Difenoconazole; Pesticide Tolerances for Emergency Exemptions, 45624-45629 [E8-17937]

Download as PDF yshivers on PROD1PC62 with RULES 45624 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 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 VerDate Aug<31>2005 13:49 Aug 05, 2008 Jkt 214001 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). ENVIRONMENTAL PROTECTION AGENCY IX. Congressional Review Act 40 CFR Part 180 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). [EPA–HQ–OPP–2008–0484; FRL–8375–5] List of Subjects in 40 CFR Part 174 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 26, 2008. Debra Edwards, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 174—[AMENDED] 1. The authority citation for part 174 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 174.501 in subpart D is revised to read as follows: I § 174.501 Bacillus thuringiensis Vip3Aa protein in corn and cotton; exemption from the requirement of a tolerance. Residues of Bacillus thuringiensis Vip3Aa proteins in or on corn or cotton are exempt from the requirement of a tolerance when used as plant– incorporated protectants in or on the food and feed commodities of corn; corn, field; corn, sweet; corn, pop; and cotton; cotton, undelinted seed; cotton, refined oil; cotton, meal; cotton, hay; cotton, hulls; cotton, forage; and cotton, gin byproducts. § 174.528 [Removed] 3. Section 174.528 is removed from Subpart D. I [FR Doc. E8–17931 Filed 8–5–08; 8:45 am] BILLING CODE 6560–50–S PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 Difenoconazole; Pesticide Tolerances for Emergency Exemptions Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes time-limited tolerances for residues of difenoconazole, 1-[2-[2-chloro-4-(4chlorophenoxy)phenyl]-4-methyl-1,3dioxolan-2-ylmethyl]-1H-1,2,4-triazole in or on almond, almond hulls, cantaloupe, cucumber, and watermelon. This action is in response to EPA’s granting crisis exemptions to the California Environmental Protection Agency and the Georgia Department of Agriculture under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on almond, almond hulls, cantaloupe, cucumber, and watermelon. This regulation establishes a maximum permissible level for residues of difenoconazole in these food commodities. The time-limited tolerances expire and are revoked on December 31, 2011. DATES: This regulation is effective August 6, 2008. Objections and requests for hearings must be received on or before October 6, 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). EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2008–0484. 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 either in the electronic docket ADDRESSES: E:\FR\FM\06AUR1.SGM 06AUR1 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations at https://www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are 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: Stacey Groce, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–2505; e-mail address: groce.stacey@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: • 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 provides 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. yshivers on PROD1PC62 with RULES B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at 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 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at https:// www.gpoaccess.gov/ecfr. VerDate Aug<31>2005 13:49 Aug 05, 2008 Jkt 214001 C. Can I File an Objection or Hearing Request? Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2008–0484 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 6, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA–HQ–OPP–2008–0484, 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. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing timelimited tolerances for residues of the fungicide difenoconazole, in or on almond at 0.05 parts per million (ppm), almond, hulls at 5.0 (ppm), cantaloupe at 1.0 (ppm), cucumber at 1.0 (ppm), PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 45625 and watermelon at 1.0 (ppm). These time-limited tolerances expire and are revoked on December 31, 2011. EPA will publish a document in the Federal Register to remove the revoked tolerances from the CFR. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related timelimited tolerances to set binding precedents for the application of section 408 of FFDCA to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. 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. . . .’’ Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ‘‘emergency conditions exist which require such exemption.’’ EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemptions for Difenoconazole on Various Commodities: Almond, Almond Hulls, Cantaloupe, Cucumber, and Watermelon and FFDCA Tolerances The California Environmental Protection Agency, Department of Pesticide Regulation, requested an E:\FR\FM\06AUR1.SGM 06AUR1 yshivers on PROD1PC62 with RULES 45626 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations emergency exemption for difenoconazole on almond and almond hulls to control Alternaria leaf blight disease, and issued a crisis exemption for this use pursuant to 40 CFR part 166, subpart C. Alternaria leaf spot disease is caused by a common fungus that results in premature defoliation and interference with hull split and nut removal of almonds. Further, it appears that in California a significant portion of the spores that cause Alternaria leaf blight disease has developed resistance against registered alternative fungicides. In addition, the Georgia Department of Agriculture requested a specific emergency exemption and subsequently issued a crisis exemption for the use of difenoconazole on cucurbits (cucumber, cantaloupe, and watermelon) as a tank mixture with cyprodinil to control gummy stem blight disease (caused by Didymella bryonia). After having reviewed the submissions, EPA determined that the conditions described by the California Department of Environmental Protection and the Georgia Department of Agriculture meet the criteria for emergency exemptions. EPA authorized under FIFRA section 18 the use of difenoconazole on almond, and almond, hulls for control of Alternaria leaf and stem blight in California, and on cantaloupe, cucumber, and watermelon in Georgia to control Gummy stem blight disease. As part of its evaluation of the emergency exemption applications, EPA assessed the potential risks presented by residues of difenoconazole in or on almond, cantaloupe, cucumber, and watermelon. