Flonicamid; Pesticide Tolerances, 52348-52352 [2016-18666]

Download as PDF 52348 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [EPA–HQ–OAR–2013–0696; FRL–9950–26– OAR] RIN 2060–AS86 Technical Amendments to Performance Specification 18 and Procedure 6 Environmental Protection Agency (EPA). ACTION: Partial withdrawal of direct final rule. AGENCY: Because the Environmental Protection Agency (EPA) received adverse comment, we are withdrawing a portion of the May 19, 2016, direct final rule that made several minor technical amendments to the performance specifications and test procedures for hydrogen chloride (HCl) continuous emission monitoring systems (CEMS). The adverse comments related to revisions to Procedure 6 and thus the EPA is withdrawing the portion of the direct final rule that revised Procedure 6. DATES: Effective August 8, 2016, the EPA withdraws the revisions to Procedure 6, sections 4.1.5, 4.1.5.1, 4.1.5.3, and 5.2.4.2, published at 81 FR 31515, on May 19, 2016. FOR FURTHER INFORMATION CONTACT: Ms. Candace Sorrell, U.S. EPA, Office of Air Quality Planning and Standards, Air Quality Assessment Division, Measurement Technology Group (Mail Code: E143–02), Research Triangle Park, NC 27711; telephone number: (919) 541–1064; fax number: (919) 541–0516; email address: sorrell.candace@epa.gov. SUPPLEMENTARY INFORMATION: On May 19, 2016, the EPA published a direct final rule that makes minor technical amendments to the performance specifications and test procedures for hydrogen chloride (HCl) continuous emission monitoring systems (CEMS). 81 FR 31515. In the direct final rule, the EPA stated that if we received adverse comment by July 5, 2016, the EPA would publish a timely withdrawal and address the comments in a subsequent final rule based on the proposed rule also published on May 19, 2016 (81 FR 31577). The May 19, 2016, direct final rule noted that if the EPA received adverse comment on an amendment, paragraph, or section of this rule and, if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. rmajette on DSK2TPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 13:12 Aug 05, 2016 Jkt 238001 In this instance, the EPA received an adverse comment on an amendment to the quality assurance provision in Procedure 6, related to above span requirements. 81 FR 31517. The portions of the direct final rule revising Performance Standard 18 are severable from the revisions to Procedure 6. Thus, the EPA is only withdrawing the revisions to Procedure 6. The EPA will address the comment in a subsequent final action, which will be based on the parallel proposed rule also published on May 19, 2016 (81 FR 31515). As stated in the parallel proposal, we will not institute a second comment period on this proposed action. The revisions to Performance Standard 18 in the May 19, 2016, direct final rule are not affected and will become effective on August 17, 2016, as provided in the direct final rule. List of Subjects in 40 CFR Part 60 Environmental protection, Administrative practice and procedure, Air pollution control, Continuous emission monitoring systems, Hydrogen chloride, Performance specifications, Test methods and procedures. Dated: July 28, 2016. Janet G. McCabe, Acting Assistant Administrator. [FR Doc. 2016–18682 Filed 8–5–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2015–0561; FRL–9949–19] Flonicamid; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of flonicamid in or on hops, tree nuts (crop group 14–12 except pistachio), and pistachio. ISK Biosciences Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective August 8, 2016. Objections and requests for hearings must be received on or before October 7, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2015–0561, 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: Susan T. Lewis, 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 Accordingly, amendatory instruction 3 in the direct final rule published in the Federal Register on May 19, 2016, at 81 FR 31520, is withdrawn as of August 8, 2016. SUMMARY: Unit I.C. of the SUPPLEMENTARY 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 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 E:\FR\FM\08AUR1.SGM 08AUR1 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations rmajette on DSK2TPTVN1PROD with RULES 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–2015–0561 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 October 7, 2016. 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– 2015–0561, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/ dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of October 21, 2015 (80 FR 63731) (FRL–9935–29), 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 5F8369) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio 44077. The petition requested that 40 CFR 180.613 be amended by establishing tolerances for residues of the insecticide flonicamid, [(N-(cyanomethyl)-4trifluoromethyl)-3pyridinecarboxamide) or (Ncyanomethyl-4- VerDate Sep<11>2014 13:12 Aug 05, 2016 Jkt 238001 trifluoromethylnicotinamide (IUPAC))], in or on hops at 20 parts per million (ppm), tree nuts (crop group 14–12) except pistachio at 0.15 parts per million (ppm), pistachio at 0.60 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, http:// 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 occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .’’ Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for flonicamid including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with flonicamid follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered 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. Specific information on the studies received and the nature of the adverse effects caused by flonicamid as well as the no- PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 52349 observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of November 14, 2012 (77 FR 67771) (FRL–9368–7). 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 the NOAEL and the LOAEL are identified. 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 http:// www.epa.gov/pesticides/factsheets/ riskassess.htm. 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. 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 E:\FR\FM\08AUR1.SGM 08AUR1 rmajette on DSK2TPTVN1PROD with RULES 52350 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations 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’s National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, the chronic dietary exposure assessment was a conservative assessment conducted using tolerance-level residues, conservative ground water/drinking water estimates, and 100 percent crop treated (PCT). iii. Cancer. Based on the data referenced in Unit III.A., EPA has concluded that flonicamid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for flonicamid. Tolerance level residues and/or 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for flonicamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of flonicamid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/ water/index.htm. The drinking water assessment was conducted using both a parent only exposure, and a total toxic residue approach, which considers the parent compound and its major degradates of concern. Total toxic residues include 4trifluoromethylnicotinic acid (TFNA), 4trifluoromethylnictinamide (TFNA– AM), 6-hydro-4-trifluoromethylnicotinic acid (TFNA–OH), N-(4trifluoromethylnicotinoyl)glycine (TFNG), and N-(4trifluoromethylnicotinoyl)glycinamide (TFNG-AM). 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 of value 9.92 ppb VerDate Sep<11>2014 13:12 Aug 05, 2016 Jkt 238001 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. 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 Web site at http:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for flonicamid includes prenatal developmental toxicity studies in rats and rabbits and a multigeneration reproduction toxicity study in rats. There is no evidence of increased susceptibility (qualitative or PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 quantitative) in rats or rabbits exposed to flonicamid in utero 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 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 the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X, except as noted below. That decision is based on the following findings: i. The toxicity database for flonicamid is nearly complete. The database is missing a subchronic inhalation study. A subchronic inhalation study is required because the use of an oral POD results in MOEs which do not meet the target MOE for a waiver (MOE=1,000). The Agency notified the registrant of the Data Call-In (DCI) for the 28-day inhalation study on January 5, 2016 and is awaiting submission of the study. In the absence of a subchronic inhalation study, EPA has retained a 10X FQPA SF to assess risks for inhalation exposure scenarios. However, residential inhalation exposures are not expected. ii. The available data base for flonicamid includes acute and subchronic neurotoxicity studies. As discussed in Unit III.A., EPA has concluded that the clinical signs observed in those studies were not the result of a neurotoxic mechanism and therefore a developmental neurotoxicity study is not required. 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 and tolerance-level residues. 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:\FR\FM\08AUR1.SGM 08AUR1 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations rmajette on DSK2TPTVN1PROD with RULES 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 30% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure. There are no residential uses for flonicamid. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of flonicamid is not expected. 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). A short-term adverse effect was identified; however, flonicamid is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for flonicamid. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was VerDate Sep<11>2014 13:12 Aug 05, 2016 Jkt 238001 identified; however, flonicamid is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediateterm residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for flonicamid. 