Ipconazole; Pesticide Tolerances, 69554-69559 [E8-27310]

Download as PDF 69554 Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Rules and Regulations Paperwork Reduction Act of 1995 This rule does not contain collection of information requirements and would not be subject to the Paperwork Reduction Act of 1980, as amended (44 U.S.C. 3501–20). List of Subjects in 28 CFR Part 0 Authority delegations (Government agencies), Government employees, Organization and functions (Government agencies), Whistleblowing. ■ Accordingly, Title 28, Part 0 of the Code of Federal Regulations is amended as follows: PART 0—[AMENDED] 1. The authority citation for Part 0 continues to read as follows: ■ Authority: 5 U.S.C. 301; 28 U.S.C. 509, 510, 515–519. § 0.114 Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 461–9739 (This is not a toll-free number). SUPPLEMENTARY INFORMATION: VA published a document in the Federal Register on September 23, 2008, at 73 FR 54693, revising the portion of the Rating Schedule regarding traumatic brain injury (TBI). In the Federal Register document, a period was left off the end of Note (4) of diagnostic code 8045 in 38 CFR 4.124a. Additionally, we provided updates to 38 CFR part 4, Appendices A and C to reflect the changes to the TBI rating criteria. An extra ‘‘4.124a’’ was erroneously added in Appendix A, and ‘‘Traumatic Brain Injury residuals’’ with diagnostic code 8045, was not added alphabetically. This document corrects those errors. List of Subjects in 38 CFR Part 4 Disability benefits, Pensions, Veterans. [Amended] 2. In § 0.114, paragraph (a)(3) is amended by removing the fee ‘‘$45’’ and adding the fee ‘‘$55’’ in its place wherever it occurs. ■ Dated: November 12, 2008. Michael B. Mukasey, Attorney General. [FR Doc. E8–27465 Filed 11–18–08; 8:45 am] BILLING CODE 4410–04–P Approved: October 29, 2008. William F. Russo, Director, Regulations Management. For the reasons set out in the preamble, VA is correcting 38 CFR part 4 as follows. ■ PART 4—SCHEDULE FOR RATING DISABILITIES 1. The authority citation for part 4 continues to read as follows: ■ DEPARTMENT OF VETERANS AFFAIRS Authority: 38 U.S.C. 1155, unless otherwise noted. 38 CFR Part 4 ■ RIN 2900–AM75 Schedule for Rating Disabilities; Evaluation of Residuals of Traumatic Brain Injury (TBI); Correction Department of Veterans Affairs. Correcting amendment. AGENCY: cprice-sewell on PROD1PC64 with RULES ACTION: SUMMARY: This document contains a minor correction to the final rulemaking that the Department of Veterans Affairs (VA) published at 73 FR 54693 on September 23, 2008. The rulemaking relates to a revision of the portion of VA’s Schedule for Rating Disabilities that addresses neurological conditions and convulsive disorders to provide detailed and updated criteria for evaluating residuals of traumatic brain injury (TBI). DATES: Effective Date: November 19, 2008. FOR FURTHER INFORMATION CONTACT: Rhonda F. Ford, Chief, Regulations Staff (211D), Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans VerDate Aug<31>2005 14:43 Nov 18, 2008 Jkt 217001 2. In § 4.124a, diagnostic code 8045, Note (4), add a period at the end of the paragraph. ■ 3. In Appendix A to Part 4, under the ‘‘Sec.’’ heading, remove from the table the second entry ‘‘4.124a’’. ■ 4. In Appendix C to Part 4— Alphabetical Index of Disabilities table, remove the entry ‘‘Traumatic brain injury residuals’’ and its diagnostic code ‘‘8045’’ and add it in alphabetical order after the entry ‘‘Toxic nephropathy’’. [FR Doc. E8–27457 Filed 11–18–08; 8:45 am] BILLING CODE 8320–01–P from seed treatment in or on cotton, peanut, soybean, dry shelled pea and bean (Subgroup 6C), cereal grains (Group 15) except rice, and forage, fodder, and straw of cereal grains (Group 16) except rice. Chemtura Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 19, 2008. Objections and requests for hearings must be received on or before January 20, 2009, 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–2007–0226. All documents in the docket are listed in the docket index available at https://www.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: Tawanda Maignan, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–8050; e-mail address: maignan.tawanda@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0226; FRL–8389–1] Ipconazole; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for residues of ipconazole PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 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). E:\FR\FM\19NOR1.SGM 19NOR1 Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Rules and Regulations • 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. cprice-sewell on PROD1PC64 with RULES B. How Can I Access Electronic Copies of this Document? In addition to accessing electronically available documents 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 e-CFR site at https://www.gpoaccess.gov/ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2007–0226 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 January 20, 2009. 