Novaluron; Pesticide Tolerances Register

Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 40027

as described under Title II of the Parts per DC 20460–0001; telephone number: Unfunded Mandates Reform Act of 1995 Commodity million (703) 305–5967; email address: (UMRA) (2 U.S.C. 1501 et seq.). [email protected]. This action does not involve any SUPPLEMENTARY INFORMATION: technical standards that would require ***** Agency consideration of voluntary Pepper ...... 1.0 I. General Information consensus standards pursuant to section ***** A. Does this action apply to me? 12(d) of the National Technology Transfer and Advancement Act of 1995 You may be potentially affected by * * * * * this action if you are an agricultural (NTTAA) (15 U.S.C. 272 note). [FR Doc. 2013–15867 Filed 7–2–13; 8:45 am] producer, food manufacturer, or VII. Congressional Review Act BILLING CODE 6560–50–P pesticide manufacturer. The following Pursuant to the Congressional Review list of North American Industrial Act (5 U.S.C. 801 et seq.), EPA will ENVIRONMENTAL PROTECTION Classification System (NAICS) codes is submit a report containing this rule and AGENCY not intended to be exhaustive, but rather other required information to the U.S. provides a guide to help readers Senate, the U.S. House of 40 CFR Part 180 determine whether this document Representatives, and the Comptroller applies to them. Potentially affected General of the United States prior to [EPA–HQ–OPP–2012–0291; FRL–9389–7] entities may include: • Crop production (NAICS code 111). publication of the rule in the Federal Novaluron; Pesticide Tolerances Register. This action is not a ‘‘major • Animal production (NAICS code rule’’ as defined by 5 U.S.C. 804(2). AGENCY: Environmental Protection 112). Agency (EPA). • Food manufacturing (NAICS code List of Subjects in 40 CFR Part 180 ACTION: Final rule. 311). Environmental protection, • Pesticide manufacturing (NAICS Administrative practice and procedure, SUMMARY: This regulation establishes code 32532). Agricultural commodities, Pesticides tolerances for residues of novaluron in B. How can I get electronic access to and pests, Reporting and recordkeeping or on peanut and soybean, seed. other related information? requirements. Makhteshim-Agan of North America Dated: June 21, 2013. requested these tolerances under the You may access a frequently updated electronic version of EPA’s tolerance Lois Rossi, Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation additionally regulations at 40 CFR part 180 through Director, Registration Division, Office of the Government Printing Office’s e-CFR Pesticide Programs. deletes the time-limited tolerance for strawberry, as that tolerance expired on site at http://www.ecfr.gov/cgi-bin/text- Therefore, 40 CFR chapter I is December 31, 2011. idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ _ amended as follows: DATES: This regulation is effective July 40tab 02.tpl. PART 180—[AMENDED] 3, 2013. Objections and requests for C. How can I file an objection or hearing hearings must be received on or before request? ■ 1. The authority citation for part 180 September 3, 2013, and must be filed in Under FFDCA section 408(g), 21 continues to read as follows: accordance with the instructions provided in 40 CFR part 178 (see also U.S.C. 346a, any person may file an Authority: 21 U.S.C. 321(q), 346a and 371. objection to any aspect of this regulation Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those ■ 2. In § 180.480 revise paragraph (a) INFORMATION). introductory text and revise the entry objections. You must file your objection ADDRESSES: The docket for this action, or request a hearing on this regulation ‘‘Pepper’’ in the table in paragraph (a) to identified by docket identification (ID) read as follows: in accordance with the instructions number EPA–HQ–OPP–2012–0291, is provided in 40 CFR part 178. To ensure § 180.480 Fenbuconazole; tolerances for available at http://www.regulations.gov proper receipt by EPA, you must residues. or at the Office of Pesticide Programs identify docket ID number EPA–HQ– (a) Tolerances are established for Regulatory Public Docket (OPP Docket) OPP–2012–0291 in the subject line on residues of the fungicide fenbuconazole, in the Environmental Protection Agency the first page of your submission. All including its metabolites and Docket Center (EPA/DC), EPA West objections and requests for a hearing degradates, in or on the commodities in Bldg., Rm. 3334, 1301 Constitution Ave. must be in writing, and must be the table below. Compliance with the NW., Washington, DC 20460–0001. The received by the Hearing Clerk on or tolerance levels specified below is to be Public Reading Room is open from 8:30 before September 3, 2013. Addresses for determined by measuring only the sum a.m. to 4:30 p.m., Monday through mail and hand delivery of objections of fenbuconazole, alpha-[2-(4- Friday, excluding legal holidays. The and hearing requests are provided in 40 chlorophenyl)-ethyl]-alpha-phenyl-3- telephone number for the Public CFR 178.25(b). (1H-1,2,4-triazole)-1-propanenitrile, and Reading Room is (202) 566–1744, and In addition to filing an objection or its metabolites RH-9129, cis-5-(4- the telephone number for the OPP hearing request with the Hearing Clerk chlorophenyl)-dihydro-3-phenyl-3-(1H- Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please 1,2,4-triazole-1-ylmethyl)-2-3 H- the visitor instructions and additional submit a copy of the filing (excluding furanone, and RH-9130, trans-5-(4- information about the docket available any Confidential Business Information chlorophenyl)-dihydro-3-phenyl-3-(1H- at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. 1,2,4-triazole-1-ylmethyl)-2-3 H- FOR FURTHER INFORMATION CONTACT: Information not marked confidential furanone, calculated as the Jennifer Gaines, Registration Division pursuant to 40 CFR part 2 may be stoichiometric equivalent of (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior fenbuconazole, in or on the following Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your agricultural commodities. Pennsylvania Ave. NW., Washington, objection or hearing request, identified