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerances under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemptions in order to address urgent non-routine situations and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these time-limited tolerances expire and are revoked on December 31, 2011, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on almond, cantaloupe, cucumber, and watermelon after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time- VerDate Aug<31>2005 13:49 Aug 05, 2008 Jkt 214001 limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether difenoconazole meets FIFRA’s registration requirements for use on almond, cantaloupe, cucumber, and watermelon or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these time-limited tolerance decisions serve as a basis for registration of difenoconazole by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for persons in any State other than California and Georgia to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for difenoconazole contact the Agency’s Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. IV. 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 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 these actions. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 of these emergency exemption requests and the time-limited tolerances for residues of difenoconazole on almond at 0.05 ppm, almond, hulls at 5.0 ppm, cantaloupe at 1.0 ppm, cucumber at 1.0 ppm, and watermelon at 1.0 ppm. EPA’s assessment of exposures and risks associated with establishing these timelimited tolerances follows. A. 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 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 difenoconazole used for human risk assessment can be found at https://www.regulations.gov in the November 9, 2007 document: Difenoconazole in/on Fruiting Vegetables, Pome Fruit, Sugar Beets, E:\FR\FM\06AUR1.SGM 06AUR1 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations yshivers on PROD1PC62 with RULES Tuberous and Corn Vegetables, and Imported Papaya. Health Effects Division (HED) Revised Risk Assessment, pages 13 and 14 of 57 in docket ID number EPA–HQ–OPP–2008– 0484. B. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to difenoconazole, EPA considered exposure under the timelimited tolerances established by this action as well as all existing difenoconazole tolerances in (40 CFR 180.475). EPA assessed dietary exposures from difenoconazole in food as follows: i. Acute exposure. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA’s acute dietary analysis assumed tolerance-level residues and 100% crop treated (PCT) for all registered and proposed crops. Tolerance-level residues were also assumed for all livestock tissues in this assessment. Experimental processing factors were used for apple juice (0.04x), potato chips (0.5x), potato granules/ flakes (0.5x), sugar beet molasses (0.6x), sugar beet refined sugar (0.6x), tomato paste (1.6x), and tomato puree (0.5x). The Dietary Exposure Evaluation Model (DEEM)TM version 7.76 default processing factors were assumed (when appropriate) for other processed commodities. The resulting acute dietary (food + water) exposure estimates are not of concern to the Agency (<100% of the aPAD at the 95th percentile of the exposure distribution for the U.S. general population (2.9% aPAD) and all population subgroups. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994–1996 and 1998 CSFII. As to residue levels in food, EPA’s chronic dietary analysis assumed tolerance-level residues and 100 PCT for all registered and proposed crops. Tolerance level residues were also assumed for all livestock tissues in this assessment. Experimental processing factors were used for apple juice (0.04x), potato chips (0.5x), potato granules/ flakes (0.5x), sugar beet molasses (0.6x), sugar beet refined sugar (0.6x), tomato paste (1.6x), and tomato puree (0.5x). The DEEMTM version 7.76 default processing factors were assumed (when appropriate) for other processed commodities. The resulting chronic dietary (food + water) exposure VerDate Aug<31>2005 13:49 Aug 05, 2008 Jkt 214001 estimates are not of concern to the Agency (<100% of the cPAD for the U.S. general population (23% cPAD) and all population subgroups. iii. Cancer. A cancer dietary assessment was not conducted for difenoconazole because the cancer noobservable-adverse-effect level (NOAEL) is higher than the chronic reference dose (RfD); therefore, the chronic dietary risk estimate is protective of any cancer effects. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for difenoconazole. 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 difenoconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of difenoconazole. 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. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCIGROW) models, the estimated drinking water concentrations (EDWCs) of difenoconazole for acute exposures are estimated to be 13.3 parts per billion (ppb) for surface water and 0.00128 ppb for ground water and for chronic exposures for non-cancer assessments are estimated to be 9.43 ppb for surface water and 0.00108 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. In this assessment, 1-in-10–year annual peak (13.3 ppb) and 1-in-10–year annual mean (9.43 ppb) residue values were used for acute and chronic dietary exposure assessments respectively. 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). Difenoconazole is currently registered for ornamental foliar treatment that could result in residential exposure. EPA assessed residential exposure using the following assumptions: Residential pesticide handlers will be exposed to short-term duration (1 to 30 days) only. The dermal and inhalation (short-term) PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 45627 residential exposure was assessed for homeowners (mixer/loader/applicator) wearing short pants and short-sleeved shirts as well as shoes plus socks using garden hose-end sprayer, pump-up compressed air sprayer, and backpack sprayer. With regard to residential postapplication exposures, no significant post application exposure is anticipated from ornamentals by residents. Therefore, no residential postapplication assessment was conducted. 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.’’ Difenoconazole is a member of the triazole-containing class of pesticides. 