Methoxyfenozide; Pesticide Tolerances for Emergency Exemptions, 27332-27337 [2016-09969]

Download as PDF 27332 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 5, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS List of Subjects in 40 CFR Part 52 ■ Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur oxides. ■ Dated: April 27, 2016. Robert A. Kaplan, Acting Regional Administrator, Region 5. 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 et seq. 2. In § 52.770 the table in paragraph (d) is amended by adding new entries for ‘‘A.B. Brown Generating Station’’ and ‘‘Clifty Creek Generating Station’’, to read as follows: § 52.770 40 CFR part 52 is amended as follows: * Identification of plan. * * (d) * * * * * EPA-APPROVED INDIANA SOURCE-SPECIFIC PROVISIONS CO date Title * * 1/11/2016 ............... 2/1/2016 ................. * * SIP rule * * EPA approval * A.B. Brown Generating Station. Clifty Creek Generating Station. N.A. N.A. * Explanation * * 5/6/16, [insert Federal Register citation]. 5/6/16, [insert Federal Register citation]. Limitation intended to support attainment designation. This regulation is effective May 6, 2016. Objections and requests for hearings must be received on or before July 5, 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). BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2014–0591, 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. ADDRESSES: [EPA–HQ–OPP–2014–0591; FRL–9945–28] Methoxyfenozide; Pesticide Tolerances for Emergency Exemptions Environmental Protection Agency (EPA). AGENCY: ACTION: Final rule. This regulation establishes time-limited tolerances for residues of methoxyfenozide in or on rice, grain and rice, bran resulting from use of methoxyfenozide in accordance with the terms of an emergency exemption issued under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This action is in response to the California Department of Pesticide Regulation’s issuance of a crisis emergency exemption under FIFRA section 18 authorizing use of the pesticide on rice, bran and rice, grain. This time-limited tolerance regulation establishes a maximum permissible level for residues of methoxyfenozide in or on these commodities. These timelimited tolerances expire on December 31, 2019. Lhorne on DSK30JT082PROD with RULES SUMMARY: VerDate Sep<11>2014 13:56 May 05, 2016 Jkt 238001 FOR FURTHER INFORMATION CONTACT: Susan 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: PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 * Limitation intended to support attainment designation. DATES: [FR Doc. 2016–10579 Filed 5–5–16; 8:45 am] * 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. 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 E:\FR\FM\06MYR1.SGM 06MYR1 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations Lhorne on DSK30JT082PROD with RULES 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–2014–0591 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 July 5, 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– 2014–0591, 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. 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 methoxyfenozide in or on rice, bran and rice, grain at 4.0 and 0.50 parts per million (ppm), respectively. These timelimited tolerances expire on December 31, 2019. 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 VerDate Sep<11>2014 13:56 May 05, 2016 Jkt 238001 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 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 Methoxyfenozide on Rice, Grain and Rice, Bran and FFDCA Tolerances The California Department of Pesticide Regulation asserted that an emergency condition existed in accordance with the criteria for approval of an emergency exemption, and utilized a crisis exemption under FIFRA section 18 to allow the use of methoxyfenozide on rice to control armyworm and Western yellow striped armyworm in Butte, Glenn, Sacramento, Sutter, Yolo, and Yuba counties. The California Department of Pesticide Regulation invoked the crisis exemption provision on August 27, 2015. After having reviewed the submission and determining that the risks associated with the emergency use were reasonable PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 27333 in comparison to the expected benefits to the California rice growers who faced the largest outbreak of armyworms in 25 years and significant economic loss, EPA concurred on the crisis exemption. The crisis exemption expired on September 10, 2015. As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of methoxyfenozide in or on rice, bran and rice, grain. 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, 2019, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on rice, bran and rice, grain 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 methoxyfenozide meets FIFRA’s registration requirements for use on rice, grain and rice, bran or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these time-limited tolerance decisions serve as a basis for registration of methoxyfenozide by a State for special local needs under FIFRA section 24(c). Nor do these tolerances by themselves 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 crisis emergency exemption for methoxyfenozide, contact the Agency’s Registration Division at the address E:\FR\FM\06MYR1.SGM 06MYR1 27334 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations provided under FOR FURTHER INFORMATION CONTACT. Lhorne on DSK30JT082PROD with RULES IV. 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 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 methoxyfenozide on rice, bran and rice, grain at 4.0 and 0.50 ppm, respectively, measured as 3-methoxy-2methylbenzoic acid 2-(3,5dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide. 