5. Aggregate cancer risk for U.S. population. Based on the information referenced in Unit III.A., EPA has concluded that the cPAD is protective of possible cancer effects from flonicamid, and as evidenced in Unit III.E.2, aggregate exposure to flonicamid is below the cPAD. 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. IV. Other Considerations A. Analytical Enforcement Methodology 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 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 52351 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 proposed an MRL for flonicamid in or on pistachio. The Codex has established an MRL for flonicamid in or on hops at 20.0 ppm. These MRLs are the same as the tolerances established for flonicamid in the United States. The Codex has also established MRLs for flonicamid in or on almond and pecan at 0.01 ppm. These MRLs are different than the tolerances established for flonicamid in the United States. The U.S. cannot harmonize the Nut, tree, group 14–12, except pistachio tolerance with the Codex MRLs on pecan and almond because residue field trial data show residues well above 0.01 ppm. C. Revisions to Petitioned-For Tolerances The Agency is removing certain commodities from the table at § 180.613 (a) to eliminate redundancies upon the establishment of new crop group tolerances that were not identified in the petition: Cucumber at 1.5 ppm and okra at 0.40 ppm. V. Conclusion Therefore, tolerances are established for residues of flonicamid, [(N(cyanomethyl)-4-trifluoromethyl)-3pyridinecarboxamide) or (Ncyanomethyl-4trifluoromethylnicotinamide (IUPAC))], in or on hops at 20.0 ppm, tree nuts (crop group 14–12) except pistachio at 0.15 ppm, and pistachio at 0.60 ppm. Also, as a housekeeping measure, the Agency is removing three individual tolerances that are subsumed within other crop group tolerances contained in § 180.613: Cucumber at 1.5 ppm is superseded by inclusion in the established vegetable, cucurbit, group 9 tolerance at 1.5 ppm; and okra at 0.40 ppm is superseded by inclusion in the established vegetable, fruiting, group 8– 10 tolerance at 0.40 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 E:\FR\FM\08AUR1.SGM 08AUR1 rmajette on DSK2TPTVN1PROD with RULES 52352 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations 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 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). VerDate Sep<11>2014 13:12 Aug 05, 2016 Jkt 238001 VII. Congressional Review Act DEPARTMENT OF THE INTERIOR 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). Office of the Secretary of the Interior List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 26, 2016. Daniel J. Rosenblatt, Acting 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, amend the table in paragraph (a)(1) as follows: ■ a. Remove the commodities ‘‘Cucumber’’ and ‘‘Okra’’. ■ b. Revise the commodities ‘‘Hop, dried cones’’ and ‘‘Nut, Tree, group 14– 12’’. ■ c. Add alphabetically the commodity ‘‘Pistachio’’. The revisions and addition read as follows: ■ 43 CFR Part 10 [NPS–WASO–NAGPRA–21514; PX.XVPAD0522.0.1] RIN 1024–AE34 Civil Penalties Inflation Adjustments; Correction AGENCY: ACTION: Office of the Secretary, Interior. Interim final rule; correction. The Office of the Secretary of the Interior is correcting an interim final rule that appeared in the Federal Register on Tuesday June 28, 2016 (81 FR 41858). This rule adjusts the level of civil monetary penalties contained in U.S. Department of the Interior regulations implementing the Native American Graves Protection and Repatriation Act with an initial ‘‘catchup’’ adjustment under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and Office of Management and Budget guidance. The corrections are administrative and procedural related to submitting comments. SUMMARY: This correction is effective August 8, 2016. DATES: A.J. North, National Park Service, 1849 C Street NW., Washington, DC 20240, telephone: 202–513–7742. FOR FURTHER INFORMATION CONTACT: In volume 81, number 124 of the Federal Register of Tuesday June 28, 2016 on page 41858, the following corrections are § 180.613 Flonicamid; tolerances for residues. made: 1. On page 41858 the RIN in the (a) * * * heading is corrected to read as follows: (1) * * * 1024–AE34 2. On page 41858, in the second Parts per Commodity million column, the text following • Federal eRulemaking Portal: http:// www.regulations.gov. is corrected to * * * * * read: Search for the Docket Number Hop, dried cones .................. 20.0 DOI–2016–0004 or RIN 1024–AE34 and Nut, Tree, group 14–12 except pistachio .................... 0.15 follow the instructions for submitting comments. * * * * * * * * * * Pistachio ............................... * * * * * * * 0.60 * * * SUPPLEMENTARY INFORMATION: Dated: July 25, 2016. Michael J. Bean, Principal Deputy Assistant Secretary for Fish and Wildlife and Parks. [FR Doc. 2016–18666 Filed 8–5–16; 8:45 am] [FR Doc. 2016–18643 Filed 8–5–16; 8:45 am] BILLING CODE 6560–50–P BILLING CODE 4310–EJ–P PO 00000 Frm 00028 Fmt 4700 Sfmt 9990 E:\FR\FM\08AUR1.SGM 08AUR1

