Abamectin (Avermectin)

Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 69653

* * * * * Environmental Protection Agency, 1200 and hearing requests are provided in 40 [FR Doc. 2011–28945 Filed 11–8–11; 8:45 am] Pennsylvania Ave., NW., Washington, CFR 178.25(b). BILLING CODE 6560–50–P DC 20460–0001; telephone number: In addition to filing an objection or (703) 305–7390; email address: hearing request with the Hearing Clerk [email protected]. as described in 40 CFR part 178, please ENVIRONMENTAL PROTECTION submit a copy of the filing that does not SUPPLEMENTARY INFORMATION: AGENCY contain any CBI for inclusion in the I. General Information public docket. Information not marked 40 CFR Part 180 confidential pursuant to 40 CFR part 2 A. Does this action apply to me? [EPA–HQ–OPP–2010–0619; FRL–8890–2] may be disclosed publicly by EPA You may be potentially affected by without prior notice. Submit a copy of Abamectin (avermectin); Pesticide this action if you are an agricultural your non-CBI objection or hearing Tolerances producer, food manufacturer, or request, identified by docket ID number pesticide manufacturer. Potentially EPA–HQ–OPP–2010–0619, by one of AGENCY: Environmental Protection affected entities may include, but are the following methods: Agency (EPA). not limited to those engaged in the • Federal eRulemaking Portal: http:// ACTION: Final rule. following activities: www.regulations.gov. Follow the on-line • Crop production (NAICS code 111). instructions for submitting comments. SUMMARY: This regulation establishes • • tolerances for residues of abamectin Animal production (NAICS code Mail: Office of Pesticide Programs 112). (OPP) Regulatory Public Docket (7502P), (avermectin) in or on onion, bulb, • subgroup 3–07A; chive, fresh leaves; Food manufacturing (NAICS code Environmental Protection Agency, 1200 chive, dried leaves; and bean, dry, seed. 311). Pennsylvania Ave., NW., Washington, • Pesticide manufacturing (NAICS This regulation additionally removes DC 20460–0001. • Delivery: OPP Regulatory Public time-limited tolerances on bean, lima, code 32532). This listing is not intended to be Docket (7502P), Environmental seed; and onion, bulb, as the tolerances exhaustive, but rather to provide a guide Protection Agency, Rm. S–4400, One will be superseded by permanent for readers regarding entities likely to be Potomac Yard (South Bldg.), 2777 S. tolerance. Interregional Research Project Crystal Dr., Arlington, VA. Deliveries Number 4 (IR–4) requested these affected by this action. Other types of are only accepted during the Docket tolerances under the Federal Food, entities not listed in this unit could also Facility’s normal hours of operation Drug, and Cosmetic Act (FFDCA). be affected. The North American Industrial Classification System (8:30 a.m. to 4 p.m., Monday through DATES: This regulation is effective (NAICS) codes have been provided to Friday, excluding legal holidays). November 9, 2011. Objections and assist you and others in determining Special arrangements should be made requests for hearings must be received whether this action might apply to for deliveries of boxed information. The on or before January 9, 2012, and must certain entities. If you have any Docket Facility telephone number is be filed in accordance with the questions regarding the applicability of (703) 305–5805. instructions provided in 40 CFR part this action to a particular entity, consult 178 (see also Unit I.C. of the II. Summary of Petitioned-For the person listed under FOR FURTHER SUPPLEMENTARY INFORMATION). Tolerance INFORMATION CONTACT. ADDRESSES: EPA has established a In the Federal Register of August 11, docket for this action under docket B. How can I get electronic access to 2010 (75 FR 48667) (FRL–8840–6), EPA identification (ID) number EPA–HQ– other related information? issued a notice pursuant to section OPP–2010–0619. All documents in the You may access a frequently updated 408(d)(3) of FFDCA, 21 U.S.C. docket are listed in the docket index electronic version of EPA’s tolerance 346a(d)(3), announcing the filing of a available at http://www.regulations.gov. regulations at 40 CFR part 180 through pesticide petition (PP 0E7738) by IR–4, Although listed in the index, some the Government Printing Office’s e-CFR 500 College Rd. East, Suite 201W, information is not publicly available, site at http://ecfr.gpoaccess.gov/cgi/t/ Princeton, NJ 08540. The petition e.g., Confidential Business Information text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ requested that 40 CFR 180.449 be (CBI) or other information whose Title40/40tab_02.tpl. amended by establishing tolerances for disclosure is restricted by statute. residues of the insecticide abamectin C. How can I file an objection or hearing Certain other material, such as (avermectin B1), a mixture of copyrighted material, is not placed on request? avermectins containing greater than or the Internet and will be publicly Under FFDCA section 408(g), 21 equal to 80% avermectin B1a (5-O- available only in hard copy form. U.S.C. 346a, any person may file an demethyl avermectin A1) and less than Publicly available docket materials are objection to any aspect of this regulation or equal to 20% avermectin B1b (5-O- available in the electronic docket at and may also request a hearing on those demethyl 25-de(1-methylpropyl)-25-(1- http://www.regulations.gov, or, if only objections. You must file your objection methylethyl) avermectin A1) and its available in hard copy, at the OPP or request a hearing on this regulation delta-8,9-isomer, in or on bean, dry, Regulatory Public Docket in Rm. S– in accordance with the instructions seed at 0.01 parts per million (ppm); 4400, One Potomac Yard (South Bldg.), provided in 40 CFR part 178. To ensure chive, dried leaves at 0.07 ppm; chive, 2777 S. Crystal Dr., Arlington, VA. The proper receipt by EPA, you must fresh leaves at 0.01 ppm; and onion, Docket Facility is open from 8:30 a.m. identify docket ID number EPA–HQ– bulb, subgroup 3–07A at 0.01 ppm. That to 4 p.m., Monday through Friday, OPP–2010–0619 in the subject line on notice referenced a summary of the excluding legal holidays. The Docket the first page of your submission. All petition prepared on behalf of IR–4 by Facility telephone number is (703) 305– objections and requests for a hearing Syngenta Crop Protection, Inc., the 5805. must be in writing, and must be registrant, which is available in the FOR FURTHER INFORMATION CONTACT: received by the Hearing Clerk on or docket, http://www.regulations.gov. Laura Nollen, Registration Division before January 9, 2012. Addresses for There were no comments received in (7505P), Office of Pesticide Programs, mail and hand delivery of objections response to the notice of filing.

