18504 Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Rules and Regulations

§ 218.32 Objection time periods. Friday, excluding legal holidays. The hearing requests are provided in 40 CFR (a) Time to file an objection. Written telephone number for the Public 178.25(b). objections, including any attachments, Reading Room is (202) 566–1744, and In addition to filing an objection or must be filed with the reviewing officer the telephone number for the OPP hearing request with the Hearing Clerk within 30 days following the Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please publication date of the legal notice of the visitor instructions and additional submit a copy of the filing (excluding the EA or final EIS in the newspaper of information about the docket available any Confidential Business Information record or the publication date of the at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. notice in the Federal Register when the FOR FURTHER INFORMATION CONTACT: Information not marked confidential Chief is the responsible official (see Andrew Ertman, Registration Division pursuant to 40 CFR part 2 may be § 218.6(c)). It is the responsibility of (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior objectors to ensure that their objection Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your is received in a timely manner. Pennsylvania Ave. NW., Washington, objection or hearing request, identified (b) Time for responding to an DC 20460–0001; telephone number: by docket ID number EPA–HQ–OPP– objection. The reviewing officer must (703) 308–9367; email address: 2011–0665, by one of the following issue a written response to the [email protected]. methods: • Federal eRulemaking Portal: http:// objector(s) concerning their objection(s) SUPPLEMENTARY INFORMATION: within 30 days following the end of the www.regulations.gov. Follow the online objection filing period. I. General Information instructions for submitting comments. Do not submit electronically any Dated: March 20, 2013. A. Does this action apply to me? information you consider to be Harris D. Sherman, You may be potentially affected by Confidential Business Information (CBI) Under Secretary, Natural Resources and this action if you are an agricultural or other information whose disclosure is Environment (NRE). producer, food manufacturer, or restricted by statute. • [FR Doc. 2013–06857 Filed 3–26–13; 8:45 am] pesticide manufacturer. The following Mail: OPP Docket, Environmental BILLING CODE 3410–11–P list of North American Industrial Protection Agency Docket Center (EPA/ Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. not intended to be exhaustive, but rather • ENVIRONMENTAL PROTECTION provides a guide to help readers Hand Delivery: To make special AGENCY determine whether this document arrangements for hand delivery or applies to them. Potentially affected delivery of boxed information, please 40 CFR Part 180 entities may include: follow the instructions at http:// • Crop production (NAICS code 111). www.epa.gov/dockets/contacts.htm. [EPA–HQ–OPP–2011–0665; FRL–9381–4] • Animal production (NAICS code Additional instructions on commenting or visiting the docket, along with more Emamectin Benzoate; Pesticide 112). • information about dockets generally, is Tolerance Food manufacturing (NAICS code 311). available at http://www.epa.gov/ AGENCY: Environmental Protection • Pesticide manufacturing (NAICS dockets. Agency (EPA). code 32532). II. Summary of Petitioned-For ACTION: Final rule. B. How can I get electronic access to Tolerance other related information? SUMMARY: This regulation establishes a In the Federal Register of September tolerance for residues of emamectin You may access a frequently updated 7, 2011 (76 FR 55329) (FRL–8886–7), benzoate in or on the cucurbit vegetable electronic version of EPA’s tolerance EPA issued a document pursuant to crop group 9. Interregional Research regulations at 40 CFR part 180 through FFDCA section 408(d)(3), 21 U.S.C. Project Number 4 (IR–4) requested this the Government Printing Office’s e-CFR 346a(d)(3), announcing the filing of a tolerance under the Federal Food, Drug, site at http://www.ecfr.gov/cgi-bin/text- pesticide petition (PP 1E7904) by IR–4, and Cosmetic Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 500 College Rd. East, Suite 201 W, 40tab_02.tpl. Princeton, NJ 08540. The petition DATES: This regulation is effective requested that 40 CFR 180.505 be March 27, 2013. Objections and requests C. How can I file an objection or hearing amended by establishing tolerances for for hearings must be received on or request? residues of the insecticide emamectin before May 28, 2013, and must be filed Under FFDCA section 408(g), 21 benzoate, 4′-epimethylamino-4′- in accordance with the instructions U.S.C. 346a, any person may file an deoxyavermectin B1 benzoate (a provided in 40 CFR part 178 (see also objection to any aspect of this regulation mixture of a minimum of 90% 4′-epi- Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those methylamino-4′-deoxyavermectin B1a INFORMATION). objections. You must file your objection and a maximum of 10% 4′-epi- ADDRESSES: The docket for this action, or request a hearing on this regulation methlyamino-4′deoxyavermectin B1b identified by docket identification (ID) in accordance with the instructions benzoate), and its metabolites 8,9 isomer number EPA–HQ–OPP–2011–0665, is provided in 40 CFR part 178. To ensure of the B1a and B1b component of the available at http://www.regulations.gov proper receipt by EPA, you must parent insecticide, in or on vegetable, or at the Office of Pesticide Programs identify docket ID number EPA–HQ– cucurbit, group 9 at 0.03 parts per Regulatory Public Docket (OPP Docket) OPP–2011–0665 in the subject line on million (ppm). That document in the Environmental Protection Agency the first page of your submission. All referenced a summary of the petition Docket Center (EPA/DC), EPA West objections and requests for a hearing prepared by Syngenta, the registrant, Bldg., Rm. 3334, 1301 Constitution Ave. must be in writing, and must be which is available in the docket, http:// NW., Washington, DC 20460–0001. The received by the Hearing Clerk on or www.regulations.gov. There were no Public Reading Room is open from 8:30 before May 28, 2013. Addresses for mail comments received in response to the a.m. to 4:30 p.m., Monday through and hand delivery of objections and notice of filing.

