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10.20 Miscellaneous Hazardous requests for hearings must be received C. How can I file an objection or hearing Materials (Hazard Class 9) on or before January 28, 2013, and must request? * * * * * be filed in accordance with the Under FFDCA section 408(g), 21 instructions provided in 40 CFR part U.S.C. 346a, any person may file an 10.20.2 Mailability 178 (see also Unit I.C. of the objection to any aspect of this regulation [Revise the second sentence of 10.20.2 SUPPLEMENTARY INFORMATION). and may also request a hearing on those as follows:] ADDRESSES: The docket for this action, objections. You must file your objection * * * A miscellaneous hazardous identified by docket identification (ID) or request a hearing on this regulation material that can qualify as an ORM–D number EPA–HQ–OPP–2009–0644, is in accordance with the instructions material (until January 1, 2015) when available at http://www.regulations.gov provided in 40 CFR part 178. To ensure intended for ground transportation, or a or at the Office of Pesticide Programs proper receipt by EPA, you must mailable air-eligible consumer Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ– commodity material when intended for in the Environmental Protection Agency OPP–2009–0644 in the subject line on air transportation, is permitted for Docket Center (EPA/DC), EPA West the first page of your submission. All domestic mail via air or surface Bldg., Rm. 3334, 1301 Constitution Ave. objections and requests for a hearing transportation, subject to the applicable NW., Washington, DC 20460–0001. The must be in writing, and must be 49 CFR requirements. Public Reading Room is open from 8:30 received by the Hearing Clerk on or 10.20.3 Marking a.m. to 4:30 p.m., Monday through before January 28, 2013. Addresses for Friday, excluding legal holidays. The mail and hand delivery of objections [Revise 10.20.3 as follows:] telephone number for the Public and hearing requests are provided in 40 For surface transportation, the Reading Room is (202) 566–1744, and CFR 178.25(b). mailpiece must be plainly and durably the telephone number for the OPP In addition to filing an objection or marked on the address side with Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk ‘‘Surface Only’’ or ‘‘Surface Mail Only’’ the visitor instructions and additional as described in 40 CFR part 178, please and ‘‘ORM–D’’ immediately following information about the docket available submit a copy of the filing (excluding or below the proper shipping name (or at http://www.epa.gov/dockets. any Confidential Business Information with a DOT square-on-point marking (CBI) for inclusion in the public docket. under 10.8b). For air transportation, FOR FURTHER INFORMATION CONTACT: Information not marked confidential packages must bear the DOT square-on- Laura Nollen, Registration Division pursuant to 40 CFR part 2 may be point marking including the symbol (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior ‘‘Y,’’ an approved DOT Class 9 Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your hazardous material warning label, Pennsylvania Ave. NW., Washington, objection or hearing request, identified Identification Number ‘‘ID8000,’’ the DC 20460–0001; telephone number: by docket ID number EPA–HQ–OPP– proper shipping name ‘‘Consumer (703) 305–7390; email address: 2009–0644, by one of the following Commodity,’’ and a shipper’s [email protected]. methods: declaration for dangerous goods. SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// * * * * * I. General Information www.regulations.gov. Follow the online We will publish an appropriate instructions for submitting comments. amendment to 39 CFR part 111 to reflect A. Does this action apply to me? Do not submit electronically any these changes. You may be potentially affected by information you consider to be CBI or Stanley F. Mires, this action if you are an agricultural other information whose disclosure is Attorney, Legal Policy and Legislative Advice. producer, food manufacturer, or restricted by statute. • Mail: OPP Docket, Environmental [FR Doc. 2012–28673 Filed 11–27–12; 8:45 am] pesticide manufacturer. The following Protection Agency Docket Center (EPA/ BILLING CODE 7710–12–P list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. Classification System (NAICS) codes is NW., Washington, DC 20460–0001. not intended to be exhaustive, but rather • Hand Delivery: To make special provides a guide to help readers ENVIRONMENTAL PROTECTION arrangements for hand delivery or determine whether this document AGENCY delivery of boxed information, please applies to them. Potentially affected follow the instructions at http:// 40 CFR Part 180 entities may include: www.epa.gov/dockets/contacts.htm. • Crop production (NAICS code 111). [EPA–HQ–OPP–2009–0644; FRL–9366–1] Additional instructions on commenting • Animal production (NAICS code Fenpropathrin; Pesticide Tolerances or visiting the docket, along with more 112). information about dockets generally, is • AGENCY: Environmental Protection Food manufacturing (NAICS code available at Agency (EPA). 