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Based upon review of the data sensitivities of major identifiable indication that abamectin (avermectin) supporting the petition, EPA has revised subgroups of consumers, including is carcinogenic or mutagenic; the proposed tolerance for chive, dried infants and children. abamection (avermectin) has been leaves. Additionally, the Agency has Abamectin (avermectin) has moderate classified as ‘‘not likely to be revised the tolerance expression for all to high acute toxicity by the oral route, carcinogenic to humans.’’ high acute toxicity by the inhalation established commodities to be Specific information on the studies route, and low acute toxicity by the consistent with current Agency policy. received and the nature of the adverse dermal route. It is slightly irritating to The reasons for these changes are effects caused by abamectin explained in Unit IV.C. the skin, but is not an ocular irritant or (avermectin) as well as the no-observed- a dermal sensitizer. The main target III. Aggregate Risk Assessment and organ for abamectin (avermectin) is the adverse-effect-level (NOAEL) and the Determination of Safety nervous system. Neurotoxicity and lowest-observed-adverse-effect-level Section 408(b)(2)(A)(i) of FFDCA developmental effects were detected in (LOAEL) from the toxicity studies can allows EPA to establish a tolerance (the multiple studies and species of test be found at http://www.regulations.gov legal limit for a pesticide chemical animals. Signs of neurotoxicity were in document: ‘‘Abamectin. Human residue in or on a food) only if EPA reported in studies of rats, mice, and Health Risk Assessment for Proposed determines that the tolerance is ‘‘safe.’’ dog and included decreases in foot Uses on the Bulb Onion Subgroup 3– Section 408(b)(2)(A)(ii) of FFDCA splay reflex, mydriasis, curvature of the 07A, Chives, and Dry Beans,’’ pp. 54–58 defines ‘‘safe’’ to mean that ‘‘there is a spine, decreased fore- and hind-limb in docket ID number EPA–HQ–OPP– reasonable certainty that no harm will grip strength, tip-toe gate, tremors, 2010–0619. result from aggregate exposure to the ataxia, or spastic movements of the B. Toxicological Points of Departure/ pesticide chemical residue, including limbs. Decreased body weight was also Levels of Concern all anticipated dietary exposures and all one of the most frequent findings. other exposures for which there is Severe effects, including death and Once a pesticide’s toxicological reliable information.’’ This includes morbid sacrifice, were noted in studies profile is determined, EPA identifies exposure through drinking water and in with rats and mice following repeated toxicological points of departure (POD) residential settings, but does not include exposures. and levels of concern to use in occupational exposure. Section Increased qualitative and/or evaluating the risk posed by human 408(b)(2)(C) of FFDCA requires EPA to quantitative susceptibility was seen in exposure to the pesticide. For hazards give special consideration to exposure prenatal developmental toxicity studies that have a threshold below which there of infants and children to the pesticide in mice and rabbits, and the is no appreciable risk, the toxicological chemical residue in establishing a reproductive toxicity and POD is used as the basis for derivation tolerance and to ‘‘ensure that there is a developmental neurotoxicity studies in of reference values for risk assessment. reasonable certainty that no harm will rats. Developmental data indicate that PODs are developed based on a careful result to infants and children from the most sensitive effect of abamectin analysis of the doses in each aggregate exposure to the pesticide (avermectin) on fetuses is the increase toxicological study to determine the chemical residue.* * *’’ in the incidence of cleft palates in mice dose at which the NOAEL and the Consistent with section 408(b)(2)(D) and rabbits in the presence of no or LOAEL. Uncertainty/safety factors are of FFDCA, and the factors specified in minimal maternal toxicity. No maternal used in conjunction with the POD to section 408(b)(2)(D) of FFDCA, EPA has or developmental toxicity was seen in calculate a safe exposure level— reviewed the available scientific data the prenatal developmental toxicity generally referred to as a population- and other relevant information in study in rats. adjusted dose (PAD) or a reference dose support of this action. EPA has The rat reproductive toxicity studies (RfD)—and a safe margin of exposure sufficient data to assess the hazards of (two 1-generation reproduction studies (MOE). For non-threshold risks, the and to make a determination on and a 2-generation reproduction study) Agency assumes that any amount of aggregate exposure for abamectin noted decreased pup body weights and/ exposure will lead to some degree of (avermectin) including exposure or survival at lower dose levels than risk. Thus, the Agency estimates risk in resulting from the tolerances established those that caused parental toxicity. The terms of the probability of an occurrence by this action. EPA’s assessment of developmental neurotoxicity studies in of the adverse effect expected in a exposures and risks associated with rats noted pup mortality and/or lifetime. For more information on the abamectin (avermectin) follows. decreased body weights in the absence of maternal toxicity; there were no signs general principles EPA uses in risk A. Toxicological Profile of neurotoxicity noted. In both the rat characterization and a complete EPA has evaluated the available reproduction and a developmental description of the risk assessment toxicity data and considered its validity, neurotoxicity study, the data clearly process, see http://www.epa.gov/ completeness, and reliability as well as indicated that the decrease in pup body pesticides/factsheets/riskassess.htm. the relationship of the results of the weight seen at one dose level rapidly A summary of the toxicological studies to human risk. EPA has also progressed to death at the next higher endpoints for abamectin (avermectin) considered available information tested dose level. Oncogenicity and used for human risk assessment is concerning the variability of the mutagenicity studies provide no shown in Table 1 of this unit.