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Based upon review of the data potential to influence GABA-mediated degeneration in the brain and in supporting the petition, EPA has events important to brain development. peripheral nerves, muscle fiber modified the level at which the Within the mammalian brain, a member degeneration) were found in most of the tolerance is being established. The of this class of compound (abamectin) emamectin studies in rats, dogs and reason for this change is explained in has been shown to have widespread mice. The dose/response curve was very Unit IV.C. binding but particularly abundant in the steep in several studies (most notably cerebellum. Through action on the with CF-1 mice and dogs), with severe III. Aggregate Risk Assessment and enteric nervous system and induction of effects (morbid sacrifice and Determination of Safety longitudinal rhythmic contractions in neuropathology) sometimes seen at the Section 408(b)(2)(A)(i) of FFDCA the isolated ileum, emamectin like LOAELs (0.1 milligram/kilogram/day allows EPA to establish a tolerance (the abamectin may therefore influence (mg/kg/day) with NOAEL of 0.075 mg/ legal limit for a pesticide chemical GABA-mediated regulation of kg/day). Although no increased residue in or on a food) only if EPA metabolism, food intake and body sensitivity was seen in developmental determines that the tolerance is ‘‘safe.’’ weight at multiple sites. Although toxicity studies in rats and rabbits, Section 408(b)(2)(A)(ii) of FFDCA GABA receptor mediated neurotoxicity increased qualitative and/or quantitative defines ‘‘safe’’ to mean that ‘‘there is a is a solid hypothesis, data in sensitivity of rat pups was seen in the reasonable certainty that no harm will mammalian preparations linking reproductive toxicity and in the result from aggregate exposure to the alterations in GABA receptor function to developmental neurotoxicity studies. pesticide chemical residue, including disruptions in neuronal excitability in The carcinogenicity and mutagenicity all anticipated dietary exposures and all vitro and in vivo, and ultimately adverse studies provide no indication that other exposures for which there is outcome are currently lacking. emamectin is carcinogenic or reliable information.’’ This includes Integral to its mechanism of action in mutagenic. Emamectin is classified as exposure through drinking water and in mammals, this class of compounds is ‘‘not likely to be carcinogenic to residential settings, but does not include also a substrate for (i.e., binds to) P- humans.’’ occupational exposure. Section glycoprotein. P-glycoprotein (P-gp) is a The available emamectin data show 408(b)(2)(C) of FFDCA requires EPA to member of the adenosine triphosphate that there is a difference in species give special consideration to exposure (ATP) binding cassette transporter sensitivity, and the data suggest the of infants and children to the pesticide proteins, which reside in the plasma following order: Rat NOAELs/LOAELs chemical residue in establishing a membrane and function as a greater than dog NOAELs/LOAELs tolerance and to ‘‘ensure that there is a transmembrane efflux pump, moving greater than mouse NOAELs/LOAELs. reasonable certainty that no harm will xenobiotics from intracellular to the The toxicity endpoints and points of result to infants and children from extracellular domain against a steep departure for risk were selected from the aggregate exposure to the pesticide concentration gradient with ATP- results of the 15-day CF-1 mouse oral chemical residue.* * * ’’ hydrolysis providing the energy for toxicity study. Consistent with FFDCA section active transport. P-gp is found in the Specific information on the studies 408(b)(2)(D), and the factors specified in canallicular surface of hepatocytes, the received and the nature of the adverse FFDCA section 408(b)(2)(D), EPA has apical surface of proximal tubular cells effects caused by emamectin benzoate as reviewed the available scientific data in the kidneys, brush border surface of well as the no-observed-adverse-effect- and other relevant information in enterocytes, luminal surface of blood level (NOAEL) and the lowest-observed- support of this action. EPA has capillaries of the brain (blood brain adverse-effect-level (LOAEL) from the sufficient data to assess the hazards of barrier), placenta, ovaries, and the toxicity studies can be found at http:// and to make a determination on testes. As an efflux transporter, P-gp acts www.regulations.gov on pages 43–50 of aggregate exposure for emamectin as a protective barrier to keep the document titled ‘‘Emamectin benzoate including exposure resulting xenobiotics out of the body by excreting Benzoate. Revised Human Health Risk from the tolerances established by this them into bile, urine, and intestinal Assessment for Proposed Uses on action. EPA’s assessment of exposures lumen and prevents accumulation of Cucurbits and Outdoor-Grown Plants in and risks associated with emamectin these compounds in the brain and Commercial Nursery Production’’ in benzoate follows. gonads, as well as the fetus. Therefore, docket ID number EPA–HQ–OPP–2011– 0665. A. Toxicological Profile some test animals, in which genetic polymorphisms compromise P-gp EPA has evaluated the available B. Toxicological Points of Departure/ expression, are particularly susceptible Levels of Concern toxicity data and considered its validity, to abamectin or emamectin-induced completeness, and reliability as well as neurotoxicity. An example is the CF-1 Once a pesticide’s toxicological the relationship of the results of the mouse. Some CF-1 mice are deficient in profile is determined, EPA identifies studies to human risk. EPA has also P-gp and are found to be highly toxicological points of departure (POD) considered available information sensitive to the neurotoxicity of and levels of concern to use in concerning the variability of the abamectin. A small population of evaluating the risk posed by human sensitivities of major identifiable humans is also found to be deficient of exposure to the pesticide. For hazards subgroups of consumers, including ATP binding cassette (ABC) transporter that have a threshold below which there infants and children. Emamectin acts by proteins due to polymorphism in the is no appreciable risk, the toxicological binding to gamma-aminobutyric acid gene encoding ABC transporter proteins POD is used as the basis for derivation (GABA) gated chloride channels at two (Dubin-Johnson Syndrome). In addition, of reference values for risk assessment. different sites, a high affinity binding collie dogs have been known to be PODs are developed based on a careful site that activates the channel and a low deficient in P-gp. analysis of the doses in each affinity site that blocks the channel. Consistent with the mode of action, toxicological study to determine the GABA plays a critical role in nervous the main target organ for emamectin is dose at which no adverse effects are system development through both non- the nervous system; clinical signs observed (the NOAEL) and the lowest synaptic and synaptic mechanisms. (tremors, ptosis, ataxia, and hunched dose at which adverse effects of concern Consequently, emamectin may have the posture) and neuropathology (neuronal are identified (the LOAEL). Uncertainty/