311). http://www.epa.gov/dockets. • ACTION: Final rule. Pesticide manufacturing (NAICS code 32532). II. Summary of Petitioned-for Tolerance SUMMARY: This regulation establishes In the Federal Register of October 7, B. How can I get electronic access to tolerances for residues of fenpropathrin 2009 (74 FR 51597) (FRL–8792–7), EPA other related information? in or on multiple commodities which issued a notice pursuant to FFDCA are identified and discussed later in this You may access a frequently updated section 408(d)(3), 21 U.S.C. 346a(d)(3), document. Interregional Research electronic version of EPA’s tolerance announcing the filing of a pesticide Project Number 4 (IR–4) requested these regulations at 40 CFR part 180 through petition (PP 9E7594) by IR–4, 500 tolerances under the Federal Food, the Government Printing Office’s e-CFR College Road East, Suite 201W, Drug, and Cosmetic Act (FFDCA). site at http://ecfr.gpoaccess.gov/cgi/t/ Princeton, NJ 08540. The petition DATES: This regulation is effective text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ requested that 40 CFR 180.466 be November 28, 2012. Objections and Title40/40tab_02.tpl. amended by establishing tolerances for

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residues of the insecticide A. Toxicological Profile forepaws in the rabbit. Developmental fenpropathrin, alpha-cyano-3-phenoxy- EPA has evaluated the available effects were limited to incomplete or benzyl 2,2,3,3- toxicity data and considered its validity, asymmetrical ossification of sternebrae tetramethylcyclopropanecarboxylate, in completeness, and reliability as well as at the maternally toxic dose in the rat. or on acerola, feijoa, guava, jaboticaba, the relationship of the results of the There were no developmental effects in passionfruit, starfruit and wax jambu at studies to human risk. EPA has also the rabbit. There were no indications of 1.5 parts per million (ppm); longan, considered available information immunotoxicity in any of the guideline lychee, pulasan, rambutan and Spanish concerning the variability of the studies, including the immunotoxicity lime at 3.0 ppm; atemoya, biriba, sensitivities of major identifiable study in rats. In a 3-generation cherimoya, custard apple, ilama, subgroups of consumers, including reproduction study in the rat, maternal and offspring effects were observed at soursop and sugar apple, at 1.0 ppm; infants and children. and tea at 2.0 ppm. That notice Fenpropathrin is a member of the the mid- and high-dose. At the high referenced a summary of the petition pyrethroid class of insecticides. dose, maternal effects included prepared on behalf of IR–4 by Valent Pyrethroids have historically been increased deaths and clinical signs of USA Corporation, the registrant, which classified into two groups—Type I and toxicity (tremors, muscle twitches, and increased sensitivity) during lactation. is available in the docket, http:// Type II, based on chemical structure www.regulations.gov. There were no Pup deaths were noted at this level. At and toxicological effects. Type I comments received in response to the the mid-dose, minimal signs of pyrethroids induce in rats a syndrome notice of filing. treatment-related effects were observed consisting of aggressive sparring, altered Based upon review of the data for both adults and pups, reducing sensitivity to external stimuli, supporting the petition, EPA has revised concern for quantitative or qualitative hyperthermia, and fine tremors, the proposed tolerances for several sensitivity. commodities. The Agency has also progressing to whole-body tremors, and There was no evidence of revised the tolerance expression for all prostration (T-syndrome). Type II carcinogenicity in either the rat or established commodities to be pyrethroids, which contain an alpha- mouse long-term dietary studies, nor consistent with current Agency policy. cyano moiety, produce in rats a was there any mutagenic activity in The reasons for these changes are syndrome that includes pawing, bacteria or cultured mammalian cells. explained in Unit IV.C. burrowing, salivation, hypothermia, and Fenpropathrin has been classified as coarse tremors leading to ‘‘not likely to be carcinogenic to III. Aggregate Risk Assessment and choreoathetosis (CS-syndrome). humans.’’ Determination of Safety Fenpropathrin is a mixed type Specific information on the studies Section 408(b)(2)(A)(i) of FFDCA pyrethroid because the biochemical received and the nature of the adverse allows EPA to establish a tolerance (the responses and resulting clinical signs of effects caused by fenpropathrin as well legal limit for a pesticide chemical neurotoxicity are intermediate between as the no-observed-adverse-effect-level residue in or on a food) only if EPA those of Type I and Type II pyrethroids. (NOAEL) and the lowest-observed- determines that the tolerance is ‘‘safe.’’ The adverse outcome pathway shared adverse-effect-level (LOAEL) from the Section 408(b)(2)(A)(ii) of FFDCA by pyrethroids involves the ability to toxicity studies can be found at http:// defines ‘‘safe’’ to mean that ‘‘there is a interact with voltage-gated sodium www.regulations.gov in the document, reasonable certainty that no harm will channels in the central and peripheral ‘‘Fenpropathrin. Human Health Risk result from aggregate exposure to the nervous systems, leading to changes in Assessment for Section 3 Registration pesticide chemical residue, including neuron firing and, ultimately, on Tropical Fruit and a Request for a all anticipated dietary exposures and all neurotoxicity. Tolerance without U.S. Registration on other exposures for which there is Fenpropathrin exhibits high acute Tea’’ at pp 40–45 in docket ID number reliable information.’’ This includes toxicity via the oral and dermal routes, EPA–HQ–OPP–2009–0644. exposure through drinking water and in but low toxicity via the inhalation route residential settings, but does not include of exposure. Fenpropathrin is a mild eye B. Toxicological Points of Departure/ occupational exposure. Section irritant, but does not cause dermal Levels of Concern 408(b)(2)(C) of FFDCA requires EPA to irritation or skin sensitization. Once a pesticide’s toxicological give special consideration to exposure Toxicological effects characteristic of profile is determined, EPA identifies of infants and children to the pesticide Type I pyrethroids were seen in most of toxicological points of departure (POD) chemical residue in establishing a the experimental toxicology studies and levels of concern to use in tolerance and to ‘‘ensure that there is a including the acute, subchronic, and evaluating the risk posed by human reasonable certainty that no harm will developmental neurotoxicity studies, exposure to the pesticide. For hazards result to infants and children from subchronic studies in the rat and dog, that have a threshold below which there aggregate exposure to the pesticide the chronic carcinogenicity study in the is no appreciable risk, the toxicological chemical residue * * * .’’ rat, the developmental studies in the rat POD is used as the basis for derivation Consistent with FFDCA section and rabbit, and in the 3-generation of reference values for risk assessment. 408(b)(2)(D), and the factors specified in reproduction study in rats. Tremors PODs are developed based on a careful FFDCA section 408(b)(2)(D), EPA has were the most common indication of analysis of the doses in each reviewed the available scientific data neurotoxicity; however, ataxia, toxicological study to determine the and other relevant information in increased sensitivity (e.g., heightened dose at which no adverse effects are support of this action. EPA has response) to external stimuli, observed (the NOAEL) and the lowest sufficient data to assess the hazards of convulsions, and increased auditory dose at which adverse effects of concern and to make a determination on startle response were also observed. are identified (the LOAEL). Uncertainty/ aggregate exposure for fenpropathrin In developmental toxicity studies in safety factors are used in conjunction including exposure resulting from the rats and rabbits, maternal toxicity with the POD to calculate a safe tolerances established by this action. included neurological effects such as exposure level—generally referred to as EPA’s assessment of exposures and risks ataxia, sensitivity to external stimuli, a population-adjusted dose (PAD) or a associated with fenpropathrin follows. tremors in the rat, and flicking of reference dose (RfD)—and a safe margin

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of exposure (MOE). For non-threshold expected in a lifetime. For more riskassess.htm. A summary of the risks, the Agency assumes that any information on the general principles toxicological endpoints for amount of exposure will lead to some EPA uses in risk characterization and a Fenpropathrin used for human risk degree of risk. Thus, the Agency complete description of the risk assessment is shown in the following estimates risk in terms of the probability assessment process, see http:// Table. of an occurrence of the adverse effect www.epa.gov/pesticides/factsheets/

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

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

Acute dietary (General population, including Wolansky BMDL1SD = aRfD = 0.05 mg/kg/ Wolansky BMD1SD = 6.4 mg/kg based on de- children ≥ 6 years old). 5.0 mg/kg. day. creased motor activity. UFA = 10X aPAD = 0.05 mg/kg/ UFH = 10X day. FQPA SF = 1X Acute dietary (< 6 years old) ...... Wolansky BMDL1SD = aRfD = 0.05 mg/kg/ Wolansky BMD1SD = 6.4 mg/kg based on de- 5.0 mg/kg. day. creased motor activity. UFA = 10X aPAD = 0.017 mg/kg/ UFH = 10X day. FQPA SF = 3X

Chronic dietary (All populations) ...... Because of the rapid reversibility of the most sensitive neurotoxicity endpoint used for quanti- fying risks, there is no increase in hazard with increasing dosing duration. Therefore, the acute dietary endpoint is protective of the endpoints from repeat dosing studies, including chronic dietary exposures. Cancer (Oral, dermal, inhalation) ...... Fenpropathrin has been classified as ‘‘not likely to be carcinogenic to humans.’’ Cancer risk is not of concern. FQPA SF = Food Quality Protection Act Safety Factor. mg/kg/day = milligram/kilogram/day. 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). BMD = Benchmark Dose Analysis. BMD1SD = dose level where effect is 1SD from control value. BMDL1SD = lower 95% confidence limit of the BMD value.

