Etoxazole; Pesticide Tolerance, 72958-72963 [E7-24983]

Download as PDF 72958 Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Rules and Regulations have sold under this section for each TABLE 2 OF § 89.102.—CORRESPONDING TIER 3 AND TIER POWER CATEGORIES Tier 3 power categories 37≤kW<75* ........................... 37≤kW<75**, 75≤kW<130 .... 130≤kW<225, 225≤kW<450, 450≤kW<560. 4 power category. You may omit the Tier 4 power categories 19≤kW<56 56≤kW<130 130≤kW≤560 mstockstill on PROD1PC66 with RULES * Applies only to use of engines rated between 37kW and 56kW by small volume equipment manufacturers. ** Includes only equipment that uses engines with a rated power greater than 56kw. (iv) Manufacturers using allowances under this paragraph (i) must comply with the notification and reporting requirements specified in paragraph (i)(7) of this section. (7) Notification and reporting. You must notify us of your intent to use the technical relief provisions of this paragraph (i) and send us an annual report to verify that you are not exceeding the allowances, as follows: (i) Before the first year you intend to use the provisions of this section, send the Designated Compliance Officer and the Designated Enforcement Officer a written notice of your intent, including: (A) Your company’s name and address, and your parent company’s name and address, if applicable. (B) Whom to contact for more information. (C) The calendar years in which you expect to use the exemption provisions of this section. (D) The name and address of the company that produces the engines you will be using for the equipment exempted under this section. (E) Your best estimate of the number of units in each power category you will produce under this section and whether you intend to comply under paragraph (d)(1) or (d)(2) of this section. (F) The number of units in each power category you have sold in previous calendar years under paragraph (d) of this section. (ii) For each year that you use the provisions of this section, send the Designated Compliance Officer and the Designated Enforcement Officer a written report by March 31 of the following year. Include in your report the total number of engines you sold in the preceding year for each power category, based on actual U.S.-directed production information. Also identify the percentages of U.S.-directed production that correspond to the number of units in each power category and the cumulative numbers and percentages of units for all the units you VerDate Aug<31>2005 18:48 Dec 21, 2007 Jkt 214001 percentage figures if you include in the report a statement that you will not be using the percent-of-production allowances in paragraph (d) of this section. (8) Recordkeeping. Keep the following records of all equipment with exempted engines you produce under this paragraph (i) for at least five full years after the final year in which allowances are available for each power category: (i) The model number, serial number, and the date of manufacture for each engine and piece of equipment. (ii) The maximum power of each engine. (iii) The total number or percentage of equipment with exempted engines, as described in paragraph (d) of this section and all documentation supporting your calculation. (iv) The notifications and reports we require under paragraph (i)(7) of this section. (9) Equipment Labeling. Any engine produced under this paragraph (i) must meet the labeling requirements of 40 CFR 89.110, but add the following statement instead of the compliance statement in 40 CFR 89.110 (b)(10): THIS ENGINE MEETS U.S. EPA EMISSION STANDARDS UNDER 40 CFR 89.102. SELLING OR INSTALLING THIS ENGINE FOR ANY PURPOSE OTHER THAN FOR THE EQUIPMENT FLEXIBILITY PROVISIONS OF 40 CFR 89.102 MAY BE A VIOLATION OF FEDERAL LAW SUBJECT TO CIVIL PENALTY. (10) Enforcement. Producing more exempted engines or equipment than we allow under this paragraph (i) or installing engines that do not meet the applicable Tier 1 emission standards described in § 89.112 violates the prohibitions in § 89.1003(a)(1). You must give us the records we require under this paragraph (i) if we ask for them (see § 89.1003(a)(2)). [FR Doc. E7–24976 Filed 12–21–07; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0309; FRL–8342–8] Etoxazole; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for residues of etoxazole in or PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 on cherry; hop, dried cones; and vegetable, cucurbit subgroup 9A. The Interregional Research Project No. 4 (IR– 4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation is effective December 26, 2007. Objections and requests for hearings must be received on or before February 25, 2008, 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: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–0309. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–7610; e-mail address: jackson.sidney@epa.gov. DATES: 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. Potentially affected entities may include, but are E:\FR\FM\26DER1.SGM 26DER1 Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Rules and Regulations not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. mstockstill on PROD1PC66 with RULES B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http://www.gpoaccess.gov/ ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 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–2007–0309 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 25, 2008. VerDate Aug<31>2005 18:48 Dec 21, 2007 Jkt 214001 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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA– HQ–OPP–2007– 0309, by one of the following methods: • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Petition for Tolerance In the Federal Register of June 27, 2007 (72 FR 35237) (FRL–8133–4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E7150) by the IR–4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.593 be amended by establishing a tolerance for residues of the insecticide etoxazole, 2(2,6-difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]-4,5dihydrooxazole, in or on cherry at 0.70 parts per million (ppm), hops, dried cones, at 7.0 ppm, and melon subgroup 9A at 0.15 ppm. That notice referenced a summary of the petition prepared by Valent U.S.A. Corporation, the registrant, which is available to the public in the docket, http:// www.regulations.gov. There were no comments received in response to the notice of filing. Based upon current data supporting the petition, EPA has corrected the commodity definition and revised proposed tolerance levels as follows: 1. For commodity cherry, a revised tolerance at 1.0 ppm from 0.70 ppm; and PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 72959 2. For the melon subgroup, the crop definition has been changed from ‘‘melon subgroup 9A’’ to ‘‘vegetable, cucurbit subgroup 9A’’ and the tolerance revised from 0.15 to 0.20 ppm. 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....’’ These provisions were added to FFDCA by the Food Quality Protection Act (FQPA) of 1996. 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 the petitioned-for tolerance for residues of in or on cherry, sweet at 0.60 ppm, cherry, tart at 0.20 ppm, hop, dried cones, at 5.0 ppm, and vegetable, cucurbit subgroup 9A at 0.15 ppm. EPA’s assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by etoxazole as well as the no-observedadverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can E:\FR\FM\26DER1.SGM 26DER1 72960 Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Rules and Regulations be found at http://www.regulations.gov. The referenced document is available in the docket established by this action, which is described under Docket #: EPA–HQ–OPP–2007–0309 and is identified in that docket as PP 6E7150; Revised: Etoxazole in/on Cherries, Hops, and Melon Subgroup 9A; Health Effects Division (HED) Risk Assessment. mstockstill on PROD1PC66 with RULES B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/ safety factors (UFs) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA–PEST/1997/ November/Day-26/p30948.htm. A summary of the toxicological endpoints for etoxazole used for human risk assessment can be found at http:// www.regulations.gov in document PP#: 6E7150. Revised: Etoxazole in/on Cherries, Hops, and Melon Subgrou 9A. Health Effects Division (HED) Risk Assessment in docket ID number EPA– HQ–OPP–2007–0309. VerDate Aug<31>2005 18:48 Dec 21, 2007 Jkt 214001 C. Exposure Assessment Dietary exposure from food and feed uses. In evaluating dietary exposure to etoxazole, EPA considered exposure under the petitioned-for tolerances as well as all existing etoxazole tolerances in (40 CFR 180.593 EPA assessed dietary exposures from etoxazole 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. An endpoint of concern attributable to a single oral dose was not selected for either the general U.S. population (including infants and children) or the females 13–50 years old population subgroup for etoxazole. The EPA evaluated the suitability of the developmental toxicity study in rabbits in which the developmental NOAEL of 200 mg/kg/day is based upon increased incidences of 27 presacral vertebrae and 27 presacral vertebrae with 13th ribs (skeletal variations) in the fetuses at the LOAEL of 1,000 mg/kg/day (limit dose). Although these developmental effects may be attributed to a single dose, the EPA concluded that etoxazole is unlikely to pose an acute risk because these effects are minor in magnitude and were observed only at the limit dose (1000 mg/kg/day). Therefore, an acute dietary exposure assessment was not performed . ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used DEEM-FCID, Version 2.03), which incorporates consumption data from United States Department of Agriculture’s (USDA’s) Continuing Surveys of Food Intakes by Individuals (CSFII), 1994–1996 and 1998. The 1994– 96, 1998 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days. Foods ‘‘as consumed’’ (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. Consumption data are averaged for the entire U.S. population and within population subgroups for chronic exposure assessment. An unrefined, chronic dietary exposure assessment was conducted for the general U.S. population and various population subgroups using EPAcalculated residues of concern (parent and metabolites) for livestock PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 commodities and tolerance-level residues for all other commodities. For all registered and proposed uses, 100% crop treated (CT) information was used, as well as DEEM 7.81 default processing factors for all commodities other than apple and grape (apple and grape residue data showed that there was no concentration in processed commodities; therefore; these default values were set to 1). iii. Cancer. EPA classified etoxazole as ‘‘not likely to be carcinogenic to humans’’. This decision was based on the lack of carcinogenicity in two studies in mice, lack of carcinogenicity in one study in rats, and the lack of hormonal and reproductive effects in special studies. Etoxozole is not a mutagen. Therefore, an exposure assessment related to cancer risk was not performed. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for etoxazole in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of etoxazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/ models/water/index.htm. The Agency conducted Tier 1 estimated drinking water concentrations (EDWCs) for etoxazole in assessing water exposure. Environmental fate data indicate that parent (etoxazole) has low mobility and relatively low persistence in soil. The major route of degradation based on the label use pattern will likely be aerobic soil degradation. Based on the aerobic soil metabolism study, Metabolite R–8 was found as a major degradate in 4 out of 5 soils tested, with a maximum of 38% of the applied dose. Metabolite R–8 is mobile and relatively persistent and could be available for runoff and leaching for periods of up to months. Metabolite R–13 was also found as a major degradate in 3 out of 5 soils tested, with a maximum of 30.0% (at 62 days) in an aerobic soil metabolism study. Based on submitted mobility data, Metabolite R–13 appears to be immobile. The Agency believes that metabolites R–8 and R–13 are likely to have similar toxicity to the parent; and, therefore, should be included in the drinking water assessment. Metabolites R–4 and R–7 were also found in aerobic soil dissipation studies, but less frequently. EPA concluded that the E:\FR\FM\26DER1.SGM 26DER1 mstockstill on PROD1PC66 with RULES Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Rules and Regulations inclusion of Metabolite R–8 should cover the exposure from R–4 and R–7. In summary, the Agency finds that for drinking water risk assessment, the residues of concern are parent, Metabolite R–8, and Metabolite R–13. FQPA Index Reservoir Screening Tool (FIRST) and Screening Concentrations In Ground Water (SCI-GROW) models were used to calculate the chronic surface water and groundwater EDWCs (parent and metabolites), respectively. Drinking water was incorporated directly in the dietary assessment using the acute concentration for surface water generated by the FIRST model. Tier 1 EDWCs results for etoxazole and metabolites R–8 and R–13 show annual average surface water concentrations of 0.332 parts per billion (ppb), 0.913 ppb and 0.0285 ppb, respectively. Tier 1 EDWCs results for etoxazole and metabolites R–8 and R–13 show ground water concentrations of 0.00173ppb, 0.316 ppb and 0.000322 ppb, respectively. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the total sum of the annual average surface water concentrations for etoxazole and metabolites R–8 and R–13 of 1.27 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). Etoxazole is not registered for use in or on any sites 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.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to etoxazole and any other substances and etoxazole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that etoxazole has a common mechanism of toxicity with other substances. For information regarding VerDate Aug<31>2005 18:48 Dec 21, 2007 Jkt 214001 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 website at http:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (‘‘10X’’) tenfold 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 safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. No quantitative or qualitative evidence of increased susceptibility was seen following in utero exposure to rats or rabbits in developmental studies. Offspring toxicity was more severe (pup mortality) than maternal toxicity (increased liver and adrenal weights) at the same dose in the rat reproduction study. Since there is qualitative evidence of increased susceptibility following exposure to etoxazole in the rat reproduction study, the EPA performed a Degree-of-Concern Analysis to: i. Determine the LOC for the effects observed when considered in the context of all available toxicity data; and ii. Identify any residual uncertainties after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment of this chemical. There is evidence of increased qualitative susceptibility in the rat reproduction study, but the concern is low since: a. The effects in pups are wellcharacterized with a clear NOAEL; b. The pup effects occur at the same dose as maternal toxicity; and, c. The doses selected for various risk assessment scenarios are lower than the doses that caused off spring toxicity. Therefore, there are no residual uncertainties for pre-/post-natal toxicity in this study. 