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–2007–0226, 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), VerDate Aug<31>2005 14:43 Nov 18, 2008 Jkt 217001 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 Facility’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 May 9, 2007 (72 FR 26374) (FRL–8121–5), 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 7F7180) by Chemtura Corporation, 199 Benson Rd., Middlebury, CT 06749. The petition requested that 40 CFR part 180 be amended by establishing permanent tolerances for residues of the fungicide ipconazole, (2-[(4chlorophenyl)methyl]-5-(1methylethyl)-1-(1H-1,2,4-triazole-1ylmethyl) cyclopentanol) from treatment of seed prior to planting, in or on food commodities cereal grains (except rice), group 15; forage, fodder and straw of cereal grains (except rice), group 16; cotton; peanut; soybean; dry pea and bean (shelled) (Subgroup 6C) at 0.01 parts per million (ppm). That notice referenced a summary of the petition prepared by Chemtura Corporation, the registrant, which is available to the public in the docket, https:// www.regulations.gov. There were no comments received in response to the notice of filing. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 69555 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 residues of ipconazole. 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. Ipconazole has low acute toxicity via the oral, dermal, and inhalation routes of exposure. It causes low to mild irritation to the eyes and skin; it is not a dermal sensitizer. Ipconazole may cause local, portal-ofentry irritation via all routes following repeated exposure. Systemic effects that were noted in dogs, mice, rabbits and/ or rats following exposure to ipconazole were generally limited to decreased body weight, body weight gain, and food consumption; and liver and kidney effects. Developmental effects were observed only at the maternally-toxic dose. Ipconazole is classified as not likely to be a human carcinogen and there is no concern for mutagenicity. Specific information on the studies received and the nature of the adverse effects caused by ipconazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in document Ipconazole. Human Health Risk Assessment for the Requested Seed Treatment Uses on Cotton, Peanut, Soybean, Dry Shelled Pea and Bean (Subgroup 6C), Cereal Grains (Groups 15 and 16) Except Rice, page number 16 in docket ID number EPA–HQ–OPP– 2007–0226. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure E:\FR\FM\19NOR1.SGM 19NOR1 69556 Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Rules and Regulations (POD) is identified as the basis for 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-, intermediate-, 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 ipconazole used for human risk assessment is shown in Table 1 of this unit. TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR IPCONAZOLE FOR USE IN HUMAN RISK ASSESSMENT Point of Departure and Uncertainty/Safety Factors Exposure/Scenario Acute dietary (General Population Including Infants and Children) Acute dietary (Females years of age) 13–50 RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects No appropriate endpoint attributable to a single dose of ipconazole was identified for this population. NOAEL = 10 mg/kg/day UFA = 10x UFH = 10x FQPA SF = 1x Acute RfD = 0.1 mg/kg/ day aPAD = 0.1 mg/kg/day Developmental Toxicity Studies in Rats and Rabbits LOAELrats = 30 mg/kg/day, based on increased visceral and skeletal variations LOAELrabbits = 50 mg/kg/day, based on increased incidence of skeletal variations and malformations Chronic dietary (All populations) NOAEL = 1.5 mg/kg/day UFA = 10x UFH = 10x FQPA SF = 1x Chronic RfD = 0.015 mg/ kg/day cPAD = 0.015 mg/kg/day Chronic Toxicity Study in Dogs LOAEL = 5 mg/kg/day, based on skin reddening (both sexes) and decreased body weight gain in females Dermal Short-Term (1 to 30 days) And Intermediate-Term (1 to 6 months) NOAEL = 150 mg/kg/day UFA = 10x UFH = 10x LOC for MOE = 100 28–Day Dermal Toxicity Study in Rats LOAEL = 1,000 mg/kg/day, based on decreased body weight, body weight gain, and food consumption, as well as, increased incidences of dermal irritation Inhalation Short-Term (1 to 30 days) And Intermediate-Term (1 to 6 months) NOAEL = 26.1 mg/kg/ day UFA = 10x UFH = 10x LOC for MOE = 100 28–Day Inhalation Toxicity Study in Rats LOAEL = 78.3 mg/kg/day, based on decreased body weight, body weight gain, and food consumption in males; clinical findings, such as alopecia, in males and/or females; meta/ hyperplasia and inflammatory cells in the respiration tract in males and/or females; and increased leukocytes in females Cancer (Oral, dermal, inhalation) Classification: Not likely to be a human carcinogen, based on 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. N/A = Not Applicable. cprice-sewell on PROD1PC64 with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to ipconazole, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary VerDate Aug<31>2005 14:43 Nov 18, 2008 Jkt 217001 exposures from ipconazole in food as follows: i. Acute and chronic exposure. In conducting the acute and chronic dietary exposure assessments EPA used the food consumption data from the USDA 1994–1996 and 1998 CSFII. As to residue levels in food, EPA acute and PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 chronic assessments used tolerancelevel residues, assumed 100% crop treated, and incorporated modelderived, conservative estimates of ipconazole residues in drinking water. ii. Cancer. Ipconazole has been classified as not likely to be carcinogenic based on carcinogenicity E:\FR\FM\19NOR1.SGM 19NOR1 cprice-sewell on PROD1PC64 with RULES Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Rules and Regulations studies in the rat and mouse which showed no evidence of an increase in the incidence of tumors. Therefore a cancer dietary exposure assessment is not needed to assess cancer risk. iii. Anticipated residue and/or percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for ipconazole. Tolerance level residues and/or 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for ipconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of ipconazole. 