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safety factors are used in conjunction degree of risk. Thus, the Agency www.epa.gov/pesticides/factsheets/ with the POD to calculate a safe estimates risk in terms of the probability riskassess.htm. exposure level—generally referred to as of an occurrence of the adverse effect A summary of the toxicological a population-adjusted dose (PAD) or a expected in a lifetime. For more endpoints for emamectin benzoate used reference dose (RfD)—and a safe margin information on the general principles for human risk assessment is shown in of exposure (MOE). For non-threshold EPA uses in risk characterization and a Table 1 of this unit. risks, the Agency assumes that any complete description of the risk amount of exposure will lead to some assessment process, see http://

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

Point of departure RfD, PAD, LOC for Exposure/scenario and uncertainty/safe- risk assessment Study and toxicological effects ty factors (mg/kg/day)

Acute dietary (All Populations) NOAEL = 0.075 mg/ aRfD = 0.00025 ...... 15-day mouse. LOAEL = 0.1 mg/kg/day based on tremors on kg/day. aPAD = 0.00025 day 3 of dosing. At the next higher dose (0.3 mg/kg/day), UFA = 10x tremors were seen at day 2 of treatment. UFH = 10x FQPA SF = 3x Chronic dietary (All populations) NOAEL= 0.075 mg/ cRfD = 0.000075 ..... 15-day mouse. LOAEL = 0.1 mg/kg/day based on moribund kg/day. cPAD = 0.000075 sacrifices, clinical signs of neurotoxicity, decreases in body UFA = 10x weight and food consumption and histopathological lesions in UFH = 10x the sciatic nerve. FQPA SF = 10x FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day. 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 used except for commodities with modified, or left in effect, demonstrating 1. Dietary exposure from food and chemical-specific processing studies. that the levels in food are not above the feed uses. In evaluating dietary Percent crop treated (PCT) data were levels anticipated. For the present exposure to emamectin benzoate, EPA used. action, EPA will issue such data call-ins considered exposure under the ii. Chronic exposure. In conducting as are required by FFDCA section petitioned-for tolerances as well as all the chronic dietary exposure assessment 408(b)(2)(E) and authorized under existing emamectin benzoate tolerances EPA used the food consumption data FFDCA section 408(f)(1). Data will be required to be submitted no later than in 40 CFR 180.505. EPA assessed dietary from the USDA 2003–2008 NHANES/ 5 years from the date of issuance of exposures from emamectin benzoate in WWEIA. As to residue levels in food, a these tolerances. food as follows: somewhat refined chronic dietary Section 408(b)(2)(F) of FFDCA states i. Acute exposure. Quantitative acute exposure assessment was conducted. that the Agency may use data on the dietary exposure and risk assessments The anticipated residue estimates, used actual percent of food treated for are performed for a food-use pesticide, for most crops, were single point estimates (averages) based on field trial assessing chronic dietary risk only if: if a toxicological study has indicated the • Condition a: The data used are possibility of an effect of concern data. Tolerance-level residues were used for tree nuts (including pistachios) and reliable and provide a valid basis to occurring as a result of a 1-day or single show what percentage of the food exposure. cottonseed oil. DEEM default processing factors were used except for derived from such crop is likely to Such effects were identified for contain the pesticide residue. emamectin benzoate. In estimating acute commodities with chemical-specific • processing studies. PCT data were used. Condition b: The exposure estimate dietary exposure, EPA used food does not underestimate exposure for any consumption information from the U.S. iii. Cancer. Based on the data significant subpopulation group. Department of Agriculture (USDA) summarized in Unit III.A., EPA has • Condition c: Data are available on 2003–2008 National Health and concluded that emamectin benzoate pesticide use and food consumption in Nutrition Examination Survey, What We does not pose a cancer risk to humans. a particular area, the exposure estimate Eat in America (NHANES/WWEIA). As Therefore, a dietary exposure does not understate exposure for the to residue levels in food, a probabilistic assessment for the purpose of assessing population in such area. acute dietary exposure assessment was cancer risk is unnecessary. In addition, the Agency must provide conducted. The anticipated residue iv. Anticipated residue and PCT for periodic evaluation of any estimates estimates, used for most crops, were information. Section 408(b)(2)(E) of used. To provide for the periodic based on field trial data. Tolerance-level FFDCA authorizes EPA to use available evaluation of the estimate of PCT as residues were used for tree nuts data and information on the anticipated required by FFDCA section 408(b)(2)(F), (including pistachios) and cottonseed residue levels of pesticide residues in EPA may require registrants to submit oil. Pesticide Data Program (PDP) food and the actual levels of pesticide data on PCT. monitoring data for years 2009 and 2010 residues that have been measured in For the acute dietary assessment, the were used for apples since apple juice food. If EPA relies on such information, Agency estimated the PCT for existing had a significant impact on exposure. EPA must require pursuant to FFDCA uses as follows: Dietary Exposure Evaluation Model section 408(f)(1) that data be provided 5 Almonds, 2.5%; apples, 20%; (DEEM) default processing factors were years after the tolerance is established, broccoli, 20%; cabbage, 25%;

