70870 Federal Register / Vol. 78, No. 229 / Wednesday, November 27, 2013 / Rules and Regulations

tetramethyl-1,3,5,7-tetroxocane, in or on or on multiple commodities which are B. How can I get electronic access to the commodity. identified and discussed later in this other related information? document. Interregional Research You may access a frequently updated Commodity Parts per Project Number 4 (IR–4) requested these million tolerances under the Federal Food, electronic version of EPA’s tolerance Drug, and Cosmetic Act (FFDCA). regulations at 40 CFR part 180 through Artichoke, globe ...... 0.07 the Government Printing Office’s e-CFR Berry, low growing, subgroup DATES: This regulation is effective site at http://www.ecfr.gov/cgi-bin/text- 13–07G ...... 6.25 November 27, 2013. Objections and idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Bushberry subgroup 13–07B .... 0.15 requests for hearings must be received _ Cactus ...... 0.07 40tab 02.tpl. Caneberry subgroup 13–07A ... 0.15 on or before January 27, 2014, and must be filed in accordance with the C. How can I file an objection or hearing Corn, field, forage ...... 0.30 request? Corn, field, grain ...... 0.05 instructions provided in 40 CFR part Corn, field, stover ...... 0.10 178 (see also Unit I.C. of the Under FFDCA section 408(g), 21 Corn, sweet, forage ...... 0.30 SUPPLEMENTARY INFORMATION). U.S.C. 346a, any person may file an Corn, sweet, kernel plus cob with husks removed ...... 0.05 ADDRESSES: The docket for this action, objection to any aspect of this regulation Corn, sweet, stover ...... 0.10 identified by docket identification (ID) and may also request a hearing on those Fruit, citrus, group 10 ...... 0.26 number EPA–HQ–OPP–2011–0905, is objections. You must file your objection Grass, forage ...... 2.0 available at http://www.regulations.gov or request a hearing on this regulation Grass, hay ...... 2.0 or at the Office of Pesticide Programs in accordance with the instructions Leaf petioles subgroup 4B ...... 0.50 Regulatory Public Docket (OPP Docket) provided in 40 CFR part 178. To ensure Lettuce ...... 1.73 in the Environmental Protection Agency proper receipt by EPA, you must Peppermint, oil ...... 12 Docket Center (EPA/DC), EPA West identify docket ID number EPA–HQ– Peppermint, tops ...... 4.0 OPP–2011–0905 in the subject line on Spearmint, oil ...... 12 Bldg., Rm. 3334, 1301 Constitution Ave. Spearmint, tops ...... 4.0 NW., Washington, DC 20460–0001. The the first page of your submission. All Taro, corm ...... 0.15 Public Reading Room is open from 8:30 objections and requests for a hearing Taro, leaves ...... 1.0 a.m. to 4:30 p.m., Monday through must be in writing, and must be Tomato ...... 0.24 Friday, excluding legal holidays. The received by the Hearing Clerk on or Vegetable, brassica, leafy, telephone number for the Public before January 27, 2014. Addresses for group 5 ...... 2.5 Reading Room is (202) 566–1744, and mail and hand delivery of objections Watercress ...... 3.2 the telephone number for the OPP and hearing requests are provided in 40 Docket is (703) 305–5805. Please review CFR 178.25(b). * * * * * the visitor instructions and additional (c) Tolerances with regional In addition to filing an objection or information about the docket available registrations. Tolerances with a regional hearing request with the Hearing Clerk at http://www.epa.gov/dockets. registration as defined in § 180.1(l) are as described in 40 CFR part 178, please established for residues of the FOR FURTHER INFORMATION CONTACT: Lois submit a copy of the filing (excluding molluscicide metaldehyde, including its Rossi, Registration Division (7505P), any Confidential Business Information metabolites and degradates, in or on the Office of Pesticide Programs, (CBI)) for inclusion in the public docket. following commodities. Compliance Environmental Protection Agency, 1200 Information not marked confidential with the specified tolerance level is to Pennsylvania Ave. NW., Washington, pursuant to 40 CFR part 2 may be be determined by measuring only DC 20460–0001; telephone number: disclosed publicly by EPA without prior metaldehyde, 2,4,6,8-tetramethyl- (703) 305–7090; email address: notice. Submit the non-CBI copy of your 1,3,5,7-tetroxocane, in or on the [email protected]. objection or hearing request, identified commodity. by docket ID number EPA–HQ–OPP– SUPPLEMENTARY INFORMATION: 2011–0905, by one of the following methods: Commodity Parts per I. General Information million • Federal eRulemaking Portal: http:// A. Does this action apply to me? Soybean, seed ...... 0.05 www.regulations.gov. Follow the online You may be potentially affected by instructions for submitting comments. * * * * * this action if you are an agricultural Do not submit electronically any [FR Doc. 2013–28370 Filed 11–26–13; 8:45 am] producer, food manufacturer, or information you consider to be CBI or other information whose disclosure is BILLING CODE 6560–50–P pesticide manufacturer. The following list of North American Industrial restricted by statute. Classification System (NAICS) codes is • Mail: OPP Docket, Environmental ENVIRONMENTAL PROTECTION not intended to be exhaustive, but rather Protection Agency Docket Center (EPA/ AGENCY provides a guide to help readers DC), (28221T), 1200 Pennsylvania Ave. determine whether this document NW., Washington, DC 20460–0001. 40 CFR Part 180 applies to them. Potentially affected • Hand Delivery: To make special [EPA–HQ–OPP–2011–0905; FRL–9902–39] entities may include: arrangements for hand delivery or • Crop production (NAICS code 111). delivery of boxed information, please Etofenprox; Pesticide Tolerances • Animal production (NAICS code follow the instructions at http:// AGENCY: Environmental Protection 112). www.epa.gov/dockets/contacts.html. Agency (EPA). Additional instructions on commenting • Food manufacturing (NAICS code ACTION: Final rule. or visiting the docket, along with more 311). information about dockets generally, is SUMMARY: This regulation establishes • Pesticide manufacturing (NAICS available at http://www.epa.gov/ tolerances for residues of etofenprox in code 32532). dockets.