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by docket ID number EPA–HQ–OPP– other exposures for which there is consistent with the primary effects in 2012–0291, by one of the following reliable information.’’ This includes the database. methods: exposure through drinking water and in Signs of neurotoxicity (piloerection, • Federal eRulemaking Portal: http:// residential settings, but does not include irregular breathing), changes in www.regulations.gov. Follow the online occupational exposure. Section functional observational batter instructions for submitting comments. 408(b)(2)(C) of FFDCA requires EPA to parameters (increased head swaying, Do not submit electronically any give special consideration to exposure abnormal gait), and neuropathology information you consider to be CBI or of infants and children to the pesticide (sciatic and tibial nerve degeneration) other information whose disclosure is chemical residue in establishing a were seen in the rat acute neurotoxicity restricted by statute. tolerance and to ‘‘ensure that there is a study at the limit dose. However, no • Mail: OPP Docket, Environmental reasonable certainty that no harm will signs of neurotoxicity or neuropathology Protection Agency Docket Center (EPA/ result to infants and children from were observed in the subchronic DC), (28221T), 1200 Pennsylvania Ave. aggregate exposure to the pesticide neurotoxicity study in rats at similar NW., Washington, DC 20460–0001. chemical residue . . . .’’ doses or in any other subchronic or • Hand Delivery: To make special Consistent with FFDCA section chronic toxicity study in rats, mice, or arrangements for hand delivery or 408(b)(2)(D), and the factors specified in dogs. Therefore, there is no concern for delivery of boxed information, please FFDCA section 408(b)(2)(D), EPA has neurotoxicity resulting from exposure to follow the instructions at http:// reviewed the available scientific data novaluron. www.epa.gov/dockets/contacts.htm. and other relevant information in There was no evidence of Additional instructions on commenting support of this action. EPA has carcinogenic potential in either the rat or visiting the docket, along with more sufficient data to assess the hazards of or mouse carcinogenicity studies. There information about dockets generally, is and to make a determination on was no concern for genotoxicity or available at http://www.epa.gov/ aggregate exposure for novaluron mutagenicity. Therefore novaluron was classified as ‘‘not likely to be dockets. including exposure resulting from the carcinogenic to humans.’’ tolerances established by this action. II. Summary of Petitioned-for Tolerance Specific information on the studies In the Federal Register of July 25, EPA’s assessment of exposures and risks received and the nature of the adverse 2012 (77 FR 43562) (FRL–9353–6), EPA associated with novaluron follows. effects caused by novaluron as well as issued a document pursuant to FFDCA A. Toxicological Profile the no-observed-adverse-effect-level section 408(d)(3), 21 U.S.C. 346a(d)(3), (NOAEL) and the lowest-observed- announcing the filing of a pesticide EPA has evaluated the available adverse-effect-level (LOAEL) from the petition (PP 2F7999) by Makhteshim- toxicity data and considered its validity, toxicity studies can be found at http:// Agan of North America, 3120 completeness, and reliability as well as www.regulations.gov in document Highwoods Blvd., Suite 100, Raleigh, the relationship of the results of the Novaluron: Human-Health Risk NC 27604. The petition requested that studies to human risk. EPA has also Assessment for Proposed Section 3 Uses 40 CFR 180.598 be amended by considered available information on Peanut and Soybean at pp. 37–40 in establishing tolerances for residues of concerning the variability of the docket ID number EPA–HQ–OPP–2012– the insecticide novaluron, N-[[[3-chloro- sensitivities of major identifiable 0291. 4-[1,1,2-trifluoro-2-(trifluoromethoxy) subgroups of consumers, including infants and children. B. Toxicological Points of Departure/ ethoxy]phenyl]amino]carbonyl]-2,6- Levels of Concern difluorobenzamide, in or on peanuts at Novaluron has low acute toxicity via 0.01 parts per million (ppm) and the oral, dermal, and inhalation routes Once a pesticide’s toxicological soybean, seed at 0.06 ppm. That of exposure. It is not an eye or skin profile is determined, EPA identifies document referenced a summary of the irritant and is not a dermal sensitizer. In toxicological points of departure (POD) petition prepared by Makhteshim-Agan subchronic and chronic toxicity studies, and levels of concern to use in of North America, the registrant, which novaluron primarily produced evaluating the risk posed by human is available in the docket, http:// hematotoxic effects such as exposure to the pesticide. For hazards www.regulations.gov. There were no methemoglobinemia, decreased that have a threshold below which there comments received in response to the hemoglobin, decreased hematocrit, and is no appreciable risk, the toxicological notice of filing. decreased red blood cells (RBCs) (or POD is used as the basis for derivation Based upon review of the data erythrocytes) associated with increased of reference values for risk assessment. supporting the petition, EPA has revised