3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 72961 the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for etoxazole is complete for FQPA assessment. ii. There is no indication that etoxazole is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. No quantitative or qualitative evidence of increased susceptibility was seen following in utero exposure to rats or rabbits in developmental studies. Although there is qualitative evidence of increased susceptibility in the rat reproduction study, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of etoxazole. The degree of concern for prenatal and/or postnatal toxicity is low. iv. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessment utilizes EPA-calculated residues of concern (parent and metabolites) for livestock commodities; tolerance-level residues for other commodities; and 100% crop treated (CT) information for all proposed uses. By using these screening-level assumptions, actual exposures/risks will not be underestimated. The dietary drinking water assessment utilized modeling results which included conservative assumptions for the parent and all degradates of concern. Conservative assumptions were used in the water models. Therefore, the water exposure assessment will not underestimate the potential risks for infant and children. v. There are no registered or proposed residential uses for etoxazole. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediateterm, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. Acute risk. An acute aggregate risk assessment was not performed because an endpoint of concern attributable to a single oral dose was not selected for any population subgroup (including infants E:\FR\FM\26DER1.SGM 26DER1 72962 Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Rules and Regulations and children). No acute risk is expected from exposure to etoxazole. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to etoxazole from food and water will utilize 8.3% of the cPAD for children 1–2 years old, the most highly exposed population subgroup. There are no residential uses for etoxazole that result in chronic residential exposure to etoxazole. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Etoxazole is not registered or proposed for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency’s LOC. 4. Aggregate cancer risk for U.S. population. A cancer aggregate risk assessment was not performed because etoxazole is not carcinogenic. Etoxazole is not expected to pose a cancer risk to humans. 5. 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 etoxazole residues. IV. Other Considerations mstockstill on PROD1PC66 with RULES A. Analytical Enforcement Methodology Adequate enforcement methodology is available to enforce the tolerance expression. The following analytical enforcement methods have been validated: The gas chromatography/mass-selective detector (GC/MSD) method used to determine etoxazole residues in/on cherry matrices is a slightly modified version of a previously-validated method (Method RM–37HM). The validated limit of quantitation (LOQ) was 0.0037 ppm and the limit of detection (LOD) was 0.0012 ppm for etoxazole in/on cherries. The GC with nitrogen-phosphorus detector (NPD) method used to determine etoxazole residues in/on hop matrices is a modified version of a previouslyvalidated method (Method RM–37). The validated LOQ was 0.2 ppm and the LOD was 0.1 ppm for etoxazole in/on dried hop cones.The nitrogenphosphorus specific flame-ionization detector (NPD) method used to determine etoxazole residues in/on VerDate Aug<31>2005 18:48 Dec 21, 2007 Jkt 214001 cantaloupe matrices is a slightly modified version of a previouslyvalidated method (Method RM–37). The validated LOQ was 0.0046 ppm and the LOD was 0.0015 ppm for etoxazole in/ on cantaloupe. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755– 5350; telephone number: (410) 305– 2905; e-mail address: residuemethods@epa.gov. B. International Residue Limits There are no established or proposed Codex, Canadian or Mexican maximum residue limits (MRLs) for etoxazole. Therefore, tolerances are established for residues of the insecticide etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]-4,5dihydrooxazole, in or on cherry at 1.0 ppm, hop, dried cones at 7.0 ppm, and vegetable, cucurbit subgroup 9A at 0.20 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA 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 rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, 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 section 408(d) of FFDCA, 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, PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 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 section 408(n)(4) of FFDCA. 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 6, 2000) do not apply to this rule. In addition, This 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) (Public Law 104–4). 