Ipconazole; Pesticide Tolerances, 15235-15240 [2014-06059]

Download as PDF wreier-aviles on DSK5TPTVN1PROD with RULES Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations Accordingly, this action merely approves a State plan as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action: • Is not a ‘‘significant regulatory action’’ subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.); • is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.); • does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); • does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and • does not provide EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a VerDate Mar<15>2010 15:37 Mar 18, 2014 Jkt 232001 report containing this action 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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 19, 2014. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today’s Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements. Dated: March 5, 2014. Jared Blumenfeld, Regional Administrator, Region IX. Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows: PART 52 [AMENDED] 1. The authority citation for Part 52 continues to read as follows: ■ Authority: 42 U.S.C. 7401 et seq. Subpart D—Arizona 2. Section 52.120 is amended by adding paragraph (c)(159) to read as follows: ■ § 52.120 * Identification of plan. * * (c) * * * PO 00000 Frm 00019 * Fmt 4700 * Sfmt 4700 15235 (159) The following plan was submitted on January 23, 2012 by the Governor’s Designee. (i) [Reserved] (ii) Additional Materials. (A) Arizona Department of Environmental Quality (1) Final Update of the Limited Maintenance Plan for the Payson PM10 Maintenance Area (December 2011), adopted by the Arizona Department of Environmental Quality on January 23, 2012. [FR Doc. 2014–05669 Filed 3–18–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2012–0796; FRL–9907–25] Ipconazole; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of ipconazole in or on vegetable, legume, group 6. Chemtura Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective March 19, 2014. Objections and requests for hearings must be received on or before May 19, 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). SUMMARY: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2012–0796, 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), EPA West 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, ADDRESSES: E:\FR\FM\19MRR1.SGM 19MRR1 15236 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations DC 20460–0001; 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. wreier-aviles on DSK5TPTVN1PROD with RULES 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–2012–0796 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 May 19, 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 VerDate Mar<15>2010 15:37 Mar 18, 2014 Jkt 232001 by docket ID number EPA–HQ–OPP– 2012–0796, 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 December 19, 2012 (77 FR 75082) (FRL–9372–6), 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 2F8076) by Chemtura Corporation, 199 Benson Rd., Middlebury, CT 06749. The petition requested that 40 CFR 180.646 be amended by establishing tolerances for residues of the fungicide ipconazole (2[(4-chlorophenyl)methyl]-5-(1methylethyl)-1-(1H-1,2,4-triazol-1ylmethyl)cyclopentanol) in or on legume vegetables, succulent or dried, crop group 6 at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by Chemtura Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 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 ipconazole including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with ipconazole 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. Ipconazole has low acute toxicity via the oral, dermal, and inhalation routes of exposure. It causes low to mild irritation to the eyes and skin; it is not a dermal sensitizer. Ipconazole may cause local, portal-ofentry irritation via all routes following repeated exposure. Systemic effects that were noted in dogs, mice, rabbits and/ or rats following exposure to ipconazole were generally limited to decreased body weight, body weight gain, and food consumption; and liver and kidney effects. Developmental effects were observed only at the maternally-toxic dose. No consistent evidence of neurotoxicity was observed following acute, subchronic, or chronic dosing in multiple species in the available ipconazole database and the triazole fungicides as a group typically show either no evidence of neurotoxicity or neurotoxicity at doses significantly higher than the regulatory points of departure. Ipconazole is classified as not likely to be a human carcinogen and there is no concern for mutagenicity. Specific information on the studies received and the nature of the adverse effects caused by ipconazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in document ‘‘Revised Ipconazole Human Health Risk Assessment of the Proposed Use on E:\FR\FM\19MRR1.SGM 19MRR1 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations Legume Vegetables (Crop Group 6)’’ on page 23 in docket ID number EPA–HQ– OPP–2012–0796. B. Toxicological Points of Departure (POD)/Levels of Concern (LOC) Once a pesticide’s toxicological profile is determined, EPA identifies toxicological POD and LOC to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors (SF) 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 nonthreshold risks, the Agency assumes that any amount of exposure will lead 15237 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 ipconazole used for human risk assessment is shown in the following Table of this unit. TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR IPCONAZOLE FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/scenario Acute dietary (females 13–50 years of age). Acute dietary (general population including infants and children). Chronic dietary (all populations) Cancer (oral, dermal, inhalation). Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects NOAEL = 10 mg/kg/ day UFA = 10x UFH = 10x FQPA SF = 1x No appropriate endpoint attributable to a single dose of ipconazole was identified for this population. NOAEL= 1.5 mg/kg/ day UFA = 10x UFH = 10x FQPA SF = 1x Acute RfD = 0.1 mg/ kg/day aPAD = 0.1 mg/kg/ day Co-critical developmental toxicity studies in rats and rabbits. LOAELrats = 30 mg/kg/day, based on increased visceral and skeletal variations. LOAELrabbits = 50 mg/kg/day, based on increased incidence of skeletal variations and malformations. Chronic RfD = 0.015 mg/kg/day cPAD = 0.015 mg/ kg/day Chronic toxicity study in dogs. LOAEL = 5 mg/kg/day, based on skin reddening (both sexes) and decreased body weight gain in females. No evidence of carcinogenicity. Classification: Not likely to be a human carcinogen, based on two adequate rodent carcinogenicity studies. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). wreier-aviles on DSK5TPTVN1PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to ipconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing ipconazole tolerances in 40 CFR 180.646. EPA assessed dietary exposures from ipconazole 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 acute endpoint attributable to a single exposure and relevant for the general population was identified in the toxicity database for ipconazole. A developmental endpoint suitable for acute assessment was identified; VerDate Mar<15>2010 17:08 Mar 18, 2014 Jkt 232001 therefore an acute dietary assessment was performed only for women of childbearing age (females 13–49 years old). In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database, Version 3.16 (DEEM–FCID), which uses food consumption information from the U.S. Department of Agriculture (USDA) 2003–2008 National Health and Nutrition Examination Surveys of What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance level residues and 100% crop treated. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003–2008 National Health and Nutrition Examination Surveys of What We Eat in America (NHANES/WWEIA). As to residue levels PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 in food, EPA used tolerance level residues and assumed 100% crop treated. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that ipconazole is not a likely carcinogen. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for ipconazole. Tolerance level residues and/or 100% crop treated 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 ipconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/ E:\FR\FM\19MRR1.SGM 19MRR1 wreier-aviles on DSK5TPTVN1PROD with RULES 15238 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations transport characteristics of ipconazole. 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 Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated drinking water concentrations (EDWCs) of ipconazole for acute exposures are estimated to be 0.173 parts per billion (ppb) for surface water and 1.01 ppb for ground water. The EDWCs of ipconazole for chronic exposures for non-cancer assessments are estimated to be 0.105 ppb for surface water and 0.822 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 1.01 ppb was used to assess the contribution from drinking water. For chronic dietary risk assessment, the water concentration of value 0.822 ppb was used to assess the contribution from drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Ipconazole is not registered for any specific use patterns that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ Ipconazole is a member of the conazole class of pesticides. Although conazoles act similarly in plants by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found; some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some VerDate Mar<15>2010 15:37 Mar 18, 2014 Jkt 232001 induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events, including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no conclusive data to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA’s procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA’s Web site at http://www.epa.gov/ pesticides/cumulative. Ipconazole is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4triazole and three triazole conjugates (triazolylalanine, triazolylacetic acid, and triazolylpyrivic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including ipconazole, U.S. EPA conducted a human health risk assessment for exposure to 1,2,4triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10x FQPA SF for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency’s complete risk assessment is found in the propiconazole reregistration docket at http:// www.regulations.gov, Docket Identification (ID) Number EPA–HQ– OPP–2005–0497. An updated dietary exposure and risk analysis for the common triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA), triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was conducted completed in May 2013, in association with a registration request for several other triazole fungicides. That analysis concluded that risk estimates were below the Agency’s level of concern for all population groups. After inclusion of ipconazole uses covered by this action, aggregate PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 risk estimates for T, TA, TAA, and TP for all durations of exposure and for all population subgroups are below the Agency’s level of concern. This updated assessment may be found on http:// www.regulations.gov by searching for the following title and docket number: ‘‘Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address The New Section 3 Registrations For Use of Prothioconazole on Bushberry Crop Subgroup 13–07B, Low Growing Berry, Except Strawberry, Crop Subgroup 13– 07H, and Cucurbit Vegetables Crop Group 9; Use of Flutriafol on Coffee; and Ipconazole on Crop Group 6’’ (located in docket ID number EPA–HQ–OPP–2012– 0876). 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 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. Offspring effects only occurred in the presence of maternal toxicity and were not considered more severe than the parental effects. Therefore, EPA concluded that there is no quantitative or qualitative evidence of increased susceptibility to rat or rabbit fetuses exposed in utero and/or post-natally to ipconazole. 