erythropoiesis. Increased spleen weights PODs are developed based on a careful the tolerance level for soybean, seed. and/or hemosiderosis in the spleen were analysis of the doses in each The reason for this change is explained considered to be due to enhanced toxicological study to determine the in Unit IV.C. removal of damaged erythrocytes and dose at which the NOAEL and the not to a direct immunotoxic effect. LOAEL are indentified. Uncertainty/ III. Aggregate Risk Assessment and There was no maternal or safety factors are used in conjunction Determination of Safety developmental toxicity seen in the rat with the POD to calculate a safe Section 408(b)(2)(A)(i) of FFDCA and rabbit developmental toxicity exposure level—generally referred to as allows EPA to establish a tolerance (the studies up to the limit doses. In the 2- a population-adjusted dose (PAD) or a legal limit for a pesticide chemical generation reproductive toxicity study reference dose (RfD)—and a safe margin residue in or on a food) only if EPA in rats, both parental and offspring of exposure (MOE). For non-threshold determines that the tolerance is ‘‘safe.’’ toxicity (increased spleen weights) were risks, the Agency assumes that any Section 408(b)(2)(A)(ii) of FFDCA observed at the same dose. Reproductive amount of exposure will lead to some defines ‘‘safe’’ to mean that ‘‘there is a toxicity (decreases in epididymal sperm degree of risk. Thus, the Agency reasonable certainty that no harm will counts and increased age at preputial estimates risk in terms of the probability result from aggregate exposure to the separation in the F1 generation) was of an occurrence of the adverse effect pesticide chemical residue, including observed at a higher dose than the expected in a lifetime. For more all anticipated dietary exposures and all increased spleen weights and were information on the general principles

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EPA uses in risk characterization and a www.epa.gov/pesticides/factsheets/ risk assessment is shown in Table 1. of complete description of the risk riskassess.htm. this unit. assessment process, see http:// A summary of the toxicological endpoints for novaluron used for human

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NOVALURON FOR USE IN HUMAN HEALTH RISK ASSESSMENT

Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment

Acute dietary (General population in- None ...... None ...... An endpoint of concern attributable to a single dose was cluding infants and children). not identified. An acute RfD was not established. Chronic dietary (All populations) ...... NOAEL = 1.1 mg/ Chronic RfD = Combined chronic toxicity/carcinogenicity feeding in rat. kg/day. 0.011 mg/kg/day. LOAEL = 30.6 mg/kg/day based on erythrocyte damage UFA = 10X cPAD = 0.011 mg/ resulting in a compensatory regenerative anemia. UFH = 10X kg/day FQPA SF = 1X Incidental oral short-term ...... NOAEL = 4.38 mg/ LOC for MOE = 90-day feeding study in rat. (1 to 30 days) and Intermediate-Term (1 kg/day. 100. LOAEL = 8.64 mg/kg/day based on clinical chemistry (de- to 6 months). UFA = 10X creased hemoglobin, hematocrit, and RBC counts) and UFH = 10X histopathology (increased hematopoiesis and hemo- FQPA SF = 1X siderosis in spleen and liver). Dermal short-term (1 to 30 days) ...... Not applicable and None ...... No toxicity was observed at the limit dose in the dermal none. study and there were no developmental toxicity concerns at the limit-dose; therefore, quantification of short- term dermal risk is not necessary. Dermal intermediate-term (1 to 6 Dermal (or oral) LOC for MOE = 90-day feeding study in rat. months). study NOAEL = 100. LOAEL = 8.64 mg/kg/day based on clinical chemistry (de- 4.38 mg/kg/day creased hemoglobin, hematocrit, and RBC counts) and (dermal absorp- histopathology (increased hematopoiesis and hemo- tion rate = 10% siderosis in spleen and liver). when appropriate). UFA = 10X UFH = 10X FQPA SF = 1X Inhalation short-term (1 to 30 days) and Inhalation (or oral) LOC for MOE = 90-day feeding study in rat. Intermediate Term (1 to 6 months). study NOAEL = 100. LOAEL = 8.64 mg/kg/day based on clinical chemistry (de- 4.38 mg/kg/day creased hemoglobin, hematocrit, and RBC counts) and (inhalation ab- histopathology (increased hematopoiesis and hemo- sorption rate = siderosis in spleen and liver). 100%). UFA = 10X UFH = 10X FQPA SF = 1X

Cancer (Oral, dermal, inhalation) ...... Classification: Not likely to be carcinogenic to humans. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment acute dietary exposure assessment is (ARs) for meat, milk, hog, and poultry 1. Dietary exposure from food and unnecessary. commodities were calculated based on feed uses. In evaluating dietary ii. Chronic exposure. In conducting the proposed/registered uses, and exposure to novaluron, EPA considered the chronic dietary exposure assessment incorporated average field trial residues, exposure under the petitioned-for EPA used the food consumption data percent crop treated for new uses tolerances as well as all existing from the USDA under the National (PCTn) data for grain sorghum and novaluron tolerances in 40 CFR 180.598. Health and Nutrition Examination sweet corn, average PCT data for apple EPA assessed dietary exposures from Survey, What We Eat in America and cotton, and an assumption of 100 novaluron in food as follows: (NHANES/WWEIA); 2003–2008. As to PCT for sugarcane, aspirated grain i. Acute exposure. Quantitative acute residue levels in food, EPA incorporated fractions (AGF), and cowpea seed. dietary exposure and risk assessments average percent crop treated (PCT) data The chronic analysis also are performed for a food-use pesticide, for apples, cabbage, cauliflower, cotton, incorporated average field trial residues, if a toxicological study has indicated the pears, potatoes, strawberries, and tolerance-level residues for the possibility of an effect of concern tomatoes and utilized estimates for PCT proposed commodities, average occurring as a result of a 1-day or single for recently registered uses for grain greenhouse trial residue for tomatoes, exposure. No such effects were sorghum and sweet corn. 100 PCT was and half-limit of quantitation (LOQ) identified in the toxicological studies assumed for the remaining food residues for food commodities other for novaluron; therefore, a quantitative commodities. Anticipated residues than those covered by a higher tolerance

