Novaluron; Pesticide Tolerances, 74978-74983 [E8-29117]

Download as PDF 74978 Federal Register / Vol. 73, No. 238 / Wednesday, December 10, 2008 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTARY INFORMATION: 40 CFR Part 180 A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. I. General Information [EPA–HQ–OPP–2007–0438 FRL–8391–5] Novaluron; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. dwashington3 on PROD1PC60 with RULES SUMMARY: This regulation establishes tolerances for residues of novaluron in or on sugarcane, cane and tomato. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). It also revokes the existing, time-limited tolerance for residues of novaluron in or on sugarcane, cane and revises the chemical name for novaluron in 40 CFR 180.598 to reflect EPA’s preferred nomenclature. DATES: This regulation is effective December 10, 2008. Objections and requests for hearings must be received on or before February 9, 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–2007–0438. 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: Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–5218; e-mail address: stanton.susan@epa.gov. VerDate Aug<31>2005 14:03 Dec 09, 2008 Jkt 217001 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–2007–0438 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 9, 2009. In addition to filing an objection or hearing request with the Hearing Clerk PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 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–2007–0438, 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 July 25, 2007 (72 FR 40877) (FRL–8137–1), 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 7E7199) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W, Princeton NJ 08540. The petition requested that 40 CFR 180.598 be amended by establishing tolerances for residues of the insecticide novaluron, 1[3-chloro-4-(1,1,2-trifluoro-2trifluoromethoxyethoxy)phenyl]-3-(2,6difluorobenzoyl)urea, in or on sugarcane, cane at 0.50 parts per million (ppm); tomato at 0.40 ppm; and tomato, paste at 0.80 ppm. That notice referenced a summary of the petition prepared on behalf of IR-4 by Makhteshim-Agan of North America, Inc., the registrant, which is available to the public in the docket, https:// www.regulations.gov. Comments were received on the notice of filing. EPA’s response to these comments is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has increased the tolerance on tomato to 1.0 ppm and determined that a separate tolerance on tomato, paste is not needed. The reasons for these changes are explained in Unit IV.D. E:\FR\FM\10DER1.SGM 10DER1 Federal Register / Vol. 73, No. 238 / Wednesday, December 10, 2008 / Rules and Regulations 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 novaluron on sugarcane, cane at 0.50 ppm and tomato at 1.0 ppm. EPA’s assessment of exposures and risks associated with establishing tolerances follows. dwashington3 on PROD1PC60 with RULES 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. Novaluron has low acute toxicity via the oral, dermal and inhalation routes of exposure. It is not an eye or skin irritant and is not a dermal sensitizer. In subchronic and chronic toxicity studies, novaluron primarily produced hematotoxic effects such as methemoglobinemia, decreased hemoglobin, decreased hematocrit and decreased red blood corpuscles (RBCs or erythrocytes) associated with increased erythropoiesis. There was no maternal or developmental toxicity seen in the rat and rabbit developmental toxicity VerDate Aug<31>2005 14:03 Dec 09, 2008 Jkt 217001 studies up to the limit doses. In the 2generation reproductive toxicity study in rats, both maternal and offspring toxicity were evidenced by spleenomegaly. Reproductive toxicity (decreases in epididymal sperm counts and increased age at preputial separation in the F1 generation) was observed only in males. Novaluron does not appear to be a potent neurotoxicant. Signs of neurotoxicity were seen in the acute neurotoxicity study in rats but only at the limit dose of 2,000 milligrams/ kilogram/day (mg/kg/day). Neurotoxic signs seen in this study included clinical signs (piloerection, fast/ irregular breathing), functional observation battery (FOB) parameters (head swaying, abnormal gait) and neuropathology (sciatic and tibial nerve degeneration). No signs of neurotoxicity or neuropathology were observed in the subchronic neurotoxicity study in rats at doses up to 1,752 mg/kg/day in males and 2,000 mg/kg/day in females or in any other subchronic or chronic toxicity study in rats, mice or dogs. There was no evidence of carcinogenic potential in either the rat or mouse carcinogenicity studies and no evidence of mutagenic activity in the submitted mutagenicity studies, including a bacterial (Salmonella, E. coli) reverse mutation assay, an in vitro mammalian chromosomal aberration assay, an in vivo mouse bone-marrow micronucleus assay and bacterial DNA damage or repair assay. Based on the results of these studies, EPA has classified novaluron as ‘‘not likely to be carcinogen to humans.’’ Specific information on the studies received and the nature of the adverse effects caused by novaluron 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 PP 7E7199 Novaluron in/on Sugarcane and Tomato. Health Effects Division (HED) Risk Assessment, pages 24 to 27 in docket ID number EPA–HQ–OPP–2007– 0438. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which the NOAEL are observed in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the LOAEL concern are identified or a benchmark PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 74979 dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/ pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for novaluron used for human risk assessment can be found at https:// www.regulations.gov in document PP7E7199 Novaluron in/on Sugarcane and Tomato. Health Effects Division (HED) Risk Assessment, pages 10 to 11 in docket ID number EPA–HQ–OPP–2007– 0438. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to novaluron, EPA considered exposure under the petitioned-for tolerances as well as all existing novaluron tolerances in 40 CFR 180.598. EPA assessed dietary exposures from novaluron in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1–day or single exposure. No such effects were identified in the toxicological studies for novaluron; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment E:\FR\FM\10DER1.SGM 10DER1 dwashington3 on PROD1PC60 with RULES 74980 Federal Register / Vol. 73, No. 238 / Wednesday, December 10, 2008 / Rules and Regulations EPA used the food consumption data from the United States Department of Agriculture (USDA) 1994–1996 and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, EPA incorporated anticipated residues (average field trial residues) for some commodities, including the new commodities (sugarcane and tomatoes); empirical processing factors for apple juice (translated to pear juice); and DEEM (ver 7.81) default processing factors for the remaining processed commodities. In estimating dietary exposure from secondary residues in livestock, EPA relied on anticipated residues for meat and milk commodities but used tolerance-level residues for poultry commodities. 100 percent crop treated (PCT) was assumed for all existing and new uses of novaluron. iii. Cancer. Based on the results of carcinogenicity studies in rats and mice, EPA has classified novaluron as ‘‘not likely to be carcinogenic to humans;’’ therefore, a quantitative cancer exposure assessment is unnecessary. iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data CallIns as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. 2. Dietary exposure from drinking water. The residues of concern in drinking water are novaluron and its chlorophenyl urea and chloroaniline degradates. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for novaluron and its degradates in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of novaluron. 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 VerDate Aug<31>2005 14:03 Dec 09, 2008 Jkt 217001 Concentration in Ground Water (SCIGROW) models, the estimated drinking water concentrations (EDWCs) of novaluron, chlorophenyl urea and chloroaniline for chronic exposures for non-cancer assessments are estimated to be 1.8 parts per billion (ppb), 0.86 ppb and 2.6 ppb, respectively, for surface water and 0.0055 ppb, 0.0045 ppb and 0.0090 ppb, respectively, for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. The highest drinking water concentrations were estimated for surface water. Of the three EDWC values for surface water, the chronic EDWC for the terminal metabolite, chloroaniline, is the highest (assuming 100 percent molar conversion from parent to aniline). This is consistent with the expected degradation pattern for novaluron. Therefore, for chronic dietary risk assessment, the water concentration value for chloroaniline of 2.6 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Novaluron 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.’’ EPA has not found novaluron to share a common mechanism of toxicity with any other substances, and novaluron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that novaluron does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// www.epa.gov/pesticides/cumulative. PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 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. The prenatal and postnatal toxicology database for novaluron includes rat and rabbit prenatal developmental toxicity studies and a 2–generation reproduction toxicity study in rats. There was no evidence of increased quantitative or qualitative susceptibility following in utero exposure of rats or rabbits in the developmental toxicity studies and no evidence of increased quantitative or qualitative susceptibility of offspring in the reproduction study. Neither maternal nor developmental toxicity was seen in the developmental studies up to the limit doses. In the reproduction study, offspring and maternal toxicity (increased absolute and relative spleen weights) were similar and occurred at the same dose; and reproductive effects (decreases in epididymal sperm counts and increased age at preputial separation in the F1 generation) occurred at a higher dose than that which resulted in maternal toxicity. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for novaluron is complete, except for immunotoxicity testing. EPA began requiring functional immunotoxicity testing of all food and non-food use pesticides on December 26, 2007. Since this requirement went into effect after the tolerance petition was submitted, these studies are not yet available for novaluron. In the absence of specific immunotoxicity studies, EPA has evaluated the available novaluron toxicity data to determine whether an additional database uncertainty factor is needed to account for potential immunotoxicity. There was no evidence of adverse effects on the organs of the E:\FR\FM\10DER1.SGM 10DER1 dwashington3 on PROD1PC60 with RULES Federal Register / Vol. 73, No. 238 / Wednesday, December 10, 2008 / Rules and Regulations immune system at the LOAEL in any study novaluron. In addition, novaluron does not belong to a class of chemicals (e.g., the organotins, heavy metals, or halogenated aromatic hydrocarbons) that would be expected to be immunotoxic. Based on the above considerations, EPA does not believe that conducting a special series 870.7800 immunotoxicity study will result in a point of departure less than the NOAEL of 0.011 mg/kg/day used in calculation the cPAD for novaluron, and therefore, an additional database uncertainty factor is not needed to account for potential immunotoxicity. ii. There were signs of neurotoxicity in the acute neurotoxicity study in rats, including clinical signs (piloerection, fast/irregular breathing), functional observation battery (FOB) parameters (head swaying, abnormal gait) and neuropathology (sciatic and tibial nerve degeneration). However, the signs observed were not severe and were seen only at the limit dose (2,000 mg/kg/day); further, the neuropathological effects that were seen at the limit dose also occurred in a few untreated control animals. No signs of neurotoxicity or neuropathology were observed in the subchronic neurotoxicity study in rats at doses up to 1,752 mg/kg/day in males, and 2,000 mg/kg/day in females or in any other subchronic or chronic toxicity study in rats, mice or dogs, including the developmental and reproduction studies. Therefore, novaluron does not appear to cause significant neurotoxicant effects, and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that novaluron 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% CT and tolerance-level or anticipated residues derived from reliable residue field trials. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to novaluron in drinking water. Residential exposures are not expected. These assessments will not underestimate the exposure and risks posed by novaluron. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates VerDate Aug<31>2005 14:03 Dec 09, 2008 Jkt 217001 to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the 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. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, novaluron is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to novaluron from food and water will utilize 74% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of novaluron 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). Novaluron is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to novaluron through food and water and will not be greater than the chronic aggregate risk. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Novaluron 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 novaluron 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. EPA has classified novaluron as ‘‘not likely to be carcinogenic to humans.’’Novaluron is not expected to pose a cancer risk. PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 74981 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 novaluron residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (a gas chromatography/electron-capture detection (GC/ECD) method; and a high pressure liquid chromatography/ ultraviolate detection (HPLC/UV) method) is available to enforce the tolerance expression. The methods 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 Canadian or Mexican MRLs have been established for novaluron on the sugarcane or tomato commodities. A CODEX MRL is established for novaluron (fat soluble) on tomato at 0.02 ppm, significantly below the U.S. tolerance being established by this regulation (1.0 ppm). The U.S. tolerance is based on a different use pattern, including both a higher application rate (12.8x higher) and shorter pre-harvest interval (PHI) (2 days vs. 7 days). For these reasons, the U.S. tolerance cannot be harmonized with the CODEX MRL at this time. C. Response to Comments EPA received comments from a private citizen complaining that she was unable to open the ‘‘proposal’’ at https:// www.regulations.gov. If by ‘‘proposal,’’ the commenter is referring to the registrant’s notice of filing, EPA notes that it is available in the docket in two common file formats, MicroSoft Word and Portable Document Format (PDF) and cannot explain the commenter’s inability to open it. User support is available for anyone having trouble using the regulations website by calling 1–877-ERUL HLP (1–877–378–5457) or by using the Web form link provided under ‘‘Contact Us.’’ D. Revisions to Petitioned-For Tolerances Based upon review of the data supporting the petition, EPA determined that the proposed tolerance on tomato should be increased to 1.0 ppm and that a separate tolerance on tomato paste is not needed. EPA revised the tolerance level for tomato based on analyses of both field- and greenhouse- E:\FR\FM\10DER1.SGM 10DER1 74982 Federal Register / Vol. 73, No. 238 / Wednesday, December 10, 2008 / Rules and Regulations grown residue trials using the Agency’s Tolerance Spreadsheet in accordance with the Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data. The tolerance level of 1.0 ppm is based on the spreadsheet results for greenhouse-grown tomatoes, the cropping scenario that resulted in the higher recommended tolerance. The submitted tomato processing data indicate that residues of novaluron are not likely to concentrate in puree but may concentrate slightly in paste. Based on the processing factor (1.1x) for paste and the highest average field trial (HAFT) residue of 0.365 ppm from the tomato trials, residues of novaluron in paste are not expected to exceed the tolerance for tomato (1.0 ppm); therefore, no tolerances for tomato processed commodities are needed. The tolerance expression at 40 CFR 180.598 uses the International Union of Pure and Applied Chemistry (IUPAC) nomenclature for novaluron (1-[3chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]-3-(2,6difluorobenzoyl)urea). Since it is EPA’s policy to use the Chemical Abstracts Service (CAS) nomenclature in tolerance expressions, EPA is revising the tolerance expression to reflect the correct CAS designation for novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy] phenyl]amino]carbonyl]-2,6difluorobenzamide). EPA has determined that it is reasonable to make this change final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is a minor change in scientific nomenclature consistent with accepted Agency policy and practice. dwashington3 on PROD1PC60 with RULES V. Conclusion Therefore, tolerances are established for residues of novaluron, N-[3-chloro-4[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy] phenyl]amino]carbonyl]-2,6difluorobenzamide, in or on sugarcane, cane at 0.50 ppm and tomato at 1.0 ppm. A time-limited tolerance of 0.15 ppm was established for residues of novaluron on sugarcane, cane in connection with a FIFRA section 18 emergency exemption granted by EPA. This tolerance (set to expire on 12/31/ 09) is superseded by the higher tolerance being established on sugarcane, cane and is no longer needed. Therefore, the time-limited tolerance is being revoked. VerDate Aug<31>2005 14:03 Dec 09, 2008 Jkt 217001 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 duty or contain any unfunded mandate PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 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 25, 2008. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: ■ PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.598 is amended by removing the entry for sugarcane, cane from the table in paragraph (b); revising paragraph (a) introductory text and alphabetically adding the following commodities to the table in paragraph (a) to read as follows: ■ § 180.598 Novaluron; tolerances for residues. (a) General. Tolerances are established for residues of the insecticide novaluron, N-[[[3-chloro-4[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy] phenyl]amino]carbonyl]-2,6difluorobenzamide, in or on the following raw agricultural commodities: E:\FR\FM\10DER1.SGM 10DER1 Federal Register / Vol. 73, No. 238 / Wednesday, December 10, 2008 / Rules and Regulations Commodity * 74983 Parts per million * * * * Sugarcane, cane 0.50 Tomato 1.0 * * * * * * * * * * I. Overview * * * * * Amendments enacted in 1992 to the Marine Protection, Research, and Sanctuaries Act (MPRSA) require that no permits for ocean dumping shall be issued for an EPA-established ocean dumping site after January 1, 1997, unless the site has received a final designation; therefore, interim ocean dumping sites that have not received a final designation are no longer available for use. Under EPA regulations, the authority to issue interim ocean dumping permits expired on April 23, 1978, and interim permits are no longer issued. Under EPA regulations, interim criteria for constituents prohibited as other than trace contaminants in material proposed for ocean dumping, as well as interim guidance used to determine the limiting permissible concentration for the suspended particulate and solid phases of the material proposed to be dumped, were applicable only until EPA announced the availability of acceptable procedures to evaluate materials for ocean dumping. On April 4, 1991, EPA and the U.S. Army Corps of Engineers announced the availability of a testing manual for dredged material entitled ‘‘Evaluation of Dredged Material Proposed for Ocean Disposal—Testing Manual,’’ which revised the 1977 EPA/ U.S. Army Corps of Engineers document, ‘‘Ecological Evaluation of Proposed Discharge of Dredged Material into Ocean Waters.’’ In addition, EPA published ‘‘Bioassay Procedures for the Ocean Disposal Permit Program,’’ which outlines acceptable procedures for nondredged material. [FR Doc. E8–29117 Filed 12–9–08; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 220, 221, 222, 223, 224, 227, and 228 [FRL–8748–4] RIN 2040–AF01 Repeal of Obsolete Regulations Under the Marine Protection, Research, and Sanctuaries Act Regarding Interim Ocean Dumping Sites, Interim Ocean Dumping Permits, and Interim Ocean Dumping Criteria AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is taking final action to repeal expired, and therefore, obsolete regulatory provisions regarding interim ocean dumping sites, interim ocean dumping permits, and interim ocean dumping criteria. Repeal of all reference to ‘‘interim’’ provisions is necessary based on legislation enacted since promulgation of the reference, EPA action since promulgation of the reference, or the passage of a date specified in a definition of the reference. This action does not make any substantive changes to EPA’s ocean dumping regulations. This is a housekeeping measure intended only to eliminate confusion by repealing obsolete regulatory text. dwashington3 on PROD1PC60 with RULES DATES: This rule is effective on January 9, 2009. FOR FURTHER INFORMATION CONTACT: David Redford, Oceans and Coastal Protection Division, Office of Wetlands, Oceans, and Watersheds, 4504T, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202–566– 1288; fax number: 202–566–1546; e-mail address: redford.david@epa.gov. SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 14:03 Dec 09, 2008 Jkt 217001 II. Background A. Potentially Affected Entities Generally, ocean dumping sites and permits are used by persons, organizations, or government bodies seeking to dispose of dredged material or other material in ocean waters. However, there are no regulated entities potentially affected by this action, because all of the regulatory provisions being repealed have expired, and therefore, have become obsolete (see Section III below). Nothing in this action alters the jurisdiction or authority of EPA or the entities regulated under PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 the Marine Protection, Research, and Sanctuaries Act. B. Marine Protection, Research, and Sanctuaries Act The Marine Protection, Research, and Sanctuaries Act of 1972, as amended, also known as the Ocean Dumping Act, regulates the transportation and dumping of material into ocean waters. Under the MPRSA, no permit may be issued for ocean dumping where such dumping will unreasonably degrade or endanger human health or the marine environment. Most material ocean dumped today is dredged material (i.e., sediments) removed from the bottom of water bodies to maintain navigation channels and berthing areas. Other materials that are currently disposed of in the ocean include fish wastes, human remains, and vessels. Ocean dumping cannot occur except pursuant to a permit under the MPRSA and its implementing regulations. The U.S. Army Corps of Engineers (USACE) issues permits for dumping dredged material in the ocean, using EPA’s environmental criteria and subject to EPA’s concurrence. For all other materials, EPA is the permitting agency. EPA also is responsible for designating recommended ocean dumping sites for all types of materials, including dredged material. EPA’s ocean dumping regulations at 40 CFR Part 228 establish procedures for the designation and management of ocean disposal sites and list the available EPA-designated ocean dumping sites by EPA Region (40 CFR 228.15). C. Interim Ocean Dumping Sites, Permits, Criteria, and Guidance When EPA originally promulgated the ocean dumping regulations in the 1970’s, the Agency made provisions for interim ocean dumping sites, interim ocean dumping permits, and interim ocean dumping criteria. These interim provisions were designed to be temporary measures that would expire under certain conditions, primarily when final sites were designated and criteria were established. As described in Section III below, all provisions related to interim ocean dumping sites, interim permits, interim criteria, and interim guidance have expired and are therefore obsolete. E:\FR\FM\10DER1.SGM 10DER1