C. Exposure Assessment were used for broccoli (translated to pose a cancer risk to humans. Therefore, 1. Dietary exposure from food and Chinese mustard cabbage and a dietary exposure assessment for the feed uses. In evaluating dietary cauliflower), watermelon, squash, purpose of assessing cancer risk is exposure to fenpropathrin, EPA oranges (translated to tangerines), unnecessary. considered exposure under the apples, apple juice, pears, blueberries iv. Anticipated residue and percent petitioned-for tolerances as well as all (translated to huckleberries), grapes, crop treated (PCT) information. Section existing fenpropathrin tolerances in 40 grape juice, and strawberries. 408(b)(2)(E) of FFDCA authorizes EPA CFR 180.466. EPA assessed dietary Distributions of field trial data were to use available data and information on exposures from fenpropathrin in food as used for cherries, peaches, plums, the anticipated residue levels of follows: grapefruit, raspberries, blackberries, pesticide residues in food and the actual i. Acute exposure. Quantitative acute apricots, cabbage, papaya, olives, levels of pesticide residues that have dietary exposure and risk assessments tomatoes, cucumbers, Brussels sprouts, been measured in food. If EPA relies on are performed for a food-use pesticide, and guava. Tolerance-level residues such information, EPA must require if a toxicological study has indicated the were assumed for all other commodities pursuant to FFDCA section 408(f)(1) possibility of an effect of concern having existing or proposed tolerances. that data be provided 5 years after the occurring as a result of a 1-day or single Dietary Exposure Evaluation Model tolerance is established, modified, or exposure. Such effects were identified (DEEM) default processing factors were left in effect, demonstrating that the for fenpropathrin. In estimating acute used for those commodities for which levels in food are not above the levels dietary exposure, EPA used food they were available. In some cases, anticipated. For the present action, EPA consumption information from the U.S. empirical processing factors were used. will issue such data call-ins as are Department of Agriculture (USDA) ii. Chronic exposure. Based on the required by FFDCA section 408(b)(2)(E) 1994–1996 and 1998 Nationwide data summarized in Unit III.A., there is and authorized under FFDCA section Continuing Surveys of Food Intake by no bincrease in hazard from repeated 408(f)(1). Data will be required to be Individuals (CSFII). As to residue levels exposures to fenpropathrin; the acute submitted no later than 5 years from the in food, EPA utilized percent crop dietary exposure assessment is date of issuance of these tolerances. treated (PCT) estimates and tolerance protective for chronic dietary exposures Section 408(b)(2)(F) of FFDCA states level residues, distributions of field trial because acute exposure levels are higher that the Agency may use data on the values, and distributions of Pesticide than chronic exposure levels. actual percent of food treated for Data Program (PDP) monitoring data. Accordingly, a dietary exposure assessing chronic dietary risk only if: Residue distributions were used for assessment for the purpose of assessing • Condition a: The data used are the commodities that made the most chronic dietary risk was not conducted. reliable and provide a valid basis to significant contributions to the risk iii. Cancer. Based on the data show what percentage of the food estimates. Distributions of USDA’s PDP summarized in Unit III.A., EPA has derived from such crop is likely to monitoring data from 2007 through 2010 concluded that fenpropathrin does not contain the pesticide residue.

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• Condition b: The exposure estimate significant subpopulations including sharing a common mechanism of does not underestimate exposure for any several regional groups. Use of this toxicity. The Agency has determined significant subpopulation group. consumption information in EPA’s risk that the pyrethroids and pyrethrins, • Condition c: Data are available on assessment process ensures that EPA’s including fenpropathrin, share a pesticide use and food consumption in exposure estimate does not understate common mechanism of toxicity. The a particular area, the exposure estimate exposure for any significant members of this group share the ability does not understate exposure for the subpopulation group and allows the to interact with voltage-gated sodium population in such area. In addition, the Agency to be reasonably certain that no channels, ultimately leading to Agency must provide for periodic regional population is exposed to neurotoxicity. The cumulative risk evaluation of any estimates used. To residue levels higher than those assessment for the pyrethroids/ provide for the periodic evaluation of estimated by the Agency. Other than the pyrethrins was published in the the estimate of PCT as required by data available through national food November 9, 2011 issue of the Federal FFDCA section 408(b)(2)(F), EPA may consumption surveys, EPA does not Register (76 FR 69726) (FRL 8888–9), require registrants to submit data on have available reliable information on and is available at http:// PCT. the regional consumption of food to The Agency estimated the PCT for which fenpropathrin may be applied in www.regulations.gov in the public existing uses as follows: a particular area. docket, EPA–HQ–OPP–2011–0746. Apples, 15%; apricots, 2.5%; 2. Dietary exposure from drinking Further information about the blueberries, 2.5%; broccoli, 2.5%; water. The Agency used screening level determination that pyrethroids and Brussels sprouts, 10%; cabbage, 2.5%; water exposure models in the dietary pyrethrins share a common mechanism cauliflower, 2.5%; cherries, 5%; cotton, exposure analysis and risk assessment of toxicity may be found in document 2.5%; cucumbers, 2.5%; grapefruit, for fenpropathrin in drinking water. ID: EPA–HQ- OPP–2008–0489–0006. 