VerDate Mar<15>2010 16:16 Nov 26, 2013 Jkt 232001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\27NOR1.SGM 27NOR1 emcdonald on DSK67QTVN1PROD with RULES Federal Register / Vol. 78, No. 229 / Wednesday, November 27, 2013 / Rules and Regulations 70871

II. Summary of Petitioned-For aggregate exposure to the pesticide developmental portion of the study, Tolerance chemical residue. . . .’’ effects were seen in maternal animals, Consistent with FFDCA section while no effects were observed in the In the Federal Register of December 8, 408(b)(2)(D), and the factors specified in offspring. In the 2-generation 2011 (76 FR 76674) (FRL–9328–8), EPA FFDCA section 408(b)(2)(D), EPA has reproductive toxicity study in rats, there issued a document pursuant to FFDCA reviewed the available scientific data was also no evidence of increased section 408(d)(3), 21 U.S.C. 346a(d)(3), and other relevant information in susceptibility of offspring. announcing the filing of a pesticide support of this action. EPA has Although etofenprox exposure does petition (PP 1E7925) by Interregional sufficient data to assess the hazards of result in some neurotoxic effects, these Research Project No. 4 (IR–4), 500 and to make a determination on effects only occur at high doses. An College Road East, Suite 201 W, aggregate exposure for etofenprox acute neurotoxicity study in the adult Princeton, NJ 08540. The petition including exposure resulting from the rat revealed no treatment-related effects. requested that 40 CFR 180.620 be tolerances established by this action. The subchronic neurotoxicity study in amended by establishing tolerances for EPA’s assessment of exposures and risks the rat showed decreased body weight residues of the insecticide etofenprox, associated with etofenprox follows. gains, increased liver weights in all dose [2-(4-ethoxyphenyl)-2-methylpropyl 3- A. Toxicological Profile groups, and increased incidence of phenoxybenzyl ether], in or on food and rearing behavior in males and abnormal feed commodities at 0.5 parts per EPA has evaluated the available gait in females. The developmental million (ppm). That document toxicity data and considered its validity, neurotoxicity study in rats showed referenced a summary of the petition completeness, and reliability as well as increased rearing behavior in mothers at prepared by Mitsui, the registrant, the relationship of the results of the the highest dose tested (HDT). In which is available in the docket, studies to human risk. EPA has also offspring, eye abnormalities were http://www.regulations.gov. There were considered available information observed at the high-dose level and no comments received in response to concerning the variability of the effects on motor/locomotor activity and the notice of filing. sensitivities of major identifiable auditory startle response observed at the Currently there are two products that subgroups of consumers, including high-dose level. contain etofenprox registered for infants and children. The immunotoxicity studies in the rat mosquito control. However, the existing In mammals, the major targets of and mouse were both negative for etofenprox are the liver, thyroid, kidney, registrations do not allow treatments on immunotoxicity. and hematopoietic system. Results from or over agricultural areas. IR–4 The cancer classification for subchronic and chronic feeding studies submitted this petition to establish etofenprox is ‘‘Not likely to be in rats indicate that males may be more tolerances for residues of etofenprox in carcinogenic to humans at doses that do sensitive to treatment-related effects of or on food and feed commodities so that not alter rat thyroid hormone etofenprox than females. All subchronic the registration can be modified to allow homeostasis.’’ This decision was based and chronic toxicity including repeated applications (aerial and on the following considerations: carcinogenicity studies showed adverse ground) over agricultural crops, pasture i. Treatment-related thyroid follicular effects (organ weights, histopathology, and rangeland. cell tumors were seen in both male and biochemistry, hematology, and clinical female rats at a dose level considered to Based upon review of the data chemistry) in two or more of the target be adequate, and not excessive, to assess supporting the petition, EPA has organs/systems. Additionally, decreases carcinogenicity; modified the level at which tolerances in body weights and food consumption ii. No treatment-related tumors were are being established. The reason for were observed in most of the studies. seen in male or female mice when tested this change is explained in Unit IV.C. In a mouse carcinogenicity study, the at a dose that was considered adequate III. Aggregate Risk Assessment and kidney was the most sensitive target to assess carcinogenicity; Determination of Safety organ, especially in males, and many iii. There is no mutagenicity concern deaths were attributed to renal lesions. for etofenprox based in vivo or in vitro Section 408(b)(2)(A)(i) of FFDCA Males showed a positive trend in renal assays; allows EPA to establish a tolerance (the cortical adenomas alone and in iv. The non-neoplastic toxicological legal limit for a pesticide chemical combined carcinomas and adenomas; evidence (i.e., thyroid growth and residue in or on a food) only if EPA however, tumor incidence was within thyroid hormonal changes) indicates determines that the tolerance is ‘‘safe.’’ the historical control range. Other that etofenprox disrupts the thyroid- Section 408(b)(2)(A)(ii) of FFDCA effects included decreased body and pituitary hormonal status; and defines ‘‘safe’’ to mean that ‘‘there is a thymus gland weights, and increased v. Rats are substantially more reasonable certainty that no harm will liver, spleen, and pituitary gland sensitive than humans to the result from aggregate exposure to the weights. Microscopic changes included development of thyroid follicular cell pesticide chemical residue, including centrilobular hepatocyte enlargement. tumors in response to thyroid hormone all anticipated dietary exposures and all Relevant toxicity studies showed no imbalance. The overall weight-of-the- other exposures for which there is quantitative or qualitative evidence of evidence was considered sufficient to reliable information.’’ This includes increased susceptibility in offspring. A indicate that etofenprox induced exposure through drinking water and in prenatal developmental toxicity study thyroid follicular tumors through an residential settings, but does not include in rabbits showed no quantitative or antithyroid mode of action. occupational exposure. Section qualitative evidence of increased Specific information on the studies 408(b)(2)(C) of FFDCA requires EPA to susceptibility in offspring, in that the received and the nature of the adverse give special consideration to exposure developmental effects were seen at effects caused by etofenprox as well as of infants and children to the pesticide doses that resulted in maternal toxicity, the no-observed-adverse-effect-level chemical residue in establishing a including death. There was no (NOAEL) and the lowest-observed- tolerance and to ‘‘ensure that there is a indication of increased susceptibility of adverse-effect-level (LOAEL) from the reasonable certainty that no harm will offspring in the 1-generation/ toxicity studies can be found at http:// result to infants and children from developmental study in rats. In the www.regulations.gov in the document

