70 parts per million. VI. Statutory and Executive Order Reviews This action establishes a tolerance 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 VerDate Sep<11>2014 17:29 Jan 25, 2018 Jkt 244001 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 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 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 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: December 18, 2017. 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 § 180.513, revise paragraph (a)(1) to read as follows: ■ § 180.513 Chlorfenapyr; tolerances for residues. (a) General. (1) Tolerances are established for residues of chlorfenapyr, 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 chlorfenapyr, 4-bromo-2-(4chlorophenyl)-1-(ethoxymethyl)-5(trifluoromethyl)-1H-pyrrole-3carbonitrile, in or on the commodity. Parts per million Commodity Tea, dried 1 ................................. Vegetable, fruiting, group 8–10 .. 70 1.0 1 There are no U.S. registrations for Tea, dried as of January 26, 2018. * * * * * [FR Doc. 2018–01487 Filed 1–25–18; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2017–0498; FRL–9971–94] Flonicamid; Pesticide Tolerances for Emergency Exemptions Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes time-limited tolerances for residues of SUMMARY: E:\FR\FM\26JAR1.SGM 26JAR1 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations flonicamid in or on prickly pear, fruit and prickly pear, pads. This action is in response to EPA’s granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on prickly pear, fruit and prickly pear, pads. This regulation establishes a maximum permissible level for residues of flonicamid in or on these commodities. The time-limited tolerances expire on December 31, 2020. DATES: This regulation is effective January 26, 2018. Objections and requests for hearings must be received on or before March 27, 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–2017–0498, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information daltland on DSKBBV9HB2PROD 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 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). VerDate Sep<11>2014 17:29 Jan 25, 2018 Jkt 244001 • 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 40 CFR part 180 through the Government Printing Office’s e-CFR site at http:// www.ecfr.gov/cgi-bin/text-idx?&c= ecfr&tpl=/ecfrbrowse/Title40/40tab_ 02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to https:// www.epa.gov/aboutepa/about-officechemical-safety-and-pollutionprevention-ocspp and select ‘‘Test Methods and Guidelines.’’ C. How can I file an objection or hearing request? Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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 EPA–HQ–OPP–2017– 0498 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 March 27, 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– 2017–0498, 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. PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 3611 • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/where-sendcomments-epa-dockets. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http:// www.epa.gov/dockets. II. Background and Statutory Findings EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for residues of insecticide 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 prickly pear, fruit at 1.5 parts per million (ppm) and prickly pear, pads at 1.5 ppm. These time-limited tolerances expire on December 31, 2020. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. 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\26JAR1.SGM 26JAR1 3612 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD 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. . . .’’ Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ‘‘emergency conditions exist which require such exemption.’’ EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Flonicamid on Prickly Pear, Fruit and Prickly Pear, Pads and FFDCA Tolerances The California Department of Pesticide Regulation (DPR) requested a specific emergency exemption for the use of flonicamid on prickly pear cactus fruit (Opuntia spp.) and nopalitos (pads) to control cochineal (Dactylopius opuntiae) in Monterey County, California. Cochineal insects are sapsucking, aggressive scale insects that are considered to be a major pest for prickly pear cactus. These insects damage the cactus plant by inserting their mouth parts into the cactus and feeding on the plant’s sap. The feeding site of the cactus begins to swell and discolor. Eventually, the outer pads of the plant will fall off and the entire cactus plant dies. Cochineal colonies were first observed in the Salinas Valley cactus plantations in 2003. Birds heavily feed on cactus fruit, and while feeding on cochineal infected plants, the birds can pick up the nymphs on their feet and aid in spreading of the population. In 2013 and 2015 reduced amounts of precipitation in Salinas, California caused the cochineal population to flourish and build to uncontrollable levels. Even though 2016 and 2017 received normal levels of rain, cochineal infestations have not been inhibited due to the amount of cochineal present and the ineffective control from registered alternatives. As a result, growers are experiencing significant damage to their prickly pear cactus crops. After having reviewed the submission, EPA determined that an emergency condition exists for this State, and that the criteria for approval of an emergency exemption are met. EPA has authorized a specific exemption under FIFRA section 18 for the use of flonicamid on prickly pear, fruit and prickly pear, pads for control of cochineal in California. VerDate Sep<11>2014 17:29 Jan 25, 2018 Jkt 244001 As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of flonicamid in or on prickly pear, fruit and prickly pear, pads. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent, non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although these time-limited tolerances expire on December 31, 2020, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on prickly pear, fruit and prickly pear, pads after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether flonicamid meets FIFRA’s registration requirements for use on prickly pear, fruit and prickly pear, pads or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this timelimited tolerance decision serves as a basis for registration of flonicamid by a State for special local needs under FIFRA section 24(c), nor does this tolerance by itself serve as the authority for persons in any State other than California to use this pesticide on the applicable crops under FIFRA section 18, absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for flonicamid, contact the Agency’s Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. IV. Aggregate Risk Assessment and Determination of Safety Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 support of this action. EPA has sufficient data to assess the hazards of, and to make a determination on, aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerances for residues of flonicamid on prickly pear, fruit at 1.5 ppm and prickly pear, pads at 1.5 ppm. EPA’s assessment of exposures and risks associated with establishing time-limited tolerances follows. A. 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:// www.epa.gov/pesticide-science-andassessing-pesticide-risks. 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 November 14, 2012 (77 FR 67771) (FRL–9368–7). B. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to flonicamid, EPA considered exposure expected under the timelimited tolerances established by this action 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. No acute effects were observed at doses well above those E:\FR\FM\26JAR1.SGM 26JAR1 daltland on DSKBBV9HB2PROD with RULES Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations likely to be encountered; therefore, an endpoint was not selected, and 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 USDA NHANES/WWEIA Survey. For the proposed section 18 use of flonicamid on prickly pear, fruit and pads, a dietary exposure assessment was not performed because there was no consumption reported for either commodity in NHANES/WWEIA. Due to the limited production and availability of prickly pear commodities, any increase in flonicamid dietary exposure from consumption of prickly pear commodities is expected to be insignificant compared to the flonicamid exposures pursuant to existing tolerances for flonicamid on various fruits and vegetables (40 CFR 180.613) which are produced in significantly greater quantities that prickly pear. These existing flonicamid tolerances are based on conservative (protective) exposure assumptions including use of tolerance level residues for all crops and 100% of the crops were treated. Therefore, any additional chronic risks from exposures of residues of flonicamid on prickly pear would likely be accounted for through the conservative assumptions underlying the existing tolerances. iii. Cancer. As discussed in Unit III.B. of the final rule published in the Federal Register of November 14, 2012 (77 FR 67771), EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to flonicamid. For the same reasons discussed in Unit IV.B.ii., regarding chronic exposure, EPA believes that any additional cancer risks from exposures of residues of flonicamid on prickly pear would likely be accounted for through the conservative assumptions underlying the existing tolerances. 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 100% CT were assumed for all food commodities included in the exposure assessment. 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 VerDate Sep<11>2014 17:29 Jan 25, 2018 Jkt 244001 https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. Based on the Pesticide Root Zone Model Ground Water (PRZM GW), 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 risk assessment, the water concentration value of 9.92 ppb was used as the flonicamid contribution from 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://www.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:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. C. 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 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 3613 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 SF 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 prenatal toxicity (kidney and blood effects). Also, there are clear NOAELs and LOAELs for all effects. The degree of concern for prenatal and/or postnatal susceptibility is, therefore low due to the lack of evidence of qualitative and quantitative susceptibility. 3. Conclusion. EPA has determined that reliable data show that the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X, except where assessing risk 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 risk 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 and 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. E:\FR\FM\26JAR1.SGM 26JAR1 3614 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES 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. concluded that the cPAD is protective of possible cancer effects from flonicamid because, as noted in Unit IV.D.2, aggregate chronic exposure to flonicamid is below the cPAD. 6. 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. D. 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 effects were observed to result from single oral exposures at doses well above those likely to be encountered, and 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 59% 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-term risk. Short-term aggregate exposure takes into account short-term residential exposure 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 term residential exposures. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term non-dietary, non-occupational exposure 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 intermediate-term residential exposures. 5. Aggregate cancer risk for U.S. population. Based on the information referenced in Unit IV.A, EPA has V. Other Considerations VerDate Sep<11>2014 17:29 Jan 25, 2018 Jkt 244001 A. Analytical Enforcement Methodology An adequate enforcement methodology (FMC Method No. P– 3561M, a liquid chromatography with tandem mass spectrometry (LC/MS/MS) method is available to enforce the tolerance expression for flonicamid and its metabolites in or on plant commodities. 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. 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. The Codex has not established a MRL for flonicamid. VI. Conclusion Therefore, time-limited tolerances are established for residues of flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3pyridinecarboxamide) and its metabolites, TFNA (4trifluoromethylnicotinic acid), TFNA– AM (4-trifluoromethylnicotinamide), and TFNG (N-(4trifluoromethylnicotinoyl)glycine), calculated as the stoichiometric PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 equivalent of flonicamid, in or on prickly pear, fruit at 1.5 ppm and prickly pear, pads at 1.5 ppm. These tolerances expire on December 31, 2020. VII. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA sections 408(e) and 408(l)(6). 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). 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 in accordance with FFDCA sections 408(e) and 408(l)(6), 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 E:\FR\FM\26JAR1.SGM 26JAR1 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations 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). VIII. 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: December 28, 2017. Michael L. Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.613, revise paragraph (b) to read as follows: ■ § 180.613 residues. Flonicamid; tolerances for daltland on DSKBBV9HB2PROD with RULES * * * * * (b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the 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 specified agricultural commodities, resulting from use of the pesticide pursuant to FFIFRA section 18 emergency exemptions. The tolerances expire on the date specified in the table. VerDate Sep<11>2014 17:29 Jan 25, 2018 Jkt 244001 Parts per million Commodity Prickly pear, fruit Prickly pear, pads .............. * * * Expiration date 1.5 1.5 * 12/31/2020 12/31/2020 BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2016–0254; FRL–9971–95] Difenoconazole; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of difenoconazole in or on multiple commodities which are identified and discussed later in this document. In addition, this regulation removes several 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 January 26, 2018. Objections and requests for hearings must be received on or before March 27, 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–2016–0254, 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 Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 20460–0001; telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? * [FR Doc. 2018–01480 Filed 1–25–18; 8:45 am] SUMMARY: 3615 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 http://www.ecfr.gov/cgi-bin/textidx?&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–2016–0254 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 March 27, 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 E:\FR\FM\26JAR1.SGM 26JAR1

