Flutolanil; Pesticide Tolerances, 33013-33018 [E8-13000]

Download as PDF 33013 Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Rules and Regulations production and consumption of CFCs, EPA is making this action effective immediately to ensure continued availability of CFCs for medical devices. Dated: June 5, 2008. Stephen L. Johnson, Administrator. List of Subjects in 40 CFR Part 82 PART 82—PROTECTION OF STRATOSPHERIC OZONE Environmental protection, Administrative practice and procedure, Air pollution control, Chemicals, Exports, Imports, Ozone, Reporting and recordkeeping requirements. I Subpart A—Production and Consumption Controls 40 CFR part 82 is amended as follows: 1. The authority citation for part 82 continues to read as follows: I 2. Section 82.8 is amended by revising the table in paragraph (a) to read as follows: I § 82.8 Grants of essential use allowances and critical use allowances. (a) * * * Authority: 42 U.S.C. 7414, 7601, 7671– 7671q. TABLE I.—ESSENTIAL USE ALLOWANCES FOR CALENDAR YEAR 2008 Company 2008 Quantity (metric tons) Chemical (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease Armstrong Pharmaceuticals ...................................................... * * * * * [FR Doc. E8–13088 Filed 6–10–08; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–1021; FRL–8365–6] Flutolanil; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for indirect or inadvertent residues of flutolanil in or on wheat and soybeans. Nichino America, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation is effective June 11, 2008. Objections and requests for hearings must be received on or before August 11, 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). DATES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–1021. To access the electronic docket, go to https:// 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 yshivers on PROD1PC62 with RULES ADDRESSES: VerDate Aug<31>2005 15:03 Jun 10, 2008 Jkt 214001 CFC–114 (production of epinephrine MDIs only) .................... 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 https://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: Lisa Jones, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–9424; e-mail address: jones.lisa@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 not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 27.0 • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). 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 https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://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 https://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 E:\FR\FM\11JNR1.SGM 11JNR1 33014 Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Rules and Regulations yshivers on PROD1PC62 with RULES provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2007–1021 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 August 11, 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–2007–1021, by one of the following methods: • Federal eRulemaking Portal: https:// 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 March 12, 2008 (73 FR 13225) (FRL–8354–6), 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 0F6159) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR 180.484 be amended by establishing tolerances for indirect or inadvertent residues of the fungicide flutolanil, N-(3-(1methylethoxy)phenyl)-2(trifluoromethyl)benzamide, and its metabolite, M-4, desisopropyl flutolanil N-(3-hydroxyphenyl)-2(trifluromethyl)benzamide, expressed as 2-(trifluoromethyl) benzoic acid and calculated as flutolanil, in or on soybean forage at 9.0 parts per million (ppm), soybean hay at 2.0 ppm, soybean seed at 0.20 ppm, wheat bran at 0.3 ppm, wheat forage at 2.0 ppm, wheat grain at VerDate Aug<31>2005 15:03 Jun 10, 2008 Jkt 214001 0.10 ppm, wheat hay at 1.0 ppm, and wheat straw at 0.30 ppm. That notice referenced a summary of the petition prepared by Nichino America, Inc., the registrant, which is available to the public in the docket, https://www.regulations.gov. One comment was received on the notice of filing. EPA’s response to these comments is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has revised all proposed tolerances except for soybean seed. The reasons for these changes are explained in Unit IV.D. The time-limited tolerances exemptions for rice, grain; rice, straw; rice, bran; and rice, hulls are removed from 40 CFR 180.484 because the expiration date of December 31, 2000 has passed. 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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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 tolerances for indirect or inadvertent residues of flutolanil, N-(3-(1methylethoxy)phenyl)-2(trifluoromethyl)benzamide, and its metabolites converted to 2(trifluoromethyl) benzoic acid and calculated as flutolanil, in or on soybean forage at 8.0 ppm, soybean hay at 2.5 ppm, soybean seed at 0.20 ppm, wheat forage at 2.5 ppm, wheat grain at 0.05 ppm, wheat hay at 1.2 ppm, wheat straw PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 at 0.20 ppm, and wheat bran at 0.20 ppm. EPA’s assessment of exposures and risks associated with establishing tolerances 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. The toxicology studies conducted on flutolanil demonstrate few or no biologically