35%; grapes, 10%; nectarines, 2.5%; These simulation models take into The Agency has conducted a oranges, 35%; peaches, 2.5%; pears, account data on the physical, chemical, quantitative analysis of the proposed 10%; plums, 2.5%; prune plums, 2.5%; and fate/transport characteristics of tolerances for fenpropathrin and has squash, 2.5%; strawberries, 50%; fenpropathrin. Further information determined that it will not contribute tangerines, 15%; tomatoes, 10%; and regarding EPA drinking water models significantly or change the overall watermelons, 2.5%. used in pesticide exposure assessment In most cases, EPA uses available data findings presented in the pyrethroid can be found at http://www.epa.gov/ cumulative risk assessment. In the from U.S. Department of Agriculture/ oppefed1/models/water/index.htm. National Agricultural Statistics Service Based on the First Index Reservoir cumulative assessment for pyrethroids, (USDA/NASS), proprietary market Screening Tool (FIRST) and Screening residential exposures were the greatest surveys, and the National Pesticide Use Concentration in Ground Water (SCI– contributor to the total exposure. As Database for the chemical/crop GROW) models, the estimated drinking there are no residential uses for combination for the most recent 6 to 7 water concentrations (EDWCs) of fenpropathrin, the proposed new uses years. EPA uses an average PCT for fenpropathrin for acute exposures are will have no impact on the residential chronic dietary risk analysis. The estimated to be 10.3 parts per billion component of the cumulative risk average PCT figure for each existing use (ppb) for surface water and 0.005 ppb estimates. is derived by combining available for ground water. Dietary exposures make a minor public and private market survey data Modeled estimates of drinking water contribution to the total pyrethroid for that use, averaging across all concentrations were directly entered exposure. The dietary exposure observations, and rounding to the into the dietary exposure model. For assessment performed in support of the nearest 5%, except for those situations acute dietary risk assessment, the water pyrethroid cumulative assessment was in which the average PCT is less than 1. concentration value of 10.3 ppb was much more highly refined than that In those cases, 1% is used as the average used to assess the contribution to performed for the single chemical, PCT and 2.5% is used as the maximum drinking water. fenpropathrin. In addition, for the PCT. EPA uses a maximum PCT for 3. From non-dietary exposure. The fenpropathrin risk assessment, the most acute dietary risk analysis. The term ‘‘residential exposure’’ is used in sensitive apical endpoint in the maximum PCT figure is the highest this document to refer to non- fenpropathrin database was selected to observed maximum value reported occupational, non-dietary exposure derive the POD. Additionally, the POD within the recent 6 years of available (e.g., for lawn and garden pest control, selected for fenpropathrin is specific to public and private market survey data indoor pest control, termiticides, and fenpropathrin, whereas the POD for the existing use and rounded up to flea and tick control on pets). selected for the cumulative assessment the nearest multiple of 5%. Fenpropathrin is not registered for any was based on common mechanism of The Agency believes that the three specific use patterns that would result conditions discussed in Unit III.C.1.iv. in residential exposure. action data that are appropriate for all have been met. With respect to 4. Cumulative effects from substances 20 pyrethroids included in the Condition a, PCT estimates are derived with a common mechanism of toxicity. cumulative assessment. The proposed from Federal and private market survey Section 408(b)(2)(D)(v) of FFDCA food uses of fenpropathrin will not data, which are reliable and have a valid requires that, when considering whether contribute significantly or change the basis. The Agency is reasonably certain to establish, modify, or revoke a overall findings in the pyrethroid that the percentage of the food treated tolerance, the Agency consider cumulative risk assessment, as the is not likely to be an underestimation. ‘‘available information’’ concerning the dietary risks are a minor component of As to Conditions b and c, regional cumulative effects of a particular total pyrethroid cumulative risk. For consumption information and pesticide’s residues and ‘‘other information regarding EPA’s efforts to consumption information for significant substances that have a common evaluate the risk of exposure to subpopulations is taken into account mechanism of toxicity.’’ pyrethroids, refer to http:// through EPA’s computer-based model The Agency is required to consider www.epa.gov/oppsrrd1/reevaluation/ for evaluating the exposure of the cumulative risks of chemicals pyrethroids-pyrethrins.html.

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D. Safety Factor for Infants and FQPA SF to 1X. The decisions regarding pharmacodynamics of homologous Children the FQPA SF being used are based on sodium channel isoforms in rats and 1. In general. Section 408(b)(2)(C) of the following considerations: humans. i. The toxicity database for In light of the high dose literature FFDCA provides that EPA shall apply fenpropathrin is not complete. While studies showing juvenile sensitivity to an additional tenfold (10X) margin of the database is considered to be pyrethroids and the absence of the safety for infants and children in the complete with respect to the guideline requested data on juvenile sensitivity to case of threshold effects to account for toxicity studies for fenpropathrin, EPA pyrethroids, EPA is retaining a 3X prenatal and postnatal toxicity and the lacks additional data to address the additional safety factor as estimated by completeness of the database on toxicity potential for juvenile sensitivity to all pharmacokinetic modeling. For several and exposure unless EPA determines pyrethroids. In light of the literature reasons, EPA concludes there are based on reliable data that a different studies indicating a possibility of reliable data showing that a 3X factor is margin of safety will be safe for infants increased sensitivity to fenpropathrin in protective of the safety of infants and and children. This additional margin of juvenile rats at high doses, EPA has children. First, the