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as a result of use on growing crops from In most cases, EPA uses available data leaders are well-established for this use; the registered use in food and feed from United States Department of and handling establishments. Additionally, Agriculture/National Agricultural 3. Resistance concerns with the empirical processing factors for apple Statistics Service (USDA/NASS), market leaders. Novaluron specifically juice (translated to pear and stone fruit proprietary market surveys, and the targets lepidopterous insects, which are juice), cottonseed oil, dried plums, and National Pesticide Use Database for the not key pests of sorghum but are key tomato paste and pure´e, and Dietary chemical/crop combination for the most pests of sweet corn. However, novaluron Exposure Evaluation Model (DEEM) recent 6–7 years. EPA uses an average has a relatively narrow spectrum of pest (ver. 7.81) default processing factors for PCT for chronic dietary risk analysis. activity when compared to the market the remaining processed commodities, The average PCT figure for each existing leader insecticides. where provided were incorporated. use is derived by combining available All information currently available iii. Cancer. Based on the data public and private market survey data has been considered for novaluron use summarized in Unit III.A., EPA has for that use, averaging across all on sorghum and sweet corn, and it is the concluded that novaluron does not pose observations, and rounding to the opinion of the Agency that it is unlikely a cancer risk to humans. Therefore, a nearest 5%, except for those situations that actual PCT for novaluron will dietary exposure assessment for the in which the average PCT is less than exceed the estimated PCT for new uses purpose of assessing cancer risk is one. In those cases, 1% is used as the during the next 5 years. unnecessary. average PCT and 2.5% is used as the The Agency believes that the three iv. Anticipated residue and percent maximum PCT. EPA uses a maximum conditions discussed in Unit III.C.1.iv. crop treated (PCT) information. Section PCT for acute dietary risk analysis. The have been met. With respect to 408(b)(2)(E) of FFDCA authorizes EPA maximum PCT figure is the highest Condition A, PCT estimates are derived to use available data and information on observed maximum value reported from Federal and private market survey the anticipated residue levels of within the recent 6 years of available data, which are reliable and have a valid pesticide residues in food and the actual public and private market survey data basis. The Agency is reasonably certain that the percentage of the food treated levels of pesticide residues that have for the existing use and rounded up to is not likely to be an underestimation. been measured in food. If EPA relies on the nearest multiple of 5%. As to Conditions b and c, regional such information, EPA must require The Agency estimated the PCT for consumption information and pursuant to FFDCA section 408(f)(1) recently approved uses as follows: consumption information for significant that data be provided 5 years after the Sweet corn at 36% and grain sorghum tolerance is established, modified, or subpopulations is taken into account at 2%. through EPA’s computer-based model left in effect, demonstrating that the EPA estimates PCTn for novaluron levels in food are not above the levels for evaluating the exposure of based on the PCT of the dominant significant subpopulations including anticipated. For the present action, EPA pesticide (i.e., the one with the greatest will issue such data call-ins as are several regional groups. Use of this PCT) on that site over the three most consumption information in EPA’s risk required by FFDCA section 408(b)(2)(E) recent years of available data. and authorized under FFDCA section assessment process ensures that EPA’s Comparisons are only made among exposure estimate does not understate 408(f)(1). Data will be required to be pesticides of the same pesticide types submitted no later than 5 years from the exposure for any significant (i.e., the dominant insecticide on the subpopulation group and allows the date of issuance of these tolerances. use site is selected for comparison with Section 408(b)(2)(F) of FFDCA states Agency to be reasonably certain that no a new insecticide). The PCTs included that the Agency may use data on the regional population is exposed to in the analysis may be for the same actual percent of food treated for residue levels higher than those pesticide or for different pesticides assessing chronic dietary risk only if: estimated by the Agency. Other than the • Condition A: The data used are since the same or different pesticides data available through national food reliable and provide a valid basis to may dominate for each year. Typically, consumption surveys, EPA does not show what percentage of the food EPA uses USDA/NASS as the source for have available reliable information on derived