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. Ipconazole is persistent and immobile in terrestrial and aquatic environments. Data are not available to estimate the leaching potential of ipconazole from treated seeds. Because ipconazole is persistent in soil, there is a potential for it to accumulate in soil on sites with use over consecutive years. Steady-state ipconazole concentrations in soil are predicted to plateau at 0.7 lbs a.i./A after 20 years of consecutive use. Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCIGROW) models, the estimated drinking water concentrations (EDWCs) of ipconazole from newly proposed seed uses on cotton, peanuts, soybean, cereal grains (except rice), and pea and bean (dry shelled) would not exceed the drinking water concentrations previously assessed for the seed treatment for potatoes. Potatoes are expected to yield the highest concentration of ipconazole due to the high seeding rates. Therefore, the Agency incorporated the drinking water concentrations from potatoes directly into the dietary analysis. For acute dietary risk assessment, the surface water concentration value of 4.589 part per billion (ppb) was used to assess the contribution to drinking water. For chronic (non-cancer) dietary risk assessment, the surface water concentration value of 1.840 ppb was used to assess the contribution of 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, VerDate Aug<31>2005 14:43 Nov 18, 2008 Jkt 217001 indoor pest control, termiticides, and flea and tick control on pets). Ipconazole is not registered for any specific use patterns that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ Ipconazole is a member of the triazole-containing class of pesticides, often referred to as the conazoles. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events. In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA’s procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA’s website at https://www.epa.gov/ pesticides/cumulative. Triazole-derived pesticides can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazolederivative pesticides, including ipconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide as of September 1, 2005. The risk assessment PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 69557 is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency’s September 1, 2005 risk assessment can be found in the propiconazole reregistration docket at https:// www.regulations.gov (Docket ID EPA– HQ–OPP–2005–0497). An addendum to the risk assessment, Dietary Exposure Assessments for the Common Triazole Metabolites 1,2,4-triazole, Triazolylalanine, Triazolylacetic Acid and Triazolylypyruvic Acid; Updated to Include New Uses of Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and Uniconazole; and a Change in Plant-back Restriction for Tetraconazole can be found at https:// www.regulations.gov in docket ID EPA– HQ–OPP–2007–0226. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA 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. Offspring effects only occurred in the presence of maternal toxicity; offspring effects were not considered more severe than the parental effects. Therefore, HED concluded that there is no quantitative or qualitative evidence of increased susceptibility to rat or rabbit fetuses exposed in utero and/or postnatally to ipconazole. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: E:\FR\FM\19NOR1.SGM 19NOR1 69558 Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Rules and Regulations i. The toxicity database for ipconazole is adequate for the purposes of this risk assessment. ii. There is no indication that ipconazole 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 ipconazole results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to ipconazole in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by ipconazole. cprice-sewell on PROD1PC64 with RULES 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-, intermediate-, 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. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. Using the exposure assumptions described in this unit for acute exposure, EPA has concluded that acute exposure to ipconazole from food and water will utilize <1% of the aPAD for the population group females 13–49 years old, the only population subgroup appropriate for inclusion in an acute dietary exposure assessment. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to ipconazole from food and water will utilize 1.2% of the cPAD for all infants (the population group receiving the greatest exposure). VerDate Aug<31>2005 14:43 Nov 18, 2008 Jkt 217001 3. Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Ipconazole is not registered for any use patterns that would result in shortterm and intermediate-term residential exposure. Therefore, the short-term and intermediate-term aggregate risk, individually is the sum of the risk from exposure to ipconazole through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk. 4. Aggregate cancer risk for U.S. population. Ipconazole has been classified as not likely to be carcinogenic, and is not expected to pose a cancer risk to humans. 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 ipconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate liquid chromatography/ mass spectrometry/mass spectrometry (LC/MS/MS) enforcement methodology (AC/3020) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; e-mail address: residuemethods@epa.gov. B. International Residue Limits No Codex MRLs have been established for ipconazole. No Canadian or Mexican MRLs have been established. C. Revisions to Petitioned-For Tolerances The proposed tolerance for crop subgroup 6C has been modified to reflect the correct commodity definition: ‘‘Pea and bean, dried shelled, except soybean, subgroup 6C.’’ V. Conclusion Therefore, tolerances are established for residues of ipconazole, (2-[(4chlorophenyl)methyl]-5-(1methylethyl)-1-(1H-1,2,4-triazole-1ylmethyl) cyclopentanol) from treatment of seed prior to planting, in or on cotton, peanut, soybean, pea and bean, dried shelled, except soybean (Subgroup 6C), cereal grains (Group 15) except rice, and PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 forage, fodder, and straw of cereal grains (Group 16) except rice at 0.01 ppm. 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, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under 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 E:\FR\FM\19NOR1.SGM 19NOR1 Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Rules and Regulations 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: November 5, 2008. Debra Edwards, Director, Office of Pesticide Programs. PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.646 is added to subpart C to read as follows: ■ § 180.646 Ipconazole; tolerances for residues. (a) General. Tolerances are established for residues of ipconazole, (2-[(4-chlorophenyl)methyl]-5-(1methylethyl)-1-(1H-1,2,4-triazole-1ylmethyl) cyclopentanol) from seed treatment in or on the following commodities: Therefore, 40 CFR Chapter I is amended as follows: ■ Commodity Parts per million Cotton, gin byproducts ............................................................................................. Cotton, undelinted seed ........................................................................................... Grain, cereal, forage, fodder and straw, group 16, except rice .............................. Grain, cereal group 15, except rice ......................................................................... Pea and bean, dried shelled, except soybean, subgroup 6C ................................. Peanut ...................................................................................................................... Soybean, forage ...................................................................................................... Soybean, seed ......................................................................................................... (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. E8–27310 Filed 11–18–08; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2008–0417; FRL–8389–5] Polyoxin D Zinc Salt; Exemption from the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. cprice-sewell on PROD1PC64 with RULES AGENCY: SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the polyoxin D zinc salt (zinc 5-[[2-amino-5-o(aminocarbonyl)-2-deoxy-Lxylonoyl]amino]-1-(5-carboxy-3,4dihydro-2,4-dioxo-1(2H)-pyrimidinyl)1,5-dideoxy-b-D-allofuranuronatein) on almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes, pistachios, pome fruits, potatoes and strawberries when applied/used as a biochemical VerDate Aug<31>2005 14:43 Nov 18, 2008 Jkt 217001 69559 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 pesticide to control and suppress fungal diseases. Arysta LifeScience North America Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of polyoxin D zinc salt (zinc 5-[[2-amino-5-o-(aminocarbonyl)-2deoxy-L-xylonoyl]amino]-1-(5-carboxy3,4-dihydro-2,4-dioxo-1(2H)pyrimidinyl)-1,5-dideoxy-b-Dallofuranuronatein). DATES: This regulation is effective November 19, 2008. Objections and requests for hearings must be received on or before January 20, 2009, 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–2008––0417. All documents in the docket are listed in the docket index available at https://www.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. PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 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: Chris Pfeifer, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–0031; e-mail address: pfeifer.chris@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 E:\FR\FM\19NOR1.SGM 19NOR1