Agencies

[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3610-3615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01480]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0498; FRL-9971-94]


Flonicamid; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes time-limited tolerances for 
residues of

[[Page 3611]]

flonicamid in or on prickly pear, fruit and prickly pear, pads.
    This action is in response to EPA's granting of an emergency 
exemption under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide on prickly pear, fruit and 
prickly pear, pads. This regulation establishes a maximum permissible 
level for residues of flonicamid in or on these commodities. The time-
limited tolerances expire on December 31, 2020.

DATES: This regulation is effective January 26, 2018. Objections and 
requests for hearings must be received on or before March 27, 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-2017-0498, 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 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select 
``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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 EPA-HQ-OPP-2017-0498 
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 March 27, 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-2017-0498, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for residues of 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, in or on prickly pear, fruit at 1.5 parts per 
million (ppm) and prickly pear, pads at 1.5 ppm. These time-limited 
tolerances expire on December 31, 2020.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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 3612]]

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. . . .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Flonicamid on Prickly Pear, Fruit and 
Prickly Pear, Pads and FFDCA Tolerances

    The California Department of Pesticide Regulation (DPR) requested a 
specific emergency exemption for the use of flonicamid on prickly pear 
cactus fruit (Opuntia spp.) and nopalitos (pads) to control cochineal 
(Dactylopius opuntiae) in Monterey County, California. Cochineal 
insects are sap-sucking, aggressive scale insects that are considered 
to be a major pest for prickly pear cactus. These insects damage the 
cactus plant by inserting their mouth parts into the cactus and feeding 
on the plant's sap. The feeding site of the cactus begins to swell and 
discolor. Eventually, the outer pads of the plant will fall off and the 
entire cactus plant dies. Cochineal colonies were first observed in the 
Salinas Valley cactus plantations in 2003. Birds heavily feed on cactus 
fruit, and while feeding on cochineal infected plants, the birds can 
pick up the nymphs on their feet and aid in spreading of the 
population. In 2013 and 2015 reduced amounts of precipitation in 
Salinas, California caused the cochineal population to flourish and 
build to uncontrollable levels. Even though 2016 and 2017 received 
normal levels of rain, cochineal infestations have not been inhibited 
due to the amount of cochineal present and the ineffective control from 
registered alternatives. As a result, growers are experiencing 
significant damage to their prickly pear cactus crops.
    After having reviewed the submission, EPA determined that an 
emergency condition exists for this State, and that the criteria for 
approval of an emergency exemption are met. EPA has authorized a 
specific exemption under FIFRA section 18 for the use of flonicamid on 
prickly pear, fruit and prickly pear, pads for control of cochineal in 
California.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of flonicamid in 
or on prickly pear, fruit and prickly pear, pads. In doing so, EPA 
considered the safety standard in FFDCA section 408(b)(2), and EPA 
decided that the necessary tolerances under FFDCA section 408(l)(6) 
would be consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent, non-routine situation and to ensure that 
the resulting food is safe and lawful, EPA is issuing these tolerances 
without notice and opportunity for public comment as provided in FFDCA 
section 408(l)(6). Although these time-limited tolerances expire on 
December 31, 2020, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on prickly pear, fruit and prickly pear, pads after 
that date will not be unlawful, provided the pesticide was applied in a 
manner that was lawful under FIFRA, and the residues do not exceed a 
level that was authorized by these time-limited tolerances at the time 
of that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
flonicamid meets FIFRA's registration requirements for use on prickly 
pear, fruit and prickly pear, pads or whether permanent tolerances for 
this use would be appropriate. Under these circumstances, EPA does not 
believe that this time-limited tolerance decision serves as a basis for 
registration of flonicamid by a State for special local needs under 
FIFRA section 24(c), nor does this tolerance by itself serve as the 
authority for persons in any State other than California to use this 
pesticide on the applicable crops under FIFRA section 18, absent the 
issuance of an emergency exemption applicable within that State. For 
additional information regarding the emergency exemption for 
flonicamid, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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 expected as a result of this emergency exemption request and 
the time-limited tolerances for residues of flonicamid on prickly pear, 
fruit at 1.5 ppm and prickly pear, pads at 1.5 ppm. EPA's assessment of 
exposures and risks associated with establishing time-limited 
tolerances follows.