VerDate Mar<15>2010 16:16 Nov 26, 2013 Jkt 232001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\27NOR1.SGM 27NOR1 emcdonald on DSK67QTVN1PROD with RULES 70872 Federal Register / Vol. 78, No. 229 / Wednesday, November 27, 2013 / Rules and Regulations

titled ‘‘Etofenprox: Section 3 Aggregate is no appreciable risk, the toxicological risks, the Agency assumes that any Human Health Risk Assessment for a POD is used as the basis for derivation amount of exposure will lead to some Label Amendment to Remove of reference values for risk assessment. degree of risk. Thus, the Agency Application Restriction Over Crop, PODs are developed based on a careful estimates risk in terms of the probability Range, and Pasture land,’’ pp. 36–41 analysis of the doses in each of an occurrence of the adverse effect docket ID number EPA–HQ–OPP–2011– toxicological study to determine the expected in a lifetime. For more 0905. dose at which no adverse effects are information on the general principles B. Toxicological Points of Departure/ observed (the NOAEL) and the lowest EPA uses in risk characterization and a Levels of Concern dose at which adverse effects of concern complete description of the risk assessment process, see http:// Once a pesticide’s toxicological are identified (the LOAEL). Uncertainty/ profile is determined, EPA identifies safety factors are used in conjunction www.epa.gov/pesticides/factsheets/ toxicological points of departure (POD) with the POD to calculate a safe riskassess.htm. and levels of concern to use in exposure level—generally referred to as A summary of the toxicological evaluating the risk posed by human a population-adjusted dose (PAD) or a endpoints for etofenprox used for exposure to the pesticide. For hazards reference dose (RfD)—and a safe margin human risk assessment is shown in the that have a threshold below which there of exposure (MOE). For non-threshold Table of this unit.

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

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

Acute dietary (All populations) .. No adverse effects attributable to a single dose were observed in oral toxicity studies, including developmental toxicity studies in rats and rabbits. Therefore, an acute reference dose was not established.

Chronic dietary (All populations) NOAEL = 3.7 mg/kg/ cRfD = 0.037 mg/kg/ Combined Chronic Toxicity/Carcinogenicity Study in Rat. day. day. LOAEL = 25.5 mg/kg/day based on increased thyroid weights. UFA = 10x cPAD = 0.037 mg/ Related to increased liver weights and histopathology UFH = 10x kg/day changes in liver and thyroid that occurred at the higher dose. FQPA SF = 1x Incidental oral short- and inter- NOAEL = 20 mg/kg/ LOC for MOE = 100 Subchronic Oral Toxicity in Rat. mediate-term (1 to 30 days day. LOAEL = 120 mg/kg/day based on decreased body weight and 1 to 6 months). UFA = 10x gain, increased liver and thyroid weights with corresponding UFH = 10x histopathology, changes in hematology and clinical chem- FQPA SF = 1x istry. Incidental oral long-term (> 6 NOAEL = 3.7 mg/kg/ LOC for MOE = 100 Combined Chronic Toxicity/Carcinogenicity Study in Rat. months). day. LOAEL = 25.5 mg/kg/day based on increased thyroid weights. UFA = 10x Related to increased liver weights and histopathology UFH = 10x changes in liver and thyroid that occurred at the higher dose. FQPA SF = 1x Inhalation short- and inter- Inhalation study ...... LOC for MOE = 100 13-Week Inhalation Toxicity in Rat. mediate-term (1 to 30 days NOAEL = 10.6 mg/ LOAEL = 52.3 mg/kg/day based on organ weight changes and and 1 to 6 months). kg/day. histopathological changes in liver, adrenals and thyroid. UFA = 10x UFH = 10x FQPA SF = 1x

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

C. Exposure Assessment possibility of an effect of concern WWEIA). The assessment assumed 1. Dietary exposure from food and occurring as a result of a 1-day or single tolerance level residues for all feed uses. In evaluating dietary exposure. No such effects were commodities, incorporated estimated exposure to etofenprox, EPA considered identified in the toxicological studies percent crop treated (PCT) values, and exposure under the petitioned-for for etofenprox; therefore, a quantitative used the Dietary Exposure Evaluation tolerances as well as all existing acute dietary exposure assessment is Model Food Commodity Intake Database etofenprox tolerances in 40 CFR unnecessary. (DEEM–FCID) default processing 180.620. EPA assessed dietary ii. Chronic exposure. In conducting factors. The submitted crop field trial exposures from etofenprox in food as the chronic dietary exposure assessment data were conducted at a rate (0.07 lb ai/ follows: EPA used the food consumption data A) 10X greater than the proposed i. Acute exposure. Quantitative acute from the U.S. Department of application rate of at 0.007 lb ai/A per dietary exposure and risk assessments Agriculture’s (USDA’s) National Health site for mosquito control. The number are performed for a food-use pesticide, and Nutrition Examination Survey, and locations of field trials were in if a toxicological study has indicated the What We Eat in America (NHANES/ accordance with the initial

