80 FR 65964 - Methoxyfenozide; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 208 (October 28, 2015)
Federal Register Volume 80, Issue 208 (October 28, 2015)
| Page Range | 65964-65968 | |
| FR Document | 2015-27461 |
[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)] [Rules and Regulations] [Pages 65964-65968] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27461] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0591; FRL-9934-14] Methoxyfenozide; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of methoxyfenozide 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 October 28, 2015. Objections and requests for hearings must be received on or before December 28, 2015, 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: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 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-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 December 28, 2015. 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. Summary of Petitioned-For Tolerance In the Federal Register of March 4, 2015 (80 FR 11611) (FRL-9922- 68), 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 4E8298) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide methoxyfenozide, (3-methoxy-2-methylbenzoic acid 2-(3,5- dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide), under paragraph (a) in or on: Chive, fresh leaves at 30.0 parts per million (ppm); fruit, stone, group 12-12, except plum, prune, fresh at 3.0 ppm; and nut, tree, group 14-12 at 0.10 ppm. The petition also proposed the following tolerances under paragraph (a) be removed upon approval of the proposed tolerances listed above: Fruit, stone, group 12, except plum, prune, fresh at 3.0 ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; and in paragraph (d), chive at 4.5 ppm be removed. The petition additionally [[Page 65965]] requested to amend the tolerances in 40 CFR 180.544 for residues of methoxyfenozide in or on onion, green, subgroup 3-07B at 5.0 ppm to onion, green, subgroup 3-07B, except chive at 5.0 ppm; and herb subgroup 19A, except chive at 400 ppm to herb subgroup 19A, except chive, fresh leaves at 400 ppm. That document referenced a summary of the petition prepared on behalf of IR-4 by Dow AgroSciences LLC, the registrant, which is available in the docket, http://www.regulations.gov. No FFDCA-related comments were received on the notice of filing. Based upon review of the data supporting the petition, EPA has determined that the amended tolerance on onion, green, subgroup 3-07B, except chive should be established in or on onion, green, subgroup 3- 07B, except chive, fresh leaves. The reasons for these changes are explained in Unit IV.C. 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 methoxyfenozide including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with methoxyfenozide 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. Many of the available short-term or subchronic toxicity studies on methoxyfenozide showed little or no toxicity. The main target organs identified from the toxicity studies in the rat and dog were the liver, thyroid, and red blood cells (RBCs). The most consistent findings across species and studies were transiently decreased RBC parameters and increased liver, thyroid, adrenal, and spleen weights. Increases in thyroid and adrenal weights were observed in the rat chronic oral study. Thyroid weights were also increased in the dog following chronic exposure. However, no accompanying histopathology was observed. Acute and subchronic oral neurotoxicity studies in the rat did not show evidence of potential neurotoxicity. In the acute study, decreased hindlimb grip strength on day 0 was reported in males. This finding was only observed at the limit dose in males and was not observed in the subchronic neurotoxicity study and was therefore not considered evidence of neurotoxicity. No clinical signs of neurotoxicity or neurohistopathology were observed in other guideline studies. No maternal or developmental effects were observed in either the rat or rabbit oral developmental toxicity studies. In the rat 2- generation reproductive toxicity study, parental effects were limited to increased liver weight and microscopic periportal hypertrophy. No offspring or reproductive toxicity was observed. In a 28-day dietary immunotoxicity study in the rat, no immunotoxicity was observed, and the only observed effect was increased liver weights. There was no evidence of carcinogenicity in the rat dietary 24- month chronic toxicity/carcinogenicity study or the mouse dietary 18- month carcinogenicity study. No mutagenic or clastogenic potential was observed in the battery of genotoxicity studies on methoxyfenozide. Based on these findings, methoxyfenozide is classified as not likely to be carcinogenic to humans. Specific information on the studies received and the nature of the adverse effects caused by methoxyfenozide as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, ``Methoxyfenozide. Human Health Draft Risk Assessment for Registration Review and New Use Risk Assessment to Support the Registration of Proposed Use on Chives, and Crop Group Expansions for Stone Fruit and Tree Nuts'' in pp. 42-47 in docket ID number EPA-HQ-OPP-2014-0591. 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 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). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to methoxyfenozide, EPA considered exposure under the petitioned-for tolerances 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 [[Page 65966]] 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 dietary exposure assessment EPA used the food consumption data from the USDA under the National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA), 2003 to 2008. As to residue levels in food, EPA used tolerance-level residues and the assumption of 100 percent crop treated (PCT) for all existing and proposed commodities. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that methoxyfenozide 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 methoxyfenozide. Tolerance level residues and/or 100 PCT were assumed for all food commodities. 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 FQPA 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 (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. 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. 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 2- 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. ii. There is no indication that methoxyfenozide is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity. iii. There is no evidence that methoxyfenozide 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 performed based on 100 PCT and tolerance-level residues. EPA [[Page 65967]] made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to methoxyfenozide in drinking water. Based on the discussion Unit III.C.3., regarding residential use patterns, EPA does not expect residential uses of methoxyfenozide to result in postapplication exposure of children or incidental oral exposures of toddlers. These assessments will not underestimate the exposure and risks posed by methoxyfenozide. 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, 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 in Unit III.C.3., 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 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. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology using high performance liquid chromatography (HPLC), with either tandem mass spectrometric detection (LC-MS/MS), or ultraviolet detection (UV) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for methoxyfenozide in or on chive or the commodities associated with herb subgroup 19A or green onion subgroup 3-07B. Codex has established an MRL in or on tree nuts at 0.1 milligram/kilogram (mg/kg), which is harmonized with the recommended tolerance of 0.10 ppm in or on tree nut crop group 14-12. However, Codex has established a tolerance in or on stone fruit at 2 mg/kg that cannot be harmonized with the EPA tolerance in or on stone fruit group 12-12, except plum, prune, fresh at 3.0 ppm because the Organization for Economic Cooperation and Development (OECD) tolerance calculations that EPA uses to calculate U.S. tolerance levels result in a tolerance that is higher than the Codex MRL, and reduction of the tolerance would result in the risk of violative residues resulting from proper use according to label directions. C. Revisions to Petitioned-For Tolerances Based on the data supporting the petition, the Agency determined that the petitioned-for tolerance on chive, fresh leaves at 30.0 ppm should be established in or on chive, fresh leaves at 30 ppm because EPA establishes tolerances using whole numbers for tolerances of 10 ppm or more, per the OECD tolerance calculation procedures. The Agency also determined that the petitioned-for-amended tolerance in or on onion, green, subgroup 3-07B, except chive should be established in or on onion, green, subgroup 3-07B, except chive, fresh leaves. This is due to the fact that only chive, fresh leaves are included in subgroup 3- 07B, and the Agency is establishing a separate tolerance for chive, fresh leaves at 30 ppm. V. Conclusion Therefore, tolerances are established for residues of methoxyfenozide, (3-methoxy-2-methylbenzoic acid 2-(3,5- [[Page 65968]] dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide), in or on chive, fresh leaves at 30 ppm; fruit, stone, group 12-12, except plum, prune, fresh at 3.0 ppm; herb subgroup 19A, except chive, fresh leaves at 400 ppm; onion, green, subgroup 3-07B, except chive, fresh leaves at 5.0 ppm; and nut, tree, group 14-12 at 0.10 ppm. This rule additionally removes the established tolerances in or on fruit, stone, group 12, except plum, prune, fresh at 3.0 ppm; herb subgroup 19A, except chive at 400 ppm; nut, tree, group 14 at 0.10 ppm; onion, green, subgroup 3- 07B at 5.0 ppm; pistachio at 0.10 ppm; and in paragraph (d)(2), chive at 4.5 ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). 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: October 20, 2015. Susan Lewis, 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: 0 a. Remove the following commodities from the table in paragraph (a): ``Fruit, stone, group 12, except plum, prune, fresh''; ``Herb subgroup 19A, except chive''; ``Nut, tree, group 14''; ``Onion, green, subgroup 3-07B''; and ``Pistachio''. 0 b. Remove the commodity ``Chive'' from the table in paragraph (d)(2). 0 c. Add alphabetically add the following commodities to the table in paragraph (a). The additions and revisions read as follows: Sec. 180.544 Methoxyfenozide; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Chive, fresh leaves..................................... 30 ------------------------------------------------------------------------ * * * * * Fruit, stone, group 12-12, except plum, prune, fresh.... 3.0 ------------------------------------------------------------------------ * * * * * Herb subgroup 19A, except chive, fresh leaves........... 400 ------------------------------------------------------------------------ * * * * * Nut, tree, group 14-12.................................. 0.10 Onion, green, subgroup 3-07B, except chive, fresh leaves 5.0 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2015-27461 Filed 10-27-15; 8:45 am] BILLING CODE 6560-50-P
![65964 Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Rules and Regulations
medical devices that are wholly or is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections
partially implanted in the body or by Monday through Friday, excluding legal and hearing requests are provided in 40
their corresponding personal monitoring holidays. The telephone number for the CFR 178.25(b).
