Methoxyfenozide; Pesticide Tolerances, 51102-51106 [2014-20376]

Download as PDF 51102 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations Dated: July 30, 2014. R.S. Ogrydziak, Captain, U.S. Coast Guard, Captain of the Port, Port Arthur. [FR Doc. 2014–20329 Filed 8–26–14; 8:45 am] BILLING CODE 9110–04–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2013–0476; FRL–9913–99] Methoxyfenozide; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of methoxyfenozide in or on pineapple. Dow AgroSciences, LLC, requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective August 27, 2014. Objections and requests for hearings must be received on or before October 27, 2014, 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–2013–0476, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency mstockstill on DSK4VPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 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). objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 27, 2014. 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– 2013–0476, 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. B. How can I get electronic access to other related information? regulated area, unless it receives permission from the on-scene Patrol Commander. Spectator vessels may safely transit outside the regulated area but may not anchor, block, loiter, or impede participants or official patrol vessels. The Coast Guard may be assisted by other federal, state or local law enforcement agencies in enforcing this regulation. This notice is issued under authority of 33 CFR 100.801 and 33 U.S.C. 1233. In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with notification of this enforcement period via Local Notice to Mariners, Marine Information Broadcasts, and Marine Safety Information Bulletins. If the Captain of the Port or his designated on-scene Patrol Commander determines that the regulated area need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area. II. Summary of Petitioned-For Tolerance You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. In the Federal Register of July 19, 2013 (78 FR 43115) (FRL–9392–9), 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 3F8179) by Dow AgroSciences, LLC, 9330 Zionsville Rd., Indianapolis, IN 46268. The petition requested that 40 CFR 180.544 be amended by establishing tolerances for residues of the insecticide methoxyfenozide, 3-methoxy-2methylbenzoic acid 2-(3,5dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on pineapple at 0.7 parts per million (ppm). That document referenced a summary of the petition prepared by Dow AgroSciences, LLC, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received on the notice of filing. 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: Lois Rossi, 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 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–2013–0476 in the subject line on the first page of your submission. All PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\FR\FM\27AUR1.SGM 27AUR1 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations 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. mstockstill on DSK4VPTVN1PROD with RULES 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. Methoxyfenozide is of low acute toxicity by the oral, dermal, and inhalation routes and is not a dermal sensitizer. Many of the VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 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 decreased red blood cell 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, but no accompanying histopathology was observed. The effects of methoxyfenozide on the blood in mammals (methemoglobinemia, decreased red blood cell parameters, Heinz body formation) are consistent with those of other hydrazine compounds. 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. There was no evidence of carcinogenicity in the rat dietary 24month 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 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 51103 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-effectlevel (NOAEL) and the Lowestobserved-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ‘‘Methoxyfenozide. Human Health Risk Assessment to Support Proposed New Section 3 Use on Pineapple’’ at p. 34 in docket ID number EPA–HQ–OPP–2013–0476. 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 at which adverse effects of concern. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level— generally referred to as a populationadjusted 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 shown in Table 1 of this unit. E:\FR\FM\27AUR1.SGM 27AUR1 51104 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR METHOXYFENOZIDE FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/scenario Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (General population including infants and children). No hazard was identified for a single oral exposure. Chronic dietary (All populations) NOAEL = 10.2 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x Chronic .................... RfD = 0.10 mg/kg/ day cPAD = 0.10 mg/kg/ day Inhalation short-term (1 to 30 days) and intermediate-term (1 to 6 months). Inhalation (or oral) study NOAEL = 16 mg/kg/day. (Inhalation absorption rate = 100%) UFA = 10x UFH = 10x FQPA SF = 1x LOC for MOE ≤100 Cancer (Oral, dermal, inhalation). Classification: Not likely to be carcinogenic to humans. Co-critical studies: Combined oral chronic toxicity/carcinogenicity-rat LOAEL = 411/491 mg/kg/day M/F, based on hematological changes (decreased RBC parameters), periportal liver hypertrophy, thyroid hypertrophy and altered colloid; possibly increased adrenal weight. Chronic oral toxicity-dog = 9.8/12.6 mg/kg/day M/F LOAEL = 106.1/110.6 mg/kg/day based on hematological changes (decreased RBC parameters, slight methemoglobinemia) and increased serum bilirubin. Two-week oral range-finding study-dog LOAEL = 90.8 mg/kg/day based on hematological changes (decreased RBC parameters, increased Heinz body count, reticulocyte counts, erythrocyte morphology and methemoglobinemia) and increased spleen weights. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day= milligram/kilogram/day. M/F = male/female MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RBC = red blood cells. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). mstockstill on DSK4VPTVN1PROD with RULES 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 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 food consumption information from the United States Department of Agriculture (USDA) 2003–2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA used tolerance-level residues from the existing and proposed use and the VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 assumption of 100% crop treated (PCT) for all crops. 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 Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for methoxyfenozide in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of methoxyfenozide. 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 Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and the Pesticide Root Zone Model Ground PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of methoxyfenozide for chronic exposures for non-cancer assessments are estimated to be 51 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.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Methoxyfenozide is currently registered for the following uses that could result in residential exposures: Ornamental uses. EPA assessed potential inhalation exposure for residential handlers treating ornamentals in and around home gardens using a backpack sprayer. A quantitative dermal assessment for residential handlers was not conducted since there is no systemic toxicity associated with dermal exposure to E:\FR\FM\27AUR1.SGM 27AUR1 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES methoxyfenozide. MOEs were calculated for the inhalation route of exposure only. 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 residential 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 VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 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. 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 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 dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made highly conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to methoxyfenozide in drinking water. 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 population adjusted dose (aPAD) and chronic population adjusted dose (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 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 51105 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 83% of the cPAD for children 1–2 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 aggregate MOEs 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 intermediateterm risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediateterm risk for methoxyfenozide. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two E:\FR\FM\27AUR1.SGM 27AUR1 51106 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations 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 (HPLC–UV) is available to enforce the tolerance expression. It is also noted that the European Food Safety Authority (EFSA) has concluded that the multiresidue QuEChERS method, combined with an HPLC–MS/MS, is adequate for tolerance enforcement in plant and animal commodities (EFSA, 2014)). 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. mstockstill on DSK4VPTVN1PROD with RULES B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for methoxyfenozide in pineapple. V. Conclusion Therefore, tolerances are established for residues of methoxyfenozide, 3methoxy-2-methylbenzoic acid 2-(3,5dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on pineapple at 0.70 ppm. VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule 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 final rule 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 final rule 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 final rule. In addition, this final rule does not impose any enforceable duty or contain PO 00000 Frm 00040 Fmt 4700 Sfmt 9990 any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (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: August 19, 2014. Lois Rossi, 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, add alphabetically the commodity ‘‘Pineapple’’ to the table in paragraph (a)(1) to read as follows: ■ § 180.544 Methoxyfenozide; Tolerance for residues. (a) * * * (1) * * * Parts per million Commodity * * * * Pineapple .................................. * * * * * * * * * [FR Doc. 2014–20376 Filed 8–26–14; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\27AUR1.SGM 27AUR1 * 0.70 *