VerDate Mar<15>2010 16:16 Nov 26, 2013 Jkt 232001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\27NOR1.SGM 27NOR1 emcdonald on DSK67QTVN1PROD with RULES Federal Register / Vol. 78, No. 229 / Wednesday, November 27, 2013 / Rules and Regulations 70873

recommendations put forth by the EPA. data on the actual percent of food randomly across the landscape without EPA recommended field trials be treated for assessing chronic dietary risk regard to land use patterns. Except for conducted at the 1x and 10x rates and only if: area wide vector control programs, this indicated that if there were residues • Condition a: The data used are approach is highly conservative in that detected in the samples collected above reliable and provide a valid basis to mosquito adulticide applications are the limit of quantification (LOQ) at both show what percentage of the food generally made to populated urban and 1x and 10x rates, then a tolerance would derived from such crop is likely to suburban areas. However, because of the be required at the level observed at the contain the pesticide residue. inherent drift of mosquito adulticides 1x rate. However, the available crop • Condition b: The exposure estimate into non-target areas, it is realistic to field trial data do not reflect the number does not underestimate exposure for any assume that some residues of etofenprox of applications proposed or the use of significant subpopulation group. may be found on agricultural crops in ground application equipment. • Condition c: Data are available on the urban-agricultural interface. Using Therefore, the Agency considered an pesticide use and food consumption in this approach, PCT estimates including analysis submitted by IR–4 of different a particular area, the exposure estimate residues on rice, which is a registered modeled runs to estimate the residues does not understate exposure for the use, are as follows: resulting from multiple aerial population in such area. Apples: 1%; almonds: 5%; apricots: applications using the Terrestrial In addition, the Agency must provide 5%; artichokes: 5%; avocados: 5%; Residue Exposure (TREX) model for periodic evaluation of any estimates broccoli: 5%; Brussels sprouts: 5%; carrots: 5%; cauliflower: 5%; celery: following repeated ultra low volume used. To provide for the periodic 5%; chicory: 5%; dates: 5%; field corn: (ULV) applications to estimate an upper evaluation of the estimate of PCT as 1%; figs: 5%; garlic: 5%; grapes: 5%; bound tolerance value. The EPA also required by FFDCA section 408(b)(2)(F), honeydew melon: 5%; kiwifruit: 5%; evaluated the proposed multiple EPA may require registrants to submit lemons: 5%; nectarines: 5%; olives: 5%; application scenarios using AGricultural data on PCT. oranges: 15%; pears: 1%; persimmons: DISPersal (AGDISP) 8.25 and assumed In most cases, EPA uses available data 5%; pistachios: 5%; plums: 5%; pluots: the same application parameters (e.g., from United States Department of 5%; pomegranates: 5%; prunes: 5%; drop size distribution, application Agriculture/National Agricultural material, and application height) as raisins: 5%; rice: 3%; tomatoes: 5%; Statistics Service (USDA/NASS), considered in the TREX analysis. A walnuts: 5%; wheat: 1%; all other crops: proprietary market surveys, and the deposition rate of 33% was assumed for (including livestock commodities, milk, National Pesticide Use Database for the aerial and ground ULV applications, and eggs) 3%. chemical/crop combination for the most which corresponds to a residue value of The Agency used the market leader recent 6–7 years. EPA uses an average 4.8 ppm (to represent the worst case) approach to develop upper bound PCT for chronic dietary risk analysis. with a wind speed of 1 mph. These percent crop treated estimates for this The average PCT figure for each existing analysis result in estimated an upper new use. Under the market leader use is derived by combining available bound value of 4.77 ppm for ground and approach, this upper bound is estimated public and private market survey data aerial applications. Therefore, the EPA as the percent of the crop treated by the determined that a tolerance of 5 ppm, for that use, averaging across all most widely used pesticide for the new which is based on conservative observations, and rounding to the use. The EPA’s usual application of the assumptions, is adequate to cover the nearest 5%, except for those situations market leader approach for deriving expected residues. The proposed in which the average PCT is less than PCT traditionally focuses on broad tolerance of 5 ppm on food and feed one. In those cases, 1% is used as the categories of pesticides (e.g., commodities significantly increases the average PCT and 2.5% is used as the insecticides, fungicides, or herbicides) dietary burdens of etofenprox in maximum PCT. EPA uses a maximum applied directly to crops for control of livestock and necessitates establishing PCT for acute dietary risk analysis. The agricultural pests. In this case, however, tolerances on livestock commodities. maximum PCT figure is the highest EPA determined that this would not be Specific information on the TREX and observed maximum value reported appropriate because mosquito AGDISP analyses can be found at within the recent 6 years of available adulticides fill a unique niche in the http://www.regulations.gov in the public and private market survey data pesticide marketplace. The amount of document titled ‘‘Spray Drift Analysis for the existing use and rounded up to general insecticide use on crops has no for the Etofenprox Label Amendment the nearest multiple of 5%. rational relationship to the amount of (Petition No. 1E7925)’’ docket ID The Agency estimated the PCT for mosquito adulticide use. Instead of number EPA–HQ–OPP–2011–0905. proposed uses of etofenprox as a using the insecticides applied directly iii. Cancer. Based on the data mosquito adulticide which may result on these crops, EPA chose the most summarized in Unit III.A., EPA has in residues on food and feed widely used mosquito adulticide in the concluded that etofenprox does not pose commodities. The PCT estimates are for states/regions that the crop is grown in. a cancer risk to humans at doses that do 35 agricultural crops which may be For occasional area wide vector control not alter rat thyroid hormone exposed to mosquito adulticide programs for West Nile Virus (WNV) or homeostasis. Because the cPAD is applications of etofenprox. The Vector-borne encephalitis (Western protective of etofenprox’s effect on agricultural crops included in the Equine Encephalitis, Eastern Equine thyroid hormones and dietary exposure analysis are apples, pears, oranges, rice, Encephalitis, or St. Louis Encephalitis) to etofenprox for the purpose of field com, wheat, and 29 crops grown this approach provides an accurate assessing cancer risk would be the same predominantly in California. The EPA estimate of the PCT for agricultural or lower than dietary exposure relevant relied on national and state level usage crops. to other chronic endpoints, a dietary data for the most widely used mosquito These estimates represent the upper exposure assessment for the purpose of insecticides to develop percent crop bound of use expected during the assessing cancer risk is unnecessary. treated estimates for new uses. The pesticide’s initial five years of iv. Anticipated residue and PCT general approach to estimating PCT was registration; that is, PCT for etofenprox information. Section 408(b)(2)(F) of to assume that all etofenprox mosquito is a threshold of use that EPA is FFDCA states that the Agency may use adulticide applications will be made reasonably certain will not be exceeded