systems, where such circumvention is Public Reading Room is (202) 566–1744, In addition to filing an objection or
undertaken by a patient for the sole and the telephone number for the OPP hearing request with the Hearing Clerk
purpose of lawfully accessing the data Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
generated by his or her own device or the visitor instructions and additional submit a copy of the filing (excluding
monitoring system and does not information about the docket available any Confidential Business Information
constitute a violation of applicable law, at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
including without limitation the Health FOR FURTHER INFORMATION CONTACT: Information not marked confidential
Insurance Portability and Susan Lewis, Registration Division pursuant to 40 CFR part 2 may be
Accountability Act of 1996, the (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
Computer Fraud and Abuse Act of 1986 Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
or regulations of the Food and Drug Pennsylvania Ave. NW., Washington, objection or hearing request, identified
Administration, and is accomplished DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP–
through the passive monitoring of number: (703) 305–7090; email address: 2014–0591, by one of the following
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[EPA–HQ–OPP–2014–0591; FRL–9934–14] • Crop production (NAICS code 111). Additional instructions on
• Animal production (NAICS code commenting or visiting the docket,
Methoxyfenozide; Pesticide Tolerances 112). along with more information about
AGENCY: Environmental Protection • Food manufacturing (NAICS code dockets generally, is available at http://
311). www.epa.gov/dockets.
Agency (EPA).
• Pesticide manufacturing (NAICS II. Summary of Petitioned-For
ACTION: Final rule.
code 32532). Tolerance
SUMMARY: This regulation establishes B. How can I get electronic access to In the Federal Register of March 4,
tolerances for residues of other related information? 2015 (80 FR 11611) (FRL–9922–68),
methoxyfenozide in or on multiple EPA issued a document pursuant to
You may access a frequently updated
commodities which are identified and FFDCA section 408(d)(3), 21 U.S.C.
electronic version of EPA’s tolerance
discussed later in this document. 346a(d)(3), announcing the filing of a
regulations at 40 CFR part 180 through
Interregional Research Project Number 4 pesticide petition (PP 4E8298) by IR–4,
the Government Printing Office’s e-CFR
(IR–4) requested these tolerances under 500 College Road East, Suite 201W,
site at http://www.ecfr.gov/cgi-bin/text-
the Federal Food, Drug, and Cosmetic Princeton, NJ 08540. The petition
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Act (FFDCA). requested that 40 CFR part 180 be
40tab_02.tpl.
DATES: This regulation is effective amended by establishing tolerances for
October 28, 2015. Objections and C. How can I file an objection or hearing residues of the insecticide
requests for hearings must be received request? methoxyfenozide, (3-methoxy-2-
on or before December 28, 2015, and Under FFDCA section 408(g), 21 methylbenzoic acid 2-(3,5-
must be filed in accordance with the U.S.C. 346a, any person may file an dimethylbenzoyl)-2-(1,1-dimethylethyl)
instructions provided in 40 CFR part objection to any aspect of this regulation hydrazide), under paragraph (a) in or
178 (see also Unit I.C. of the and may also request a hearing on those on: Chive, fresh leaves at 30.0 parts per
SUPPLEMENTARY INFORMATION). objections. You must file your objection million (ppm); fruit, stone, group 12–12,
ADDRESSES: The docket for this action, or request a hearing on this regulation except plum, prune, fresh at 3.0 ppm;
identified by docket identification (ID) in accordance with the instructions and nut, tree, group 14–12 at 0.10 ppm.
number EPA–HQ–OPP–2014–0591, is provided in 40 CFR part 178. To ensure The petition also proposed the
available at http://www.regulations.gov proper receipt by EPA, you must following tolerances under paragraph (a)
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– be removed upon approval of the
Lhorne on DSK5TPTVN1PROD with RULES
Regulatory Public Docket (OPP Docket) OPP–2014–0591 in the subject line on proposed tolerances listed above: Fruit,
in the Environmental Protection Agency the first page of your submission. All stone, group 12, except plum, prune,
Docket Center (EPA/DC), West William objections and requests for a hearing fresh at 3.0 ppm; nut, tree, group 14 at
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be 0.10 ppm; pistachio at 0.10 ppm; and in
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or paragraph (d), chive at 4.5 ppm be
20460–0001. The Public Reading Room before December 28, 2015. Addresses for removed. The petition additionally
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![65968 Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Rules and Regulations
dimethylbenzoyl)-2-(1,1-dimethylethyl) or tribal governments, on the ■ c. Add alphabetically add the
hydrazide), in or on chive, fresh leaves relationship between the national following commodities to the table in
at 30 ppm; fruit, stone, group 12–12, government and the States or tribal paragraph (a).
except plum, prune, fresh at 3.0 ppm; governments, or on the distribution of The additions and revisions read as
herb subgroup 19A, except chive, fresh power and responsibilities among the follows:
leaves at 400 ppm; onion, green, various levels of government or between
subgroup 3–07B, except chive, fresh the Federal Government and Indian § 180.544 Methoxyfenozide; tolerances for
residues.