Agencies

[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Rules and Regulations]
[Pages 52348-52352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18666]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0561; FRL-9949-19]


Flonicamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flonicamid in or on hops, tree nuts (crop group 14-12 except 
pistachio), and pistachio. ISK Biosciences Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 8, 2016. Objections and 
requests for hearings must be received on or before October 7, 2016, 
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-2015-0561, 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: Susan T. Lewis, 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

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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation

[[Page 52349]]

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-2015-0561 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 October 7, 2016. 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-2015-0561, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.

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

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 21, 2015 (80 FR 63731) (FRL-
9935-29), 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 
5F8369) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, 
Concord, Ohio 44077. The petition requested that 40 CFR 180.613 be 
amended by establishing tolerances for residues of the insecticide 
flonicamid, [(N-(cyanomethyl)-4-trifluoromethyl)-3-pyridinecarboxamide) 
or (N-cyanomethyl-4-trifluoromethylnicotinamide (IUPAC))], in or on 
hops at 20 parts per million (ppm), tree nuts (crop group 14-12) except 
pistachio at 0.15 parts per million (ppm), pistachio at 0.60 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, http://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 occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for flonicamid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with flonicamid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered 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. 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 are discussed in the final rule 
published in the Federal Register of November 14, 2012 (77 FR 67771) 
(FRL-9368-7).

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 the NOAEL and the LOAEL are identified. 
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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    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.

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

[[Page 52350]]

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's National 
Health and Nutrition Examination Survey, What We Eat in America, 
(NHANES/WWEIA). As to residue levels in food, the chronic dietary 
exposure assessment was a conservative assessment conducted using 
tolerance-level residues, conservative ground water/drinking water 
estimates, and 100 percent crop treated (PCT).
    iii. Cancer. Based on the data referenced in Unit III.A., EPA has 
concluded that flonicamid does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for flonicamid. Tolerance level residues and/or 100 PCT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for flonicamid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of flonicamid. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    The drinking water assessment was conducted using both a parent 
only exposure, and a total toxic residue approach, which considers the 
parent compound and its major degradates of concern. Total toxic 
residues include 4-trifluoromethylnicotinic acid (TFNA), 4-
trifluoromethylnictinamide (TFNA-AM), 6-hydro-4-
trifluoromethylnicotinic acid (TFNA-OH), N-(4-
trifluoromethylnicotinoyl)glycine (TFNG), and N-(4-
trifluoromethylnicotinoyl)glycinamide (TFNG-AM).
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW), 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 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.
    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 Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicity database for flonicamid includes prenatal developmental 
toxicity studies in rats and rabbits and a multi-generation 
reproduction toxicity study in rats. There is no evidence of increased 
susceptibility (qualitative or quantitative) in rats or rabbits exposed 
to flonicamid in utero 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 
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 the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X, except as noted below. That decision is 
based on the following findings:
    i. The toxicity database for flonicamid is nearly complete. The 
database is missing a subchronic inhalation study. A subchronic 
inhalation study is required because the use of an oral POD results in 
MOEs which do not meet the target MOE for a waiver (MOE=1,000). The 
Agency notified the registrant of the Data Call-In (DCI) for the 28-day 
inhalation study on January 5, 2016 and is awaiting submission of the 
study. In the absence of a subchronic inhalation study, EPA has 
retained a 10X FQPA SF to assess risks for inhalation exposure 
scenarios. However, residential inhalation exposures are not expected.
    ii. The available data base for flonicamid includes acute and 
subchronic neurotoxicity studies. As discussed in Unit III.A., EPA has 
concluded that the clinical signs observed in those studies were not 
the result of a neurotoxic mechanism and therefore a developmental 
neurotoxicity study is not required.
    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 and tolerance-level residues. 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.