high doses that safety is commonly referred to as the requested proposals for study protocols produced juvenile sensitivity in the Food Quality Protection Act, Safety which could identify and quantify literature studies are well above normal Factor (FQPA SF). In applying this fenpropathrin’s potential juvenile dietary exposure levels of pyrethroids to provision, EPA either retains the default sensitivity. The reasons discussed in juveniles and these lower levels of value of 10X, or uses a different Unit III.D.3.ii, and the uncertainty exposure are not expected to overwhelm additional safety factor when reliable regarding the protectiveness of the the ability to metabolize pyrethroids as data available to EPA support the choice intraspecies uncertainty factor raised by occurred with the high doses used in of a different factor. the literature studies warrant the literature studies. This is confirmed 2. Prenatal and postnatal sensitivity. application of an additional 3X for risk by the lack of a finding of increased The fenpropathrin toxicity database assessments for infants and children sensitivity in prenatal and postnatal includes developmental toxicity studies less than 6 years of age. guideline studies in any pyrethroid, in rats and rabbits and a 3-generation ii. There is no evidence that including fenpropathrin, despite the reproduction study in rats, and a fenpropathrin results in increased relatively high doses used in those developmental neurotoxicity (DNT) susceptibility in in utero rats or rabbits studies. Second, the portions of both the study in rats. There was no evidence of in the prenatal developmental studies or inter- and intraspecies uncertainty increased qualitative or quantitative in young rats in a 3-generation rat factors that account for potential susceptibility noted in any of these reproduction study. This is consistent pharmacodynamic differences studies. This lack of susceptibility is with the results of the guideline pre- (generally considered to be consistent with the results of the natal and postnatal testing for other approximately 3X for each factor) are guideline prenatal and postnatal testing pyrethroid pesticides. There are, likely to overstate the risk of inter- and for other pyrethroid pesticides. however, high dose LD50 studies intraspecies pharmacodynamic There are several in vitro and in vivo (studies assessing what dose results in differences given the data showing studies that indicate pharmacodynamic lethality to 50 percent of the tested similarities in pharmacodynamics contributions to pyrethroid toxicity are population) in the scientific literature between juveniles and adults and not age-dependent. A study of the indicating that pyrethroids can result in between humans and rats. Finally, as toxicity database for pyrethroid increased quantitative sensitivity in the indicated, pharmacokinetic modeling chemicals also noted no residual young. Examination of pharmacokinetic only predicts a 3X difference between uncertainties regarding age-related and pharmacodynamic data indicates juveniles and adults. sensitivities for the young, based on the that the sensitivity observed at high iii. There are no residual uncertainties absence of prenatal sensitivity observed doses is related to pyrethroid age- identified in the exposure databases. in 76 guideline studies for 24 dependent pharmacokinetics, the Although the acute dietary exposure pyrethroids and the scientific literature. activity of enzymes associated with the estimates are refined, as described in However, high-dose studies at LD50 metabolism of pyrethroids. Predictive Unit III.C.1.i., the exposure estimates doses noted that younger animals were pharmacokinetic models indicate that will not underestimate risk for the more susceptible to the toxicity of the differential adult-juvenile established and proposed uses of pyrethroids. These age-related pharmacokinetics will result in fenpropathrin. The residue levels used differences in toxicity are principally otherwise equivalent administered are based on distributions of residues due to age-dependent pharmacokinetics; doses for adults and juveniles producing from field trial data, monitoring data the activity of enzymes associated with a 3X greater dose at the target organ in reflecting actual residues found in the the metabolism of pyrethroids increases juveniles compared to adults. food supply, and tolerance-level with age. Nonetheless, the typical No evidence of increased quantitative residues for several commodities; the environmental exposures to pyrethroids or qualitative susceptibility was seen in use of estimated PCT information; and, are not expected to overwhelm the the pyrethroid scientific literature when appropriate, processing factors clearance capacity in juveniles. In related to pharmacodynamics (the effect measured in processing studies or support, at a dose of 4.0 milligrams/ of pyrethroids at the target tissue) both default high-end factors representing the kilogram (mg/kg) for deltamethrin (near with regard to interspecies differences maximum concentration of residue into the Wolansky study LOAEL value of 3.0 between rats and humans and to a processed commodity. EPA made mg/kg for deltamethrin), the change in differences between juveniles and conservative (protective) assumptions in the acoustic startle response was similar adults. Specifically, there are in vitro the ground and surface water modeling between adult and young rats. pharmacodynamic data and in vivo data used to assess exposure to fenpropathrin 3. Conclusion. EPA is reducing the indicating similar responses between in drinking water. These assessments FQPA SF to 3X for infants and children adult and juvenile rats at low doses and will not underestimate the exposure and less than 6 years of age. For the general data indicating that the rat is a risks posed by fenpropathrin. population, including children greater conservative model compared to the Further information about the than 6 years of age, EPA is reducing the human based on species-specific reevaluation of the FQPA SF for