significant toxic effects. Liver effects in rats included increases in absolute and relative liver weight in the absence of clinical chemistry and/or histopathology findings. In dogs, there was an elevation in alkaline phosphatase and cholesterol levels together with dose-related increases in absolute and relative liver weights, slightly enlarged livers, and an increase in severity of glycogen deposition. The increased liver weights are considered to be an adaptive response to flutolanil treatment and not an adverse effect. Based on the lack of evidence of carcinogenicity and the lack of evidence of mutagenicity, flutolanil is classified as ‘‘not likely to be carcinogenic to humans’’. Flutolanil is not neurotoxic, and it is not a developmental or reproductive toxicant. No maternal, reproductive, or developmental toxicity was observed at the limit dose. There was no evidence for increased susceptibility of rat or rabbit fetuses to in utero exposure or rat pups to post-natal exposure to flutolanil. No toxic effects were observed in studies in which flutolanil was administered by the dermal route of exposure at the limit dose. Specific information on the studies received and the nature of the adverse effects caused by flutolanil 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 https:// www.regulations.gov in the document ‘‘Flutolanil, Human Health Risk Assessment. Requests for Inadvertent or Indirect Tolerances for use on soybean, wheat, corn and cotton, November 27, 2007’’ beginning on page 7 in docket ID number EPA–HQ–OPP–2007–1021. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for E:\FR\FM\11JNR1.SGM 11JNR1 Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Rules and Regulations derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). 33015 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 greater than that 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 https://www.epa.gov/ pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for flutolanil used for human risk assessment is shown in the following table. TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUTOLANIL FOR USE IN HUMAN RISK ASSESSMENT Point of Departure and Uncertainty/Safety Factors Exposure/Scenario RfD, PAD, LOC for Risk Assessment Acute dietary (all populations) Study and Toxicological Effects No appropriate toxicological endpoint attributable to a single exposure (dose) was identified from the oral toxicity studies including developmental toxicity studies in rats and rabbits. Chronic dietary (all populations) Cancer (oral, dermal, inhalation) NOAEL = 50 mg/kg/day UFA = 10x UFH = 10x FQPA SF = 1x Chronic RfD = 0.5 mg/ kg/day cPAD = 0.5 mg/kg/day 2–year chronic study in dogs, MRID no. 40342922 LOAEL = 250 mg/kg/day based on increased incidence of clinical toxic signs (emesis, salivation, and soft stool) ‘‘Not likely to be carcinogenic to humans’’ based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. yshivers on PROD1PC62 with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to flutolanil and metabolites, EPA considered exposure under the petitioned-for tolerances as well as all existing flutolanil tolerances in (40 CFR 180.484). EPA assessed dietary exposures from flutolanil in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1–day or single exposure. No such effects were identified in the toxicological studies for flutolanil; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture (USDA) 1994–1996 and 1998 CSFII. As to residue levels in food, VerDate Aug<31>2005 15:03 Jun 10, 2008 Jkt 214001 EPA assumed that tolerance-level residues were used for all crops. iii. Cancer. Flutolanil has been classified as ‘‘Not likely to be Carcinogenic to Humans’’ therefore a cancer dietary exposure assessment was not performed. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for flutolanil in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of flutolanil. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/oppefed1/models/ water/index.htm. The Agency used the First Approximation Rice Model (FARM) to estimate pesticide concentrations in surface water after applying flutolanil on rice and Screening Concentrations in Ground Water (SCI-GROW), which predicts pesticide concentrations in ground water. In general, EPA will use PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 Generic Expected Environmental Concentrations (GENEEC) (a Tier 1 model) before using Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) (a Tier 2 model) for a screening-level assessment for surface water, but given the unique hydrological issues arising from pesticide application to rice paddies, EPA used the FARM rather than GENEEC or PRZM/EXAMS for surface water estimates. Based on the SCI-GROW model, and the FARM (to estimate pesticide concentrations in surface water after applying flutolanil on rice) the estimated environmental concentrations (EECs) of flutolanil for acute exposures are estimated to be 3.8 parts per billion (ppb) for surface water and 0.34 ppb for ground water. The EECs for chronic exposures are estimated to be 3.8 ppb for surface water and 0.34 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the E:\FR\FM\11JNR1.SGM 11JNR1 33016 Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Rules and Regulations yshivers on PROD1PC62 with RULES water concentration of value 3.8 ppb was used to access 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). Flutolanil is currently registered for the following uses that could result in residential exposures: Turf grass and ornamental plants. Although residential (non-occupational) exposure exists, a quantitative exposure assessment was not conducted since no toxicological endpoint attributable to acute, shortterm or intermediate-term exposure have been identified and the current use pattern does not indicate chronic or long-term exposure (6 or more months of continuous exposure) potential. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found flutolanil to share a common mechanism of toxicity with any other substances, and flutolanil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that flutolanil does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure (MOE) 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 (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when VerDate Aug<31>2005 15:03 Jun 10, 2008 Jkt 214001 reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There was no evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure or rat pups to postnatal exposure to flutolanil. Flutolanil is not neurotoxic, and it is not a developmental or reproductive toxicant. No maternal, reproductive, or developmental toxicity was observed at the limit dose. 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 flutolanil is complete. ii. There is no indication that flutolanil is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that flutolanil results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure data bases. The dietary food exposure assessments were performed based on 100 percent crop treated (PCT) and tolerance-level residues. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to flutolanil in drinking water. The level of residential exposure was not assessed as flutolanil was found to have no toxic endpoints corresponding to the duration of exposures in the residential setting. These assessments will not underestimate the exposure and risks posed by flutolanil. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 product of all applicable UFs is not exceeded. 1. Acute risk. No appropriate endpoint attributable to a single exposure (dose) was identified from oral toxicity studies for the general population or for females aged thirteen years or older. Flutolanil is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to flutolanil and metabolites from food and water will utilize 1% of the cPAD for the most highly exposed population subgroup (infants less than one year old). Based on the use pattern, chronic residential exposure to residues of flutolanil is not expected. 3. Short and intermediate-term risk. Short-term and intermediate-term aggregate exposure assessment takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no flutolanil toxicity from short-term or intermediate-term dermal and inhalation exposure was identified, flutolanil is not expected to pose a short-term or intermediate-term dermal or inhalation risk. 4. Aggregate cancer risk for U.S. population. EPA has classified flutolanil as ‘‘not likely’’ to be a human carcinogen. 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 flutolanil residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate common moiety high performance liquid chromatography/ mass spectrometry (HPLC/MS) method (Method AU/95R/04) is available which determines residues of flutolanil and metabolites as 2-trifluoromethyl benzoic acid (2-TFBA). 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; e-mail address: residuemethods@epa.gov. B. International Residue Limits Codex maximum residue limits (MRLs) are established for residues of flutolanil per se in rice commodities at 1–10 ppm, and in livestock commodities at 0.05–0.2 ppm. There are no wheat or soybean Codex MRL’s. E:\FR\FM\11JNR1.SGM 11JNR1 Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Rules and Regulations Codex MRL’s differ from established tolerances for the following commodities: Rice, grain; cattle, goat and hog kidney, and cattle, goat and hog liver. No Canadian or Mexican MRLs have been established for flutolanil. The Agency’s tolerance levels are based on analyses of the residue field trial data using EPA’s Tolerance Spreadsheet in accordance with the Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data, Standard Operating Procedure (SOP). C. Response to Comments One comment was received from a private citizen objecting to the establishment of tolerances for flutolanil. The commenter criticized EPA’s reliance on toxicology testing on animals. The Agency has received, and responded to, similar comments from this commenter on numerous previous occasions. Refer to Federal Register 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005) and, 69 FR 63096 (October 29, 2004) for the Agency’s response to these objections. yshivers on PROD1PC62 with RULES D. Revisions to Petitioned-For Tolerances Based upon review of the data supporting the petition, EPA determined that the proposed tolerances should be revised as follows: Soybean, forage decreased from 9.0 ppm to 8.0 ppm; soybean, hay increased from 2.0 ppm to 2.5 ppm; wheat, forage increased from 2.0 ppm to 2.5 ppm; wheat, grain decreased from 0.1 ppm to 0.05 ppm; wheat, hay increased from 1.0 ppm to 1.2 ppm; wheat, straw decreased from 0.3 ppm to 0.20 