Agencies

[Federal Register Volume 73, Number 238 (Wednesday, December 10, 2008)]
[Rules and Regulations]
[Pages 74978-74983]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29117]



[[Page 74978]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0438 FRL-8391-5]


Novaluron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
novaluron in or on sugarcane, cane and tomato. Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA). It also revokes the existing, 
time-limited tolerance for residues of novaluron in or on sugarcane, 
cane and revises the chemical name for novaluron in 40 CFR 180.598 to 
reflect EPA's preferred nomenclature.

DATES: This regulation is effective December 10, 2008. Objections and 
requests for hearings must be received on or before February 9, 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-2007-0438. 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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    In addition to accessing 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-2007-0438 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before February 9, 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-2007-0438, 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 July 25, 2007 (72 FR 40877) (FRL-8137-
1), 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 
7E7199) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201W, Princeton NJ 08540. The petition requested that 
40 CFR 180.598 be amended by establishing tolerances for residues of 
the insecticide novaluron, 1-[3-chloro-4-(1,1,2-trifluoro-2-
trifluoromethoxyethoxy)phenyl]-3-(2,6-difluorobenzoyl)urea, in or on 
sugarcane, cane at 0.50 parts per million (ppm); tomato at 0.40 ppm; 
and tomato, paste at 0.80 ppm. That notice referenced a summary of the 
petition prepared on behalf of IR-4 by Makhteshim-Agan of North 
America, Inc., the registrant, which is available to the public in the 
docket, https://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA has 
increased the tolerance on tomato to 1.0 ppm and determined that a 
separate tolerance on tomato, paste is not needed. The reasons for 
these changes are explained in Unit IV.D.