leaves at 5.0 ppm; and nut, tree, group tribes. Thus, the Agency has determined
14–12 at 0.10 ppm. This rule that Executive Order 13132, entitled (a) * * *
additionally removes the established ‘‘Federalism’’ (64 FR 43255, August 10,
tolerances in or on fruit, stone, group Parts per
1999) and Executive Order 13175, Commodity million
12, except plum, prune, fresh at 3.0 entitled ‘‘Consultation and Coordination
ppm; herb subgroup 19A, except chive with Indian Tribal Governments’’ (65 FR
at 400 ppm; nut, tree, group 14 at 0.10 67249, November 9, 2000) do not apply * * * * *
ppm; onion, green, subgroup 3–07B at to this action. In addition, this action Chive, fresh leaves ............... 30
5.0 ppm; pistachio at 0.10 ppm; and in does not impose any enforceable duty or
paragraph (d)(2), chive at 4.5 ppm. contain any unfunded mandate as
* * * * *
VI. Statutory and Executive Order described under Title II of the Unfunded
Fruit, stone, group 12–12,
Reviews Mandates Reform Act (UMRA) (2 U.S.C. except plum, prune, fresh 3.0
1501 et seq.).
This action establishes tolerances This action does not involve any
under FFDCA section 408(d) in technical standards that would require * * * * *
response to a petition submitted to the Agency consideration of voluntary Herb subgroup 19A, except
Agency. The Office of Management and consensus standards pursuant to section chive, fresh leaves ............ 400
Budget (OMB) has exempted these types 12(d) of the National Technology
of actions from review under Executive Transfer and Advancement Act
Order 12866, entitled ‘‘Regulatory * * * * *
(NTTAA) (15 U.S.C. 272 note). Nut, tree, group 14–12 ......... 0.10
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action VII. Congressional Review Act Onion, green, subgroup 3–
07B, except chive, fresh
has been exempted from review under Pursuant to the Congressional Review leaves ................................ 5.0
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
not subject to Executive Order 13211, submit a report containing this rule and * * * * *
entitled ‘‘Actions Concerning other required information to the U.S.
Regulations That Significantly Affect Senate, the U.S. House of * * * * *
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller [FR Doc. 2015–27461 Filed 10–27–15; 8:45 am]
FR 28355, May 22, 2001) or Executive General of the United States prior to BILLING CODE 6560–50–P
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal
Children from Environmental Health Register. This action is not a ‘‘major
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2).
April 23, 1997). This action does not DEPARTMENT OF HOMELAND
contain any information collections List of Subjects in 40 CFR Part 180 SECURITY
subject to OMB approval under the Environmental protection, Federal Emergency Management
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, Agency
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides
any special considerations under and pests, Reporting and recordkeeping 44 CFR Part 67
Executive Order 12898, entitled requirements.
‘‘Federal Actions to Address [Docket ID FEMA–2015–0001]
Dated: October 20, 2015.
Environmental Justice in Minority
Populations and Low-Income Susan Lewis, Final Flood Elevation Determinations
Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
Pesticide Programs. AGENCY: Federal Emergency
1994). Management Agency, DHS.
Since tolerances and exemptions that Therefore, 40 CFR chapter I is
are established on the basis of a petition amended as follows: ACTION: Final rule.
under FFDCA section 408(d), such as
PART 180—[AMENDED] SUMMARY: Base (1% annual-chance)
the tolerance in this final rule, do not
Flood Elevations (BFEs) and modified
require the issuance of a proposed rule, ■ 1. The authority citation for part 180 BFEs are made final for the
the requirements of the Regulatory continues to read as follows: communities listed below. The BFEs
Flexibility Act (RFA) (5 U.S.C. 601 et
Authority: 21 U.S.C. 321(q), 346a and 371. and modified BFEs are the basis for the
seq.), do not apply.
floodplain management measures that
This action directly regulates growers, ■ 2. In § 180.544: each community is required either to
food processors, food handlers, and food ■ a. Remove the following commodities
adopt or to show evidence of being
retailers, not States or tribes, nor does from the table in paragraph (a): ‘‘Fruit,
already in effect in order to qualify or
this action alter the relationships or stone, group 12, except plum, prune,
Lhorne on DSK5TPTVN1PROD with RULES
remain qualified for participation in the
distribution of power and fresh’’; ‘‘Herb subgroup 19A, except
National Flood Insurance Program
responsibilities established by Congress chive’’; ‘‘Nut, tree, group 14’’; ‘‘Onion,
(NFIP).
in the preemption provisions of FFDCA green, subgroup 3–07B’’; and
section 408(n)(4). As such, the Agency ‘‘Pistachio’’. DATES: The date of issuance of the Flood
has determined that this action will not ■ b. Remove the commodity ‘‘Chive’’ Insurance Rate Map (FIRM) showing
have a substantial direct effect on States from the table in paragraph (d)(2). BFEs and modified BFEs for each
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Document Created: 2018-02-27 08:57:50
Document Modified: 2018-02-27 08:57:50
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective October 28, 2015. Objections and requests for hearings must be received on or before December 28, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 80 FR 65964 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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