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/ VerDate Sep<11>2014 13:56 May 05, 2016 Jkt 238001 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 methoxyfenozide used for human risk assessment is discussed in Table 1 of Unit III B. of the final rule published in the Federal Register of August 27, 2014 (79 FR 51103) (FRL– 9913–99). Further, the Agency’s exposure and risk assessment for the emergency use on rice, bran and rice, grain is discussed in greater detail in ‘‘Methoxyfenozide: Human Health Risk Assessment for the Proposed Use of the Insecticide (Associated with Section 18 Registration) on Rice in California,’’ January 5, 2016 is available in the docket at the address provided under ADDRESSES. B. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to methoxyfenozide, EPA considered exposure under the timelimited tolerances established by this action as well as all existing methoxyfenozide tolerances in 40 CFR 180.544. EPA assessed dietary exposures from methoxyfenozide 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 methoxyfenozide; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic aggregate dietary (food and drinking water) exposure and risk assessment, EPA used the Dietary Exposure Evaluation Model software (Version 3.16) with the Food Commodity Intake Database (DEEM– FCID). This software includes 2003 to 2008 food consumption data from the United States Department of Agriculture’s (USDA’s) National Health PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 and Nutrition Examination Survey, What We Eat in America (NHANES/ WWEIA). All current and proposed uses of methoxyfenozide, were included in this assessment. As to residue levels in food, the chronic dietary assessment assumes 100% crop treated (PCT). DEEM (Version 7.81) default processing factors were used for most processed commodities that do not have individual tolerances. The only exception was a processing factor of 0.2X that was used for orange juice from a processing study. The chronic dietary assessment is highly conservative (protective); therefore, providing an upper-bound estimate of dietary exposure and risk. iii. Cancer. Based on the data referenced in Unit IV.A., EPA has concluded that methoxyfenozide should be classified as ‘‘Not Likely to Be Carcinogenic to Humans.’’ As a result, a cancer dietary exposure assessment for the purpose of assessing cancer risk is unnecessary for methoxyfenozide, and was not conducted. 2. Dietary exposure from drinking water. The residues of concern in drinking water are methoxyfenozide and the degradates, RH–117,236 and RH– 131,154, which are only present at low concentrations. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for methoxyfenozide and its degradates in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of methoxyfenozide and its degradates. 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. Based on the FPQA Index Reservoir Screening Tool (FIRST), Screening Concentration in Ground Water (SCI– GROW), and the Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated drinking water concentrations (EDWCs) of methoxyfenozide and its degradates for chronic exposures for non-cancer assessments are estimated to be 7.57 parts per billion (ppb) for surface water and 214 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 214 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure E:\FR\FM\06MYR1.SGM 06MYR1 Lhorne on DSK30JT082PROD with RULES Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Methoxyfenozide is currently registered for use on ornamentals in and around home gardens, which could result in residential exposures. EPA assessed residential exposure using the following assumptions: Residential handlers were assessed for potential short-term inhalation exposures from mixing, loading, and applying methoxyfenozide. A quantitative dermal assessment for residential handlers was not conducted since there is no systemic toxicity associated with dermal exposures to methoxyfenozide. Adult postapplication exposures were not quantitatively assessed since no dermal hazard was identified for methoxyfenozide and inhalation exposures are typically negligible in outdoor settings. Furthermore, the inhalation exposure assessment performed for residential handlers is representative of worse case inhalation exposures and is considered protective for post-application inhalation exposure scenarios. Post-application oral exposure to children is not expected since the extent to which young children engage in activities associated with areas where treated ornamentals are grown (or utilize these areas for prolonged periods of play) is low. Therefore, an incidental oral post-application exposure assessment was not conducted. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/ science/trac6a05.pdf. 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 methoxyfenozide to share a common mechanism of toxicity with any other substances, and methoxyfenozide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that methoxyfenozide 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 VerDate Sep<11>2014 13:56 May 05, 2016 Jkt 238001 chemicals, see EPA’s Web site at http: //www.epa.gov/pesticides/cumulative. 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 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 SF when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There is no evidence of qualitative or quantitative susceptibility of the developing fetus or offspring, based on the developmental and reproductive toxicity study results for methoxyfenozide. No developmental toxicity was observed in either the rat or rabbit developmental toxicity studies, and there was no evidence of offspring or reproductive toxicity in the rat twogeneration reproductive toxicity study. 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. That decision is based on the following findings: i. The toxicity database for methoxyfenozide is complete, including studies addressing potential pre- and post-natal susceptibility, neurotoxicity, and immunotoxicity. ii. There is no evidence that methoxyfenozide is neurotoxic, and a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity are not required. iii. There is no residual uncertainty, and no evidence increased susceptibility in the developing or young animal. iv. The dietary exposure assessments do not underestimate potential exposure from food and drinking water, and the use pattern indicates a low potential for residential exposure. 