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cauliflower, 20%; celery, 40%; cotton, for comparison with a new insecticide). have available reliable information on 2.5%; lettuce, 20%; pears, 20%; The market leader included in the the regional consumption of food to peppers, 15%; spinach, 10%; tomatoes, estimation may not be the same for each which emamectin benzoate may be 20%. year since different pesticides may applied in a particular area. For the chronic dietary assessment, dominate at different times. 2. Dietary exposure from drinking the Agency estimated the PCT for Typically, EPA uses USDA/NASS as water. The Agency used screening level existing uses as follows: the source data because it is publicly water exposure models in the dietary Almonds, 1%; apples, 10%; broccoli, available and directly reports values for exposure analysis and risk assessment 5%; cabbage, 10%; cauliflower, 10%; PCT. When a specific use site is not for emamectin benzoate in drinking celery, 25%; cotton, 1%; lettuce, 10%; reported by USDA/NASS, EPA uses water. These simulation models take pears, 5%; peppers, 5%; spinach, 5%; proprietary data and calculates the PCT into account data on the physical, tomatoes, 10%. given reported data on acres treated and chemical, and fate/transport In most cases, EPA uses available data acres grown. If no data are available, characteristics of emamectin benzoate. from USDA/National Agricultural EPA may extrapolate PCT for new uses Further information regarding EPA Statistics Service (NASS), proprietary from other crops, if the production area drinking water models used in pesticide market surveys, and the National and pest spectrum are substantially exposure assessment can be found at Pesticide Use Database for the chemical/ similar. http://www.epa.gov/oppefed1/models/ crop combination for the most recent 6 A retrospective analysis to validate water/index.htm. to 7 years. EPA uses an average PCT for this approach shows few cases where Based on the Pesticide Root Zone chronic dietary risk analysis. The the PCT for the market leaders were Model/Exposure Analysis Modeling average PCT figure for each existing use exceeded. Further review of these cases System (PRZM/EXAMS) and Screening is derived by combining available identified factors contributing to the Concentration in Ground Water (SCI– public and private market survey data exceptionally high use of a new GROW) models, the estimated drinking for that use, averaging across all pesticide. To evaluate whether the PCT water concentrations (EDWCs) of observations, and rounding to the for new uses for emamectin benzoate emamectin benzoate for acute exposures nearest 5%, except for those situations could be exceeded, EPA considered are estimated to be between 0 and 0.465 in which the average PCT is less than 1. whether there may be unusually high parts per billion (ppb) for surface water In those cases, 1% is used as the average pest pressure, as indicated in emergency and 0.00054 ppb for ground water, and PCT and 2.5% is used as the maximum exemption requests for emamectin for chronic exposures are estimated to PCT. EPA uses a maximum PCT for benzoate; the pest spectrum of the new be 0.150 ppb for surface water and acute dietary risk analysis. The pesticide in comparison with the market 0.00054 ppb for ground water. maximum PCT figure is the highest leaders and whether the market leaders Modeled estimates of drinking water observed maximum value reported are well established for that use; and concentrations were directly entered within the recent 6 years of available whether pest resistance issues with past into the dietary exposure model. For public and private market survey data market leaders provide emamectin acute dietary risk assessment, a drinking for the existing use and rounded up to benzoate with significant market water residue distribution based on the the nearest multiple of 5%. potential. Given currently available PRZM/EXAMS modeling was used. For For the acute dietary assessment, the information, EPA concludes that it is chronic dietary risk assessment, the Agency estimated the PCT for new uses unlikely that actual PCT for emamectin water concentration value of 0.150 ppb as follows: benzoate will exceed the estimated PCT was used to assess the contribution to Cantaloupe, 51%; cucumber, 26%; for new uses during the next 5 years. drinking water. squash, 46%; watermelon, 21%. The Agency believes that the three 3. From non-dietary exposure. The For the chronic dietary assessment, conditions discussed in Unit III.C.1.iv. term ‘‘residential exposure’’ is used in the Agency estimated the PCT for new have been met. With respect to this document to refer to non- uses as follows: Condition a, PCT estimates are derived occupational, non-dietary exposure Cantaloupe, 40%; cucumber, 14%; from Federal and private market survey (e.g., for lawn and garden pest control, squash, 29%; watermelon, 19%. data, which are reliable and have a valid indoor pest control, termiticides, and EPA estimates of the PCT for new basis. The Agency is reasonably certain flea and tick control on pets). uses of emamectin benzoate represent that the percentage of the food treated Emamectin benzoate is not registered the upper bound of the use expected is not likely to be an underestimation. for any specific use patterns that would during the pesticide’s initial 5 years of As to Conditions b and c, regional result in residential exposure. registration; that is, PCT for new uses of consumption information and 4. Cumulative effects from substances emamectin benzoate is a threshold of consumption information for significant with a common mechanism of toxicity. use that EPA is reasonably certain will subpopulations is taken into account Section 408(b)(2)(D)(v) of FFDCA not be exceeded for each registered use through EPA’s computer-based model requires that, when considering whether site. The PCT recommended for use in for evaluating the exposure of to establish, modify, or revoke a the chronic dietary assessment for new significant subpopulations including tolerance, the Agency consider uses is calculated as the average PCT of several regional groups. Use of this ‘‘available information’’ concerning the the market leader or leaders, (i.e., the consumption information in EPA’s risk cumulative effects of a particular pesticide(s) with the greatest PCT) on assessment process ensures that EPA’s pesticide’s residues and ‘‘other that site over the three most recent years exposure estimate does not understate substances that have a common of available data. The PCT exposure for any significant mechanism of toxicity.’’ recommended for use in the acute subpopulation group and allows the OPP’s ‘‘Guidance For Identifying dietary assessment for new uses is the Agency to be reasonably certain that no Pesticide Chemicals and Other maximum observed PCT over the same regional population is exposed to Substances that have a Common period. Comparisons are only made residue levels higher than those Mechanism of Toxicity’’ (Ref. 1) among pesticides of the same pesticide estimated by the Agency. Other than the describes the weight of the evidence types (e.g., the market leader for data available through national food approach for determining whether or insecticides on the use site is selected consumption surveys, EPA does not not a group of pesticides share a