from such crop is likely to raw PCT data because it is publicly the regional consumption of food to contain the pesticide residue. available and doesn not have to be which novaluron may be applied in a • Condition B: The exposure estimate calculated from available data sources. particular area. does not underestimate exposure for any When a specific use site is not surveyed 2. Dietary exposure from drinking significant subpopulation group. by USDA/NASS, EPA uses proprietary water. The residues of concern in • Condition C: Data are available on data and calculates the estimated PCT. drinking water are novaluron and it pesticide use and food consumption in The estimated PCT for new uses, chlorophenyl urea and chloroaniline a particular area, the exposure estimate based on the average PCT of the market degradates. The Agency used screening- does not understate exposure for the leader, is appropriate for use in the level water exposure models in the population in such area. chronic dietary risk assessment. This dietary exposure analysis and risk In addition, the Agency must provide method of estimating a PCT for a new assessment for novaluron and its for periodic evaluation of any estimates use of a registered pesticide or a new degradates in drinking water. These used. To provide for the periodic pesticide produces a high-end estimate simulation models take into account evaluation of the estimate of PCT as that is unlikely, in most cases, to be data on the physical, chemical, and fate/ required by FFDCA section 408(b)(2)(F), exceeded during the initial five years of transport characteristics of novaluron. EPA may require registrants to submit actual use. The predominant factors that Further information regarding EPA data on PCT. bear on whether the estimated PCT for drinking water models used in pesticide The Agency estimated the PCT for new uses could be exceeded are: exposure assessment can be found at existing uses as follows: Apples at 10%; 1. The extent of pest pressure on the http://www.epa.gov/oppefed1/models/ cabbage at 10%; cauliflower at < 2.5%, crops in question; water/index.htm. cotton at < 2.5%, pears at 15%, potatoes 2. The pest spectrum of the new EPA utilized the Pesticide Root Zone at < 2.5%, strawberries at 35%, and pesticide in comparison with the market Model/Exposure Analysis Modeling tomatoes at < 1%. leaders as well as whether the market System (PRZM/EXAMS) for estimating

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parent novaluron in surface water, the Further information regarding EPA up to the limit doses. In the 2-generation Tier 1 FQPA Index Reservoir Screening standard assumptions and generic reproductive study in rats, offspring and Tool (FIRST) model for surface water inputs for residential exposures may be parental toxicity (increased absolute and estimates for chlorophenyl urea and found at http://www.epa.gov/pesticides/ relative spleen weights) were similar chloroaniline degradates, and the trac/science/trac6a05.pdf. and occurred at the same dose; Screening Concentration in Ground 4. Cumulative effects from substances additionally, reproductive effects Water (SCI–GROW) model for with a common mechanism of toxicity. (decreases in epididymal sperm counts novaluron, chorophenyl urea, and Section 408(b)(2)(D)(v) of FFDCA and increased age at preputial chloroaniline in ground water. Based on requires that, when considering whether separation in the F1 generation) these models, the estimated drinking to establish, modify, or revoke a occurred at a higher dose than that water concentrations (EDWCs) of tolerance, the Agency consider which resulted in parental toxicity. novaluron, chlorophenyl urea, and ‘‘available information’’ concerning the 3. Conclusion. EPA has determined chloroaniline for chronic exposures for cumulative effects of a particular that reliable data show the safety of non-cancer assessments are estimated to pesticide’s residues and ‘‘other infants and children would be be 0.41 parts per billion (ppb), 0.375 substances that have a common adequately protected if the FQPA SF ppb, and 3.301 ppb respectively, for mechanism of toxicity.’’ were reduced to 1X. That decision is surface water and 0.00137 ppb, 0.00149 EPA has not found novaluron to share based on the following findings: ppb, and 0.00658 ppb respectively for a common mechanism of toxicity with i. The toxicity database for novaluron ground water. any other substances, and novaluron is complete. ii. There is minimal indication that Modeled estimates of drinking water does not appear to produce a toxic novaluron is a neurotoxic chemical and concentrations were directly entered metabolite produced by other there is no need for a developmental into the dietary exposure model. The substances. For the purposes of this neurotoxicity study or additional UFs to highest 1-in-10 year annual mean tolerance action, therefore, EPA has account for neurotoxicity. surface water EDWCs were combined to assumed that novaluron does not have a common mechanism of toxicity with iii. There is no evidence that estimate drinking water exposures. For other substances. For information novaluron results in increased chronic dietary risk assessment, the regarding EPA’s efforts to determine susceptibility in in utero rats or rabbits water concentration of value 4.086 ppb which chemicals have a common in the prenatal developmental studies or was used to assess the contribution to mechanism of toxicity and to evaluate in young rats in the 2-generation drinking water. the cumulative effects of such reproduction study. 