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 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 27335 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 so, there is no acute dietary endpoint of concern. Therefore, methoxyfenozide 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 methoxyfenozide from food and water will utilize 84% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation regarding residential use patterns, chronic residential exposure to residues of methoxyfenozide 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). Methoxyfenozide is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to methoxyfenozide. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 540. Because EPA’s level of concern for methoxyfenozide is a MOE of 100 or below, these MOEs are not of concern. 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, methoxyfenozide 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 E:\FR\FM\06MYR1.SGM 06MYR1 27336 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations 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 methoxyfenozide. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, methoxyfenozide is not expected to pose a cancer risk to humans. 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 methoxyfenozide residues. EPA concludes that there is reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to methoxyfenozide residues because the Section 18 emergency use of methoxyfenozide on rice will result in negligible increases in dietary exposure to all subgroups relative to the safety findings reached in the August 27, 2014 Federal Register document. V. Other Considerations A. Analytical Enforcement Methodology An adequate enforcement methodology is available to enforce the tolerance expression, using high performance liquid chromatography (HPLC), with either tandem mass spectrometric detection (LC–MS/MS), or ultraviolet detection (UV). 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. Lhorne on DSK30JT082PROD with RULES B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting VerDate Sep<11>2014 13:56 May 05, 2016 Jkt 238001 organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. There are currently no established Codex or Canadian MRLs for methoxyfenozide residues in rice commodities. VI. Conclusion Therefore, time-limited tolerances are established for residues of methoxyfenozide, (3-methoxy-2methylbenzoic acid 2-(3,5dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide), in or on rice, grain at 0.50 ppm; and rice, bran at 4.0 ppm. These tolerances will expire on December 31, 2019. 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 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 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). 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: April 21, 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 § 180.544, revise paragraph (b) to read as follows: ■ § 180.544 Methoxyfenozide; tolerances for residues. * E:\FR\FM\06MYR1.SGM * * 06MYR1 * * Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations (b) Section 18 emergency exemptions. Time-limited tolerances are established for residues of the insecticide methoxyfenozide, including its metabolites and degradates in or on the commodities listed in the table below, resulting from use of the pesticide under a Section 18 emergency exemption granted by EPA. Compliance with the tolerance levels specified in the following table is to be determined by measuring only methoxyfenozide (3methoxy-2-methylbenzoic acid 2-(3,5dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) in or on the commodity. Commodity Parts per million Rice, bran 4.0 Rice, grain. * * 0.50 * * Expiration/ revocation date I. General Information December 31, 2019. December 31, 2019. * [FR Doc. 2016–09969 Filed 5–5–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2015–0035; FRL–9945–68] Clethodim; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of clethodim in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 6, 2016. Objections and requests for hearings must be received on or before July 5, 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). SUMMARY: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2015–0035, 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., Lhorne on DSK30JT082PROD with RULES ADDRESSES: VerDate Sep<11>2014 13:56 May 05, 2016 Jkt 238001 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 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: 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 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–2015–0035 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 July 5, 2016. Addresses for mail and hand delivery of objections and PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 27337 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– 2015–0035, 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 Wednesday, May 20, 2015 (80 FR 28925) (FRL–9927– 39), 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 4E8334) by Interregional Research Project Number 4 (IR–4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.458 be amended by establishing tolerances for residues of the herbicide clethodim, 2[(1E)-1-[[[(2E)-3-chloro-2propenyl]oxy]imino]propyl]-5-[2(ethylthio)propyl]-3-hydroxy-2cyclohexen-1-one, and its metabolites containing the 5-(2ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, calculated as the stoichiometric equivalent of clethodim, in or on stevia at 12 parts per million (ppm); pome fruit group 11–10 at 0.2 ppm; stone fruit group 12–12 at 0.2 ppm; bulb onion subgroup 3–07A at 0.2 ppm; low growing berry subgroup 13–07G, except cranberry at 3.0 ppm; rapeseed subgroup 20A, except flax 0.5 ppm; E:\FR\FM\06MYR1.SGM 06MYR1