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 biological 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. However, this class of compounds can form the common metabolite 1,2,4triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). To support existing tolerances and to establish new tolerances for triazole-derived pesticides, including difenoconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of any triazole-derived E:\FR\FM\06AUR1.SGM 06AUR1 45628 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations i. The toxicity database for difenoconazole is complete. ii. There is no indication that difenoconazole 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 difenoconazole results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2–generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to difenoconazole 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 difenoconazole. C. Safety Factor for Infants and Children yshivers on PROD1PC62 with RULES fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of UFs) and potential dietary and nondietary exposures (i.e., high-end estimates of both dietary and nondietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment included evaluations of risks for various subgroups, including those comprised of infants and children. The Agency’s complete risk assessment can be found in the propiconazole reregistration docket at https://www.regulations.gov, (Docket ID number EPA–HQ–OPP– 2005–0497). 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 the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at https:// www.epa.gov/pesticides/cumulative. 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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to difenoconazole will occupy 9% of the aPAD for (the population group all infants (< 1 year old)) the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to difenoconazole from food and water will utilize 65% of the cPAD for (children 1-2 years old) the population group receiving the greatest exposure. Based on the residential use patterns, chronic residential exposure to 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 SF when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Developmental toxicity studies showed no increased sensitivity in fetuses as compared to maternal animals following in utero exposures in rats and rabbits, and prenatal/postnatal exposure in the 2–generation toxicity study in arts. There was no evidence of abnormalities in the development of the fetal nervous system in the prenatal/postnatal studies. 3. Conclusion. EPA has determined that reliable data show that 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: VerDate Aug<31>2005 13:49 Aug 05, 2008 Jkt 214001 D. Aggregate Risks and Determination of Safety PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 residues of difenoconazole is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Difenoconazole is currently registered for an ornamental foliar use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to difenoconazole. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures aggregated result in aggregate MOEs of greater than or equal to 170. Therefore, short-term aggregate exposure to difenoconazole is not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). The Agency believes residential pesticide handlers will be exposed to short-term duration (1-30 days) only. Therefore, intermediate and long-term aggregate risks are not of concern. Difenoconazole is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to difenoconazole through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk. 5. Aggregate cancer risk for U.S. population.The chronic dietary risk assessment is protective of carcinogenic effects of difenoconazole. The cancer NOAEL is higher than the chronic RfD. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to difenoconazole residues. V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (Method AG-575B) 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; E:\FR\FM\06AUR1.SGM 06AUR1 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations telephone number: (410) 305–2905; email address: residuemethods@epa.gov. B. International Residue Limits There are no Codex, Canadian, or Mexican Maximum Residue Limits (MRLs) for difenoconazole. yshivers on PROD1PC62 with RULES VI. Conclusion Therefore, time-limited tolerances are established for residues of difenoconazole, 1-[2-[2-chloro-4-(4chlorophenoxy) phenyl]-4-methyl-1,3dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on almond at 0.05 parts per million (ppm), almond, hulls at 5.0 (ppm), and cantaloupe at 1.0 (ppm), cucumber at 1.0 (ppm), and watermelon at 1.0 (ppm). These tolerances expire and are revoked on December 31, 2011. VII. Statutory and Executive Order Reviews This final rule establishes tolerances under sections 408(e) and 408(l)(6) 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 in accordance with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions VerDate Aug<31>2005 13:49 Aug 05, 2008 Jkt 214001 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). VIII. 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: July 25, 2008. Lois 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. PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 45629 2. Section 180.475 is amended by adding text to paragraph (b) to read as follows: I § 180.475 Difenoconazole; tolerances for residues. * * * * * (b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the fungicide difenoconazole in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. The tolerances expire and are revoked on the date specified in the table. Parts per million Commodity Almond .............. Almond, hulls .... Cantaloupe ....... Cucumber ......... Watermelon ...... * * * 0.05 5.0 1.0 1.0 1.0 * Expiration/ revocation date 12/31/11 12/31/11 12/31/11 12/31/11 12/31/11 * [FR Doc. E8–17937 Filed 8–5–08; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0221; FRL–8367–5] Dodine; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for residues of dodine in or on bananas and peanuts. Agriphar S.A. c/o Ceres International LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective August 6, 2008. Objections and requests for hearings must be received on or before October 6, 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–2007–0221. 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 E:\FR\FM\06AUR1.SGM 06AUR1