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), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal Register. This final rule 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: December 14, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I E:\FR\FM\26DER1.SGM 26DER1 Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Rules and Regulations identification (ID) number EPA–HQ– OPP–2007–0545. To access the I 1. The authority citation for part 180 electronic docket, go to http:// continues to read as follows: www.regulations.gov, select ‘‘Advanced Authority: 21 U.S.C. 321(q), 346a and 371. Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated I 2. Section 180.593 is amended by and select the ‘‘Submit’’ button. Follow alphabetically adding the following the instructions on the regulations.gov commodities to the table in paragraph website to view the docket index or (a) to read as follows: access available documents. All § 180.593 Etoxazole; tolerances for documents in the docket are listed in residues. the docket index available in (a) * * * regulations.gov. Although listed in the index, some information is not publicly Commodity Parts per million available, e.g., Confidential Business Information (CBI) or other information * * * * * Cherry ............................. 1.0 whose disclosure is restricted by statute. Certain other material, such as * * * * * Hop, dried cones ............ 7.0 copyrighted material, is not placed on * * * * * the Internet and will be publicly Vegetable, cucurbit subavailable only in hard copy form. group 9A ..................... 0.20 Publicly available docket materials are available in the electronic docket at * * * * * http://www.regulations.gov, or, if only [FR Doc. E7–24983 Filed 12–21–07; 8:45 am] available in hard copy, at the OPP BILLING CODE 6560–50–S Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The ENVIRONMENTAL PROTECTION Docket Facility is open from 8:30 a.m. AGENCY to 4 p.m., Monday through Friday, excluding legal holidays. The Docket 40 CFR Part 180 Facility telephone number is (703) 305– [EPA–HQ–OPP–2007–0545; FRL–8342–1] 5805. FOR FURTHER INFORMATION CONTACT: Aspergillus Flavus AF36 on Corn; Shanaz Bacchus, Biopesticides and Temporary Exemption From the Pollution Prevention Division (7511P), Requirement of a Tolerance Office of Pesticide Programs, Environmental Protection Agency, 1200 AGENCY: Environmental Protection Pennsylvania Ave., NW., Washington, Agency (EPA). DC 20460–0001; telephone number: ACTION: Final rule. (703) 308–8097; e-mail address: SUMMARY: This regulation establishes a bacchus.shanaz@epa.gov. temporary exemption from the SUPPLEMENTARY INFORMATION: requirement of a tolerance for residues I. General Information of the Aspergillus flavus AF36 on corn when applied/used before corn tasseling A. Does this Action Apply to Me? occurs. Arizona Cotton Research and You may be potentially affected by Protection Council submitted a petition this action if you are an agricultural to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended producer, food manufacturer, or pesticide manufacturer. Potentially by the Food Quality Protection Act of affected entities may include, but are 1996 (FQPA), requesting the temporary not limited to: tolerance exemption. This regulation • Crop production (NAICS code 111). eliminates the need to establish a • Animal production (NAICS code maximum permissible level for residues 112). of Aspergillus flavus AF36. The • Food manufacturing (NAICS code temporary tolerance exemption expires 311). on December 31, 2011. • Pesticide manufacturing (NAICS DATES: This regulation is effective code 32532). December 26, 2007. Objections and This listing is not intended to be requests for hearings must be received exhaustive, but rather provides a guide on or before February 25, 2008, and for readers regarding entities likely to be must be filed in accordance with the affected by this action. Other types of instructions provided in 40 CFR part entities not listed in this unit could also 178 (see also Unit I.C. of the be affected. The North American SUPPLEMENTARY INFORMATION). Industrial Classification System ADDRESSES: EPA has established a (NAICS) codes have been provided to docket for this action under docket assist you and others in determining mstockstill on PROD1PC66 with RULES PART 180—[AMENDED] VerDate Aug<31>2005 18:48 Dec 21, 2007 Jkt 214001 PO 00000 Frm 00065 Fmt 4700 Sfmt 4700 72963 whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in section 5 of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the regulations promulgated to carry out that provision of FIFRA (40 CFR part 172). If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this ‘‘Federal Register’’ document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http:// www.gpoaccess.gov/ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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–2007–0545 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 25, 2008. 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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA–HQ–OPP–2007–0545, by one of the following methods. • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the on-line instructions for submitting comments. E:\FR\FM\26DER1.SGM 26DER1