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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ABAMECTIN (AVERMECTIN) FOR USE IN HUMAN HEALTH RISK ASSESSMENT

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

Acute dietary (General pop- NOAEL = 0.5 mg/kg/day ... Acute RfD = 0.005 mg/kg/ 12-Week dose-range finding study in dogs ulation including infants UFA = 10x day. LOAEL = 1.0 mg/kg/day based on mydriasis seen 1–5 and children). UFH = 10x FQPA SF = 1x aPAD = 0.005 mg/kg/day .. times during the first week of treatment; Acute neurotoxicity study in rats LOAEL = 1.5 mg/kg/day based on increased incidence of foot splay. Chronic dietary (All popu- NOAEL= 0.12 mg/kg/day .. Chronic RfD = 0.0012 mg/ Combined data: Three rat reproduction studies and lations). UFA = 10x kg/day. two rat developmental neurotoxicity studies UFH = 10x cPAD = 0.0004 mg/kg/day LOAEL = 0.2 mg/kg/day based on decreased pup FQPA SF = 3x body weight in pups at 0.2 mg/kg/day. Incidental oral short- and in- NOAEL= 0.12 mg/kg/day .. LOC for MOE = 300 ...... Combined data: Three rat reproduction studies and termediate-term (1 to 30 UFA = 10x two rat developmental neurotoxicity studies days and 1 to 6 months). UFH = 10x LOAEL = 0.2 mg/kg/day based on decreased pup FQPA SF = 3x body weight. Dermal (all durations) ...... Dermal (or oral) study ...... LOC for MOE = 300 ...... Combined data: Three rat reproduction studies and NOAEL = 0.12 mg/kg/day two rat developmental neurotoxicity studies UFA = 10x LOAEL = 0.2 mg/kg/day based on decreased pup UFH = 10x body weight. FQPA SF = 3x Inhalation (all durations) ...... Dermal (or oral) study ...... LOC for MOE = 300 ...... Combined data: Three rat reproduction studies and NOAEL = 0.12 mg/kg/day two rat developmental neurotoxicity studies UFA = 10x LOAEL = 0.2 mg/kg/day based on decreased pup UFH = 10x body weight. FQPA SF = 3x

Cancer (Oral, dermal, inha- ‘‘Not likely to be carcinogenic to humans’’ based on the absence of significant increase in tumor incidence in two lation). adequate rodent carcinogenicity studies.