Agencies

[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Rules and Regulations]
[Pages 51102-51106]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20376]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0476; FRL-9913-99]


Methoxyfenozide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
methoxyfenozide in or on pineapple. Dow AgroSciences, LLC, requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective August 27, 2014. Objections and 
requests for hearings must be received on or before October 27, 2014, 
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-2013-0476, 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: Lois Rossi, 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/Title40/40tab02.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-2013-0476 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
October 27, 2014. 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-2013-0476, 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 July 19, 2013 (78 FR 43115) (FRL-9392-
9), 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 
3F8179) by Dow AgroSciences, LLC, 9330 Zionsville Rd., Indianapolis, IN 
46268. The petition requested that 40 CFR 180.544 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, in or on pineapple at 
0.7 parts per million (ppm). That document referenced a summary of the 
petition prepared by Dow AgroSciences, LLC, the registrant, which is 
available in the docket, http://www.regulations.gov. No comments were 
received on the notice of filing.

[[Page 51103]]

 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. Methoxyfenozide is of low acute toxicity by the oral, dermal, 
and inhalation routes and is not a dermal sensitizer. 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 decreased red blood cell 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, but no 
accompanying histopathology was observed. The effects of 
methoxyfenozide on the blood in mammals (methemoglobinemia, decreased 
red blood cell parameters, Heinz body formation) are consistent with 
those of other hydrazine compounds.
    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.
    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 Risk 
Assessment to Support Proposed New Section 3 Use on Pineapple'' at p. 
34 in docket ID number EPA-HQ-OPP-2013-0476.