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common mechanism of toxicity. This the specificity of such interaction on the in rats and rabbits, increased qualitative guidance defines mechanism of toxicity adverse outcome would need to be and/or quantitative sensitivity of rat as the major steps leading to a toxic shown experimentally. GABAA pups was seen in the reproductive effect following interaction of a receptors have multiple binding sites toxicity study and in the developmental pesticide with biological targets. All which have been proposed to relate to neurotoxicity study. In the reproduction steps leading to an effect do not need to adverse outcomes. For example, Dawson study, whole body tremors, hind limb be specifically understood. Rather, it is et al. (Ref. 4) showed for a group of extension, and hind limb splay were the identification of the crucial events avermectin-like compounds that rank seen in the F1 and F2 pups while these following chemical interaction that are order for anticonvulsant activity did not clinical signs were not seen in F0 required in order to describe a parallel the rank order for affinity at the parental animals at similar dose levels. mechanism of toxicity. For example, a [3H]ivermectin site. The authors In addition, a greater incidence of mechanism of toxicity may be described hypothesized that these findings may be decreased fertility was seen in the F1 by knowing the following: A chemical related to differential affinity or efficacy parental females than in the F0 females. binds to a given biological target in at subtypes of the GABAA receptor. In the developmental neurotoxicity vitro, and causes the receptor-related Other reports have indicated species study, no maternal effect was seen at the molecular response; in vivo it also leads differences in abamectin effects on highest dose tested whereas dose-related to the molecular response and causes a GABAA receptor function in the mouse decrease in open-field motor activity number of intervening biological and as compared to the rat (Ref. 5). was seen in the mid-dose in pups on

morphological steps that result in an In conclusion, although GABAA postnatal day 17. Body tremors, hind- adverse effect. In this context a common receptor mediated neurotoxicity may be limb extension, and auditory startle a common mechanism endpoint for the mechanism of toxicity pertains to two or were also found in the high dose pups. macrocyclic lactone pesticides, data 3. Conclusion. Based on currently more pesticide chemicals or other demonstrating the interactions of available data, EPA is retaining the 10X substances that cause a common toxic emamectin and abamectin with FQPA safety factor for chronic effect to human health by the same, or mammalian GABA receptors are not assessments and is using a 3X FQPA essentially the same, sequence of major A available, and data in mammalian safety factor for acute assessments. This biochemical events. Hence, the preparations linking alterations in decision is based on the following underlying basis of the toxicity is the GABA receptor function to disruptions findings: same, or essentially the same, for each A in neuronal excitability in vitro and in i. Completeness of the toxicity chemical. In the case of the macrocyclic vivo, and ultimately adverse outcome, database. The toxicology database used lactone pesticides (e.g., abamectin, are also currently lacking for this class to assess prenatal and postnatal emamectin, and avermectin), there is a of compounds. In the absence of such exposure to emamectin contains all wealth of data on the insecticidal data, the key biological steps leading to required studies with exception of an mechanism of action for avermectin: Its the adverse outcome (i.e., the immunotoxicity study and a subchronic insecticidal actions are mediated by mammalian mechanism of action) inhalation toxicity study, which are data interaction with the glutamate-gated cannot be established and by extension gaps. chloride channels and GABAA gated a common mechanism of toxicity cannot The Agency evaluated subchronic, chloride channels. This is presumed to be established. chronic, carcinogenicity, developmental be the insecticidal mechanism of action For information regarding EPA’s and reproduction studies as well as of emamectin and abamectin as well. efforts to determine which chemicals acute and subchronic neurotoxicity Insecticidal mechanism of action does have a common mechanism of toxicity studies for any effects that might not indicate a common mechanism of and to evaluate the cumulative effects of indicate that emamectin induced toxicity for human health. Further, such chemicals, see EPA’s Web site at changes in the organs generally mammals lack glutamate-gated chloride http://www.epa.gov/pesticides/ associated with immunological toxicity. channels; the toxic actions of cumulative. In the studies evaluated, only the 14- avermectin appear to be mediated via week oral toxicity study in dogs showed D. Safety Factor for Infants and interaction with GABAA and possibly an increase in the incidence of thymus glycine gated chloride channels. There Children atrophy at 1 mg/kg/day. In the 1-year is evidence that avermectin B1a binds to 1. In general. Section 408(b)(2)(C) of feeding study in dogs, thymus atrophy GABAA receptors and activates Cl FFDCA provides that EPA shall apply was not reported at similar dose levels flux into neurons (Refs. 2 and 3). an additional tenfold (10X) margin of tested. Currently, the point of departure However, there is a paucity of data safety for infants and children in the for risk assessment is 0.075 mg/kg/day, regarding the resultant alterations in case of threshold effects to account for which is more than 10 times less than cellular excitability of mammalian prenatal and postnatal toxicity and the the dose where thymus atrophy had neurons and neural networks (i.e., completeness of the database on toxicity been reported. Therefore, since the changes in cellular excitability and and exposure unless EPA determines acute and chronic RfD’s are 0.00025 mg/ altered network function as documented based on reliable data that a different kg/day and 0.000075 mg/kg/day, with pyrethroids), as well as in vivo margin of safety will be safe for infants respectively, the Agency does not measurements of altered excitability and children. This additional margin of believe an immunotoxicity study will associated with adverse outcomes. safety is commonly referred to as the result in a lower point of departure Thus, while the downstream steps FQPA Safety Factor (SF). In applying (POD) than that which is currently in leading to toxicity via disruption of this provision, EPA either retains the use for overall risk assessment. As such, GABAA receptor function for avermectin default value of 10X, or uses a different a database uncertainty factor is not can be postulated, experimental data additional safety factor when reliable necessary to account for the lack of an supporting these actions are lacking. In data available to EPA support the choice immunotoxicity study. addition, specific data demonstrating of a different factor. In regards to the inhalation toxicity GABAA receptor interaction in 2. Prenatal and postnatal sensitivity. study, there are currently no residential mammalian preparations are lacking for Although no increased sensitivity was uses registered for emamectin benzoate, abamectin and emamectin. Moreover, seen in developmental toxicity studies and therefore, lack of this study does