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pyrethroids may be found in document residential exposure plus chronic dried would be 3.0 ppm. However, for ID: EPA–HQ–OPP–2011–0746–0011, at exposure to food and water (considered the purposes of harmonization of the regulations.gov. to be a background exposure level). U.S. tolerance with the established Because no intermediate-term adverse Codex MRL, EPA is recommending the E. Aggregate Risks and Determination of effect was identified, fenpropathrin is tolerance of 2.0 ppm for tea, dried. The Safety not expected to pose an intermediate- Agency considers this tolerance level to EPA determines whether acute and term risk. be adequate because the highest field chronic dietary pesticide exposures are 5. Aggregate cancer risk for U.S. trial value noted for tea, dried was 1.38 safe by comparing aggregate exposure population. Based on the lack of ppm. estimates to the acute PAD (aPAD) and evidence of carcinogenicity in two C. Revisions to Petitioned-for Tolerances chronic PAD (cPAD). For linear cancer adequate rodent carcinogenicity studies, risks, EPA calculates the lifetime fenpropathrin is not expected to pose a Based on the data supporting the probability of acquiring cancer given the cancer risk to humans. petitions, EPA revised the proposed estimated aggregate exposure. Short- 6. Determination of safety. Based on tolerances on acerola, feijoa, guava, term, intermediate-term, and chronic- these risk assessments, EPA concludes jaboticaba, passionfruit, startfruit and term risks are evaluated by comparing that there is a reasonable certainty that wax jambu from 1.5 ppm to 3.0 ppm; the estimated aggregate food, water, and no harm will result to the general longan, lychee, pulasan, rambutan, and residential exposure to the appropriate population, or to infants and children Spanish lime from 3.0 ppm to 7.0 ppm; PODs to ensure that an adequate MOE from aggregate exposure to and atemoya, birba, cherimoya, custard exists. fenpropathrin residues. apple, ilama, soursop, and sugar apple, 1. Acute risk. Using the exposure from 1.0 ppm to 1.5 ppm. The Agency assumptions discussed in this unit for IV. Other Considerations revised these tolerance levels based on acute exposure, the acute dietary A. Analytical Enforcement Methodology analysis of the residue field trial data exposure from food and water to using the OECD tolerance calculation fenpropathrin will occupy 97% of the An adequate enforcement procedures. EPA also revised the aPAD for children 3 to 5 years old, the methodology utilizing gas proposed commodity definition for tea population group receiving the greatest chromatography with electron capture to tea, dried in order to reflect the exposure from the dietary assessment detection (GC/ECD, Residue Method Agency’s commodity nomenclature. for infants and children less than 6 Number RM–22–4) is available to Finally, the Agency has revised the years old; and 27% of the aPAD for enforce the tolerance expression. tolerance expression to clarify (1) that, children 6 to 12 years old, the The method may be requested from: as provided in FFDCA section 408(a)(3), population group receiving the greatest Chief, Analytical Chemistry Branch, the tolerance covers metabolites and exposure from the dietary assessment Environmental Science Center, 701 degradates of fenpropathrin not for the general population other than Mapes Rd., Ft. Meade, MD 20755–5350; specifically mentioned; and (2) that children less than 6 years old. telephone number: (410) 305–2905; compliance with the specified tolerance 2. Chronic risk. Based on the data email address: levels is to be determined by measuring summarized in Unit III.A., there is no [email protected]. only the specific compounds mentioned increase in hazard with increasing B. International Residue Limits in the tolerance expression. dosing duration. Furthermore, chronic dietary exposures will be lower than In making its tolerance decisions, EPA V. Conclusion acute exposures. Therefore, the acute seeks to harmonize U.S. tolerances with Therefore, tolerances are established aggregate assessment is protective of international standards whenever for residues of fenpropathrin, alpha- potential chronic aggregate exposures. possible, consistent with U.S. food cyano-3-phenoxy-benzyl 2,2,3,3- 3. Short-term risk. Short-term safety standards and agricultural tetramethylcyclopropanecarboxylate, in aggregate exposure takes into account practices. EPA considers the or on acerola, feijoa, guava, jaboticaba, short-term residential exposure plus international maximum residue limits passionfruit, starfruit and wax jambu at chronic exposure to food and water (MRLs) established by the Codex 3.0 ppm; longan, lychee, pulasan, (considered to be a background Alimentarius Commission (Codex), as rambutan and Spanish lime, at 7.0 ppm; exposure level). A short-term adverse required by FFDCA section 408(b)(4). atemoya, biriba, cherimoya, custard effect was identified; however, The Codex Alimentarius is a joint apple, ilama, soursop and sugar apple, fenpropathrin is not registered for any United Nations Food and Agriculture at 1.5 ppm; and tea, dried at 2.0 ppm. use patterns that would result in short- Organization/World Health term residential exposure. Short-term Organization food standards program, VI. Statutory and Executive Order risk is assessed based on short-term and it is recognized as an international Reviews residential exposure plus chronic food safety standards-setting This final rule establishes tolerances dietary exposure. Because there is no organization in trade agreements to under FFDCA section 408(d) in short-term residential exposure and which the United States is a party. EPA response to a petition submitted to the acute dietary exposure has already been may establish a tolerance that is Agency. The Office of Management and assessed under the appropriately different from a Codex MRL; however, Budget (OMB) has exempted these types protective aPAD (which is at least as FFDCA section 408(b)(4) requires that of actions from review under Executive protective as the POD used to assess EPA explain the reasons for departing Order 12866, entitled ‘‘Regulatory short-term risk), no further assessment from the Codex level. Planning and Review’’ (58 FR 51735, of short-term risk is necessary, and EPA The Codex has established MRLs for October 4, 1993). Because this final rule relies on the acute dietary risk fenpropathrin in or on tea, green and has been exempted from review under assessment for evaluating short-term black at 2.0 ppm. Using the Executive Order 12866, this final rule is risk for fenpropathrin. Organization for Economic Cooperation not subject to Executive Order 13211, 4. Intermediate-term risk. and Development (OECD) MRL entitled ‘‘Actions Concerning Intermediate-term aggregate exposure calculation procedures, the Regulations That Significantly Affect takes into account intermediate-term recommended U.S. tolerance for tea, Energy Supply, Distribution, or Use’’ (66