Agencies

[Federal Register Volume 73, Number 152 (Wednesday, August 6, 2008)]
[Rules and Regulations]
[Pages 45624-45629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17937]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0484; FRL-8375-5]


Difenoconazole; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-
4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole in or on almond, 
almond hulls, cantaloupe, cucumber, and watermelon. This action is in 
response to EPA's granting crisis exemptions to the California 
Environmental Protection Agency and the Georgia Department of 
Agriculture under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizing use of the pesticide on almond, 
almond hulls, cantaloupe, cucumber, and watermelon. This regulation 
establishes a maximum permissible level for residues of difenoconazole 
in these food commodities. The time-limited tolerances expire and are 
revoked on December 31, 2011.

DATES: This regulation is effective August 6, 2008. Objections and 
requests for hearings must be received on or before October 6, 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-2008-0484. 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 either in the electronic docket

[[Page 45625]]

at https://www.regulations.gov, or, if only available in hard copy, at 
the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. 
S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, 
VA. The hours of operation of this Docket Facility are 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: Stacey Groce, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-2505; e-mail address: groce.stacey@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:
     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 provides 
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 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 the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), 
any person may file an objection to any aspect of this regulation and 
may also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2008-0484 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before October 6, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0484, 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. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
time-limited tolerances for residues of the fungicide difenoconazole, 
in or on almond at 0.05 parts per million (ppm), almond, hulls at 5.0 
(ppm), cantaloupe at 1.0 (ppm), cucumber at 1.0 (ppm), and watermelon 
at 1.0 (ppm). These time-limited tolerances expire and are revoked on 
December 31, 2011. EPA will publish a document in the Federal Register 
to remove the revoked tolerances from the CFR.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA to other tolerances and 
exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance 
or an exemption from the requirement of a tolerance on its own 
initiative, i.e., without having received any petition from an outside 
party.
    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Difenoconazole on Various Commodities: 
Almond, Almond Hulls, Cantaloupe, Cucumber, and Watermelon and FFDCA 
Tolerances