Agencies

[Federal Register Volume 73, Number 224 (Wednesday, November 19, 2008)]
[Rules and Regulations]
[Pages 69554-69559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27310]


=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0226; FRL-8389-1]


Ipconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
ipconazole from seed treatment in or on cotton, peanut, soybean, dry 
shelled pea and bean (Subgroup 6C), cereal grains (Group 15) except 
rice, and forage, fodder, and straw of cereal grains (Group 16) except 
rice. Chemtura Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 19, 2008. Objections and 
requests for hearings must be received on or before January 20, 2009, 
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-2007-0226. All documents in the 
docket are listed in the docket index available at https://
www.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: Tawanda Maignan, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8050; e-mail address: maignan.tawanda@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).

[[Page 69555]]

     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 electronically available documents 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 e-CFR site 
at https://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2007-0226 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 January 20, 2009.
    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-2007-0226, 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 Facility'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 May 9, 2007 (72 FR 26374) (FRL-8121-5), 
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 7F7180) 
by Chemtura Corporation, 199 Benson Rd., Middlebury, CT 06749. The 
petition requested that 40 CFR part 180 be amended by establishing 
permanent tolerances for residues of the fungicide ipconazole, (2-[(4-
chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-ylmethyl) 
cyclopentanol) from treatment of seed prior to planting, in or on food 
commodities cereal grains (except rice), group 15; forage, fodder and 
straw of cereal grains (except rice), group 16; cotton; peanut; 
soybean; dry pea and bean (shelled) (Subgroup 6C) at 0.01 parts per 
million (ppm). That notice referenced a summary of the petition 
prepared by Chemtura Corporation, the registrant, which is available to 
the public in the docket, https://www.regulations.gov. There were no 
comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    Consistent with 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 residues of ipconazole. 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. Ipconazole has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. It causes low to mild irritation to the 
eyes and skin; it is not a dermal sensitizer. Ipconazole may cause 
local, portal-of-entry irritation via all routes following repeated 
exposure. Systemic effects that were noted in dogs, mice, rabbits and/
or rats following exposure to ipconazole were generally limited to 
decreased body weight, body weight gain, and food consumption; and 
liver and kidney effects. Developmental effects were observed only at 
the maternally-toxic dose. Ipconazole is classified as not likely to be 
a human carcinogen and there is no concern for mutagenicity. Specific 
information on the studies received and the nature of the adverse 
effects caused by ipconazole as well as the no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from 
the toxicity studies can be found at https://www.regulations.gov in 
document Ipconazole. Human Health Risk Assessment for the Requested 
Seed Treatment Uses on Cotton, Peanut, Soybean, Dry Shelled Pea and 
Bean (Subgroup 6C), Cereal Grains (Groups 15 and 16) Except Rice, page 
number 16 in docket ID number EPA-HQ-OPP-2007-0226.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure

[[Page 69556]]

(POD) is identified as the basis for 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-, intermediate-
, 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 ipconazole used for 
human risk assessment is shown in Table 1 of this unit.

     Table 1.--Summary of Toxicological Doses and Endpoints for Ipconazole 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 (General Population       No appropriate endpoint attributable to a single dose of ipconazole was
 Including Infants and Children)                             identified for this population.
--------------------------------------
Acute dietary (Females 13-50 years of  NOAEL = 10 mg/kg/day     Acute RfD = 0.1 mg/kg/   Developmental Toxicity
 age)                                  UFA = 10x..............   day                      Studies in Rats and
                                       UFH = 10x..............  aPAD = 0.1 mg/kg/day...   Rabbits
                                       FQPA SF = 1x...........                           LOAELrats = 30 mg/kg/
                                                                                          day, based on
                                                                                          increased visceral and
                                                                                          skeletal variations
                                                                                         LOAELrabbits = 50 mg/kg/
                                                                                          day, based on
                                                                                          increased incidence of
                                                                                          skeletal variations
                                                                                          and malformations
--------------------------------------
Chronic dietary (All populations)      NOAEL = 1.5 mg/kg/day    Chronic RfD = 0.015 mg/  Chronic Toxicity Study
                                       UFA = 10x..............   kg/day                   in Dogs
                                       UFH = 10x..............  cPAD = 0.015 mg/kg/day.  LOAEL = 5 mg/kg/day,
                                       FQPA SF = 1x...........                            based on skin
                                                                                          reddening (both sexes)
                                                                                          and decreased body
                                                                                          weight gain in females
--------------------------------------
Dermal Short-Term (1 to 30 days) And   NOAEL = 150 mg/kg/day    LOC for MOE = 100        28-Day Dermal Toxicity
 Intermediate-Term (1 to 6 months)     UFA = 10x..............                            Study in Rats
                                       UFH = 10x..............                           LOAEL = 1,000 mg/kg/
                                                                                          day, based on
                                                                                          decreased body weight,
                                                                                          body weight gain, and
                                                                                          food consumption, as
                                                                                          well as, increased
                                                                                          incidences of dermal
                                                                                          irritation
--------------------------------------
Inhalation Short-Term (1 to 30 days)   NOAEL = 26.1 mg/kg/day   LOC for MOE = 100        28-Day Inhalation
 And Intermediate-Term (1 to 6         UFA = 10x..............                            Toxicity Study in Rats
 months)                               UFH = 10x..............                           LOAEL = 78.3 mg/kg/day,
                                                                                          based on decreased
                                                                                          body weight, body
                                                                                          weight gain, and food
                                                                                          consumption in males;
                                                                                          clinical findings,
                                                                                          such as alopecia, in
                                                                                          males and/or females;
                                                                                          meta/hyperplasia and
                                                                                          inflammatory cells in
                                                                                          the respiration tract
                                                                                          in males and/or
                                                                                          females; and increased
                                                                                          leukocytes in females
--------------------------------------
Cancer (Oral, dermal, inhalation)          Classification: Not likely to be a human carcinogen, based on 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. N/A = Not Applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ipconazole, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from ipconazole in food 
as follows:
    i. Acute and chronic exposure. In conducting the acute and chronic 
dietary exposure assessments EPA used the food consumption data from 
the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA 
acute and chronic assessments used tolerance-level residues, assumed 
100% crop treated, and incorporated model-derived, conservative 
estimates of ipconazole residues in drinking water.
     ii. Cancer. Ipconazole has been classified as not likely to be 
carcinogenic based on carcinogenicity