[[Page 74979]]

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 novaluron on sugarcane, cane at 0.50 ppm and 
tomato at 1.0 ppm. EPA's assessment of exposures and risks associated 
with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Novaluron has low acute toxicity via the oral, dermal and 
inhalation routes of exposure. It is not an eye or skin irritant and is 
not a dermal sensitizer. In subchronic and chronic toxicity studies, 
novaluron primarily produced hematotoxic effects such as 
methemoglobinemia, decreased hemoglobin, decreased hematocrit and 
decreased red blood corpuscles (RBCs or erythrocytes) associated with 
increased erythropoiesis.
    There was no maternal or developmental toxicity seen in the rat and 
rabbit developmental toxicity studies up to the limit doses. In the 2-
generation reproductive toxicity study in rats, both maternal and 
offspring toxicity were evidenced by spleenomegaly. Reproductive 
toxicity (decreases in epididymal sperm counts and increased age at 
preputial separation in the F1 generation) was observed only in males.
    Novaluron does not appear to be a potent neurotoxicant. Signs of 
neurotoxicity were seen in the acute neurotoxicity study in rats but 
only at the limit dose of 2,000 milligrams/kilogram/day (mg/kg/day). 
Neurotoxic signs seen in this study included clinical signs 
(piloerection, fast/irregular breathing), functional observation 
battery (FOB) parameters (head swaying, abnormal gait) and 
neuropathology (sciatic and tibial nerve degeneration). No signs of 
neurotoxicity or neuropathology were observed in the subchronic 
neurotoxicity study in rats at doses up to 1,752 mg/kg/day in males and 
2,000 mg/kg/day in females or in any other subchronic or chronic 
toxicity study in rats, mice or dogs.
    There was no evidence of carcinogenic potential in either the rat 
or mouse carcinogenicity studies and no evidence of mutagenic activity 
in the submitted mutagenicity studies, including a bacterial 
(Salmonella, E. coli) reverse mutation assay, an in vitro mammalian 
chromosomal aberration assay, an in vivo mouse bone-marrow micronucleus 
assay and bacterial DNA damage or repair assay. Based on the results of 
these studies, EPA has classified novaluron as ``not likely to be 
carcinogen to humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by novaluron 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 PP 7E7199 Novaluron in/on Sugarcane and 
Tomato. Health Effects Division (HED) Risk Assessment, pages 24 to 27 
in docket ID number EPA-HQ-OPP-2007-0438.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which the 
NOAEL are observed in the toxicology study identified as appropriate 
for use in risk assessment. However, if a NOAEL cannot be determined, 
the LOAEL concern are identified or a benchmark dose (BMD) approach is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for novaluron used for 
human risk assessment can be found at https://www.regulations.gov in 
document PP-7E7199 Novaluron in/on Sugarcane and Tomato. Health Effects 
Division (HED) Risk Assessment, pages 10 to 11 in docket ID number EPA-
HQ-OPP-2007-0438.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to novaluron, EPA considered exposure under the petitioned-for 
tolerances as well as all existing novaluron tolerances in 40 CFR 
180.598. EPA assessed dietary exposures from novaluron in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for novaluron; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment

[[Page 74980]]