    The California Environmental Protection Agency, Department of 
Pesticide Regulation, requested an

[[Page 45626]]

emergency exemption for difenoconazole on almond and almond hulls to 
control Alternaria leaf blight disease, and issued a crisis exemption 
for this use pursuant to 40 CFR part 166, subpart C. Alternaria leaf 
spot disease is caused by a common fungus that results in premature 
defoliation and interference with hull split and nut removal of 
almonds. Further, it appears that in California a significant portion 
of the spores that cause Alternaria leaf blight disease has developed 
resistance against registered alternative fungicides.
    In addition, the Georgia Department of Agriculture requested a 
specific emergency exemption and subsequently issued a crisis exemption 
for the use of difenoconazole on cucurbits (cucumber, cantaloupe, and 
watermelon) as a tank mixture with cyprodinil to control gummy stem 
blight disease (caused by Didymella bryonia).
    After having reviewed the submissions, EPA determined that the 
conditions described by the California Department of Environmental 
Protection and the Georgia Department of Agriculture meet the criteria 
for emergency exemptions. EPA authorized under FIFRA section 18 the use 
of difenoconazole on almond, and almond, hulls for control of 
Alternaria leaf and stem blight in California, and on cantaloupe, 
cucumber, and watermelon in Georgia to control Gummy stem blight 
disease.
    As part of its evaluation of the emergency exemption applications, 
EPA assessed the potential risks presented by residues of 
difenoconazole in or on almond, cantaloupe, cucumber, and watermelon. 
In doing so, EPA considered the safety standard in section 408(b)(2) of 
FFDCA, and EPA decided that the necessary tolerances under section 
408(l)(6) of FFDCA would be consistent with the safety standard and 
with FIFRA section 18. Consistent with the need to move quickly on the 
emergency exemptions in order to address urgent non-routine situations 
and to ensure that the resulting food is safe and lawful, EPA is 
issuing these tolerances without notice and opportunity for public 
comment as provided in section 408(l)(6) of FFDCA. Although these time-
limited tolerances expire and are revoked on December 31, 2011, under 
section 408(l)(5) of FFDCA, residues of the pesticide not in excess of 
the amounts specified in the tolerances remaining in or on almond, 
cantaloupe, cucumber, and watermelon after that date will not be 
unlawful, provided the pesticide was applied in a manner that was 
lawful under FIFRA, and the residues do not exceed a level that was 
authorized by these time-limited tolerances at the time of that 
application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
difenoconazole meets FIFRA's registration requirements for use on 
almond, cantaloupe, cucumber, and watermelon or whether permanent 
tolerances for these uses would be appropriate. Under these 
circumstances, EPA does not believe that these time-limited tolerance 
decisions serve as a basis for registration of difenoconazole by a 
State for special local needs under FIFRA section 24(c). Nor do these 
tolerances serve as the basis for persons in any State other than 
California and Georgia to use this pesticide on the applicable crops 
under FIFRA section 18 absent the issuance of an emergency exemption 
applicable within that State. For additional information regarding the 
emergency exemption for difenoconazole contact the Agency's 
Registration Division at the address provided under FOR FURTHER 
INFORMATION CONTACT.