ppm; and wheat, bran decreased from 0.3 ppm to 0.20 ppm. EPA revised these tolerance levels based on analysis of the residue field trial data using the Agency’s Tolerance Spreadsheet in accordance with the Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data Standard Operating Procedure (SOP). V. Conclusion Therefore, tolerances are established for indirect or inadvertent residues of flutolanil, N-(3-(1methylethoxy)phenyl)-2(trifluoromethyl)benzamide, and its metabolites converted to 2(trifluoromethyl) benzoic acid and calculated as flutolanil, in or on soybean, forage at 8.0 ppm, soybean, hay at 2.5 ppm, soybean, seed at 0.20 ppm, wheat, forage at 2.5 ppm, wheat, grain at 0.05 ppm, wheat, hay at 1.2 ppm, wheat, straw at 0.20 ppm, and wheat, bran at 0.20 ppm. Additionally, expired time-limited tolerances for rice, grain; rice, straw; VerDate Aug<31>2005 15:03 Jun 10, 2008 Jkt 214001 rice, bran; and rice, hulls are removed from 40 CFR part 180.484: VI. Statutory and Executive Order Reviews This final rule establishes tolerances 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 final rule has been exempted from review under Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 33017 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: May 29, 2008. Lois A. Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.484 is amended by removing paragraph (a)(2), removing the heading to paragraph (a)(1), redesignating paragraph (a)(1) as paragraph (a) and revising paragraph (d) to read as follows: I § 180.484 Flutolanil (N-(3-(1methylethoxy)phenyl)-2(trifluoromethyl)benzamide); tolerances for residues. * * * * * (d) Indirect or inadvertent residues. Tolerances are established for the indirect or inadvertent residues of the fungicide flutolanil, N-(3-(1methylethoxy)phenyl)-2(trifluoromethyl)benzamide, and its metabolites converted to 2(trifluoromethyl) benzoic acid and E:\FR\FM\11JNR1.SGM 11JNR1 33018 Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Rules and Regulations calculated as flutolanil, in or on the following commodities: Commodity Parts per million Soybean, forage .............................................................................................................................................. Soybean, hay ................................................................................................................................................... Soybean, seed ................................................................................................................................................. Wheat, bran ..................................................................................................................................................... Wheat, forage .................................................................................................................................................. Wheat, grain .................................................................................................................................................... Wheat, hay ....................................................................................................................................................... Wheat, straw [FR Doc. E8–13000 Filed 6–10–08; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0535; FRL–8366–4] Bifenthrin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. yshivers on PROD1PC62 with RULES AGENCY: SUMMARY: This regulation establishes tolerances for residues of the insecticide bifenthrin (2-methyl [1,1’-biphenyl]-3yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1propenyl)-2,2dimethylcyclopropanecarboxylate in or on food commodities bushberry subgroup 13-07B; and leafy petioles subgroup 4B. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition, this action revises previously established time-limited tolerances for residues of bifenthrin in or on orchardgrass, forage and orchardgrass, hay in response to the approval of a specific exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing the use of this insecticide on orchardgrass in the State of Oregon to control western orchardgrass billbug. Residue data have been submitted indicating the need to increase the tolerances from their original level. This regulation establishes maximum permissible levels of residues of bifenthrin in these food/ feed commodities. The time-limited tolerances expire and are revoked on December 31, 2009. DATES: This regulation is effective June 11, 2008. Objections and requests for hearings must be received on or before August 11, 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). VerDate Aug<31>2005 15:03 Jun 10, 2008 Jkt 214001 EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–0535. To access the electronic docket, go to https:// 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 https://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. ADDRESSES: 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 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 8.0 2.5 0.20 0.20 2.5 0.05 1.2 0.20 not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). 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 https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://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 https://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– E:\FR\FM\11JNR1.SGM 11JNR1