EPA used the food consumption data from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys of Food 
Intakes by Individuals (CSFII). As to residue levels in food, EPA 
incorporated anticipated residues (average field trial residues) for 
some commodities, including the new commodities (sugarcane and 
tomatoes); empirical processing factors for apple juice (translated to 
pear juice); and DEEM (ver 7.81) default processing factors for the 
remaining processed commodities. In estimating dietary exposure from 
secondary residues in livestock, EPA relied on anticipated residues for 
meat and milk commodities but used tolerance-level residues for poultry 
commodities. 100 percent crop treated (PCT) was assumed for all 
existing and new uses of novaluron.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA has classified novaluron as ``not likely to be 
carcinogenic to humans;'' therefore, a quantitative cancer exposure 
assessment is unnecessary.
    iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA 
authorizes EPA to use available data and information on the anticipated 
residue levels of pesticide residues in food and the actual levels of 
pesticide residues that have been measured in food. If EPA relies on 
such information, EPA must require pursuant to FFDCA section 408(f)(1) 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. For the present action, EPA will 
issue such Data Call-Ins as are required by FFDCA section 408(b)(2)(E) 
and authorized under FFDCA section 408(f)(1). Data will be required to 
be submitted no later than 5 years from the date of issuance of these 
tolerances.
    2. Dietary exposure from drinking water. The residues of concern in 
drinking water are novaluron and its chlorophenyl urea and 
chloroaniline degradates. The Agency used screening level water 
exposure models in the dietary exposure analysis and risk assessment 
for novaluron and its degradates in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of novaluron. 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 
novaluron, chlorophenyl urea and chloroaniline for chronic exposures 
for non-cancer assessments are estimated to be 1.8 parts per billion 
(ppb), 0.86 ppb and 2.6 ppb, respectively, for surface water and 0.0055 
ppb, 0.0045 ppb and 0.0090 ppb, respectively, for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The highest drinking water 
concentrations were estimated for surface water. Of the three EDWC 
values for surface water, the chronic EDWC for the terminal metabolite, 
chloroaniline, is the highest (assuming 100 percent molar conversion 
from parent to aniline). This is consistent with the expected 
degradation pattern for novaluron. Therefore, for chronic dietary risk 
assessment, the water concentration value for chloroaniline of 2.6 ppb 
was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Novaluron 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.''
    EPA has not found novaluron to share a common mechanism of toxicity 
with any other substances, and novaluron does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that novaluron does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at https://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure 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. The prenatal and postnatal 
toxicology database for novaluron includes rat and rabbit prenatal 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. There was no evidence of increased quantitative or 
qualitative susceptibility following in utero exposure of rats or 
rabbits in the developmental toxicity studies and no evidence of 
increased quantitative or qualitative susceptibility of offspring in 
the reproduction study. Neither maternal nor developmental toxicity was 
seen in the developmental studies up to the limit doses. In the 
reproduction study, offspring and maternal toxicity (increased absolute 
and relative spleen weights) were similar and occurred at the same 
dose; and reproductive effects (decreases in epididymal sperm counts 
and increased age at preputial separation in the F1 generation) 
occurred at a higher dose than that which resulted in maternal 
toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for novaluron is complete, except for 
immunotoxicity testing. EPA began requiring functional immunotoxicity 
testing of all food and non-food use pesticides on December 26, 2007. 
Since this requirement went into effect after the tolerance petition 
was submitted, these studies are not yet available for novaluron. In 
the absence of specific immunotoxicity studies, EPA has evaluated the 
available novaluron toxicity data to determine whether an additional 
database uncertainty factor is needed to account for potential 
immunotoxicity. There was no evidence of adverse effects on the organs 
of the

[[Page 74981]]

immune system at the LOAEL in any study novaluron. In addition, 
novaluron does not belong to a class of chemicals (e.g., the 
organotins, heavy metals, or halogenated aromatic hydrocarbons) that 
would be expected to be immunotoxic. Based on the above considerations, 
EPA does not believe that conducting a special series 870.7800 
immunotoxicity study will result in a point of departure less than the 
NOAEL of 0.011 mg/kg/day used in calculation the cPAD for novaluron, 
and therefore, an additional database uncertainty factor is not needed 
to account for potential immunotoxicity.
    ii. There were signs of neurotoxicity in the acute neurotoxicity 
study in rats, including clinical signs (piloerection, fast/irregular 
breathing), functional observation battery (FOB) parameters (head 
swaying, abnormal gait) and neuropathology (sciatic and tibial nerve 
degeneration). However, the signs observed were not severe and were 
seen only at the limit dose (2,000 mg/kg/day); further, the 
neuropathological effects that were seen at the limit dose also 
occurred in a few untreated control animals. No signs of neurotoxicity 
or neuropathology were observed in the subchronic neurotoxicity study 
in rats at doses up to 1,752 mg/kg/day in males, and 2,000 mg/kg/day in 
females or in any other subchronic or chronic toxicity study in rats, 
mice or dogs, including the developmental and reproduction studies. 
Therefore, novaluron does not appear to cause significant neurotoxicant 
effects, and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that novaluron 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% CT and tolerance-level or anticipated residues derived from 
reliable residue field trials. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to novaluron in drinking water. Residential exposures are not 
expected. These assessments will not underestimate the exposure and 
risks posed by novaluron.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
novaluron is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
novaluron from food and water will utilize 74% of the cPAD for children 
1 to 2 years old, the population group receiving the greatest exposure. 
Based on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of novaluron 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). Novaluron is 
not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term aggregate risk is the sum of the 
risk from exposure to novaluron through food and water and will not be 
greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Novaluron 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 novaluron 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. EPA has classified 
novaluron as ``not likely to be carcinogenic to humans.''Novaluron is 
not expected to pose a cancer risk.
    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 novaluron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a gas chromatography/electron-
capture detection (GC/ECD) method; and a high pressure liquid 
chromatography/ultraviolate detection (HPLC/UV) method) is available to 
enforce the tolerance expression. The methods 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 Canadian or Mexican MRLs have been established for novaluron on 
the sugarcane or tomato commodities. A CODEX MRL is established for 
novaluron (fat soluble) on tomato at 0.02 ppm, significantly below the 
U.S. tolerance being established by this regulation (1.0 ppm). The U.S. 
tolerance is based on a different use pattern, including both a higher 
application rate (12.8x higher) and shorter pre-harvest interval (PHI) 
(2 days vs. 7 days). For these reasons, the U.S. tolerance cannot be 
harmonized with the CODEX MRL at this time.