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment ii. Chronic exposure. In conducting as are required by FFDCA section 1. Dietary exposure from food and the chronic dietary exposure assessment 408(b)(2)(E) and authorized under feed uses. In evaluating dietary EPA used the food consumption data FFDCA section 408(f)(1). Data will be exposure to abamectin (avermectin), from the USDA 1994–1996 and 1998 required to be submitted no later than EPA considered exposure under the CSFII. As to residue levels in food, EPA 5 years from the date of issuance of petitioned-for tolerances as well as all utilized tolerance level residues for the these tolerances. existing abamectin (avermectin) proposed crops and okra, and average Section 408(b)(2)(F) of FFDCA states tolerances in 40 CFR 180.449. EPA residues from field trials for the that the Agency may use data on the assessed dietary exposures from remaining crops. Empirical processing actual percent of food treated for abamectin (avermectin) in food as factors and PCT were also used, when assessing chronic dietary risk only if: • follows: available. Condition A: The data used are i. Acute exposure. Quantitative acute iii. Cancer. Based on the data reliable and provide a valid basis to dietary exposure and risk assessments summarized in Unit III.A., EPA has show what percentage of the food are performed for a food-use pesticide, concluded that abamectin (avermectin) derived from such crop is likely to if a toxicological study has indicated the does not pose a cancer risk to humans. contain the pesticide residue. possibility of an effect of concern Therefore, a dietary exposure • Condition B: The exposure estimate occurring as a result of a 1-day or single assessment for the purpose of assessing does not underestimate exposure for any exposure. cancer risk is unnecessary. significant subpopulation group. Such effects were identified for iv. Anticipated residue and PCT • Condition C: Data are available on abamectin (avermectin). In estimating information. Section 408(b)(2)(E) of pesticide use and food consumption in acute dietary exposure, EPA used food FFDCA authorizes EPA to use available a particular area, the exposure estimate consumption information from the data and information on the anticipated does not understate exposure for the United States Department of Agriculture residue levels of pesticide residues in population in such area. (USDA) 1994–1996 and 1998 food and the actual levels of pesticide In addition, the Agency must provide Nationwide Continuing Surveys of Food residues that have been measured in for periodic evaluation of any estimates Intake by Individuals (CSFII). As to food. If EPA relies on such information, used. To provide for the periodic residue levels in food, EPA utilized EPA must require pursuant to FFDCA evaluation of the estimate of PCT as tolerance level residues for the proposed section 408(f)(1) that data be provided 5 required by FFDCA section 408(b)(2)(F), crops and okra and anticipated residues years after the tolerance is established, EPA may require registrants to submit for the remaining commodities. modified, or left in effect, demonstrating data on PCT. Empirical processing factors and that the levels in food are not above the For the acute dietary assessment, the percent crop treated (PCT) data were levels anticipated. For the present maximum PCT for existing uses were also used, when available. action, EPA will issue such data call-ins estimated as follows:

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Almonds, 75%; apples, 10%; apricots, several regional groups. Use of this assessed for short- and intermediate- 5%; avocados, 60%; cantaloupes, 30%; consumption information in EPA’s risk term residential handler and celery, 65%; cherries, 2.5%; cotton, assessment process ensures that EPA’s postapplication exposures (dermal and 20%; cucumbers, 10%; grapefruit, 80%; exposure estimate does not understate inhalation). Children were assessed for grapes, 25%; honeydew, 35%; lemons, exposure for any significant short- and intermediate-term 55%; lettuce, 20%; oranges, 45%; subpopulation group and allows the postapplication dermal, inhalation, and peaches, 2.5%; pears, 80%; pecans, Agency to be reasonably certain that no incidental ingestion exposures (hand-to- 2.5%; peppers, 25%; potatoes, 2.5%; regional population is exposed to mouth and object-to-mouth). prunes, 10%; pumpkins, 10%; spinach, residue levels higher than those Recreational exposures to turf are 45%; squash, 10%; strawberries, 45%; estimated by the Agency. Other than the expected to be similar to, or less than, tangerines, 65%; tomatoes, 20%; data available through national food those described above, and were walnuts, 20%; and watermelons, 10%. consumption surveys, EPA does not therefore not assessed. Further For the chronic dietary assessment, have available reliable information on information regarding EPA standard the average PCT for existing uses were the regional consumption of food to assumptions and generic inputs for estimated as follows: which abamectin (avermectin) may be residential exposures may be found at Almonds, 50%; apples, 5%; apricots, applied in a particular area. http://www.epa.gov/pesticides/trac/ 5%; avocados, 40%; cantaloupes, 15%; 2. Dietary exposure from drinking science/trac6a05.pdf. celery, 40%; cherries, 1%; cotton, 5%; water. The Agency used screening level 4. Cumulative effects from substances cucumbers, 5%; grapefruit, 60%; grapes, water exposure models in the dietary with a common mechanism of toxicity. 10%; honeydew, 20%; lemons, 35%; exposure analysis and risk assessment Section 408(b)(2)(D)(v) of FFDCA lettuce, 10%; oranges, 25%; peaches, for abamectin (avermectin) in drinking requires that, when considering whether 1%; pears, 70%; pecans, 1%; peppers, water. These simulation models take to establish, modify, or revoke a 10%; potatoes, 1%; prunes, 2.5%; into account data on the physical, tolerance, the Agency consider pumpkins, 2.5%; spinach, 20%; squash, chemical, and fate/transport ‘‘available information’’ concerning the 5%; strawberries, 30%; tangerines, 60%; characteristics of abamectin cumulative effects of a particular tomatoes, 10%; walnuts, 10%; and (avermectin). Further information pesticide’s residues and ‘‘other watermelons, 5%. regarding EPA drinking water models substances that have a common In most cases, EPA uses available data used in pesticide exposure assessment mechanism of toxicity.’’ EPA has not from United States Department of can be found at http://www.epa.gov/ found abamectin (avermectin) to share a Agriculture/National Agricultural oppefed1/models/water/index.htm. common mechanism of toxicity with Statistics Service (USDA/NASS), Based on the Pesticide Root Zone any other substances, and abamectin proprietary market surveys, and the Model/Exposure Analysis Modeling (avermectin) does not appear to produce National Pesticide Use Database for the System (PRZM/EXAMS) and Screening a toxic metabolite produced by other chemical/crop combination for the most Concentration in Ground Water (SCI– substances. For the purposes of this recent 6–7 years. EPA uses an average GROW) models, the estimated drinking tolerance action, therefore, EPA has PCT for chronic dietary risk analysis. water concentrations (EDWCs) of assumed that abamectin (avermectin) The average PCT figure for each existing abamectin (avermectin) for acute does not have a common mechanism of use is derived by combining available exposures are estimated to be 2.3 parts toxicity with other substances. For public and private market survey data per billion (ppb) for surface water and information regarding EPA’s efforts to for that use, averaging across all 1.6 × 10¥3 ppb for ground water, and for determine which chemicals have a observations, and rounding to the chronic exposures for non-cancer common mechanism of toxicity and to nearest 5%, except for those situations assessments are estimated to be 1.3 ppb evaluate the cumulative effects of such in which the average PCT is less than for surface water and 1.6 × 10¥3 ppb for chemicals, see EPA’s Web site at one. In those cases, 1% is used as the ground water. http://www.epa.gov/pesticides/ average PCT and 2.5% is used as the Modeled estimates of drinking water cumulative. maximum PCT. EPA uses a maximum concentrations were directly entered PCT for acute dietary risk analysis. The into the dietary exposure model. For D. Safety Factor for Infants and maximum PCT figure is the highest acute dietary risk assessment, the water Children observed maximum value reported concentration value of 2.3 ppb was used 1. In general. Section 408(b)(2)(C) of within the recent 6 years of available to assess the contribution to drinking FFDCA provides that EPA shall apply public and private market survey data water. For chronic dietary risk an additional tenfold (10X) margin of for the existing use and rounded up to assessment, the water concentration of safety for infants and children in the the nearest multiple of 5%. value 1.3 ppb was used to assess the case of threshold effects to account for The Agency believes that the three contribution to drinking water. prenatal and postnatal toxicity and the conditions discussed in Unit III.C.1.iv. 3. From non-dietary exposure. The completeness of the database on toxicity have been met. With respect to term ‘‘residential exposure’’ is used in and exposure unless EPA determines Condition A, PCT estimates are derived this document to refer to non- based on reliable data that a different from Federal and private market survey occupational, non-dietary exposure margin of safety will be safe for infants data, which are reliable and have a valid (e.g., for lawn and garden pest control, and children. This additional margin of basis. The Agency is reasonably certain indoor pest control, termiticides, and safety is commonly referred to as the that the percentage of the food treated flea and tick control on pets). FQPA Safety Factor (SF). In applying is not likely to be an underestimation. Abamectin (avermectin) is currently this provision, EPA either retains the As to Conditions B and C, regional registered for the following uses that default value of 10X, or uses a different consumption information and could result in residential handler and additional safety factor when reliable consumption information for significant postapplication exposures: Granular data available to EPA support the choice subpopulations is taken into account baits used to treat lawns and indoor of a different factor. through EPA’s computer-based model crack and crevice dust products. EPA 2. Prenatal and postnatal sensitivity. for evaluating the exposure of assessed residential exposure using the The abamectin (avermectin) toxicity significant subpopulations including following assumptions: Adults were database is adequate to evaluate

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potential increased susceptibility of the dose-response curve and the severe gate, tremors, ataxia, or spastic infants and children, and includes effects noted. movements of the limbs were reported developmental toxicity studies in rat, Additionally, this adjusted point of in various studies with different mice, and rabbits; two 1-generation rat departure (0.04 mg/kg/day) would durations of abamectin (avermectin) reproductive toxicity studies in rat; a 2- address the concerns for the increased exposure in rats, mice, and dogs. generation reproductive toxicity study susceptibility seen at higher doses in the However, the results of two submitted in rat; and two developmental 2-generation reproduction study in rats rat developmental neurotoxicity studies neurotoxicity studies in rat. No (LOAEL = 0.4 mg/kg/day), prenatal did not show any evidence of developmental effects were seen in the developmental study in mice (LOAEL = neurotoxicity. rat developmental toxicity study. 