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 ipconazole is complete. The Agency waived the requirement for an Immunotoxicity study for ipconazole as there is minimal evidence that ipconazole targets the immune system, nor are the conazoles of a chemical class expected to have an adverse effect on the immune system. An increase in leukocytes was observed in females at 78.3 mg/kg/day in the 28day inhalation study, however this was not of concern because it was the only evidence of potential immunotoxicity in E:\FR\FM\19MRR1.SGM 19MRR1 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations wreier-aviles on DSK5TPTVN1PROD with RULES the entire ipconazole database, the effect occurred at a dose 10-fold higher than the dose (7.8 mg/kg/day) that caused portal-of-entry effects in the same study, and the effect occurred at a dose much greater than the PODs chosen for risk assessment. The overall weight of evidence suggests that ipconazole does not target the immune system. ii. There is no consistent evidence of neurotoxicity in the available databases. Clinical signs suggestive of neurotoxicity were observed in the in vivo mammalian cytogenetics study; however, they were seen at relatively high doses, which far exceed the anticipated dietary exposure, and no other signs were observed in any of the other studies, including studies with neurotoxicity assessments. Based on the lack of evidence in the database, EPA waived the requirement for the acute neurotoxicity study. Also, the subchronic neurotoxicity study requirement is considered to be satisfied by the neurotoxicity assessments performed in both the rat subchronic and chronic toxicity/carcinogenicity studies in which no signs of neurotoxicity were observed. This is consistent with what is known about the triazole fungicides as a class, which typically show either no evidence of neurotoxicity or neurotoxicity at doses significantly higher than the regulatory points of departure. Therefore, ipconazole is not considered to be neurotoxic and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that ipconazole results in increased susceptibility following in utero exposure for rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study, and there are no residual uncertainties with respect to pre- or postnatal exposure. iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to ipconazole in drinking water. These assessments will not underestimate the exposure and risks posed by ipconazole. 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-, VerDate Mar<15>2010 15:37 Mar 18, 2014 Jkt 232001 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 exposure estimates from acute dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to ipconazole will occupy <1% of the aPAD for females 13–49 years old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to ipconazole from food and water will utilize <1% of the cPAD for children 1–2 years old the population group receiving the greatest exposure. There are no residential uses for ipconazole. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term adverse effect was identified; however, ipconazole is not registered for any use patterns that would result in short-term residential exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for ipconazole. 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, ipconazole is not registered for any use patterns that would result in intermediate-term residential 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 ipconazole. PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 15239 5. Aggregate cancer risk for U.S. population. Ipconazole has been classified as not likely to be carcinogenic, and 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 ipconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (liquid chromatography/mass spectrometry/mass spectrometry (LC/ MS/MS) (AC/3020)) 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 ipconazole on vegetable, legume, group 6. C. Revisions to Petitioned-for Tolerances The petitioner requested a tolerance for residues of ipconazole in or on ‘‘legume vegetables succulent or dried, crop group 6’’. EPA is correcting the commodity term and establishing a tolerance for ‘‘vegetable, legume, group 6’’. V. Conclusion Therefore, tolerances are established for residues of ipconazole (2-[(4chlorophenyl)methyl]-5-(1- E:\FR\FM\19MRR1.SGM 19MRR1 15240 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations wreier-aviles on DSK5TPTVN1PROD with RULES methylethyl)-1-(1H-1,2,4-triazol-1ylmethyl)cyclopentanol) in or on vegetable, legume, group 6 at 0.01 ppm. EPA is revising the tolerance expression for ipconazole to clarify that metabolites and degradates are covered by the tolerances and to specify how compliance with the tolerances is to be measured. The existing tolerances for pea and bean, dried shelled, except soybean, subgroup 6C at 0.01 ppm and soybean, seed at 0.01 ppm will be removed from paragraph (a) of § 180.646 as these tolerances are encompassed within vegetable, legume, group 6. VI. Statutory and Executive Order Reviews This final rule 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 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This 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 VerDate Mar<15>2010 15:37 Mar 18, 2014 Jkt 232001 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). § 180.646 Ipconazole; tolerances for residues. VII. Congressional Review Act DEPARTMENT OF HEALTH AND HUMAN SERVICES 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: March 12, 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 § 180.646: a. Revise the introductory text in paragraph (a). ■ b. Remove ‘‘Pea and bean, dried shelled, except soybean, subgroup 6C’’, and ‘‘Soybean, seed’’ from the table in paragraph (a). ■ c. Add alphabetically ‘‘Vegetable, legume, group 6’’ to the table in paragraph (a). The amendments read as follows: ■ ■ PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 (a) General. Tolerances are established for residues of ipconazole, including its metabolites and degradates, in or on the commodities listed in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only ipconazole (2-[(4chlorophenyl)methyl]-5-(1methylethyl)-1-(1H-1,2,4-triazol-1ylmethyl)cyclopentanol) in or on the commodity. Parts per million Commodity * * * Vegetable, legume, group 6 * * * * * * 0.01 * [FR Doc. 2014–06059 Filed 3–18–14; 8:45 am] BILLING CODE 6560–50–P 45 CFR Part 156 [CMS–9943–IFC] RIN 0938–AS28 Patient Protection and Affordable Care Act; Third Party Payment of Qualified Health Plan Premiums Centers for Medicare and Medicaid Services, Department of Health and Human Services (HHS). ACTION: Interim final rule with comment period. AGENCY: This interim final rule requires issuers of qualified health plans (QHPs), including stand-alone dental plans (SADPs), to accept premium and cost-sharing payments made on behalf of enrollees by the Ryan White HIV/ AIDS Program, other Federal and State government programs that provide premium and cost sharing support for specific individuals, and Indian tribes, tribal organizations, and urban Indian organizations. SUMMARY: Effective Date: This interim final rule is effective on March 14, 2014. Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on May 13, 2014. ADDRESSES: In commenting, please refer to file code CMS–9943–IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit DATES: E:\FR\FM\19MRR1.SGM 19MRR1