Agencies

[Federal Register Volume 73, Number 113 (Wednesday, June 11, 2008)]
[Rules and Regulations]
[Pages 33013-33018]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13000]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1021; FRL-8365-6]


Flutolanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for indirect or 
inadvertent residues of flutolanil in or on wheat and soybeans. Nichino 
America, Inc. requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 11, 2008. Objections and 
requests for hearings must be received on or before August 11, 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-2007-1021. To access the 
electronic docket, go to https://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 https://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: Lisa Jones, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9424; e-mail address: jones.lisa@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 not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://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 https://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

[[Page 33014]]

provided in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2007-1021 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 August 11, 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-2007-1021, by one of the following methods:
     Federal eRulemaking Portal: https://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 March 12, 2008 (73 FR 13225) (FRL-8354-
6), 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 
0F6159) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, 
Wilmington, DE 19808. The petition requested that 40 CFR 180.484 be 
amended by establishing tolerances for indirect or inadvertent residues 
of the fungicide flutolanil, N-(3-(1-methylethoxy)phenyl)-2-
(trifluoromethyl)benzamide, and its metabolite, M-4, desisopropyl 
flutolanil N-(3-hydroxyphenyl)-2-(trifluromethyl)benzamide, expressed 
as 2-(trifluoromethyl) benzoic acid and calculated as flutolanil, in or 
on soybean forage at 9.0 parts per million (ppm), soybean hay at 2.0 
ppm, soybean seed at 0.20 ppm, wheat bran at 0.3 ppm, wheat forage at 
2.0 ppm, wheat grain at 0.10 ppm, wheat hay at 1.0 ppm, and wheat straw 
at 0.30 ppm.
    That notice referenced a summary of the petition prepared by 
Nichino America, Inc., the registrant, which is available to the public 
in the docket, https://www.regulations.gov. One comment was received on 
the notice of filing. EPA's response to these comments is discussed in 
Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised all proposed tolerances except for soybean seed. The reasons 
for these changes are explained in Unit IV.D.
    The time-limited tolerances exemptions for rice, grain; rice, 
straw; rice, bran; and rice, hulls are removed from 40 CFR 180.484 
because the expiration date of December 31, 2000 has passed.

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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 
tolerances for indirect or inadvertent residues of flutolanil, N-(3-(1-
methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, and its metabolites 
converted to 2-(trifluoromethyl) benzoic acid and calculated as 
flutolanil, in or on soybean forage at 8.0 ppm, soybean hay at 2.5 ppm, 
soybean seed at 0.20 ppm, wheat forage at 2.5 ppm, wheat grain at 0.05 
ppm, wheat hay at 1.2 ppm, wheat straw at 0.20 ppm, and wheat bran at 
0.20 ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances 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.
    The toxicology studies conducted on flutolanil demonstrate few or 
no biologically significant toxic effects. Liver effects in rats 
included increases in absolute and relative liver weight in the absence 
of clinical chemistry and/or histopathology findings. In dogs, there 
was an elevation in alkaline phosphatase and cholesterol levels 
together with dose-related increases in absolute and relative liver 
weights, slightly enlarged livers, and an increase in severity of 
glycogen deposition. The increased liver weights are considered to be 
an adaptive response to flutolanil treatment and not an adverse effect. 
Based on the lack of evidence of carcinogenicity and the lack of 
evidence of mutagenicity, flutolanil is classified as ``not likely to 
be carcinogenic to humans''.
    Flutolanil is not neurotoxic, and it is not a developmental or 
reproductive toxicant. No maternal, reproductive, or developmental 
toxicity was observed at the limit dose. There was no evidence for 
increased susceptibility of rat or rabbit fetuses to in utero exposure 
or rat pups to post-natal exposure to flutolanil. No toxic effects were 
observed in studies in which flutolanil was administered by the dermal 
route of exposure at the limit dose.
    Specific information on the studies received and the nature of the 
adverse effects caused by flutolanil 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 https://
www.regulations.gov in the document ``Flutolanil, Human Health Risk 
Assessment. Requests for Inadvertent or Indirect Tolerances for use on 
soybean, wheat, corn and cotton, November 27, 2007'' beginning on page 
7 in docket ID number EPA-HQ-OPP-2007-1021.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for

[[Page 33015]]

derivation of reference values for risk assessment. The POD may be 
defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk 
assessment. Uncertainty/safety factors (UFs) are used in conjunction 
with the POD 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 dietary 
risks by comparing aggregate food and water 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 
POD by all applicable UFs. Aggregate short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    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 
greater than that 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 https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flutolanil used for 
human risk assessment is shown in the following table.