VerDate Mar<15>2010 16:16 Nov 26, 2013 Jkt 232001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\27NOR1.SGM 27NOR1 emcdonald on DSK67QTVN1PROD with RULES 70874 Federal Register / Vol. 78, No. 229 / Wednesday, November 27, 2013 / Rules and Regulations

for each registered use site. The PCT consumption information for significant use. Handler exposure is expected to be recommended for use in the chronic subpopulations is taken into account short-term in duration and because dietary assessment is calculated as the through EPA’s computer-based model there was no adverse dermal effect average PCT of the market leader or for evaluating the exposure of identified for etofenprox, risk was leaders, (i.e., the one(s) with the greatest significant subpopulations including assessed only for exposure via the PCT) on that site over the three most several regional groups. Use of this inhalation route. There is also potential recent years of available data. The consumption information in EPA’s risk for post-application exposure for comparisons are only made among assessment process ensures that EPA’s individuals as a result of being in an pesticides of the same pesticide type exposure estimate does not understate environment that has been previously (e.g., the market leader for insecticides exposure for any significant treated with etofenprox. Because of the on the use site is selected for subpopulation group and allows the registered indoor uses, intermediate- comparison with a new insecticide). Agency to be reasonably certain that no term post application exposures are The market leader included in the regional population is exposed to possible. However, since the short- and estimation may not be the same for each residue levels higher than those intermediate-term endpoints and PODs year since different pesticides may estimated by the Agency. Other than the for inhalation and oral routes are the dominate at different times. Typically, data available through national food same, the short-term exposure and risk EPA uses USDA National Agricultural consumption surveys, EPA does not estimates are considered to be protective Statistics Service (NASS) as the source have available reliable information on of potential intermediate-term exposure of data because it is publicly available the regional consumption of food to and risk. Because adverse dermal and directly reports values for PCT. which etofenprox may be applied in a toxicity effects were not identified for When a specific use site is not reported particular area. etofenprox, only short- and by USDA/NASS, EPA uses proprietary 2. Dietary exposure from drinking intermediate-term post-application data and calculates the PCT given water. The Agency used screening level inhalation exposures were assessed for reported data on acres treated and acres water exposure models in the dietary adults and short- and intermediate-term grown. If no data are available, EPA may exposure analysis and risk assessment post-application inhalation and extrapolate PCT from other crops for etofenprox in drinking water. These incidental oral exposures were assessed (proxies), if the crop management and simulation models take into account for children. Additionally, long-term pest spectrum are substantially similar. data on the physical, chemical, and fate/ post-application incidental oral A retrospective analysis to validate this transport characteristics of etofenprox. exposure to children from petting approach shows few cases where the Further information regarding EPA treated cats or dogs was also assessed. PCT for the market leaders were drinking water models used in pesticide The worst-case residential short-term exceeded. Further review of these cases exposure assessment can be found at exposure for adults is from post- identified factors contributing to the http://www.epa.gov/oppefed1/models/ application inhalation exposure from exceptionally high use of a new water/index.htm. treatment of flying insects. The worst- pesticide. Given the results of this Based on the Tier 1 Rice Model and case residential short-term exposure for review, to evaluate whether the PCT for Screening Concentration in Ground etofenprox could be exceeded, EPA Water (SCI–GROW) models, the children 1 to 2 years old is from considered whether there may be estimated drinking water concentrations combined inhalation and oral hand-to- unusually high mosquito pressure or (EDWCs) of etofenprox for chronic mouth post-application exposures from disease transmission potential; whether exposures are estimated to be 1.2 ppb treatment of flying insects. EPA ¥ the market leaders are well established for surface water and 3.0 × 10 3 ppb for typically combines exposures for for that use; and whether pest resistance ground water. treatments to control the same pests (e.g. issues with past market leaders provide Modeled estimates of drinking water flea treatment on surfaces and on pets) etofenprox with significant market concentrations were directly entered because such treatments could potential. Given currently available into the dietary exposure model. For reasonably be expected to occur on the information, EPA concludes it is chronic dietary risk assessment, the same day. But a similar presumption is unlikely that actual PCT for etofenprox water concentration of value 1.2 ppb not generally followed for exposures for will exceed the estimated PCT for new was used to assess the contribution to treatments to control different pests. For uses during the next five years. drinking water. etofenprox, EPA has not combined Specific information on the 3. From non-dietary exposure. The short-term exposures from use of methodology to estimate PCT can be term ‘‘residential exposure’’ is used in etofenprox to control flying insects and found at http://www.regulations.gov in this document to refer to non- its use to control fleas, ticks, and bed the document titled ‘‘BEAD Estimate of occupational, non-dietary exposure bugs. Several factors support this the Percent Crop Treated for New Use (e.g., for lawn and garden pest control, approach for etofenprox. First, EPA’s (PCTn) of Etofenprox when used as a indoor pest control, termiticides, and manner of estimating short-term Mosquito Adulticide in Agricultural flea and tick control on pets). residential exposures is very Areas’’ docket ID number EPA–HQ– Etofenprox is currently registered for the conservative. When assessing individual OPP–2011–0905. following uses that could result in short-term residential post-application The Agency believes that the three residential exposures: Cat and dog spot- exposure scenarios, EPA assumes conditions discussed in Unit III.C.1.iv. on treatments, as a bed bug treatment, exposure occurs at the level of zero-day have been met. With respect to as indoor space and crack and crevice residues (i.e., day of application Condition a, PCT estimates are derived sprays, and as indoor and outdoor residues) on each day of the short-term from Federal and private market survey foggers. EPA assessed residential exposure period (1–30 days), instead of data, which are reliable and have a valid exposure using the following incorporating information on residue basis. The Agency is reasonably certain assumptions: Adults can potentially be decline values. EPA also assumes that that the percentage of the food treated exposed to etofenprox residues during an individual performs the same post- is not likely to be an underestimation. residential application of etofenprox, application activities, intended to As to Conditions b and c, regional including indoor surface-directed and represent high-end exposures as consumption information and aerosol space spray and outdoor fogger described in the Residential SOPs, for