0.75 mg/kg/day), the prenatal iv. There are no residual uncertainties However, increased quantitative developmental toxicity study in rabbits identified in the exposure databases. susceptibility was noted in the prenatal (LOAEL = 2 mg/kg/day), and the 1- The acute and chronic dietary exposure developmental toxicity studies in mice generation rat reproduction study assessments were refined and utilized and rabbits, the rat reproductive toxicity (LOAEL = 0.2 mg/kg/day). tolerance level or anticipated residues, studies, and the developmental With respect to acute dietary default or empirical processing factors, neurotoxicity studies in rat. exposure, the endpoint selected for risk and PCT estimates. EPA made 3. Conclusion. In previous abamectin assessment is based on mydriasis conservative (protective) assumptions in (avermectin) risk assessments, the 10x observed in dogs. The EPA determined the ground and surface water modeling FQPA safety factor was retained as a that the additional 3x factor applied to used to assess exposure to abamectin database uncertainty factor for the lack chronic and other exposure scenarios is (avermectin) in drinking water. EPA of a developmental neurotoxicity study. not applicable to acute exposure for the used similarly conservative assumptions Two developmental neurotoxicity following reasons: to assess postapplication exposure of a. The concerns noted for steepness of studies have now been submitted and children as well as incidental oral the dose-response curve and the severity reviewed and the findings in these exposure of toddlers. These assessments of effects were not seen in the studies studies were considered in the will not underestimate the exposure and where mydriasis occurred. identification of toxicological points of risks posed by abamectin (avermectin). b. The reduced body weights noted in departure and uncertainty/safety factors. studies following repeated exposure to E. Aggregate Risks and Determination of EPA has determined that reliable data abamectin (avermectin) are not a single Safety show the safety of infants and children dose effect. EPA determines whether acute and would be adequately protected if the c. The increased susceptibility seen in chronic dietary pesticide exposures are FQPA SF were reduced to 1X for the the prenatal developmental toxicity safe by comparing aggregate exposure acute dietary assessment and 3X for all studies, reproductive toxicity studies, estimates to the acute PAD (aPAD) and assessments other than acute dietary. and the developmental neurotoxicity chronic PAD (cPAD). For linear cancer That decision is based on the following studies were seen at a dose lower risks, EPA calculates the lifetime findings: (LOAEL 0.2 mg/kg/day) than the dose probability of acquiring cancer given the i. For all risk assessments involving (LOAEL 1.0 mg/kg/day) that caused estimated aggregate exposure. Short-, repeated exposures to abamectin mydriasis. intermediate-, and chronic-term risks (avermectin), EPA determined that a 3x Therefore, EPA has determined that it are evaluated by comparing the safety factor would be appropriate, would be appropriate if the FQPA SF estimated aggregate food, water, and based on the severity of effects (decrease were reduced to 1X for the acute dietary residential exposure to the appropriate in pup body weight and mortality) and assessment. PODs to ensure that an adequate MOE the steepness of the dose-response curve ii. The toxicity database for abamectin exists. seen in the developmental neurotoxicity (avermectin) is complete, except for 1. Acute risk. Using the exposure study and three reproductive toxicity immunotoxicity testing. Recent changes assumptions discussed in this unit for studies in the rat. These studies have to 40 CFR part 158 imposed new data acute exposure, the acute dietary documented a very narrow dose range requirements for immunotoxicity testing exposure from food and water to from NOAEL (0.12 mg/kg/day) to (OPPTS Guideline 870.7800) for abamectin (avermectin) will occupy adverse effect (0.2 mg/kg/day) to severe pesticide registration. However, the 30% of the aPAD for infants less than adverse effect (0.4 mg/kg/day). Dose toxicity database for abamectin 1 year old, the population group spacing is commonly greater than 2x (avermectin) provides no indication of receiving the greatest exposure. between NOAEL and LOAEL, and the immunotoxicity and abamectin 2. Chronic risk. Using the exposure 3x difference between the NOAEL and (avermectin) does not belong to a class assumptions described in this unit for the dose that induced mortality in the of chemicals that would be expected to chronic exposure, EPA has concluded pups in the developmental be immunotoxic. EPA does not believe that chronic exposure to abamectin neurotoxicity study provides little that conducting an immunotoxicity (avermectin) from food and water will margin of safety for the severity of the study will result in a NOAEL less than utilize 50% of the cPAD for children 1– effects seen. the NOAELs of 0.5 mg/kg/day and 0.12 2 years old the population group Retaining an additional 3x FQPA mg/kg/day already set for abamectin receiving the greatest exposure. Based safety factor effectively provides a 10x (avermectin) acute and repeated on the explanation in Unit III.C.3., margin between the dose which causes exposures, respectively, and an regarding residential use patterns, death (0.4 mg/kg/day) and the NOAEL additional uncertainty factor is not chronic residential exposure to residues adjusted by the additional safety factor needed to account for potential of abamectin (avermectin) is not (0.12 mg/kg/day/3x = 0.04 mg/kg/day). immunotoxicity. expected. A dose spacing of 10x between a iii. Signs of neurotoxicity ranging 3. Short- and intermediate-term risk. NOAEL and LOAEL is as broad, if not from decrease in foot splay reflex, Short- and intermediate-term aggregate broader, than the dose spacing generally mydriasis (i.e., excessive dilation of the exposure takes into account short- and used in animal testing and thus removes pupil), curvature of the spine, decreased intermediate-term residential exposure the residual concern of the steepness of fore- and hind-limb grip strength, tip-toe plus chronic exposure to food and water