Agencies

[Federal Register Volume 79, Number 53 (Wednesday, March 19, 2014)]
[Rules and Regulations]
[Pages 15235-15240]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06059]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0796; FRL-9907-25]


Ipconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
ipconazole in or on vegetable, legume, group 6. Chemtura Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective March 19, 2014. Objections and 
requests for hearings must be received on or before May 19, 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-2012-0796, 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), EPA West 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,

[[Page 15236]]

DC 20460-0001; 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-2012-0796 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 
May 19, 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-2012-0796, 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 December 19, 2012 (77 FR 75082) (FRL-
9372-6), 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 
2F8076) by Chemtura Corporation, 199 Benson Rd., Middlebury, CT 06749. 
The petition requested that 40 CFR 180.646 be amended by establishing 
tolerances for residues of the fungicide ipconazole (2-[(4-
chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol) in or on legume vegetables, succulent or dried, 
crop group 6 at 0.01 parts per million (ppm). That document referenced 
a summary of the petition prepared by Chemtura Corporation, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for ipconazole including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with ipconazole 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. Ipconazole has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. It causes low to mild irritation to the 
eyes and skin; it is not a dermal sensitizer. Ipconazole may cause 
local, portal-of-entry irritation via all routes following repeated 
exposure. Systemic effects that were noted in dogs, mice, rabbits and/
or rats following exposure to ipconazole were generally limited to 
decreased body weight, body weight gain, and food consumption; and 
liver and kidney effects. Developmental effects were observed only at 
the maternally-toxic dose. No consistent evidence of neurotoxicity was 
observed following acute, subchronic, or chronic dosing in multiple 
species in the available ipconazole database and the triazole 
fungicides as a group typically show either no evidence of 
neurotoxicity or neurotoxicity at doses significantly higher than the 
regulatory points of departure. Ipconazole is classified as not likely 
to be a human carcinogen and there is no concern for mutagenicity. 
Specific information on the studies received and the nature of the 
adverse effects caused by ipconazole 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 ``Revised Ipconazole Human Health Risk 
Assessment of the Proposed Use on

[[Page 15237]]

Legume Vegetables (Crop Group 6)'' on page 23 in docket ID number EPA-
HQ-OPP-2012-0796.