3. From non-dietary exposure. The chemicals, see EPA’s Web site at iv. There are no residual uncertainties term ‘‘residential exposure’’ is used in http://www.epa.gov/pesticides/ identified in the exposure databases. this document to refer to non- cumulative. The chronic dietary food exposure occupational, non-dietary exposure assessment was performed using (e.g., for lawn and garden pest control, D. Safety Factor for Infants and anticipated residues derived from indoor pest control, termiticides, and Children reliable residue field trials, tolerance- flea and tick control on pets). Novaluron 1. In general. Section 408(b)(2)(C) of level residues for proposed is currently registered for the following FFDCA provides that EPA shall apply commodities, average PCT data for some uses that could result in residential an additional tenfold (10X) margin of commodities, and PCTn data for grain exposures: Indoor and outdoor uses for safety for infants and children in the sorghum and sweet corn. For the the control of crickets (cracks and case of threshold effects to account for remaining food commodities, 100 PCT crevice and spot treatments) in prenatal and postnatal toxicity and the was assumed. The registered food residential areas such as homes and completeness of the database on toxicity handling use was also incorporated into apartment buildings, and their and exposure unless EPA determines the dietary assessment. EPA made immediate surroundings, and on modes based on reliable data that a different conservative (protective) assumptions in of transportation. There is a potential for margin of safety will be safe for infants the ground and surface water modeling exposure in residential settings during and children. This additional margin of used to assess exposure to novaluron in the application process for homeowners safety is commonly referred to as the drinking water. EPA used similarly who use products containing novaluron. FQPA Safety Factor (SF). In applying conservative assumptions to assess post- Additionally, exposure routes were this provision, EPA either retains the application exposure of children as well assessed for post-application exposures default value of 10X, or uses a different as incidental oral exposure of toddlers. for adults and children via inhalation additional safety factor when reliable These assessments will not routes and post-application incidental data available to EPA support the choice underestimate the exposure and risks oral (hand-to-mouth) exposure for of a different factor. posed by novaluron. children (1 to < 2 years old). 2. Prenatal and postnatal sensitivity. Additionally, a combined residential The prenatal and postnatal toxicology E. Aggregate Risks and Determination of assessment that consisted of children (1 database for novaluron includes rat and Safety to < 2 years old) inhalation and oral rabbit prenatal developmental toxicity EPA determines whether acute and (hand-to-mouth) post-application studies and a 2-generation reproduction chronic dietary pesticide exposures are exposure was included. Details of the toxicity study in rats. There was no safe by comparing aggregate exposure residential risk exposure and risk evidence of increased quantitative or estimates to the acute PAD (aPAD) and assessment are contained in the EPA qualitative susceptibility following in chronic PAD (cPAD). For linear cancer public docket EPA–HQ–OPP–2010– utero exposure to rats or rabbits in the risks, EPA calculates the lifetime 0466 at http://www.regulations.gov in developmental toxicity studies and no probability of acquiring cancer given the document ‘‘Novaluron: Human-Health evidence of increased quantitative or estimated aggregate exposure. Short-, Risk Assessment for Proposed Section 3 qualitative susceptibility of offspring in intermediate-, and chronic-term risks Uses on Sweet Corn and in Food-or the reproduction study. Neither are evaluated by comparing the Feed-Handling Establishments’’ on pp. maternal nor developmental toxicity estimated aggregate food, water, and 21–26. was seen in the developmental studies residential exposure to the appropriate

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PODs to ensure that an adequate MOE from aggregate exposure to novaluron ethoxy]phenyl]amino]carbonyl]-2,6- exists. residues. difluorobenzamide, in or on peanut and 1. Acute risk. An acute aggregate risk soybean, seed at 0.01 and 0.07 ppm, IV. Other Considerations assessment takes into account acute respectively. exposure estimates from dietary A. Analytical Enforcement Methodology This regulation additionally deletes consumption of food and drinking Adequate enforcement methodology the time-limited tolerance for water. No adverse effect resulting from (gas chromatography/electron-capture strawberry, as that tolerance expired on a single oral exposure was identified detection (GC/ECD) method and a high- December 31, 2011. and no acute dietary endpoint was performance liquid chromatography/ VI. Statutory and Executive Order selected. Therefore, novaluron is not ultraviolet (HPLC/UV) method) are Reviews expected to pose an acute risk. available to enforce the tolerance 2. Chronic risk. Using the exposure This final rule establishes tolerances expression. under FFDCA section 408(d) in assumptions described in this unit for The method may be requested from: response to a petition submitted to the chronic exposure, EPA has concluded Chief, Analytical Chemistry Branch, Agency. The Office of Management and that chronic exposure to novaluron from Environmental Science Center, 701 Budget (OMB) has exempted these types food and water will utilize 55% of the Mapes Rd., Ft. Meade, MD 20755–5350; of actions from review under Executive cPAD for children 1 to 2 years old, the telephone number: (410) 305–2905; Order 12866, entitled ‘‘Regulatory population group receiving the greatest email address: Planning