A. 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://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    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 November 14, 2012 (77 FR 67771) 
(FRL-9368-7).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flonicamid, EPA considered exposure expected under the 
time-limited tolerances established by this action 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. No acute effects were observed at doses well 
above those

[[Page 3613]]

likely to be encountered; therefore, an endpoint was not selected, and 
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 USDA NHANES/
WWEIA Survey. For the proposed section 18 use of flonicamid on prickly 
pear, fruit and pads, a dietary exposure assessment was not performed 
because there was no consumption reported for either commodity in 
NHANES/WWEIA. Due to the limited production and availability of prickly 
pear commodities, any increase in flonicamid dietary exposure from 
consumption of prickly pear commodities is expected to be insignificant 
compared to the flonicamid exposures pursuant to existing tolerances 
for flonicamid on various fruits and vegetables (40 CFR 180.613) which 
are produced in significantly greater quantities that prickly pear. 
These existing flonicamid tolerances are based on conservative 
(protective) exposure assumptions including use of tolerance level 
residues for all crops and 100% of the crops were treated. Therefore, 
any additional chronic risks from exposures of residues of flonicamid 
on prickly pear would likely be accounted for through the conservative 
assumptions underlying the existing tolerances.
    iii. Cancer. As discussed in Unit III.B. of the final rule 
published in the Federal Register of November 14, 2012 (77 FR 67771), 
EPA has concluded that a nonlinear RfD approach is appropriate for 
assessing cancer risk to flonicamid. For the same reasons discussed in 
Unit IV.B.ii., regarding chronic exposure, EPA believes that any 
additional cancer risks from exposures of residues of flonicamid on 
prickly pear would likely be accounted for through the conservative 
assumptions underlying the existing tolerances.
    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 100% CT 
were assumed for all food commodities included in the exposure 
assessment.
    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://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW), 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 risk 
assessment, the water concentration value of 9.92 ppb was used as the 
flonicamid contribution from 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://www.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://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

C. 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 SF 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 multi-generation 
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 prenatal toxicity (kidney and blood effects). Also, there are clear 
NOAELs and LOAELs for all effects. The degree of concern for prenatal 
and/or postnatal susceptibility is, therefore low due to the lack of 
evidence of qualitative and quantitative susceptibility.
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X, except where assessing risk 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 risk 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 
and 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.

[[Page 3614]]

    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.

D. 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 effects were observed to result from single 
oral exposures at doses well above those likely to be encountered, and 
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 59% 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-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure 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 term 
residential exposures.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure 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 intermediate-term residential exposures.
    5. Aggregate cancer risk for U.S. population. Based on the 
information referenced in Unit IV.A, EPA has concluded that the cPAD is 
protective of possible cancer effects from flonicamid because, as noted 
in Unit IV.D.2, aggregate chronic exposure to flonicamid is below the 
cPAD.
    6. 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.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (FMC Method No. P-3561M, a 
liquid chromatography with tandem mass spectrometry (LC/MS/MS) method 
is available to enforce the tolerance expression for flonicamid and its 
metabolites in or on plant commodities. 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.
    The Codex has not established a MRL for flonicamid.

VI. Conclusion

    Therefore, time-limited 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 prickly pear, fruit at 1.5 ppm and 
prickly pear, pads at 1.5 ppm. These tolerances expire on December 31, 
2020.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 
408(l)(6). 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). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), 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

[[Page 3615]]

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).

VIII. 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: December 28, 2017.
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, revise paragraph (b) to read as follows:


Sec.  [emsp14]180.613   Flonicamid; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
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 specified agricultural 
commodities, resulting from use of the pesticide pursuant to FFIFRA 
section 18 emergency exemptions. The tolerances expire on the date 
specified in the table.

------------------------------------------------------------------------
                                                 Parts per    Expiration
                   Commodity                      million        date
------------------------------------------------------------------------
Prickly pear, fruit...........................          1.5   12/31/2020
Prickly pear, pads............................          1.5   12/31/2020
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-01480 Filed 1-25-18; 8:45 am]
 BILLING CODE 6560-50-P