B. Toxicological Points of Departure (POD)/Levels of Concern (LOC)

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological POD and LOC to use in evaluating the risk 
posed by human exposure to the pesticide. For hazards that have a 
threshold below which there is no appreciable risk, the toxicological 
POD is used as the basis for derivation of reference values for risk 
assessment. PODs are developed based on a careful analysis of the doses 
in each toxicological study to determine the dose at which no adverse 
effects are observed (the NOAEL) and the lowest dose at which adverse 
effects of concern are identified (the LOAEL). Uncertainty/safety 
factors (SF) 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 ipconazole used for 
human risk assessment is shown in the following Table of this unit.

   Table--Summary of Toxicological Doses and Endpoints for Ipconazole 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 (females 13-50       NOAEL = 10 mg/kg/day  Acute RfD = 0.1 mg/  Co-critical developmental toxicity
 years of age).                    UFA = 10x...........   kg/day               studies in rats and rabbits.
                                   UFH = 10x...........  aPAD = 0.1 mg/kg/    LOAELrats = 30 mg/kg/day, based on
                                   FQPA SF = 1x........   day.                 increased visceral and skeletal
                                                                               variations.
                                                                              LOAELrabbits = 50 mg/kg/day, based
                                                                               on increased incidence of
                                                                               skeletal variations and
                                                                               malformations.
Acute dietary (general population  No appropriate
 including infants and children).   endpoint
                                    attributable to a
                                    single dose of
                                    ipconazole was
                                    identified for this
                                    population.
Chronic dietary (all populations)  NOAEL= 1.5 mg/kg/day  Chronic RfD = 0.015  Chronic toxicity study in dogs.
                                   UFA = 10x...........   mg/kg/day           LOAEL = 5 mg/kg/day, based on skin
                                   UFH = 10x...........  cPAD = 0.015 mg/kg/   reddening (both sexes) and
                                   FQPA SF = 1x........   day.                 decreased body weight gain in
                                                                               females.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  No evidence of carcinogenicity. Classification: Not likely to be a human
                                    carcinogen, based on two adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). 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 ipconazole, EPA considered exposure under the petitioned-
for tolerances as well as all existing ipconazole tolerances in 40 CFR 
180.646. EPA assessed dietary exposures from ipconazole 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 acute endpoint attributable to a single exposure and relevant 
for the general population was identified in the toxicity database for 
ipconazole. A developmental endpoint suitable for acute assessment was 
identified; therefore an acute dietary assessment was performed only 
for women of child-bearing age (females 13-49 years old). In estimating 
acute dietary exposure, EPA used the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database, Version 3.16 (DEEM-
FCID), which uses food consumption information from the U.S. Department 
of Agriculture (USDA) 2003-2008 National Health and Nutrition 
Examination Surveys of What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA assumed tolerance level residues and 100% 
crop treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
National Health and Nutrition Examination Surveys of What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA used 
tolerance level residues and assumed 100% crop treated.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that ipconazole is not a likely carcinogen. Therefore, a 
dietary exposure assessment for the purpose of assessing cancer risk is 
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for ipconazole. Tolerance level residues and/or 100% 
crop treated 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 ipconazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/

[[Page 15238]]