Agencies

[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Rules and Regulations]
[Pages 72958-72963]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24983]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0309; FRL-8342-8]


Etoxazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
etoxazole in or on cherry; hop, dried cones; and vegetable, cucurbit 
subgroup 9A. The Interregional Research Project No. 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective December 26, 2007. Objections and 
requests for hearings must be received on or before February 25, 2008, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0309. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: jackson.sidney@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. 
Potentially affected entities may include, but are

[[Page 72959]]

not limited to those engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0309 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before February 25, 2008.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007- 0309, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6E7150) by the IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.593 be amended by 
establishing a tolerance for residues of the insecticide etoxazole, 2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on cherry at 0.70 parts per million (ppm), hops, 
dried cones, at 7.0 ppm, and melon subgroup 9A at 0.15 ppm. That notice 
referenced a summary of the petition prepared by Valent U.S.A. 
Corporation, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon current data supporting the petition, EPA has corrected 
the commodity definition and revised proposed tolerance levels as 
follows:
    1. For commodity cherry, a revised tolerance at 1.0 ppm from 0.70 
ppm; and
    2. For the melon subgroup, the crop definition has been changed 
from ``melon subgroup 9A'' to ``vegetable, cucurbit subgroup 9A'' and 
the tolerance revised from 0.15 to 0.20 ppm.

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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    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 the petitioned-for tolerance 
for residues of in or on cherry, sweet at 0.60 ppm, cherry, tart at 
0.20 ppm, hop, dried cones, at 5.0 ppm, and vegetable, cucurbit 
subgroup 9A at 0.15 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by etoxazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can

[[Page 72960]]

be found at http://www.regulations.gov. The referenced document is 
available in the docket established by this action, which is described 
under Docket : EPA-HQ-OPP-2007-0309 and is identified in that 
docket as PP 6E7150; Revised: Etoxazole in/on Cherries, Hops, and Melon 
Subgroup 9A; Health Effects Division (HED) Risk Assessment.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-term, intermediate-term, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for etoxazole used for 
human risk assessment can be found at http://www.regulations.gov in 
document PP: 6E7150. Revised: Etoxazole in/on Cherries, Hops, 
and Melon Subgrou 9A. Health Effects Division (HED) Risk Assessment in 
docket ID number EPA-HQ-OPP-2007-0309.