     Table 1.--Summary of Toxicological Doses and Endpoints for Flutolanil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)                                                          No appropriate
                                                                                          toxicological endpoint
                                                                                          attributable to a
                                                                                          single exposure (dose)
                                                                                          was identified from
                                                                                          the oral toxicity
                                                                                          studies including
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 50 mg/kg/day     Chronic RfD = 0.5 mg/kg/ 2-year chronic study in
                                       UFA = 10x..............   day                      dogs, MRID no.
                                       UFH = 10x..............  cPAD = 0.5 mg/kg/day...   40342922
                                       FQPA SF = 1x...........                           LOAEL = 250 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of clinical
                                                                                          toxic signs (emesis,
                                                                                          salivation, and soft
                                                                                          stool)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)         ``Not likely to be carcinogenic to humans'' based on the absence of
                                           significant tumor increases in two adequate rodent carcinogenicity
                                                                        studies.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE =
  margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flutolanil and metabolites, EPA considered exposure under 
the petitioned-for tolerances as well as all existing flutolanil 
tolerances in (40 CFR 180.484). EPA assessed dietary exposures from 
flutolanil in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
flutolanil; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 CSFII. As to 
residue levels in food, EPA assumed that tolerance-level residues were 
used for all crops.
    iii. Cancer. Flutolanil has been classified as ``Not likely to be 
Carcinogenic to Humans'' therefore a cancer dietary exposure assessment 
was not performed.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for flutolanil in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of flutolanil. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    The Agency used the First Approximation Rice Model (FARM) to 
estimate pesticide concentrations in surface water after applying 
flutolanil on rice and Screening Concentrations in Ground Water (SCI-
GROW), which predicts pesticide concentrations in ground water. In 
general, EPA will use Generic Expected Environmental Concentrations 
(GENEEC) (a Tier 1 model) before using Pesticide Root Zone/Exposure 
Analysis Modeling System (PRZM/EXAMS) (a Tier 2 model) for a screening-
level assessment for surface water, but given the unique hydrological 
issues arising from pesticide application to rice paddies, EPA used the 
FARM rather than GENEEC or PRZM/EXAMS for surface water estimates.
    Based on the SCI-GROW model, and the FARM (to estimate pesticide 
concentrations in surface water after applying flutolanil on rice) the 
estimated environmental concentrations (EECs) of flutolanil for acute 
exposures are estimated to be 3.8 parts per billion (ppb) for surface 
water and 0.34 ppb for ground water. The EECs for chronic exposures are 
estimated to be 3.8 ppb for surface water and 0.34 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the

[[Page 33016]]

water concentration of value 3.8 ppb was used to access 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).
    Flutolanil is currently registered for the following uses that 
could result in residential exposures: Turf grass and ornamental 
plants. Although residential (non-occupational) exposure exists, a 
quantitative exposure assessment was not conducted since no 
toxicological endpoint attributable to acute, short-term or 
intermediate-term exposure have been identified and the current use 
pattern does not indicate chronic or long-term exposure (6 or more 
months of continuous exposure) potential.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found flutolanil to share a common mechanism of 
toxicity with any other substances, and flutolanil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
flutolanil does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure (MOE) 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 (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased susceptibility of rat or rabbit fetuses to in utero exposure 
or rat pups to post-natal exposure to flutolanil. Flutolanil is not 
neurotoxic, and it is not a developmental or reproductive toxicant. No 
maternal, reproductive, or developmental toxicity was observed at the 
limit dose.
    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 flutolanil is complete.
    ii. There is no indication that flutolanil is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that flutolanil results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
data bases. The dietary food exposure assessments were performed based 
on 100 percent crop treated (PCT) and tolerance-level residues.
     EPA made conservative (protective) assumptions in the ground water 
and surface water modeling used to assess exposure to flutolanil in 
drinking water. The level of residential exposure was not assessed as 
flutolanil was found to have no toxic endpoints corresponding to the 
duration of exposures in the residential setting. These assessments 
will not underestimate the exposure and risks posed by flutolanil.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. No appropriate endpoint attributable to a single 
exposure (dose) was identified from oral toxicity studies for the 
general population or for females aged thirteen years or older. 
Flutolanil is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
flutolanil and metabolites from food and water will utilize 1% of the 
cPAD for the most highly exposed population subgroup (infants less than 
one year old). Based on the use pattern, chronic residential exposure 
to residues of flutolanil is not expected.
    3. Short and intermediate-term risk. Short-term and intermediate-
term aggregate exposure assessment takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
     Because no flutolanil toxicity from short-term or intermediate-
term dermal and inhalation exposure was identified, flutolanil is not 
expected to pose a short-term or intermediate-term dermal or inhalation 
risk.
    4. Aggregate cancer risk for U.S. population. EPA has classified 
flutolanil as ``not likely'' to be a human carcinogen.
    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 flutolanil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate common moiety high performance liquid chromatography/
mass spectrometry (HPLC/MS) method (Method AU/95R/04) is available 
which determines residues of flutolanil and metabolites as 2-
trifluoromethyl benzoic acid (2-TFBA). 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; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    Codex maximum residue limits (MRLs) are established for residues of 
flutolanil per se in rice commodities at 1-10 ppm, and in livestock 
commodities at 0.05-0.2 ppm. There are no wheat or soybean Codex MRL's.