C. Response to Comments

    EPA received comments from a private citizen complaining that she 
was unable to open the ``proposal'' at https://www.regulations.gov. If 
by ``proposal,'' the commenter is referring to the registrant's notice 
of filing, EPA notes that it is available in the docket in two common 
file formats, MicroSoft Word and Portable Document Format (PDF) and 
cannot explain the commenter's inability to open it. User support is 
available for anyone having trouble using the regulations website by 
calling 1-877-ERUL HLP (1-877-378-5457) or by using the Web form link 
provided under ``Contact Us.''

D. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA 
determined that the proposed tolerance on tomato should be increased to 
1.0 ppm and that a separate tolerance on tomato paste is not needed. 
EPA revised the tolerance level for tomato based on analyses of both 
field- and greenhouse-

[[Page 74982]]

grown residue trials using the Agency's Tolerance Spreadsheet in 
accordance with the Agency's Guidance for Setting Pesticide Tolerances 
Based on Field Trial Data. The tolerance level of 1.0 ppm is based on 
the spreadsheet results for greenhouse-grown tomatoes, the cropping 
scenario that resulted in the higher recommended tolerance. The 
submitted tomato processing data indicate that residues of novaluron 
are not likely to concentrate in puree but may concentrate slightly in 
paste. Based on the processing factor (1.1x) for paste and the highest 
average field trial (HAFT) residue of 0.365 ppm from the tomato trials, 
residues of novaluron in paste are not expected to exceed the tolerance 
for tomato (1.0 ppm); therefore, no tolerances for tomato processed 
commodities are needed.
    The tolerance expression at 40 CFR 180.598 uses the International 
Union of Pure and Applied Chemistry (IUPAC) nomenclature for novaluron 
(1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoro-methoxyethoxy)phenyl]-3-
(2,6-difluorobenzoyl)urea). Since it is EPA's policy to use the 
Chemical Abstracts Service (CAS) nomenclature in tolerance expressions, 
EPA is revising the tolerance expression to reflect the correct CAS 
designation for novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide). 
EPA has determined that it is reasonable to make this change final 
without prior proposal and opportunity for comment, because public 
comment is not necessary, in that the change has no substantive effect 
on the tolerance, but rather is a minor change in scientific 
nomenclature consistent with accepted Agency policy and practice.

V. Conclusion

    Therefore, tolerances are established for residues of novaluron, N-
[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide, 
in or on sugarcane, cane at 0.50 ppm and tomato at 1.0 ppm.
    A time-limited tolerance of 0.15 ppm was established for residues 
of novaluron on sugarcane, cane in connection with a FIFRA section 18 
emergency exemption granted by EPA. This tolerance (set to expire on 
12/31/09) is superseded by the higher tolerance being established on 
sugarcane, cane and is no longer needed. Therefore, the time-limited 
tolerance is being revoked.

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 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 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 180.598 is amended by removing the entry for sugarcane, cane 
from the table in paragraph (b); revising paragraph (a) introductory 
text and alphabetically adding the following commodities to the table 
in paragraph (a) to read as follows:


Sec.  180.598  Novaluron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide novaluron, N-[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide, 
in or on the following raw agricultural commodities:

[[Page 74983]]



----------------------------------------------------------------------------------------------------------------
                            Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Sugarcane, cane                                                                                             0.50
----------------------------------------------------------------------------------------------------------------
Tomato                                                                                                       1.0
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
* * * * *
 [FR Doc. E8-29117 Filed 12-9-08; 8:45 am]
BILLING CODE 6560-50-S