transport characteristics of ipconazole. 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 Pesticide Root Zone Model Ground Water (PRZM 
GW) models, the estimated drinking water concentrations (EDWCs) of 
ipconazole for acute exposures are estimated to be 0.173 parts per 
billion (ppb) for surface water and 1.01 ppb for ground water.
    The EDWCs of ipconazole for chronic exposures for non-cancer 
assessments are estimated to be 0.105 ppb for surface water and 0.822 
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 1.01 ppb was used to 
assess the contribution from drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.822 ppb was used to 
assess the contribution from drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Ipconazole is not 
registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Ipconazole is a member of the conazole class of pesticides. 
Although conazoles act similarly in plants by inhibiting ergosterol 
biosynthesis, there is not necessarily a relationship between their 
pesticidal activity and their mechanism of toxicity in mammals. 
Structural similarities do not constitute a common mechanism of 
toxicity. Evidence is needed to establish that the chemicals operate by 
the same, or essentially the same, sequence of major biochemical events 
(EPA, 2002). In conazoles, however, a variable pattern of toxicological 
responses is found; some are hepatotoxic and hepatocarcinogenic in 
mice. Some induce thyroid tumors in rats. Some induce developmental, 
reproductive, and neurological effects in rodents. Furthermore, the 
conazoles produce a diverse range of biochemical events, including 
altered cholesterol levels, stress responses, and altered DNA 
methylation. It is not clearly understood whether these biochemical 
events are directly connected to their toxicological outcomes. Thus, 
there is currently no conclusive data to indicate that conazoles share 
common mechanisms of toxicity and EPA is not following a cumulative 
risk approach based on a common mechanism of toxicity for the 
conazoles. For information regarding EPA's procedures for cumulating 
effects from substances found to have a common mechanism of toxicity, 
see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
    Ipconazole is a triazole-derived pesticide. This class of compounds 
can form the common metabolite 1,2,4-triazole and three triazole 
conjugates (triazolylalanine, triazolylacetic acid, and 
triazolylpyrivic acid). To support existing tolerances and to establish 
new tolerances for triazole-derivative pesticides, including 
ipconazole, U.S. EPA conducted a human health risk assessment for 
exposure to 1,2,4-triazole, triazolylalanine, and triazolylacetic acid 
resulting from the use of all current and pending uses of any triazole-
derived fungicide. The risk assessment is a highly conservative, 
screening-level evaluation in terms of hazards associated with common 
metabolites (e.g., use of a maximum combination of uncertainty factors) 
and potential dietary and non-dietary exposures (i.e., high end 
estimates of both dietary and non-dietary exposures). In addition, the 
Agency retained the additional 10x FQPA SF for the protection of 
infants and children. The assessment includes evaluations of risks for 
various subgroups, including those comprised of infants and children. 
The Agency's complete risk assessment is found in the propiconazole 
reregistration docket at http://www.regulations.gov, Docket 
Identification (ID) Number EPA-HQ-OPP-2005-0497.
    An updated dietary exposure and risk analysis for the common 
triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA), 
triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was 
conducted completed in May 2013, in association with a registration 
request for several other triazole fungicides. That analysis concluded 
that risk estimates were below the Agency's level of concern for all 
population groups. After inclusion of ipconazole uses covered by this 
action, aggregate risk estimates for T, TA, TAA, and TP for all 
durations of exposure and for all population subgroups are below the 
Agency's level of concern. This updated assessment may be found on 
http://www.regulations.gov by searching for the following title and 
docket number: ``Common Triazole Metabolites: Updated Aggregate Human 
Health Risk Assessment to Address The New Section 3 Registrations For 
Use of Prothioconazole on Bushberry Crop Subgroup 13-07B, Low Growing 
Berry, Except Strawberry, Crop Subgroup 13-07H, and Cucurbit Vegetables 
Crop Group 9; Use of Flutriafol on Coffee; and Ipconazole on Crop Group 
6'' (located in docket ID number EPA-HQ-OPP-2012-0876).

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 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. Offspring effects only 
occurred in the presence of maternal toxicity and were not considered 
more severe than the parental effects. Therefore, EPA concluded that 
there is no quantitative or qualitative evidence of increased 
susceptibility to rat or rabbit fetuses exposed in utero and/or post-
natally to ipconazole.
    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 ipconazole is complete. The Agency 
waived the requirement for an Immunotoxicity study for ipconazole as 
there is minimal evidence that ipconazole targets the immune system, 
nor are the conazoles of a chemical class expected to have an adverse 
effect on the immune system. An increase in leukocytes was observed in 
females at 78.3 mg/kg/day in the 28-day inhalation study, however this 
was not of concern because it was the only evidence of potential 
immunotoxicity in