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(considered to be a background Alimentarius Commission (Codex), as Budget (OMB) has exempted these types exposure level). Abamectin (avermectin) required by FFDCA section 408(b)(4). of actions from review under Executive is currently registered for uses that The Codex Alimentarius is a joint U.N. Order 12866, entitled Regulatory could result in short- and intermediate- Food and Agriculture Organization/ Planning and Review (58 FR 51735, term residential exposures, and the World Health Organization food October 4, 1993). Because this final rule Agency has determined that it is standards program, and it is recognized has been exempted from review under appropriate to aggregate chronic as an international food safety Executive Order 12866, this final rule is exposure through food and water with standards-setting organization in trade not subject to Executive Order 13211, short- and intermediate-term residential agreements to which the United States entitled Actions Concerning Regulations exposures to abamectin (avermectin). is a party. EPA may establish a tolerance That Significantly Affect Energy Supply, Using the exposure assumptions that is different from a Codex MRL; Distribution, or Use (66 FR 28355, May described in this unit for short- and however, FFDCA section 408(b)(4) 22, 2001) or Executive Order 13045, intermediate-term exposures, EPA has requires that EPA explain the reasons entitled Protection of Children from concluded the combined short- and for departing from the Codex level. Environmental Health Risks and Safety intermediate-term food, water, and There are currently no Codex MRLs Risks (62 FR 19885, April 23, 1997). residential exposures result in aggregate for abamectin (avermectin) on This final rule does not contain any MOEs of 1200 for the general population commodities associated with this information collections subject to OMB and 500 for children 1–2 years old. petition. approval under the Paperwork Because EPA’s level of concern for Reduction Act (PRA), 44 U.S.C. 3501 et C. Revisions to Petitioned-For seq., nor does it require any special abamectin (avermectin) is a MOE of 300 Tolerances or below, these MOEs are not of considerations under Executive Order concern. Based upon review of the data 12898, entitled Federal Actions to 4. Aggregate cancer risk for U.S. supporting the petition, EPA revised the Address Environmental Justice in population. Based on the lack of proposed tolerance for chive, dried Minority Populations and Low-Income evidence of carcinogenicity in two leaves from 0.07 ppm to 0.02 ppm. EPA Populations (59 FR 7629, February 16, adequate rodent carcinogenicity studies, revised the tolerance level based on 1994). abamectin (avermectin) is not expected analysis of the residue field trial data Since tolerances and exemptions that to pose a cancer risk to humans. using the Agency’s Tolerance are established on the basis of a petition 5. Determination of safety. Based on Spreadsheet in accordance with the under section 408(d) of FFDCA, such as these risk assessments, EPA concludes Agency’s Guidance for Setting Pesticide the tolerance in this final rule, do not that there is a reasonable certainty that Tolerances Based on Field Trial Data. require the issuance of a proposed rule, no harm will result to the general Additionally, the Agency has revised the requirements of the Regulatory population, or to infants and children the tolerance expression to clarify: Flexibility Act (RFA) (5 U.S.C. 601 et from aggregate exposure to abamectin 1. That, as provided in FFDCA section seq.) do not apply. (avermectin) residues. 408(a)(3), the tolerance covers This final rule directly regulates metabolites and degradates of abamectin growers, food processors, food handlers, IV. Other Considerations (avermectin) not specifically mentioned; and food retailers, not States or tribes, A. Analytical Enforcement Methodology and nor does this action alter the 2. That compliance with the specified relationships or distribution of power Adequate enforcement methodologies tolerance levels is to be determined by and responsibilities established by are available in Pesticide Analytical measuring only the specific compounds Congress in the preemption provisions Manual II (PAM II) for citrus and mentioned in the tolerance expression. of section 408(n)(4) of FFDCA. As such, processed fractions (Method I), ginned the Agency has determined that this cottonseed (Method IA), and bovine V. Conclusion action will not have a substantial direct tissues and milk (Method II). Therefore, tolerances are established effect on States or tribal governments, Additionally, Method M–073 and M– for residues of abamectin (avermectin), on the relationship between the national 936–95–2 have been validated by the avermectin B1 [a mixture of avermectins government and the States or tribal Agency and submitted for inclusion in containing greater than or equal to 80% governments, or on the distribution of PAM II as enforcement methods. These avermectin B1a (5-O-demethyl power and responsibilities among the five methods are adequate for avermectin A1) and less than or equal to various levels of government or between enforcement of the tolerances on plants 20% avermectin B1b (5-O-demethyl-25- the Federal Government and Indian and livestock. de(1-methylpropyl)-25-(1-methylethyl) tribes. Thus, the Agency has determined Method M–073 and M–936–95–2 may avermectin A1)] and its delta-8,9-isomer, that Executive Order 13132, entitled be requested from: Chief, Analytical in or on onion, bulb, subgroup 3–07A at Federalism (64 FR 43255, August 10, Chemistry Branch, Environmental 0.01 ppm; chive, fresh leaves at 0.01 1999) and Executive Order 13175, Science Center, 701 Mapes Rd., Ft. ppm; chive, dried leaves at 0.02 ppm; entitled Consultation and Coordination Meade, MD 20755–5350; telephone and bean, dry, seed at 0.01 ppm. This with Indian Tribal Governments (65 FR number: (410) 305–2905; email address: regulation additionally removes the 67249, November 9, 2000) do not apply [email protected]. time-limited tolerances on bean, lima, to this final rule. In addition, this final rule does not impose any enforceable B. International Residue Limits seed at 0.005 ppm; and onion, bulb at 0.005 ppm, as they will be superseded duty or contain any unfunded mandate In making its tolerance decisions, EPA by permanent tolerances. as described under Title II of the seeks to harmonize U.S. tolerances with Unfunded Mandates Reform Act of 1995 international standards whenever VI. Statutory and Executive Order (UMRA) (Pub. L. 104–4). possible, consistent with U.S. food Reviews This action does not involve any safety standards and agricultural This final rule establishes tolerances technical standards that would require practices. EPA considers the under section 408(d) of FFDCA in Agency consideration of voluntary international maximum residue limits response to a petition submitted to the consensus standards pursuant to section (MRLs) established by the Codex Agency. The Office of Management and 12(d) of the National Technology