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not impact the Agency’s assessment of (death and neuropathology), exacerbate • Although there was evidence of prenatal and postnatal exposure. the concern raised by the steep dose increased susceptibility in the DNT Another completeness issue with response curve. study, an endpoint of concern was not regard to the toxicity database is that iii. The completeness of the exposure identified for acute dietary risk EPA is using a short-term study for long- database. The assessment for food assessment for prenatal exposures term risk assessment. The data incorporates somewhat refined because the adverse effect at the LOAEL submitted show that CF–1 mice, which anticipated residue estimates for most (i.e., decrease in open field motor lack glycoprotein, are the most sensitive commodities that were derived from activity) was seen only on postnatal day species/strand of animal tested. EPA field trial data and PCT. The availability 17 and not seen after a single exposure; only has data on CF–1 mice in short- and use of monitoring data and food • The POD selected for acute dietary term studies. Longer-term studies used preparation-reduction factors for risk assessment is a NOAEL (with a CD–1 mice. Hence a short-term study in washing, cooking, etc. may have clear LOAEL) seen after repeated dosing CF–1 mice was used to choose the resulted in a more refined estimate of but is used for assessing acute risk (i.e., chronic Point of Departure. The dietary exposure. Therefore, exposures a very conservative approach). extrapolation from a short-term study in to residues in food are not expected to Therefore, the Agency is confident CF–1 mice to a long-term POD be exceeded. that the retention of a 3X FQPA Safety introduces additional uncertainty into The dietary drinking water Factor (to account for the steepness of the risk assessment process. assessment utilizes water concentration the dose response curve) will not ii. Potential prenatal and postnatal values generated by model and underestimate risk and provides toxicity. Although no increased associated modeling parameters which reasonable certainty of no harm from sensitivity was seen in developmental are designed to provide conservative, exposure to emamectin benzoate. toxicity studies in rats and rabbits, health protective, high-end estimates of increased qualitative and/or quantitative water concentrations which will not E. Aggregate Risks and Determination of sensitivity of rat pups was seen in the likely be exceeded. Safety reproductive toxicity study and in the Taking all of these findings into EPA determines whether acute and developmental neurotoxicity study. A account, EPA has concluded that there chronic dietary pesticide exposures are degree-of-concern analysis was are not reliable data supporting safe by comparing aggregate exposure conducted to determine whether or not lowering of the default 10X FQPA safety estimates to the acute PAD (aPAD) and an additional safety factor is needed to factor for chronic exposures. chronic PAD (cPAD). For linear cancer account for the increased susceptibility Specifically, EPA does not have reliable risks, EPA calculates the lifetime in pups; it was concluded that the data showing that infants and children probability of acquiring cancer given the degree-of-concern was low for both 2- will be adequately protected using the estimated aggregate exposure. Short-, generation reproduction and traditional inter- and intra-species safety intermediate-, and chronic-term risks developmental neurotoxicity studies. factors due to the steepness of the dose- are evaluated by comparing the The reasons are as follows: response curve, the severity of effects at estimated aggregate food, water, and For the 2-generation reproduction the LOAEL (death and neuropathology), residential exposure to the appropriate study, (1) there was a clear NOAEL for and the use of a short-term study for PODs to ensure that an adequate MOE the offspring toxicity, and (2) the long-term risk assessment. The Agency exists. decreased fertility seen in F1 adults did not use a chronic study for the POD 1. Acute risk. Using the exposure might have been due to because the chronic studies were assumptions discussed in this unit for histopathological lesions in the brain conducted in rats, dogs, and CD–1 mice. acute exposure, the acute dietary and central nervous system (seen in Taking all of these findings into exposure from food and drinking water both F0 and F1 generations), rather than account, for acute exposures, EPA has to emamectin benzoate will occupy 60% due to a direct effect on the concluded that there are reliable data of the aPAD for children 1–2 years old, reproductive system. supporting lowering the default 10X the population group receiving the For the developmental neurotoxicity FQPA safety factor to 3X. Although the greatest exposure. study, (1) although multiple offspring steepness of the dose-response curve 2. Chronic risk. Using the exposure effects (including decreased pup body and the severity of the effects at the assumptions described in this unit for weight, head and body tremors, LOAEL introduce uncertainty with chronic exposure, EPA has concluded hindlimb extension and splay, changes regard to whether the inter- and intra- that chronic exposure to emamectin in motor activity and auditory startle) species safety factors are protective of benzoate from food and water will were seen at the highest dose, and no infants and children from acute effects, utilize 16% of the cPAD for all infants maternal effects were seen at any dose, EPA has concluded that use of the 15- less than 1 year old, the population there was a clear NOAEL for offspring day neurotoxicity CF–1 mouse study group receiving the greatest exposure. toxicity at the low dose, and (2) the provides reliable data to reduce the There are no residential uses for offspring LOAEL (at the mid dose) is FQPA safety factor for acute emamectin benzoate. based on a single effect seen on only one assessments from 10X to 3X. The 3. Short-term risk. Short- and day (decreased motor activity on Agency determined that a 3X FQPA intermediate-term aggregate exposure postnatal day 17) and no other offspring Safety Factor is adequate for assessing takes into account short- and toxicity was seen at the LOAEL. acute dietary risk based on the following intermediate-term residential exposure Two other considerations raise weight of evidence considerations: plus chronic exposure to food and water residual concerns about whether the • An endpoint of concern attributable (considered to be a background traditional safety factors are protective to a single exposure was not identified exposure level). of potential prenatal and postnatal for in utero effects since there was no Both short- and intermediate-term toxicity. First, the steepness of the dose- concern for developmental toxicity and adverse effects were identified; response curve means that there is a there was no indication of increased however, emamectin benzoate is not small margin of error provided by susceptibility (qualitative or registered for any use patterns that reliance on the study NOAEL. Second, quantitative) of rat or rabbit fetuses to in would result in either short- or the severity of effects at the LOAEL utero exposure to emamectin; intermediate-term residential exposure.