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FR 28355, May 22, 2001) or Executive General of the United States prior to Parts per Order 13045, entitled ‘‘Protection of publication of the rule in the Federal Commodity million Children from Environmental Health Register. This action is not a ‘‘major Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). April 23, 1997). This final rule does not ***** List of Subjects in 40 CFR Part 180 Passionfruit ...... 3.0 contain any information collections subject to OMB approval under the Environmental protection, ***** Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, Pulasan ...... 7.0 U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides Rambutan ...... 7.0 any special considerations under and pests, Reporting and recordkeeping Executive Order 12898, entitled requirements. ***** ‘‘Federal Actions to Address Dated: November 15, 2012. Soursop ...... 1.5 Spanish lime ...... 7.0 Environmental Justice in Minority Lois Rossi, Populations and Low-Income Director, Registration Division, Office of ***** Populations’’ (59 FR 7629, February 16, Pesticide Programs. 1994). Starfruit ...... 3.0 Since tolerances and exemptions that Therefore, 40 CFR chapter I is amended as follows: ***** are established on the basis of a petition Sugar apple ...... 1.5 under FFDCA section 408(d), such as PART 180—[AMENDED] Tea, dried 1 ...... 2.0 the tolerance in this final rule, do not require the issuance of a proposed rule, ■ 1. The authority citation for part 180 ***** the requirements of the Regulatory continues to read as follows: Wax jambu ...... 3.0 Flexibility Act (RFA) (5 U.S.C. 601 et Authority: 21 U.S.C. 321(q), 346a and 371. 1 There are no U.S. registrations as of No- seq.), do not apply. vember 28, 2012, for the use of fenpropathrin This final rule directly regulates ■ 2. In § 180.466, paragraph (a), revise on tea, dried. growers, food processors, food handlers, the introductory text, alphabetically add and food retailers, not States or tribes, the following commodities and footnote * * * * * [FR Doc. 2012–28721 Filed 11–27–12; 8:45 am] nor does this action alter the 1 to the table to read as follows: relationships or distribution of power BILLING CODE 6560–50–P and responsibilities established by § 180.466 Fenpropathrin; tolerances for Congress in the preemption provisions residues. (a) General. Tolerances are ENVIRONMENTAL PROTECTION of FFDCA section 408(n)(4). As such, AGENCY the Agency has determined that this established for residues of action will not have a substantial direct fenpropathrin, including its metabolites 40 CFR Part 180 effect on States or tribal governments, and degradates, in or on the on the relationship between the national commodities in the following table. [EPA–HQ–OPP–2012–0060; FRL–9365–1] government and the States or tribal Compliance with the tolerance levels governments, or on the distribution of specified below is to be determined by Dinotefuran; Pesticide Tolerances measuring only fenpropathrin (alpha- power and responsibilities among the AGENCY: Environmental Protection cyano-3-phenoxy-benzyl 2,2,3,3 various levels of government or between Agency (EPA). the Federal Government and Indian tetramethylcyclopropanecarboxylate). ACTION: tribes. Thus, the Agency has determined Final rule. that Executive Order 13132, entitled Parts per Commodity million SUMMARY: This regulation establishes ‘‘Federalism’’ (64 FR 43255, August 10, tolerances for residues of dinotefuran in 1999) and Executive Order 13175, Acerola ...... 3.0 or on rice grain, egg, and poultry meat entitled ‘‘Consultation and Coordination byproducts. Mitsui Chemicals Agro Inc., with Indian Tribal Governments’’ (65 FR ***** c/o Landis International, Inc., requested 67249, November 9, 2000) do not apply Atemoya ...... 1.5 these tolerances under the Federal Food, to this final rule. In addition, this final Drug, and Cosmetic Act (FFDCA). rule does not impose any enforceable ***** DATES: This regulation is effective duty or contain any unfunded mandate Biriba ...... 1.5 November 28, 2012. Objections and as described under Title II of the ***** requests for hearings must be received Unfunded Mandates Reform Act of 1995 Cherimoya ...... 1.5 on or before January 28, 2013, and must (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any be filed in accordance with the ***** instructions provided in 40 CFR part technical standards that would require Custard apple ...... 1.5 Agency consideration of voluntary 178 (see also Unit I.C. of the consensus standards pursuant to section ***** SUPPLEMENTARY INFORMATION). 12(d) of the National Technology Feijoa ...... 3.0 ADDRESSES: The docket for this action, Transfer and Advancement Act of 1995 identified by docket identification (ID) (NTTAA) (15 U.S.C. 272 note). ***** number EPA–HQ–OPP–2012–0060, is Guava ...... 3.0 available at http://www.regulations.gov VII. Congressional Review Act or at the Office of Pesticide Programs Pursuant to the Congressional Review ***** Regulatory Public Docket (OPP Docket) Ilama ...... 1.5 Act (5 U.S.C. 801 et seq.), EPA will Jaboticaba ...... 3.0 in the Environmental Protection Agency submit a report containing this rule and Docket Center (EPA/DC), EPA West other required information to the U.S. ***** Bldg., Rm. 3334, 1301 Constitution Ave. Senate, the U.S. House of Longan ...... 7.0 NW., Washington, DC 20460–0001. The Representatives, and the Comptroller Lychee ...... 7.0 Public Reading Room is open from 8:30

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