[[Page 15239]]

the entire ipconazole database, the effect occurred at a dose 10-fold 
higher than the dose (7.8 mg/kg/day) that caused portal-of-entry 
effects in the same study, and the effect occurred at a dose much 
greater than the PODs chosen for risk assessment. The overall weight of 
evidence suggests that ipconazole does not target the immune system.
    ii. There is no consistent evidence of neurotoxicity in the 
available databases. Clinical signs suggestive of neurotoxicity were 
observed in the in vivo mammalian cytogenetics study; however, they 
were seen at relatively high doses, which far exceed the anticipated 
dietary exposure, and no other signs were observed in any of the other 
studies, including studies with neurotoxicity assessments. Based on the 
lack of evidence in the database, EPA waived the requirement for the 
acute neurotoxicity study. Also, the subchronic neurotoxicity study 
requirement is considered to be satisfied by the neurotoxicity 
assessments performed in both the rat subchronic and chronic toxicity/
carcinogenicity studies in which no signs of neurotoxicity were 
observed. This is consistent with what is known about the triazole 
fungicides as a class, which typically show either no evidence of 
neurotoxicity or neurotoxicity at doses significantly higher than the 
regulatory points of departure. Therefore, ipconazole is not considered 
to be neurotoxic and there is no need for a developmental neurotoxicity 
study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that ipconazole results in increased 
susceptibility following in utero exposure for rats or rabbits in the 
prenatal developmental studies or in young rats in the 2-generation 
reproduction study, and there are no residual uncertainties with 
respect to pre- or postnatal exposure.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to ipconazole in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by ipconazole.

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 exposure estimates from acute dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
ipconazole will occupy <1% of the aPAD for females 13-49 years old, the 
population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
ipconazole from food and water will utilize <1% of the cPAD for 
children 1-2 years old the population group receiving the greatest 
exposure. There are no residential uses for ipconazole.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    A short-term adverse effect was identified; however, ipconazole is 
not registered for any use patterns that would result in short-term 
residential exposure. Because there is no short-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess short-term risk), no further assessment of 
short-term risk is necessary, and EPA relies on the chronic dietary 
risk assessment for evaluating short-term risk for ipconazole.
    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, 
ipconazole is not registered for any use patterns that would result in 
intermediate-term residential 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 ipconazole.
    5. Aggregate cancer risk for U.S. population. Ipconazole has been 
classified as not likely to be carcinogenic, and 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 ipconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectrometry/mass spectrometry (LC/MS/MS) (AC/3020)) 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 ipconazole on vegetable, 
legume, group 6.

C. Revisions to Petitioned-for Tolerances

    The petitioner requested a tolerance for residues of ipconazole in 
or on ``legume vegetables succulent or dried, crop group 6''. EPA is 
correcting the commodity term and establishing a tolerance for 
``vegetable, legume, group 6''.

V. Conclusion

    Therefore, tolerances are established for residues of ipconazole 
(2-[(4-chlorophenyl)methyl]-5-(1-

[[Page 15240]]

methylethyl)-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol) in or on 
vegetable, legume, group 6 at 0.01 ppm. EPA is revising the tolerance 
expression for ipconazole to clarify that metabolites and degradates 
are covered by the tolerances and to specify how compliance with the 
tolerances is to be measured. The existing tolerances for pea and bean, 
dried shelled, except soybean, subgroup 6C at 0.01 ppm and soybean, 
seed at 0.01 ppm will be removed from paragraph (a) of Sec.  180.646 as 
these tolerances are encompassed within vegetable, legume, group 6.

VI. Statutory and Executive Order Reviews

    This final rule 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 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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This 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: March 12, 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.  180.646:
0
a. Revise the introductory text in paragraph (a).
0
b. Remove ``Pea and bean, dried shelled, except soybean, subgroup 6C'', 
and ``Soybean, seed'' from the table in paragraph (a).
0
c. Add alphabetically ``Vegetable, legume, group 6'' to the table in 
paragraph (a).
    The amendments read as follows:


Sec.  180.646  Ipconazole; tolerances for residues.

    (a) General. Tolerances are established for residues of ipconazole, 
including its metabolites and degradates, in or on the commodities 
listed in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only ipconazole (2-
[(4-chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol) in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Vegetable, legume, group 6..............................            0.01
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-06059 Filed 3-18-14; 8:45 am]
BILLING CODE 6560-50-P