[[Page 69557]]

studies in the rat and mouse which showed no evidence of an increase in 
the incidence of tumors. Therefore a cancer dietary exposure assessment 
is not needed to assess cancer risk.
     iii. Anticipated residue and/or percent crop treated (PCT) 
information. EPA did not use anticipated residue and/or PCT information 
in the dietary assessment for ipconazole. Tolerance level residues and/
or 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for ipconazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of ipconazole. 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.
    Ipconazole is persistent and immobile in terrestrial and aquatic 
environments. Data are not available to estimate the leaching potential 
of ipconazole from treated seeds. Because ipconazole is persistent in 
soil, there is a potential for it to accumulate in soil on sites with 
use over consecutive years. Steady-state ipconazole concentrations in 
soil are predicted to plateau at 0.7 lbs a.i./A after 20 years of 
consecutive use.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of ipconazole from 
newly proposed seed uses on cotton, peanuts, soybean, cereal grains 
(except rice), and pea and bean (dry shelled) would not exceed the 
drinking water concentrations previously assessed for the seed 
treatment for potatoes. Potatoes are expected to yield the highest 
concentration of ipconazole due to the high seeding rates. Therefore, 
the Agency incorporated the drinking water concentrations from potatoes 
directly into the dietary analysis.
    For acute dietary risk assessment, the surface water concentration 
value of 4.589 part per billion (ppb) was used to assess the 
contribution to drinking water.
    For chronic (non-cancer) dietary risk assessment, the surface water 
concentration value of 1.840 ppb was used to assess the contribution of 
drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Ipconazole is not registered for any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Ipconazole is a member of the triazole-containing class of 
pesticides, often referred to as the conazoles. Although conazoles act 
similarly in plants (fungi) by inhibiting ergosterol biosynthesis, 
there is not necessarily a relationship between their pesticidal 
activity and their mechanism of toxicity in mammals. Structural 
similarities do not constitute a common mechanism of toxicity. Evidence 
is needed to establish that the chemicals operate by the same, or 
essentially the same, sequence of major biochemical events. In 
conazoles, however, a variable pattern of toxicological responses is 
found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce 
thyroid tumors in rats. Some induce developmental, reproductive, and 
neurological effects in rodents. Furthermore, the conazoles produce a 
diverse range of biochemical events including altered cholesterol 
levels, stress responses, and altered DNA methylation. It is not 
clearly understood whether these biochemical events are directly 
connected to their toxicological outcomes. Thus, there is currently no 
evidence to indicate that conazoles share common mechanisms of toxicity 
and EPA is not following a cumulative risk approach based on a common 
mechanism of toxicity for the conazoles. For information regarding 
EPA's procedures for cumulating effects from substances found to have a 
common mechanism of toxicity, see EPA's website at https://www.epa.gov/
pesticides/cumulative.
    Triazole-derived pesticides can form the common metabolite 1,2,4-
triazole and two triazole conjugates (triazole alanine and triazole 
acetic acid). To support existing tolerances and to establish new 
tolerances for triazole-derivative pesticides, including ipconazole, 
EPA conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazole alanine, and triazole acetic acid resulting from the 
use of all current and pending uses of any triazole-derived fungicide 
as of September 1, 2005. The risk assessment is a highly conservative, 
screening-level evaluation in terms of hazards associated with common 
metabolites (e.g., use of a maximum combination of uncertainty factors) 
and potential dietary and non-dietary exposures (i.e., high end 
estimates of both dietary and non-dietary exposures). In addition, the 
Agency retained the additional 10X FQPA safety factor for the 
protection of infants and children. The assessment includes evaluations 
of risks for various subgroups, including those comprised of infants 
and children. The Agency's September 1, 2005 risk assessment can be 
found in the propiconazole reregistration docket at https://
www.regulations.gov (Docket ID EPA-HQ-OPP-2005-0497). An addendum to 
the risk assessment, Dietary Exposure Assessments for the Common 
Triazole Metabolites 1,2,4-triazole, Triazolylalanine, Triazolylacetic 
Acid and Triazolylypyruvic Acid; Updated to Include New Uses of 
Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and Uniconazole; 
and a Change in Plant-back Restriction for Tetraconazole can be found 
at https://www.regulations.gov in docket ID EPA-HQ-OPP-2007-0226.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA 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. Offspring effects only 
occurred in the presence of maternal toxicity; offspring effects were 
not considered more severe than the parental effects. Therefore, HED 
concluded that there is no quantitative or qualitative evidence of 
increased susceptibility to rat or rabbit fetuses exposed in utero and/
or post-natally to ipconazole.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:

[[Page 69558]]

    i. The toxicity database for ipconazole is adequate for the 
purposes of this risk assessment.
    ii. There is no indication that ipconazole 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 ipconazole results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to ipconazole in 
drinking water. EPA used similarly conservative assumptions to assess 
post-application exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by ipconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic 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-, intermediate-, 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. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Using the exposure assumptions described in this unit 
for acute exposure, EPA has concluded that acute exposure to ipconazole 
from food and water will utilize <1% of the aPAD for the population 
group females 13-49 years old, the only population subgroup appropriate 
for inclusion in an acute dietary exposure assessment.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
ipconazole from food and water will utilize 1.2% of the cPAD for all 
infants (the population group receiving the greatest exposure).
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Ipconazole is not registered for any use patterns that would result 
in short-term and intermediate-term residential exposure. Therefore, 
the short-term and intermediate-term aggregate risk, individually is 
the sum of the risk from exposure to ipconazole through food and water, 
which has already been addressed, and will not be greater than the 
chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Ipconazole has been 
classified as not likely to be carcinogenic, and is not expected to 
pose a cancer risk to humans.
    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 ipconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate liquid chromatography/mass spectrometry/mass spectrometry 
(LC/MS/MS) enforcement methodology (AC/3020) is available to enforce 
the tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: residuemethods@epa.gov.

B. International Residue Limits

    No Codex MRLs have been established for ipconazole. No Canadian or 
Mexican MRLs have been established.

C. Revisions to Petitioned-For Tolerances

    The proposed tolerance for crop subgroup 6C has been modified to 
reflect the correct commodity definition: ``Pea and bean, dried 
shelled, except soybean, subgroup 6C.''

V. Conclusion

    Therefore, tolerances are established for residues of ipconazole, 
(2-[(4-chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-
ylmethyl) cyclopentanol) from treatment of seed prior to planting, in 
or on cotton, peanut, soybean, pea and bean, dried shelled, except 
soybean (Subgroup 6C), cereal grains (Group 15) except rice, and 
forage, fodder, and straw of cereal grains (Group 16) except rice at 
0.01 ppm.

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, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under 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

[[Page 69559]]

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: November 5, 2008.
Debra Edwards,
Director, 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 180.646 is added to subpart C to read as follows:


Sec.  180.646  Ipconazole; tolerances for residues.

    (a) General. Tolerances are established for residues of ipconazole, 
(2-[(4-chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-
ylmethyl) cyclopentanol) from seed treatment in or on the following 
commodities:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Cotton, gin byproducts................................                                                      0.01
Cotton, undelinted seed...............................                                                      0.01
Grain, cereal, forage, fodder and straw, group 16,                                                          0.01
 except rice..........................................
Grain, cereal group 15, except rice...................                                                      0.01
Pea and bean, dried shelled, except soybean, subgroup                                                       0.01
 6C...................................................
Peanut................................................                                                      0.01
Soybean, forage.......................................                                                      0.01
Soybean, seed.........................................                                                      0.01
----------------------------------------------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. E8-27310 Filed 11-18-08; 8:45 am]
BILLING CODE 6560-50-S
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