Agencies

[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Rules and Regulations]
[Pages 27332-27337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09969]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0591; FRL-9945-28]


Methoxyfenozide; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of methoxyfenozide in or on rice, grain and rice, bran 
resulting from use of methoxyfenozide in accordance with the terms of 
an emergency exemption issued under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA). This action is in 
response to the California Department of Pesticide Regulation's 
issuance of a crisis emergency exemption under FIFRA section 18 
authorizing use of the pesticide on rice, bran and rice, grain. This 
time-limited tolerance regulation establishes a maximum permissible 
level for residues of methoxyfenozide in or on these commodities. These 
time-limited tolerances expire on December 31, 2019.

DATES: This regulation is effective May 6, 2016. Objections and 
requests for hearings must be received on or before July 5, 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-2014-0591, 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 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:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]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.

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

[[Page 27333]]

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-2014-0591 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 July 5, 
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-2014-0591, 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. 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 methoxyfenozide in 
or on rice, bran and rice, grain at 4.0 and 0.50 parts per million 
(ppm), respectively. These time-limited tolerances expire on December 
31, 2019.
    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 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 Methoxyfenozide on Rice, Grain and Rice, 
Bran and FFDCA Tolerances

    The California Department of Pesticide Regulation asserted that an 
emergency condition existed in accordance with the criteria for 
approval of an emergency exemption, and utilized a crisis exemption 
under FIFRA section 18 to allow the use of methoxyfenozide on rice to 
control armyworm and Western yellow striped armyworm in Butte, Glenn, 
Sacramento, Sutter, Yolo, and Yuba counties. The California Department 
of Pesticide Regulation invoked the crisis exemption provision on 
August 27, 2015. After having reviewed the submission and determining 
that the risks associated with the emergency use were reasonable in 
comparison to the expected benefits to the California rice growers who 
faced the largest outbreak of armyworms in 25 years and significant 
economic loss, EPA concurred on the crisis exemption. The crisis 
exemption expired on September 10, 2015.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of 
methoxyfenozide in or on rice, bran and rice, grain. 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, 2019, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerances 
remaining in or on rice, bran and rice, grain 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 
methoxyfenozide meets FIFRA's registration requirements for use on 
rice, grain and rice, bran or whether permanent tolerances for this use 
would be appropriate. Under these circumstances, EPA does not believe 
that these time-limited tolerance decisions serve as a basis for 
registration of methoxyfenozide by a State for special local needs 
under FIFRA section 24(c). Nor do these tolerances by themselves 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 crisis emergency exemption for 
methoxyfenozide, contact the Agency's Registration Division at the 
address

[[Page 27334]]

provided under FOR FURTHER INFORMATION CONTACT.