and Review’’ (58 FR 51735, exposure. The residential exposure [email protected]. assessment was conducted using high- October 4, 1993). Because this final rule end estimates of use and potential B. International Residue Limits has been exempted from review under exposure providing a conservative, In making its tolerance decisions, EPA Executive Order 12866, this final rule is health protective estimate of risk. seeks to harmonize U.S. tolerances with not subject to Executive Order 13211, 3. Short-term risk. Short-term international standards whenever entitled ‘‘Actions Concerning aggregate exposure takes into account possible, consistent with U.S. food Regulations That Significantly Affect short-term residential exposure plus safety standards and agricultural Energy Supply, Distribution, or Use’’ (66 chronic exposure to food and water practices. EPA considers the FR 28355, May 22, 2001) or Executive (considered to be a background international maximum residue limits Order 13045, entitled ‘‘Protection of exposure level). Novaluron is currently (MRLs) established by the Codex Children from Environmental Health registered for uses that could result in Alimentarius Commission (Codex), as Risks and Safety Risks’’ (62 FR 19885, short-term residential exposure, and the required by FFDCA section 408(b)(4). April 23, 1997). This final rule does not Agency has determined that it is The Codex Alimentarius is a joint contain any information collections appropriate to aggregate chronic United Nations Food and Agriculture subject to OMB approval under the exposure through food and water with Organization/World Health Paperwork Reduction Act (PRA) (44 short-term residential exposures to Organization food standards program, U.S.C. 3501 et seq.), nor does it require novaluron. and it is recognized as an international any special considerations under Using the exposure assumptions food safety standards-setting Executive Order 12898, entitled described in this unit for short-term organization in trade agreements to ‘‘Federal Actions to Address exposures, EPA has concluded the which the United States is a party. EPA Environmental Justice in Minority combined short-term food, water, and may establish a tolerance that is Populations and Low-Income residential exposures result in aggregate different from a Codex MRL; however, Populations’’ (59 FR 7629, February 16, MOEs of 2,520 for adults and 480 for FFDCA section 408(b)(4) requires that 1994). children 1–2 years old. Because EPA’s EPA explain the reasons for departing Since tolerances and exemptions that level of concern for novaluron is a MOE from the Codex level. are established on the basis of a petition of 100 or below, these MOEs are not of The Codex has established an MRL for under FFDCA section 408(d), such as concern. residues of novaluron in or on immature the tolerance in this final rule, do not 4. Intermediate-term risk. soybean seed at 0.01 ppm. Immature require the issuance of a proposed rule, Intermediate-term aggregate exposure soybean seed (edamame) is not covered the requirements of the Regulatory takes into account intermediate-term by soybean, seed; therefore, Flexibility Act (RFA) (5 U.S.C. 601 et residential exposure plus chronic harmonization is not an issue for the seq.), do not apply. exposure to food and water (considered proposed soybean use. There is no This final rule directly regulates to be a background exposure level). An Codex MRL for peanut. growers, food processors, food handlers, intermediate-term aggregate exposure and food retailers, not States or tribes, (food+drinking water+residential) C. Revisions to Petitioned-for Tolerances nor does this action alter the assessment was not conducted since Based on analysis from the residue relationships or distribution of power residential intermediate-term exposures field trial data supporting the petition and responsibilities established by are not likely due to the intermittent and use of the Organization for Congress in the preemption provisions nature of applications by homeowners. Economic Cooperation and of FFDCA section 408(n)(4). As such, 5. Aggregate cancer risk for U.S. Development tolerance calculation the Agency has determined that this population. Based on the lack of procedures, EPA revised the proposed action will not have a substantial direct evidence of carcinogenicity in two tolerance on soybean, seed from 0.06 effect on States or tribal governments, adequate rodent carcinogenicity studies, ppm to 0.07 ppm. Additionally, the on the relationship between the national novaluron is not expected to pose a commodity term for peanuts is being government and the States or tribal cancer risk to humans. revised. governments, or on the distribution of 6. Determination of safety. Based on power and responsibilities among the these risk assessments, EPA concludes V. Conclusion various levels of government or between that there is a reasonable certainty that Therefore, tolerances are established the Federal Government and Indian no harm will result to the general for residues of novaluron, N-[[[3-chloro- tribes. Thus, the Agency has determined population, or to infants and children 4-[1,1,2-trifluoro-2-(trifluoromethoxy) that Executive Order 13132, entitled