[[Page 52351]]

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 30% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for flonicamid. Based on the 
explanation in Unit III.C.3., regarding residential use patterns, 
chronic residential exposure to residues of flonicamid is not expected.
    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). A short-term 
adverse effect was identified; however, flonicamid is not registered 
for any use patterns that would result in short-term residential 
exposure. Short-term risk is assessed based on short-term residential 
exposure plus chronic dietary exposure. Because there is no short-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess short-term risk), no further 
assessment of short-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short-term risk for 
flonicamid.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
flonicamid is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
flonicamid.
    5. Aggregate cancer risk for U.S. population. Based on the 
information referenced in Unit III.A., EPA has concluded that the cPAD 
is protective of possible cancer effects from flonicamid, and as 
evidenced in Unit III.E.2, aggregate exposure to flonicamid is below 
the cPAD.
    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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    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 proposed an MRL for flonicamid in or on 
pistachio. The Codex has established an MRL for flonicamid in or on 
hops at 20.0 ppm. These MRLs are the same as the tolerances established 
for flonicamid in the United States. The Codex has also established 
MRLs for flonicamid in or on almond and pecan at 0.01 ppm. These MRLs 
are different than the tolerances established for flonicamid in the 
United States. The U.S. cannot harmonize the Nut, tree, group 14-12, 
except pistachio tolerance with the Codex MRLs on pecan and almond 
because residue field trial data show residues well above 0.01 ppm.

C. Revisions to Petitioned-For Tolerances

    The Agency is removing certain commodities from the table at Sec.  
180.613 (a) to eliminate redundancies upon the establishment of new 
crop group tolerances that were not identified in the petition: 
Cucumber at 1.5 ppm and okra at 0.40 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of flonicamid, 
[(N-(cyanomethyl)-4-trifluoromethyl)-3-pyridinecarboxamide) or (N-
cyanomethyl-4-trifluoromethylnicotinamide (IUPAC))], in or on hops at 
20.0 ppm, tree nuts (crop group 14-12) except pistachio at 0.15 ppm, 
and pistachio at 0.60 ppm.
    Also, as a housekeeping measure, the Agency is removing three 
individual tolerances that are subsumed within other crop group 
tolerances contained in Sec.  180.613: Cucumber at 1.5 ppm is 
superseded by inclusion in the established vegetable, cucurbit, group 9 
tolerance at 1.5 ppm; and okra at 0.40 ppm is superseded by inclusion 
in the established vegetable, fruiting, group 8-10 tolerance at 0.40 
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

[[Page 52352]]

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 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 Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 26, 2016.
Daniel J. Rosenblatt,
Acting 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, amend the table in paragraph (a)(1) as follows:
0
a. Remove the commodities ``Cucumber'' and ``Okra''.
0
b. Revise the commodities ``Hop, dried cones'' and ``Nut, Tree, group 
14-12''.
0
c. Add alphabetically the commodity ``Pistachio''.
    The revisions and addition read as follows:


Sec.  180.613  Flonicamid; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Hop, dried cones........................................            20.0
Nut, Tree, group 14-12 except pistachio.................            0.15
 
                                * * * * *
Pistachio...............................................            0.60
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-18666 Filed 8-5-16; 8:45 am]
 BILLING CODE 6560-50-P