IV. 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 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 methoxyfenozide on rice, 
bran and rice, grain at 4.0 and 0.50 ppm, respectively, measured as 3-
methoxy-2-methylbenzoic acid 2-(3,5-dimethylbenzoyl)-2-(1,1-
dimethylethyl)-hydrazide. 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for methoxyfenozide used 
for human risk assessment is discussed in Table 1 of Unit III B. of the 
final rule published in the Federal Register of August 27, 2014 (79 FR 
51103) (FRL-9913-99). Further, the Agency's exposure and risk 
assessment for the emergency use on rice, bran and rice, grain is 
discussed in greater detail in ``Methoxyfenozide: Human Health Risk 
Assessment for the Proposed Use of the Insecticide (Associated with 
Section 18 Registration) on Rice in California,'' January 5, 2016 is 
available in the docket at the address provided under ADDRESSES.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to methoxyfenozide, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing 
methoxyfenozide tolerances in 40 CFR 180.544. EPA assessed dietary 
exposures from methoxyfenozide 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 methoxyfenozide; therefore, 
a quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic aggregate dietary 
(food and drinking water) exposure and risk assessment, EPA used the 
Dietary Exposure Evaluation Model software (Version 3.16) with the Food 
Commodity Intake Database (DEEM-FCID). This software includes 2003 to 
2008 food consumption data from the United States Department of 
Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). All current and proposed 
uses of methoxyfenozide, were included in this assessment. As to 
residue levels in food, the chronic dietary assessment assumes 100% 
crop treated (PCT). DEEM (Version 7.81) default processing factors were 
used for most processed commodities that do not have individual 
tolerances. The only exception was a processing factor of 0.2X that was 
used for orange juice from a processing study. The chronic dietary 
assessment is highly conservative (protective); therefore, providing an 
upper-bound estimate of dietary exposure and risk.
    iii. Cancer. Based on the data referenced in Unit IV.A., EPA has 
concluded that methoxyfenozide should be classified as ``Not Likely to 
Be Carcinogenic to Humans.'' As a result, a cancer dietary exposure 
assessment for the purpose of assessing cancer risk is unnecessary for 
methoxyfenozide, and was not conducted.
    2. Dietary exposure from drinking water. The residues of concern in 
drinking water are methoxyfenozide and the degradates, RH-117,236 and 
RH-131,154, which are only present at low concentrations. The Agency 
used screening-level water exposure models in the dietary exposure 
analysis and risk assessment for methoxyfenozide and its degradates in 
drinking water. These simulation models take into account data on the 
physical, chemical, and fate/transport characteristics of 
methoxyfenozide and its degradates. 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.
    Based on the FPQA Index Reservoir Screening Tool (FIRST), Screening 
Concentration in Ground Water (SCI-GROW), and the Pesticide Root Zone 
Model Ground Water (PRZM GW) models, the estimated drinking water 
concentrations (EDWCs) of methoxyfenozide and its degradates for 
chronic exposures for non-cancer assessments are estimated to be 7.57 
parts per billion (ppb) for surface water and 214 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 214 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

[[Page 27335]]