[[Page 33017]]

Codex MRL's differ from established tolerances for the following 
commodities: Rice, grain; cattle, goat and hog kidney, and cattle, goat 
and hog liver. No Canadian or Mexican MRLs have been established for 
flutolanil.
    The Agency's tolerance levels are based on analyses of the residue 
field trial data using EPA's Tolerance Spreadsheet in accordance with 
the Agency's Guidance for Setting Pesticide Tolerances Based on Field 
Trial Data, Standard Operating Procedure (SOP).

C. Response to Comments

    One comment was received from a private citizen objecting to the 
establishment of tolerances for flutolanil. The commenter criticized 
EPA's reliance on toxicology testing on animals. The Agency has 
received, and responded to, similar comments from this commenter on 
numerous previous occasions. Refer to Federal Register 70 FR 37686 
(June 30, 2005), 70 FR 1354 (January 7, 2005) and, 69 FR 63096 (October 
29, 2004) for the Agency's response to these objections.

D. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA 
determined that the proposed tolerances should be revised as follows: 
Soybean, forage decreased from 9.0 ppm to 8.0 ppm; soybean, hay 
increased from 2.0 ppm to 2.5 ppm; wheat, forage increased from 2.0 ppm 
to 2.5 ppm; wheat, grain decreased from 0.1 ppm to 0.05 ppm; wheat, hay 
increased from 1.0 ppm to 1.2 ppm; wheat, straw decreased from 0.3 ppm 
to 0.20 ppm; and wheat, bran decreased from 0.3 ppm to 0.20 ppm. EPA 
revised these tolerance levels based on analysis of the residue field 
trial data using the Agency's Tolerance Spreadsheet in accordance with 
the Agency's Guidance for Setting Pesticide Tolerances Based on Field 
Trial Data Standard Operating Procedure (SOP).

V. Conclusion

    Therefore, tolerances are established for indirect or inadvertent 
residues of flutolanil, N-(3-(1-methylethoxy)phenyl)-2-
(trifluoromethyl)benzamide, and its metabolites converted to 2-
(trifluoromethyl) benzoic acid and calculated as flutolanil, in or on 
soybean, forage at 8.0 ppm, soybean, hay at 2.5 ppm, soybean, seed at 
0.20 ppm, wheat, forage at 2.5 ppm, wheat, grain at 0.05 ppm, wheat, 
hay at 1.2 ppm, wheat, straw at 0.20 ppm, and wheat, bran at 0.20 ppm.
    Additionally, expired time-limited tolerances for rice, grain; 
rice, straw; rice, bran; and rice, hulls are removed from 40 CFR part 
180.484:

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final 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 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) (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: May 29, 2008.
Lois A. Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.484 is amended by removing paragraph (a)(2), removing 
the heading to paragraph (a)(1), redesignating paragraph (a)(1) as 
paragraph (a) and revising paragraph (d) to read as follows:


Sec.  180.484  Flutolanil (N-(3-(1-methylethoxy)phenyl)-2-
(trifluoromethyl)benzamide); tolerances for residues.

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent residues of the fungicide flutolanil, 
N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, and its 
metabolites converted to 2-(trifluoromethyl) benzoic acid and

[[Page 33018]]

calculated as flutolanil, in or on the following commodities:

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
Soybean, forage.....................                                 8.0
Soybean, hay........................                                 2.5
Soybean, seed.......................                                0.20
Wheat, bran.........................                                0.20
Wheat, forage.......................                                 2.5
Wheat, grain........................                                0.05
Wheat, hay..........................                                 1.2
Wheat, straw                                                        0.20
------------------------------------------------------------------------

[FR Doc. E8-13000 Filed 6-10-08; 8:45 am]
BILLING CODE 6560-50-S