VerDate Mar<15>2010 16:16 Nov 26, 2013 Jkt 232001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\27NOR1.SGM 27NOR1 emcdonald on DSK67QTVN1PROD with RULES Federal Register / Vol. 78, No. 229 / Wednesday, November 27, 2013 / Rules and Regulations 70875

the same amount of time every day over iii. Neurotoxic effects. Pyrethroid generation reproduction toxicity study, the short-term exposure period, rather toxicity is manifested through toxicity in the offspring occurred at the than averaging post-application activity neurological syndromes described as level of parental toxicity (increased levels and exposures over that period. either T (fine tremors), CS organs weights and associated Second, these exposure estimates are (choreoathetosis and salivation), or pathological changes occurred in both then compared to points of departure some combination thereof, depending the pups and parents). In the that are typically based on weeks of on the structure. Open literature developmental neurotoxicity study in dosing in test animals. Longer exposure supports a correlation between the rats, the observed eye abnormalities periods generally produce lower points modification in sodium channel kinetics associated with body injuries could not of departure. For etofenprox, the short- and the resulting syndrome. be disassociated from possible altered, term risk assessment is particularly Etofenprox is not included in the treatment-related maternal behavior. conservative because the point of pyrethroid common mechanism 3. Conclusion. EPA has determined departure for the short-term (1 to 30- grouping or included in the cumulative that reliable data show the safety of days) risk assessment is based on a risk assessment because etofenprox does infants and children would be toxicity study involving continuous not exhibit these key characteristics. adequately protected if the FQPA SF exposure over 90 days. Third, usage Etofenprox is an ether compound; were reduced to 1x. That decision is survey data indicate that concurrent use pyrethroids are esters. Etofenprox based on the following findings: of separate pesticide products that exposure does not result in the i. The toxicity database for etofenprox contain the same active ingredient to neurotoxic syndromes typical of is complete. treat the same or different pests does not pyrethroids and no available data ii. An acute neurotoxicity study in the typically occur. Combining conservative suggest the molecular target for adult rat revealed no treatment-related exposure estimates with a conservative etofenprox is the sodium channel. effects. The subchronic neurotoxicity point of departure for an event that is For the purposes of this tolerance study in the rat showed decreased body action, therefore, EPA has not assumed itself improbable (co-occurrence of use weight gains, increased liver weights in that etofenprox has a common of the same pesticide to control different all dose groups, and increased incidence mechanism of toxicity with other pests) would unrealistically overstate of rearing behavior and abnormal gait, pyrethroids. For information regarding exposure. all in the absence of histopathological EPA’s efforts to determine which Further information regarding EPA changes. The developmental chemicals have a common mechanism standard assumptions and generic neurotoxicity study in rats showed of toxicity and to evaluate the inputs for residential exposures may be increased rearing behavior in mothers. cumulative effects of such chemicals, found at http://www.epa.gov/pesticides/ In offspring, eye lesions (including see the policy statements released by trac/science/trac6a05.pdf. sclera and lens hemorrhage), which are EPA’s Office of Pesticide Programs 4. Cumulative effects from substances concerning common mechanism sometimes associated with aggressive with a common mechanism of toxicity. determinations and procedures for maternal behavior, were observed prior Section 408(b)(2)(D)(v) of FFDCA cumulating effects from substances to weaning at the highest dose tested. requires that, when considering whether found to have a common mechanism on Effects on motor/locomotor activity and to establish, modify, or revoke a EPA’s Web site at http://www.epa.gov/ auditory startle response were also tolerance, the Agency consider pesticides/cumulative/. observed in the high-dose treatment ‘‘available information’’ concerning the groups on PND 58. These latter isolated, cumulative effects of a particular D. Safety Factor for Infants and post-ontogenic effects of treatment are pesticide’s residues and ‘‘other Children not presumed to occur following a substances that have a common 1. In general. Section 408(b)(2)(C) of single dose. mechanism of toxicity.’’ FFDCA provides that EPA shall apply Evidence of neurotoxicity was also Unlike other pesticides for which EPA an additional tenfold (10X) margin of observed in other studies. In a has followed a cumulative risk approach safety for infants and children in the subchronic mouse study piloerection, based on a common mechanism of case of threshold effects to account for hunched posture, lethargy, body toxicity, EPA has not made a common prenatal and postnatal toxicity and the tremors, and an unsteady gait were mechanism of toxicity finding as to completeness of the database on toxicity noted in both sexes above the limit etofenprox. Although etofenprox shares and exposure unless EPA determines dose. The rat developmental study some structural characteristics with based on reliable data that a different showed increased salivation in all synthetic pyrethroids, it is not included margin of safety will be safe for infants treatment groups of the F0 generation in the pyrethroid cumulative and children. This additional margin of and decreased (non-statistically assessment. Naturally occurring safety is commonly referred to as the significant) mobility (both sexes) and pyrethrins and the synthetic pyrethroids FQPA Safety Factor (SF). In applying rearing behavior (males) in the F1 (collectively called ‘pyrethroids’) are this provision, EPA either retains the generation. In the 2-generation grouped for purposes of cumulative risk default value of 10X, or uses a different reproduction study F1 pups exhibited assessed based on the following shared additional safety factor when reliable clinical signs of body tremors, lethargy, characteristics: data available to EPA support the choice unsteady gait, and abnormal movements i. Common structure. Pyrethrins and of a different factor. during most of the lactation period at pyrethroids share a common structure; 2. Prenatal and postnatal sensitivity. the high dose. acid and alcohol moieties joined There is no indication of increased However, residual concern for through an ether linkage; quantitative or qualitative susceptibility neurotoxicity is low based on the ii. Sodium channel disruption. In of the developing offspring in toxicology following: vitro studies demonstrate the ability of database for etofenprox. Developmental a. Signs of neurotoxicity in the pyrethroids to modify mammalian effects were seen at doses that caused database occur only at the high dose sodium channel kinetics, leading to maternal toxicity. No developmental level in each study; alterations in membrane excitability and effects were seen in the rat 1-generation/ b. The studies show clear and well- firing potentials; developmental study. In the 2- defined NOAELs;