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 at which adverse 
effects of concern. 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 shown in Table 1 of this unit.

[[Page 51104]]



     Table 1--Summary of Toxicological Doses and Endpoints for Methoxyfenozide for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of  departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC  for    Study and toxicological effects
                                      safety factors       risk  assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  No hazard was identified for a single oral exposure.
 including infants and children).
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 10.2 mg/kg/   Chronic............  Co-critical studies:
                                    day.                 RfD = 0.10 mg/kg/    Combined oral chronic toxicity/
                                   UFA = 10x...........   day.                 carcinogenicity-rat
                                   UFH = 10x...........  cPAD = 0.10 mg/kg/   LOAEL = 411/491 mg/kg/day M/F,
                                   FQPA SF = 1x........   day.                 based on hematological changes
                                                                               (decreased RBC parameters),
                                                                               periportal liver hypertrophy,
                                                                               thyroid hypertrophy and altered
                                                                               colloid; possibly increased
                                                                               adrenal weight.
                                                                              Chronic oral toxicity-dog = 9.8/
                                                                               12.6 mg/kg/day M/F
                                                                              LOAEL = 106.1/110.6 mg/kg/day
                                                                               based on hematological changes
                                                                               (decreased RBC parameters, slight
                                                                               methemoglobinemia) and increased
                                                                               serum bilirubin.
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE <=100..  Two-week oral range-finding study-
 days) and intermediate-term (1     study NOAEL = 16 mg/                       dog
 to 6 months).                      kg/day.                                   LOAEL = 90.8 mg/kg/day based on
                                   (Inhalation                                 hematological changes (decreased
                                    absorption rate =                          RBC parameters, increased Heinz
                                    100%).                                     body count, reticulocyte counts,
                                   UFA = 10x...........                        erythrocyte morphology and
                                   UFH = 10x...........                        methemoglobinemia) and increased
                                   FQPA SF = 1x........                        spleen weights.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day= milligram/kilogram/day. M/F = male/female MOE = margin of exposure. NOAEL = no-observed-
  adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RBC = red blood cells. RfD =
  reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
  potential variation in sensitivity among members of the human population (intraspecies).

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 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 food consumption information from the United States 
Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA used tolerance-level residues from the 
existing and proposed use and the assumption of 100% crop treated (PCT) 
for all crops.
    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 Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for methoxyfenozide in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of methoxyfenozide. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and the Pesticide Root Zone Model Ground Water 
(PRZM GW), the estimated drinking water concentrations (EDWCs) of 
methoxyfenozide for chronic exposures for non-cancer assessments are 
estimated to be 51 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 the following uses that 
could result in residential exposures: Ornamental uses. EPA assessed 
potential inhalation exposure for residential handlers treating 
ornamentals in and around home gardens using a backpack sprayer. A 
quantitative dermal assessment for residential handlers was not 
conducted since there is no systemic toxicity associated with dermal 
exposure to

[[Page 51105]]

methoxyfenozide. MOEs were calculated for the inhalation route of 
exposure only.
    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 residential 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.
    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 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 dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made highly conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to methoxyfenozide in drinking water. 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 population adjusted dose (aPAD) and chronic population adjusted 
dose (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 83% of the cPAD for 
children 1-2 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 aggregate MOEs 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

[[Page 51106]]

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 (HPLC-UV) is available to enforce 
the tolerance expression. It is also noted that the European Food 
Safety Authority (EFSA) has concluded that the multiresidue QuEChERS 
method, combined with an HPLC-MS/MS, is adequate for tolerance 
enforcement in plant and animal commodities (EFSA, 2014)).
    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 
pineapple.

V. Conclusion

    Therefore, tolerances are established for residues of 
methoxyfenozide, 3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on pineapple at 
0.70 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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: August 19, 2014.
Lois Rossi,
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, add alphabetically the commodity ``Pineapple'' to 
the table in paragraph (a)(1) to read as follows:


Sec.  180.544  Methoxyfenozide; Tolerance for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Pineapple..................................................         0.70
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-20376 Filed 8-26-14; 8:45 am]
BILLING CODE 6560-50-P