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‘‘Federalism’’ (64 FR 43255, August 10, Parts per Resources and Services Administration 1999) and Executive Order 13175, Commodity million (HRSA), 5600 Fishers Lane, Room 12C– entitled ‘‘Consultation and Coordination 06, Rockville, Maryland 20857, or by with Indian Tribal Governments’’ (65 FR ***** telephone (301) 443–7577. 67249, November 9, 2000) do not apply SUPPLEMENTARY INFORMATION: On to this final rule. In addition, this final * * * * * December 16, 2011, HHS published a rule does not impose any enforceable (b) Section 18 emergency exemptions. notice of proposed rulemaking (NPRM) duty or contain any unfunded mandate [Reserved] in the Federal Register (76 FR 78216) to as described under Title II of the * * * * * include VCAs within the definition of Unfunded Mandates Reform Act of 1995 [FR Doc. 2013–15869 Filed 7–2–13; 8:45 am] organs covered by the OPTN final rule (UMRA) (2 U.S.C. 1501 et seq.). BILLING CODE 6560–50–P and to make a corresponding change to This action does not involve any the definition of human organs covered technical standards that would require by section 301 of NOTA. The NPRM Agency consideration of voluntary DEPARTMENT OF HEALTH AND provided for a 60-day comment period consensus standards pursuant to section HUMAN SERVICES and HHS received 29 comment letters 12(d) of the National Technology raising a variety of issues. HHS has Transfer and Advancement Act of 1995 42 CFR Part 121 carefully considered all comments in (NTTAA) (15 U.S.C. 272 note). RIN 0906–AA73 developing this rule, as outlined in Section III below, presenting a summary VII. Congressional Review Act Organ Procurement and of all major comments and Pursuant to the Congressional Review Transplantation Network Departmental responses. Act (5 U.S.C. 801 et seq.), EPA will I. Background submit a report containing this rule and AGENCY: Health Resources and Services other required information to the U.S. Administration (HRSA), Department of As discussed in the NPRM, the Senate, the U.S. House of Health and Human Services (HHS). transplant community has referred to Representatives, and the Comptroller ACTION: Final rule. the transplants of intact vascularized General of the United States prior to body parts such as hands and faces as publication of the rule in the Federal SUMMARY: HHS is issuing this final rule composite tissue allograft transplants. Register. This action is not a ‘‘major (herein referred to as ‘‘this rule’’) to add As tissues, these components have been rule’’ as defined by 5 U.S.C. 804(2). vascularized composite allografts under the regulatory jurisdiction of the (VCAs) as specified herein to the Food and Drug Administration (FDA). List of Subjects in 40 CFR Part 180 definition of organs covered by the rules For the reasons outlined in the NPRM, Environmental protection, governing the operation of the Organ the Secretary believes that these Administrative practice and procedure, Procurement and Transplantation components, based on their clinical Agricultural commodities, Pesticides Network (OPTN) (herein referred to as characteristics, are more characteristic and pests, Reporting and recordkeeping the OPTN final rule). When it enacted of organs as defined specifically in requirements. the National Organ Transplant Act in NOTA and subsequently by regulation 1984, Congress included a definition of in the case of intestines and blood Dated: June 25, 2013. the term organ and authorized the vessels used in conjunction with organ G. Jeffrey Herndon, Secretary to expand this definition by transplantation. For the purpose of this Acting Director, Registration Division, Office regulation. The Secretary has previously regulation, these components are of Pesticide Programs. exercised this authority and expanded described as vascularized composite Therefore, 40 CFR chapter I is the statutory definition of organ. Prior to allografts (VCAs). amended as follows: this rule, the OPTN final rule defined Human cells or tissue intended for covered organs as ‘‘a human kidney, implantation, transplantation, infusion, PART 180—[AMENDED] liver, heart, lung, or pancreas, or or transfer into a human recipient are intestine (including the esophagus, regulated as human cells, tissues, and ■ 1. The authority citation for part 180 stomach, small and/or large intestine, or cellular and tissue-based products (or continues to read as follows: any portion of the gastrointestinal tract). HCT/Ps). FDA regulates HCT/Ps under Authority: 21 U.S.C. 321(q), 346a and 371. Blood vessels recovered from an organ section 361 of the Public Health Service ■ 2. In § 180.598: donor during the recovery of such Act (42 U.S.C. 264) and 21 CFR parts ■ a. Add alphabetically the organ(s) are considered part of an organ 1270 and 1271. Examples of such commodities to the table in paragraph with which they are procured for tissues are bone, skin, corneas, (a). purposes of this part if the vessels are ligaments, tendons, dura mater, heart ■ b. Remove and reserve paragraph (b). intended for use in organ valves, hematopoietic stem/progenitor transplantation and labeled ‘For use in cells derived from peripheral and cord § 180.598 Novaluron; tolerances for organ transplantation only.’ ’’ This rule blood, oocytes, and semen. FDA does residues. also includes a corresponding change to not regulate the transplantation of (a) General. *** the definition of human organs covered vascularized human organ transplants by section 301 of the National Organ such as kidney, liver, heart, lung, or Parts per Transplant Act of 1984, as amended pancreas. FDA regulations provide that Commodity million (NOTA). ‘‘vascularized human organs for transplantation’’ are not considered DATES: The final rule is effective July 3, HCT/Ps. 21 CFR 1271.3(d)(1). HRSA ***** 2014. Peanut ...... 0.01 oversees the transplantation of FOR FURTHER INFORMATION CONTACT: vascularized human organs. ***** James Bowman, M.D., Medical Director, At present, face and hand allografts, Soybean, seed ...... 0.07 Division of Transplantation, Healthcare and other body parts meeting the Systems Bureau (HSB), Health proposed definition of VCAs, are not

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