VerDate Mar<15>2010 16:16 Nov 26, 2013 Jkt 232001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\27NOR1.SGM 27NOR1 emcdonald on DSK67QTVN1PROD with RULES 70876 Federal Register / Vol. 78, No. 229 / Wednesday, November 27, 2013 / Rules and Regulations

c. The signs of neurotoxicity are well- residential exposure to the appropriate Using the exposure assumptions characterized in terms of their effects in PODs to ensure that an adequate MOE described in this unit for short-term offspring; and exists. exposures, EPA has concluded the d. The PODs used for risk assessment 1. Acute risk. An acute aggregate risk combined short-term food, water, and are protective of neurotoxicity seen in assessment takes into account acute residential exposures result in aggregate the database. exposure estimates from dietary MOEs of 420 for children 1- < 2 years No systemic toxicity was observed in consumption of food and drinking old, and 1,700 for adults. Because EPA’s the 28-day dermal study in rabbits up to water. No adverse effect resulting from level of concern for etofenprox is a MOE 1,000 mg/kg/day. In this study, clinical a single oral exposure was identified of 100 or below, these MOEs are not of signs were evaluated and signs such as and no acute dietary endpoint was concern. piloerection, hunched posture, lethargy, selected. Therefore, etofenprox is not 4. Aggregate cancer risk for U.S. body tremors, an unsteady gait and expected to pose an acute risk. population. Based on the data salivation, seen in the oral repeated 2. Chronic risk. Using the exposure summarized in Units III.A. and dose studies discussed in this unit, were assumptions described in this unit for III.C.1.iii., EPA has concluded that not observed. With neurotoxic signs chronic exposure, EPA has concluded etofenprox does not pose a cancer risk occurring only at high doses in the oral that chronic exposure to etofenprox to humans. studies and a dermal absorption factor from food and water will utilize 32% of 5. Determination of safety. Based on (DAF) of 7% for etofenprox, neurotoxic the cPAD for children 1–2 years old, the these risk assessments, EPA concludes manifestations via the dermal route are population group receiving the greatest that there is a reasonable certainty that not expected below the limit dose. exposure. no harm will result to the general Therefore, concern for neurotoxicity There is potential chronic/long-term population or to infants and children following dermal exposure is low. exposure to etofenprox via dietary from aggregate exposure to etofenprox iii. As discussed in this unit, there is (which is considered background residues. no indication of increased quantitative or qualitative susceptibility of the exposure) and residential (which is IV. Other Considerations considered primary) exposure pathways developing offspring in the toxicology A. Analytical Enforcement Methodology database for etofenprox. for children 1 to < 2 years old. Chronic/ iv. There are no residual uncertainties long-term exposure to etofenprox for For crop commodities, adequate identified in the exposure databases. adults is expected via the dietary enforcement methodology (liquid The chronic dietary exposure (background exposure) and residential chromatography/mass spectrometry/ assessment utilizes tolerance residue (primary) exposure pathways; however, mass spectrometry (LC/MS/MS)) is levels for all commodities based on there is no dermal hazard identified for available to enforce the tolerance conservative modeled estimates. The etofenprox, incidental oral exposure is expression. For livestock commodities, residue level of 5 ppm is considered an not expected for adults, and inhalation adequate enforcement methodology (gas upper bound estimate for both ground exposure is not expected for adults from chromatography/mass spectrometry and aerial applications that assume the treating pets; therefore, chronic/long- (GC/MS)) is available to enforce the conservative deposition onto term risk is best represented by the risk tolerance expression. surrounding crops following a ULV from dietary exposure described in this The methods may be requested from: mosquito adulticide application. The unit. Chief, Analytical Chemistry Branch, dietary assessment also assumes The aggregate long-term MOE for Environmental Science Center, 701 conservative, upper-bound PCT children 1 to < 2 years old, including Mapes Rd., Ft. Meade, MD 20755–5350; estimates for the proposed uses. By dietary exposure (food and water) and telephone number: (410) 305–2905; using these screening level assessments, incidental oral exposures from contact email address: residuemethods@ actual exposures/risks are not expected with treated pets is 180. Because EPA’s epa.gov. level of concern for etofenprox is a MOE to be underestimated. EPA made B. International Residue Limits conservative (protective) assumptions in of 100 or below, this MOE is not of the ground and surface water modeling concern. In making its tolerance decisions, EPA used to assess exposure to etofenprox in 3. Short- and intermediate-term risk. seeks to harmonize U.S. tolerances with drinking water. EPA used similarly Short- and intermediate-term aggregate international standards whenever conservative assumptions to assess post- exposure takes into account short- and possible, consistent with U.S. food application exposure of children as well intermediate-term residential exposure safety standards and agricultural as incidental oral exposure of toddlers. plus chronic exposure to food and water practices. EPA considers the These assessments will not (considered to be a background international maximum residue limits underestimate the exposure and risks exposure level). Etofenprox is currently (MRLs) established by the Codex posed by etofenprox. registered for uses that could result in Alimentarius Commission (Codex), as short- and intermediate-term residential required by FFDCA section 408(b)(4). E. Aggregate Risks and Determination of exposure, and the Agency has The Codex Alimentarius is a joint Safety determined that it is appropriate to United Nations Food and Agriculture EPA determines whether acute and aggregate chronic exposure through food Organization/World Health chronic dietary pesticide exposures are and water with short- and intermediate- Organization food standards program, safe by comparing aggregate exposure term residential exposures to and it is recognized as an international estimates to the acute PAD (aPAD) and etofenprox. food safety standards-setting chronic PAD (cPAD). For linear cancer As noted in Unit III.C.3., because the organization in trade agreements to risks, EPA calculates the lifetime short- and intermediate-term endpoints which the United States is a party. EPA probability of acquiring cancer given the and PODs for inhalation and oral routes may establish a tolerance that is estimated aggregate exposure. Short-, are the same, the short-term exposure different from a Codex MRL; however, intermediate-, and chronic-term risks and risk estimates are considered to be FFDCA section 408(b)(4) requires that are evaluated by comparing the protective of potential intermediate- EPA explain the reasons for departing estimated aggregate food, water, and term exposure and risk. from the Codex level.