C. Exposure Assessment

    Dietary exposure from food and feed uses. In evaluating dietary 
exposure to etoxazole, EPA considered exposure under the petitioned-for 
tolerances as well as all existing etoxazole tolerances in (40 CFR 
180.593 EPA assessed dietary exposures from etoxazole 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.
    An endpoint of concern attributable to a single oral dose was not 
selected for either the general U.S. population (including infants and 
children) or the females 13-50 years old population subgroup for 
etoxazole. The EPA evaluated the suitability of the developmental 
toxicity study in rabbits in which the developmental NOAEL of 200 mg/
kg/day is based upon increased incidences of 27 presacral vertebrae and 
27 presacral vertebrae with 13th ribs (skeletal variations) in the 
fetuses at the LOAEL of 1,000 mg/kg/day (limit dose). Although these 
developmental effects may be attributed to a single dose, the EPA 
concluded that etoxazole is unlikely to pose an acute risk because 
these effects are minor in magnitude and were observed only at the 
limit dose (1000 mg/kg/day). Therefore, an acute dietary exposure 
assessment was not performed .
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used DEEM-FCID, Version 2.03), which incorporates 
consumption data from United States Department of Agriculture's 
(USDA's) Continuing Surveys of Food Intakes by Individuals (CSFII), 
1994-1996 and 1998. The 1994-96, 1998 data are based on the reported 
consumption of more than 20,000 individuals over two non-consecutive 
survey days. Foods ``as consumed'' (e.g., apple pie) are linked to EPA-
defined food commodities (e.g. apples, peeled fruit - cooked; fresh or 
N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using 
publicly available recipe translation files developed jointly by USDA/
ARS and EPA. Consumption data are averaged for the entire U.S. 
population and within population subgroups for chronic exposure 
assessment.
    An unrefined, chronic dietary exposure assessment was conducted for 
the general U.S. population and various population subgroups using EPA-
calculated residues of concern (parent and metabolites) for livestock 
commodities and tolerance-level residues for all other commodities. For 
all registered and proposed uses, 100% crop treated (CT) information 
was used, as well as DEEM 7.81 default processing factors for all 
commodities other than apple and grape (apple and grape residue data 
showed that there was no concentration in processed commodities; 
therefore; these default values were set to 1).
    iii. Cancer. EPA classified etoxazole as ``not likely to be 
carcinogenic to humans''. This decision was based on the lack of 
carcinogenicity in two studies in mice, lack of carcinogenicity in one 
study in rats, and the lack of hormonal and reproductive effects in 
special studies. Etoxozole is not a mutagen. Therefore, an exposure 
assessment related to cancer risk was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for etoxazole in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
etoxazole. Further information regarding EPA drinking water models used 
in pesticide exposure assessment can be found at http://www.epa.gov/
oppefed1/models/water/index.htm.
    The Agency conducted Tier 1 estimated drinking water concentrations 
(EDWCs) for etoxazole in assessing water exposure. Environmental fate 
data indicate that parent (etoxazole) has low mobility and relatively 
low persistence in soil. The major route of degradation based on the 
label use pattern will likely be aerobic soil degradation. Based on the 
aerobic soil metabolism study, Metabolite R-8 was found as a major 
degradate in 4 out of 5 soils tested, with a maximum of 38% of the 
applied dose. Metabolite R-8 is mobile and relatively persistent and 
could be available for runoff and leaching for periods of up to months. 
Metabolite R-13 was also found as a major degradate in 3 out of 5 soils 
tested, with a maximum of 30.0% (at 62 days) in an aerobic soil 
metabolism study. Based on submitted mobility data, Metabolite R-13 
appears to be immobile. The Agency believes that metabolites R-8 and R-
13 are likely to have similar toxicity to the parent; and, therefore, 
should be included in the drinking water assessment. Metabolites R-4 
and R-7 were also found in aerobic soil dissipation studies, but less 
frequently. EPA concluded that the

[[Page 72961]]

inclusion of Metabolite R-8 should cover the exposure from R-4 and R-7. 
In summary, the Agency finds that for drinking water risk assessment, 
the residues of concern are parent, Metabolite R-8, and Metabolite R-
13.
    FQPA Index Reservoir Screening Tool (FIRST) and Screening 
Concentrations In Ground Water (SCI-GROW) models were used to calculate 
the chronic surface water and groundwater EDWCs (parent and 
metabolites), respectively. Drinking water was incorporated directly in 
the dietary assessment using the acute concentration for surface water 
generated by the FIRST model. Tier 1 EDWCs results for etoxazole and 
metabolites R-8 and R-13 show annual average surface water 
concentrations of 0.332 parts per billion (ppb), 0.913 ppb and 0.0285 
ppb, respectively. Tier 1 EDWCs results for etoxazole and metabolites 
R-8 and R-13 show ground water concentrations of 0.00173ppb, 0.316 ppb 
and 0.000322 ppb, respectively.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the total sum of the annual average surface water 
concentrations for etoxazole and metabolites R-8 and R-13 of 1.27 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).
    Etoxazole is not registered for use in or on any sites 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to etoxazole and any other 
substances and etoxazole does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that etoxazole has 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 website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold 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 safety factor. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. No quantitative or 
qualitative evidence of increased susceptibility was seen following in 
utero exposure to rats or rabbits in developmental studies. Offspring 
toxicity was more severe (pup mortality) than maternal toxicity 
(increased liver and adrenal weights) at the same dose in the rat 
reproduction study.
    Since there is qualitative evidence of increased susceptibility 
following exposure to etoxazole in the rat reproduction study, the EPA 
performed a Degree-of-Concern Analysis to:
    i. Determine the LOC for the effects observed when considered in 
the context of all available toxicity data; and
    ii. Identify any residual uncertainties after establishing toxicity 
endpoints and traditional uncertainty factors to be used in the risk 
assessment of this chemical. There is evidence of increased qualitative 
susceptibility in the rat reproduction study, but the concern is low 
since:
    a. The effects in pups are well-characterized with a clear NOAEL;
    b. The pup effects occur at the same dose as maternal toxicity; 
and,
    c. The doses selected for various risk assessment scenarios are 
lower than the doses that caused off spring toxicity.
    Therefore, there are no residual uncertainties for pre-/post-natal 
toxicity in this study.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for etoxazole is complete for FQPA 
assessment.
    ii. There is no indication that etoxazole is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. No quantitative or qualitative evidence of increased 
susceptibility was seen following in utero exposure to rats or rabbits 
in developmental studies. Although there is qualitative evidence of 
increased susceptibility in the rat reproduction study, the Agency did 
not identify any residual uncertainties after establishing toxicity 
endpoints and traditional UFs to be used in the risk assessment of 
etoxazole. The degree of concern for prenatal and/or postnatal toxicity 
is low.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessment utilizes EPA-
calculated residues of concern (parent and metabolites) for livestock 
commodities; tolerance-level residues for other commodities; and 100% 
crop treated (CT) information for all proposed uses. By using these 
screening-level assumptions, actual exposures/risks will not be 
underestimated. The dietary drinking water assessment utilized modeling 
results which included conservative assumptions for the parent and all 
degradates of concern. Conservative assumptions were used in the water 
models. Therefore, the water exposure assessment will not underestimate 
the potential risks for infant and children.
    v. There are no registered or proposed residential uses for 
etoxazole.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment was not performed 
because an endpoint of concern attributable to a single oral dose was 
not selected for any population subgroup (including infants