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Short- and intermediate-term risk is EPA explain the reasons for departing Meinke PT, McKernan RM. (2000) assessed based on short- and from the Codex level. Anticonvulsant and adverse effects of intermediate-term residential exposure The Codex has not established a MRL avermectin analogs in mice are mediated plus chronic dietary exposure. Because for emamectin benzoate on cucurbits. through the gama-aminobutyric acid (A) receptor. Journal of Pharmacology and there is no short- or intermediate-term C. Revisions to Petitioned-For Experimental Therapeutics 295: 1051– residential exposure and chronic dietary Tolerances 1060. exposure has already been assessed 5. Soderlund DM, Adams PM, Bloomquist JR. under the appropriately protective Based on the review of the residue Differences in the action of avermectin cPAD (which is at least as protective as data submitted with the petition, the B1a on the GABAA receptor complex of the POD used to assess short- or proposed tolerance level of 0.03 ppm is mouse and rat. Biochemical Biophysical intermediate-term risk), no further being modified to 0.02 ppm. Research Communications. 1987 Jul assessment of short- or intermediate- Also, EPA has revised the tolerance 31;146(2):692–8. term risk is necessary, and EPA relies on expression to clarify (1) that, as VII. Statutory and Executive Order the chronic dietary risk assessment for provided in FFDCA section 408(a)(3), Reviews the tolerance covers metabolites and evaluating short- and intermediate-term This final rule establishes tolerances risk for emamectin benzoate. degradates of emamectin benzoate not specifically mentioned; and (2) that under FFDCA section 408(d) in 4. Aggregate cancer risk for U.S. compliance with the specified tolerance response to a petition submitted to the population. Based on the lack of levels is to be determined by measuring Agency. The Office of Management and evidence of carcinogenicity in two only the specific compounds mentioned Budget (OMB) has exempted these types adequate rodent carcinogenicity studies, in the tolerance expression. of actions from review under Executive emamectin benzoate is not expected to Order 12866, entitled ‘‘Regulatory pose a cancer risk to humans. V. Conclusion Planning and Review’’ (58 FR 51735, 5. Determination of safety. Based on Therefore, a tolerance is established October 4, 1993). Because this final rule these risk assessments, EPA concludes for residues of emamectin, including its has been exempted from review under that there is a reasonable certainty that metabolites and degradates, in or on the Executive Order 12866, this final rule is no harm will result to the general cucurbit vegetable group 9 at 0.02 ppm. not subject to Executive Order 13211, population or to infants and children Compliance with the tolerance levels entitled ‘‘Actions Concerning from aggregate exposure to emamectin specified is to be determined by Regulations That Significantly Affect benzoate residues. measuring only the sum of emamectin (a Energy Supply, Distribution, or Use’’ (66 ′ FR 28355, May 22, 2001) or Executive IV. Other Considerations mixture of a minimum of 90% 4 -epi- methylamino-4′-deoxyavermectin B1a Order 13045, entitled ‘‘Protection of A. Analytical Enforcement Methodology and maximum of 10% 4′-epi- Children from Environmental Health methylamino-4′-deoxyavermectin B ) Risks and Safety Risks’’ (62 FR 19885, Adequate enforcement methodology 1b and its metabolites 8,9-isomer of the B April 23, 1997). This final rule does not (high performance liquid 1a and B component of the parent (8,9- contain any information collections chromatography with fluorescence 1b ZMA), or 4′-deoxy-4′-epi-amino- subject to OMB approval under the detection (HPLC/FLD)) is available to avermectin B and 4′-deoxy-4′-epi- Paperwork Reduction Act (PRA) (44 enforce the tolerance expression. 1a amino-avermectin B1b; 4′-deoxy-4′-epi- U.S.C. 3501 et seq.), nor does it require The method may be requested from: amino avermectin B1a (AB1a); 4′-deoxy- any special considerations under Chief, Analytical Chemistry Branch, 4′-epi-(N-formyl-N-methyl)amino- Executive Order 12898, entitled Environmental Science Center, 701 avermectin (MFB1a); and 4′-deoxy-4′- ‘‘Federal Actions to Address Mapes Rd., Ft. Meade, MD 20755–5350; epi-(N-formyl)amino-avermectin B1a Environmental Justice in Minority telephone number: (410) 305–2905; (FAB1a), calculated as the stoichiometric Populations and Low-Income email address: equivalent of emamectin. Populations’’ (59 FR 7629, February 16, [email protected]. 1994). VI. References B. International Residue Limits Since tolerances and exemptions that The following literature was are established on the basis of a petition In making its tolerance decisions, EPA referenced in the preamble of this under FFDCA section 408(d), such as seeks to harmonize U.S. tolerances with document. the tolerance in this final rule, do not international standards whenever 1. OPP’s ‘‘Guidance for Identifying Pesticide require the issuance of a proposed rule, possible, consistent with U.S. food Chemicals and Other Substances that the requirements of the Regulatory safety standards and agricultural have a Common Mechanism of Toxicity’’ Flexibility Act (RFA) (5 U.S.C. 601 et practices. EPA considers the (USEPA, 1999); http://www.epa.gov/ seq.), do not apply. international maximum residue limits fedrgstr/EPA-PEST/1999/February/Day- This final rule directly regulates (MRLs) established by the Codex 05/6055.pdf. growers, food processors, food handlers, Alimentarius Commission (Codex), as 2. balis IM, Eldefrawi AT, Eldefrawi ME. and food retailers, not States or tribes, Actions of avermectin B1a on the gamma- required by FFDCA section 408(b)(4). aminobutyric acidA receptor and nor does this action alter the The Codex Alimentarius is a joint chloride channels in rat brain. Journal of relationships or distribution of power United Nations Food and Agriculture Biochemical Toxicology. 1986 and responsibilities established by Organization/World Health Mar;1(1):69–82. Congress in the preemption provisions Organization food standards program, 3. Huang J, Casida JE. (1997) Avermectin B1a of FFDCA section 408(n)(4). As such, and it is recognized as an international binds to high- and low-affinity sites with the Agency has determined that this food safety standards-setting dual effects on the gama-aminobutyric action will not have a substantial direct organization in trade agreements to acid-gated chloride channel of cultured effect on States or tribal governments, cerebellar granule neurons. Journal of which the United States is a party. EPA Pharmacology and Experimental on the relationship between the national may establish a tolerance that is Therapeutics. 281: 261–266. government and the States or tribal different from a Codex MRL; however, 4. Dawson GR, Wafford KA, Smith A, governments, or on the distribution of FFDCA section 408(b)(4) requires that Marshall GR, Bayley PJ, Schaeffer JM, power and responsibilities among the