IV. 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 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 these actions. EPA has sufficient 
data to assess the hazards of and to make a determination on aggregate 
exposure expected as a result of these emergency exemption requests and 
the time-limited tolerances for residues of difenoconazole on almond at 
0.05 ppm, almond, hulls at 5.0 ppm, cantaloupe at 1.0 ppm, cucumber at 
1.0 ppm, and watermelon at 1.0 ppm. EPA's assessment of exposures and 
risks associated with establishing these time-limited tolerances 
follows.

A. 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 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 difenoconazole used 
for human risk assessment can be found at https://www.regulations.gov in 
the November 9, 2007 document: Difenoconazole in/on Fruiting 
Vegetables, Pome Fruit, Sugar Beets,

[[Page 45627]]

Tuberous and Corn Vegetables, and Imported Papaya. Health Effects 
Division (HED) Revised Risk Assessment, pages 13 and 14 of 57 in docket 
ID number EPA-HQ-OPP-2008-0484.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to difenoconazole, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing 
difenoconazole tolerances in (40 CFR 180.475). EPA assessed dietary 
exposures from difenoconazole in food as follows:
    i. Acute exposure. In estimating acute dietary exposure, EPA used 
food consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA's 
acute dietary analysis assumed tolerance-level residues and 100% crop 
treated (PCT) for all registered and proposed crops. Tolerance-level 
residues were also assumed for all livestock tissues in this 
assessment. Experimental processing factors were used for apple juice 
(0.04x), potato chips (0.5x), potato granules/flakes (0.5x), sugar beet 
molasses (0.6x), sugar beet refined sugar (0.6x), tomato paste (1.6x), 
and tomato puree (0.5x). The Dietary Exposure Evaluation Model 
(DEEM)\TM\ version 7.76 default processing factors were assumed (when 
appropriate) for other processed commodities. The resulting acute 
dietary (food + water) exposure estimates are not of concern to the 
Agency (<100% of the aPAD at the 95\th\ percentile of the exposure 
distribution for the U.S. general population (2.9% aPAD) and all 
population subgroups.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA's chronic dietary 
analysis assumed tolerance-level residues and 100 PCT for all 
registered and proposed crops. Tolerance level residues were also 
assumed for all livestock tissues in this assessment. Experimental 
processing factors were used for apple juice (0.04x), potato chips 
(0.5x), potato granules/flakes (0.5x), sugar beet molasses (0.6x), 
sugar beet refined sugar (0.6x), tomato paste (1.6x), and tomato puree 
(0.5x). The DEEM\TM\ version 7.76 default processing factors were 
assumed (when appropriate) for other processed commodities. The 
resulting chronic dietary (food + water) exposure estimates are not of 
concern to the Agency (<100% of the cPAD for the U.S. general 
population (23% cPAD) and all population subgroups.
    iii. Cancer. A cancer dietary assessment was not conducted for 
difenoconazole because the cancer no-observable-adverse-effect level 
(NOAEL) is higher than the chronic reference dose (RfD); therefore, the 
chronic dietary risk estimate is protective of any cancer effects.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for difenoconazole. 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 difenoconazole in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of difenoconazole. 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.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
difenoconazole for acute exposures are estimated to be 13.3 parts per 
billion (ppb) for surface water and 0.00128 ppb for ground water and 
for chronic exposures for non-cancer assessments are estimated to be 
9.43 ppb for surface water and 0.00108 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. In this assessment, 1-in-10-
year annual peak (13.3 ppb) and 1-in-10-year annual mean (9.43 ppb) 
residue values were used for acute and chronic dietary exposure 
assessments respectively.
    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).
    Difenoconazole is currently registered for ornamental foliar 
treatment that could result in residential exposure. EPA assessed 
residential exposure using the following assumptions: Residential 
pesticide handlers will be exposed to short-term duration (1 to 30 
days) only. The dermal and inhalation (short-term) residential exposure 
was assessed for homeowners (mixer/loader/applicator) wearing short 
pants and short-sleeved shirts as well as shoes plus socks using garden 
hose-end sprayer, pump-up compressed air sprayer, and backpack sprayer. 
With regard to residential post-application exposures, no significant 
post application exposure is anticipated from ornamentals by residents. 
Therefore, no residential post-application assessment was conducted.
    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.''
    Difenoconazole is a member of the triazole-containing class of 
pesticides. 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 biological 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.
    However, this class of compounds can form the common metabolite 
1,2,4-triazole and two triazole conjugates (triazolylalanine and 
triazolylacetic acid). To support existing tolerances and to establish 
new tolerances for triazole-derived pesticides, including 
difenoconazole, EPA conducted a human health risk assessment for 
exposure to 1,2,4-triazole, triazolylalanine, and triazolylacetic acid 
resulting from the use of all current and pending uses of any triazole-
derived