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Transfer and Advancement Act of 1995 Parts per identification (ID) number EPA–HQ– (NTTAA), Public Law 104–113, section Commodity million OPP–2011–0583. All documents in the 12(d) (15 U.S.C. 272 note). docket are listed in the docket index available at http://www.regulations.gov. VII. Congressional Review Act ***** Although listed in the index, some The Congressional Review Act, 5 Bean, dry, seed ...... 0.01 information is not publicly available, U.S.C. 801 et seq., generally provides e.g., Confidential Business Information that before a rule may take effect, the ***** (CBI) or other information whose agency promulgating the rule must disclosure is restricted by statute. submit a rule report to each House of Chive, dried leaves ...... 0.02 Certain other material, such as Chive, fresh leaves ...... 0.01 the Congress and to the Comptroller copyrighted material, is not placed on the Internet and will be publicly General of the United States. EPA will ***** submit a report containing this rule and available only in hard copy form. other required information to the U.S. Onion, bulb, subgroup 3–07A 0.01 Publicly available docket materials are Senate, the U.S. House of available in the electronic docket at Representatives, and the Comptroller ***** http://www.regulations.gov, or, if only General of the United States prior to available in hard copy, at the OPP publication of this final rule in the Regulatory Public Docket in Rm. S– Federal Register. This final rule is not (b) Section 18 emergency exemptions. 4400, One Potomac Yard (South Bldg.), a ‘‘major rule’’ as defined by 5 U.S.C. [Reserved] 2777 S. Crystal Dr., Arlington, VA. The 804(2). * * * * * Docket Facility is open from 8:30 a.m. [FR Doc. 2011–28666 Filed 11–8–11; 8:45 am] to 4 p.m., Monday through Friday, List of Subjects in 40 CFR Part 180 BILLING CODE 6560–50–P excluding legal holidays. The Docket Facility telephone number is (703) 305– Environmental protection, 5805. Administrative practice and procedure, ENVIRONMENTAL PROTECTION Agricultural commodities, Pesticides AGENCY FOR FURTHER INFORMATION CONTACT: and pests, Reporting and recordkeeping Alganesh Debesai, Registration Division requirements. 40 CFR Part 180 (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Dated: September 30, 2011. [EPA–HQ–OPP–2011–0583; FRL–8891–4] Pennsylvania Ave., NW., Washington, Daniel J. Rosenblatt, Methacrylic Acid-Methyl Methacrylate- DC 20460–0001; telephone number: Acting Director, Registration Division, Office Polyethylene Glycol Monomethyl Ether (703) 308–8353; email address: of Pesticide Programs. Methacrylate Graft Copolymer; [email protected]. Therefore, 40 CFR chapter I is Tolerance Exemption SUPPLEMENTARY INFORMATION: amended as follows: AGENCY: Environmental Protection I. General Information Agency (EPA). PART 180—[AMENDED] ACTION: Final rule. A. Does this action apply to me? ■ 1. The authority citation for part 180 SUMMARY: This regulation establishes an You may be potentially affected by continues to read as follows: exemption from the requirement of a this action if you are an agricultural producer, food manufacturer, or Authority: 21 U.S.C. 321(q), 346a and 371. tolerance for residues of methacrylic acid-methyl methacrylate-polyethylene pesticide manufacturer. Potentially ■ 2. Section 180.449 is amended in glycol monomethyl ether methacrylate affected entities may include, but are paragraph (a) by revising the graft copolymer when used as an inert not limited to: introductory text and alphabetically ingredient in a pesticide chemical • Crop production (NAICS code 111). adding the following commodities to the formulation. Akzo Noel Surface • Animal production (NAICS code table and by revising paragraph (b) to Chemistry LLC submitted a petition to 112). EPA under the Federal Food, Drug, and read as follows: • Cosmetic Act (FFDCA), requesting an Food manufacturing (NAICS code § 180.449 Avermectin B1 and its delta-8,9- exemption from the requirement of a 311). isomer; tolerances for residues. tolerance. This regulation eliminates the • Pesticide manufacturing (NAICS (a) General. Tolerances are need to establish a maximum code 32532). established for residues of abamectin permissible level for residues of This listing is not intended to be (avermectin), including its metabolites methacrylic acid-methyl methacrylate- exhaustive, but rather provides a guide and degradates, in or on the polyethylene glycol monomethyl ether for readers regarding entities likely to be commodities in the following table. methacrylate graft copolymer on food or affected by this action. Other types of Compliance with the tolerance levels feed commodities. entities not listed in this unit could also specified in the following table is to be DATES: This regulation is effective be affected. The North American determined by measuring only November 9, 2011. Objections and Industrial Classification System avermectin B1 [a mixture of avermectins requests for hearings must be received (NAICS) codes have been provided to containing greater than or equal to 80% on or before January 9, 2012, and must assist you and others in determining avermectin B1a (5-O-demethyl be filed in accordance with the whether this action might apply to avermectin A1) and less than or equal to instructions provided in 40 CFR part certain entities. If you have any 20% avermectin B1b (5-O-demethyl-25- 178 (see also Unit I.C. of the questions regarding the applicability of de(1-methylpropyl)-25-(1-methylethyl) SUPPLEMENTARY INFORMATION). this action to a particular entity, consult avermectin A1)] and its delta-8,9-isomer ADDRESSES: EPA has established a the person listed under FOR FURTHER in or on the following commodities: docket for this action under docket INFORMATION CONTACT.

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