(e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Methoxyfenozide is 
currently registered for use on ornamentals in and around home gardens, 
which could result in residential exposures. EPA assessed residential 
exposure using the following assumptions: Residential handlers were 
assessed for potential short-term inhalation exposures from mixing, 
loading, and applying methoxyfenozide. A quantitative dermal assessment 
for residential handlers was not conducted since there is no systemic 
toxicity associated with dermal exposures to methoxyfenozide. Adult 
post-application exposures were not quantitatively assessed since no 
dermal hazard was identified for methoxyfenozide and inhalation 
exposures are typically negligible in outdoor settings. Furthermore, 
the inhalation exposure assessment performed for residential handlers 
is representative of worse case inhalation exposures and is considered 
protective for post-application inhalation exposure scenarios.
    Post-application oral exposure to children is not expected since 
the extent to which young children engage in activities associated with 
areas where treated ornamentals are grown (or utilize these areas for 
prolonged periods of play) is low. Therefore, an incidental oral post-
application exposure assessment was not conducted. Further information 
regarding EPA standard assumptions and generic inputs for residential 
exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 methoxyfenozide to share a common mechanism of 
toxicity with any other substances, and methoxyfenozide does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
methoxyfenozide 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.

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 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 
SF when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
qualitative or quantitative susceptibility of the developing fetus or 
offspring, based on the developmental and reproductive toxicity study 
results for methoxyfenozide. No developmental toxicity was observed in 
either the rat or rabbit developmental toxicity studies, and there was 
no evidence of offspring or reproductive toxicity in the rat two-
generation reproductive toxicity study.
    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. That decision is based on the following 
findings:
    i. The toxicity database for methoxyfenozide is complete, including 
studies addressing potential pre- and post-natal susceptibility, 
neurotoxicity, and immunotoxicity.
    ii. There is no evidence that methoxyfenozide is neurotoxic, and a 
developmental neurotoxicity study or additional uncertainty factors 
(UFs) to account for neurotoxicity are not required.
    iii. There is no residual uncertainty, and no evidence increased 
susceptibility in the developing or young animal.
    iv. The dietary exposure assessments do not underestimate potential 
exposure from food and drinking water, and the use pattern indicates a 
low potential for residential exposure.

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 effect resulting from a single oral exposure 
was identified and so, there is no acute dietary endpoint of concern. 
Therefore, methoxyfenozide 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 
methoxyfenozide from food and water will utilize 84% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation regarding residential use patterns, 
chronic residential exposure to residues of methoxyfenozide 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). 
Methoxyfenozide is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to methoxyfenozide.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in an aggregate MOE of 540. Because 
EPA's level of concern for methoxyfenozide is a MOE of 100 or below, 
these MOEs are not of concern.
    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, 
methoxyfenozide 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

[[Page 27336]]

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 methoxyfenozide.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, methoxyfenozide is not expected to pose a cancer risk to 
humans.
    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 methoxyfenozide residues.
    EPA concludes that there is reasonable certainty that no harm will 
result to the general population, or to infants and children, from 
aggregate exposure to methoxyfenozide residues because the Section 18 
emergency use of methoxyfenozide on rice will result in negligible 
increases in dietary exposure to all subgroups relative to the safety 
findings reached in the August 27, 2014 Federal Register document.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology is available to enforce the 
tolerance expression, using high performance liquid chromatography 
(HPLC), with either tandem mass spectrometric detection (LC-MS/MS), or 
ultraviolet detection (UV).
    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.
    There are currently no established Codex or Canadian MRLs for 
methoxyfenozide residues in rice commodities.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
methoxyfenozide, (3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl)-hydrazide), in or on rice, grain 
at 0.50 ppm; and rice, bran at 4.0 ppm. These tolerances will expire on 
December 31, 2019.

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 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: April 21, 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.  180.544, revise paragraph (b) to read as follows:


Sec.  180.544  Methoxyfenozide; tolerances for residues.

* * * * *

[[Page 27337]]

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide methoxyfenozide, including 
its metabolites and degradates in or on the commodities listed in the 
table below, resulting from use of the pesticide under a Section 18 
emergency exemption granted by EPA. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only methoxyfenozide (3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) in or on the 
commodity.

------------------------------------------------------------------------
                                  Parts per
           Commodity               million   Expiration/ revocation date
------------------------------------------------------------------------
Rice, bran.....................         4.0  December 31, 2019.
Rice, grain....................        0.50  December 31, 2019.
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-09969 Filed 5-5-16; 8:45 am]
 BILLING CODE 6560-50-P