[[Page 45628]]

fungicide. The risk assessment is a highly conservative, screening-
level evaluation in terms of hazards associated with common metabolites 
(e.g., use of a maximum combination of UFs) 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 included evaluations of risks for various subgroups, 
including those comprised of infants and children. The Agency's 
complete risk assessment can be found in the propiconazole 
reregistration docket at https://www.regulations.gov, (Docket ID number 
EPA-HQ-OPP-2005-0497).
    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 the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at https://
www.epa.gov/pesticides/cumulative.

C. 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 SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Developmental toxicity 
studies showed no increased sensitivity in fetuses as compared to 
maternal animals following in utero exposures in rats and rabbits, and 
prenatal/postnatal exposure in the 2-generation toxicity study in arts. 
There was no evidence of abnormalities in the development of the fetal 
nervous system in the prenatal/postnatal studies.
    3. Conclusion. EPA has determined that reliable data show that 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 difenoconazole is complete.
    ii. There is no indication that difenoconazole 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 difenoconazole results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to difenoconazole 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 
difenoconazole.

D. 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to difenoconazole will occupy 9% of the aPAD for (the population group 
all infants (< 1 year old)) the population group receiving the greatest 
exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
difenoconazole from food and water will utilize 65% of the cPAD for 
(children 1-2 years old) the population group receiving the greatest 
exposure. Based on the residential use patterns, chronic residential 
exposure to residues of difenoconazole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Difenoconazole is currently registered for an ornamental foliar use 
that could result in short-term residential exposure and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short-term residential exposures to difenoconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in aggregate MOEs of 
greater than or equal to 170. Therefore, short-term aggregate exposure 
to difenoconazole is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). The Agency believes residential pesticide 
handlers will be exposed to short-term duration (1-30 days) only. 
Therefore, intermediate and long-term aggregate risks are not of 
concern.
    Difenoconazole is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to difenoconazole through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population.The chronic dietary 
risk assessment is protective of carcinogenic effects of 
difenoconazole. The cancer NOAEL is higher than the chronic RfD.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to difenoconazole residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method AG-575B) 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;

[[Page 45629]]

telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican Maximum Residue Limits 
(MRLs) for difenoconazole.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy) phenyl]-4-methyl-
1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on almond at 0.05 
parts per million (ppm), almond, hulls at 5.0 (ppm), and cantaloupe at 
1.0 (ppm), cucumber at 1.0 (ppm), and watermelon at 1.0 (ppm). These 
tolerances expire and are revoked on December 31, 2011.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and 
408(l)(6) 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 in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of 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).

VIII. 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: July 25, 2008.
Lois 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 180.475 is amended by adding text to paragraph (b) to read 
as follows:


Sec.  180.475  Difenoconazole; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
fungicide difenoconazole in or on the specified agricultural 
commodities, resulting from use of the pesticide pursuant to FIFRA 
section 18 emergency exemptions. The tolerances expire and are revoked 
on the date specified in the table.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Almond........................................         0.05     12/31/11
Almond, hulls.................................          5.0     12/31/11
Cantaloupe....................................          1.0     12/31/11
Cucumber......................................          1.0     12/31/11
Watermelon....................................          1.0     12/31/11
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-17937 Filed 8-5-08; 8:45 am]
BILLING CODE 6560-50-S