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various levels of government or between commodities in the table below. Unit I.C. of the SUPPLEMENTARY the Federal Government and Indian Compliance with the tolerance levels INFORMATION). tribes. Thus, the Agency has determined specified below is to be determined by ADDRESSES: The docket for this action, that Executive Order 13132, entitled measuring only the sum of emamectin (a identified by docket identification (ID) ‘‘Federalism’’ (64 FR 43255, August 10, mixture of a minimum of 90% 4′-epi- ′ number EPA–HQ–OPP–2012–0488, is 1999) and Executive Order 13175, methylamino-4 -deoxyavermectin B1a available at http://www.regulations.gov entitled ‘‘Consultation and Coordination and maximum of 10% 4′-epi- ′ or at the Office of Pesticide Programs with Indian Tribal Governments’’ (65 FR methylamino-4 -deoxyavermectin B1b) Regulatory Public Docket (OPP Docket) 67249, November 9, 2000) do not apply and its metabolites 8,9-isomer of the B1a in the Environmental Protection Agency to this final rule. In addition, this final and B1b component of the parent (8,9- ′ ′ Docket Center (EPA/DC), EPA West rule does not impose any enforceable ZMA), or 4 -deoxy-4 -epi-amino- Bldg., Rm. 3334, 1301 Constitution Ave. duty or contain any unfunded mandate avermectin B1a and 4’-deoxy-4’-epi- NW., Washington, DC 20460–0001. The as described under Title II of the amino-avermectin B1b; 4′-deoxy-4′-epi- ′ Public Reading Room is open from 8:30 Unfunded Mandates Reform Act of 1995 amino avermectin B1a (AB1a); 4 -deoxy- a.m. to 4:30 p.m., Monday through (UMRA) (2 U.S.C. 1501 et seq.). 4′-epi-(N-formyl-N-methyl)amino- ′ ′ Friday, excluding legal holidays. The This action does not involve any avermectin (MFB1a); and 4 -deoxy-4 - telephone number for the Public technical standards that would require epi-(N-formyl)amino-avermectin B1a Reading Room is (202) 566–1744, and Agency consideration of voluntary (FAB1a), calculated as the stoichiometric the telephone number for the OPP consensus standards pursuant to section equivalent of emamectin. Docket is (703) 305–5805. Please review 12(d) of the National Technology the visitor instructions and additional Transfer and Advancement Act of 1995 Parts per Commodity million information about the docket available (NTTAA) (15 U.S.C. 272 note). at http://www.epa.gov/dockets. VII. Congressional Review Act FOR FURTHER INFORMATION CONTACT: Julie ***** Chao, Registration Division (7505P), Pursuant to the Congressional Review Vegetable, cucurbit, group 9 0.02 Act (5 U.S.C. 801 et seq.), EPA will Office of Pesticide Programs, submit a report containing this rule and ***** Environmental Protection Agency, 1200 other required information to the U.S. Pennsylvania Ave. NW., Washington, Senate, the U.S. House of (2) Tolerances are established for DC 20460–0001; telephone number: Representatives, and the Comptroller emamectin, including its metabolites (703) 308–8735; email address: General of the United States prior to and degradates, in or on the [email protected]. publication of the rule in the Federal commodities in the table below. SUPPLEMENTARY INFORMATION: Register. This action is not a ‘‘major Compliance with the tolerance levels rule’’ as defined by 5 U.S.C. 804(2). specified below is to be determined by I. General Information measuring only the sum of emamectin List of Subjects in 40 CFR Part 180 A. Does this action apply to me? (MAB1a + MAB1b isomers) and the You may be potentially affected by Environmental protection, associated 8,9-Z isomers (8,9-1a and 8,9- this action if you are an agricultural Administrative practice and procedure, ZB1b). Agricultural commodities, Pesticides producer, food manufacturer, or * * * * * pesticide manufacturer. The following and pests, Reporting and recordkeeping [FR Doc. 2013–06758 Filed 3–26–13; 8:45 am] requirements. list of North American Industrial BILLING CODE 6560–50–P Classification System (NAICS) codes is Dated: March 19, 2013. not intended to be exhaustive, but rather Lois Rossi, ENVIRONMENTAL PROTECTION provides a guide to help readers Director, Registration Division, Office of AGENCY determine whether this document Pesticide Programs. applies to them. Potentially affected Therefore, 40 CFR chapter I is 40 CFR Part 180 entities may include: amended as follows: • Crop production (NAICS code 111). [EPA–HQ–OPP–2012–0488; FRL–9377–3] • Animal production (NAICS code PART 180—[AMENDED] Thiamethoxam; Pesticide Tolerances 112). • Food manufacturing (NAICS code ■ 1. The authority citation for part 180 AGENCY: Environmental Protection 311). continues to read as follows: Agency (EPA). • Pesticide manufacturing (NAICS Authority: 21 U.S.C. 321(q), 346a and 371. ACTION: Final rule. code 32532). ■ 2. § 180.505, is amended by: SUMMARY: This regulation establishes a B. How can I get electronic access to ■ i. Revise paragraph (a)(1) introductory tolerance for residues of the insecticide other related information? text and paragraph (a)(2) introductory thiamethoxam in or on tea, and amends You may access a frequently updated text; the existing tolerance for residues of ■ ii. Add alphabetically an entry for electronic version of EPA’s tolerance thiamethoxam in or on coffee. Syngenta ‘‘Vegetable, cucurbit, group 9’’ to the regulations at 40 CFR part 180 through Crop Protection, Inc., requested these table in paragraph (a)(1). the Government Printing Office’s e-CFR tolerances under the Federal Food, The added and revised text read as Web site at http://www.ecfr.gov/cgi-bin/ Drug, and Cosmetic Act (FFDCA). follows: text-idx?&c=ecfr&tpl=/ecfrbrowse/ DATES: This regulation is effective Title40/40tab_02.tpl. § 180.505 Emamectin; tolerances for March 27, 2013. Objections and requests residues. for hearings must be received on or C. How can I file an objection or hearing (a) General. (1) Tolerances are before May 28, 2013, and must be filed request? established for emamectin, including its in accordance with the instructions Under FFDCA section 408(g), 21 metabolites and degradates, in or on the provided in 40 CFR part 178 (see also U.S.C. 346a, any person may file an

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