[[Page 72962]]

and children). No acute risk is expected from exposure to etoxazole.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to etoxazole 
from food and water will utilize 8.3% of the cPAD for children 1-2 
years old, the most highly exposed population subgroup. There are no 
residential uses for etoxazole that result in chronic residential 
exposure to etoxazole. Therefore, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Etoxazole is not registered or proposed for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water, which do not exceed the 
Agency's LOC.
    4. Aggregate cancer risk for U.S. population. A cancer aggregate 
risk assessment was not performed because etoxazole is not 
carcinogenic. Etoxazole is not expected to pose a cancer risk to 
humans.
    5. 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 etoxazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression.
    The following analytical enforcement methods have been validated: 
The gas chromatography/mass-selective detector (GC/MSD) method used to 
determine etoxazole residues in/on cherry matrices is a slightly 
modified version of a previously-validated method (Method RM-37HM). The 
validated limit of quantitation (LOQ) was 0.0037 ppm and the limit of 
detection (LOD) was 0.0012 ppm for etoxazole in/on cherries. The GC 
with nitrogen-phosphorus detector (NPD) method used to determine 
etoxazole residues in/on hop matrices is a modified version of a 
previously-validated method (Method RM-37). The validated LOQ was 0.2 
ppm and the LOD was 0.1 ppm for etoxazole in/on dried hop cones.The 
nitrogen-phosphorus specific flame-ionization detector (NPD) method 
used to determine etoxazole residues in/on cantaloupe matrices is a 
slightly modified version of a previously-validated method (Method RM-
37). The validated LOQ was 0.0046 ppm and the LOD was 0.0015 ppm for 
etoxazole in/on cantaloupe.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Road, Fort Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican 
maximum residue limits (MRLs) for etoxazole.
    Therefore, tolerances are established for residues of the 
insecticide etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-
2-ethoxyphenyl]-4,5-dihydrooxazole, in or on cherry at 1.0 ppm, hop, 
dried cones at 7.0 ppm, and vegetable, cucurbit subgroup 9A at 0.20 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA 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 rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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 6, 2000) do not apply to this rule. In addition, This 
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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: December 14, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

[[Page 72963]]

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. Section 180.593 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.593  Etoxazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cherry...............................................                1.0
                                * * * * *
Hop, dried cones.....................................                7.0
                                * * * * *
Vegetable, cucurbit subgroup 9A......................               0.20
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-24983 Filed 12-21-07; 8:45 am]
BILLING CODE 6560-50-S