VerDate Mar<15>2010 16:16 Nov 26, 2013 Jkt 232001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\27NOR1.SGM 27NOR1 emcdonald on DSK67QTVN1PROD with RULES Federal Register / Vol. 78, No. 229 / Wednesday, November 27, 2013 / Rules and Regulations 70877

Codex has established etofenprox Planning and Review’’ (58 FR 51735, VII. Congressional Review Act MRLs on several crop and livestock October 4, 1993). Because this final rule commodities at levels that range from has been exempted from review under Pursuant to the Congressional Review 0.01–8.0 ppm. These MRLs are different Executive Order 12866, this final rule is Act (5 U.S.C. 801 et seq.), EPA will than the tolerances established for not subject to Executive Order 13211, submit a report containing this rule and etofenprox in the United States. Codex entitled ‘‘Actions Concerning other required information to the U.S. and U.S. MRLs/tolerances could not be Regulations That Significantly Affect Senate, the U.S. House of harmonized due to differences in the Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller use pattern used to derive the FR 28355, May 22, 2001) or Executive General of the United States prior to tolerances. Codex MRLs were based on Order 13045, entitled ‘‘Protection of publication of the rule in the Federal field trial data from foliar and granular Children from Environmental Health Register. This action is not a ‘‘major use of etofenprox to kill crop pests in Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). agricultural fields whereas the U.S. April 23, 1997). This final rule does not List of Subjects in 40 CFR Part 180 tolerances were based on aerial contain any information collections application over crops to kill subject to OMB approval under the Environmental protection, mosquitoes. Different application Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, amounts, frequencies, and techniques U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides are used for these different use patterns any special considerations under and pests, Reporting and recordkeeping and thus harmonization with Codex Executive Order 12898, entitled requirements. cannot be achieved. ‘‘Federal Actions to Address Dated: November 13, 2013. Environmental Justice in Minority C. Revisions to Petitioned-For G. Jeffrey Herndon, Populations and Low-Income Tolerances Populations’’ (59 FR 7629, February 16, Acting Director, Registration Division, Office of Pesticide Programs. The proposed tolerance at 0.5 ppm 1994). was estimated using limited field trial Since tolerances and exemptions that Therefore, 40 CFR chapter I is data. These data were determined to be are established on the basis of a petition amended as follows: insufficient to support the proposed use under FFDCA section 408(d), such as pattern. Subsequently, the applicant the tolerance in this final rule, do not PART 180—[AMENDED] submitted modeling results using the require the issuance of a proposed rule, Terrestrial Residue Exposure Model the requirements of the Regulatory ■ 1. The authority citation for part 180 (TREX) which estimated residues Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows: following repeated ULV applications seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371. and concluded residues were likely to This final rule directly regulates ■ peak at 1.5 ppm following repeated growers, food processors, food handlers, 2. In § 180.620, revise the table in aerial applications to agricultural crops. and food retailers, not States or tribes, paragraph (a) to read as follows: EPA estimated an upper-bound crop nor does this action alter the § 180.620 Etofenprox; tolerances for residue estimate of 5.0 ppm following relationships or distribution of power residues. repeated ULV aerial and ground and responsibilities established by applications. In addition, based on the Congress in the preemption provisions (a) * * * Agency review, it was determined that of FFDCA section 408(n)(4). As such, Parts per tolerances were required on livestock the Agency has determined that this Commodity million commodities as well. action will not have a substantial direct effect on States or tribal governments, Cattle, fat ...... 10.0 V. Conclusion on the relationship between the national Cattle, meat ...... 0.40 Therefore, tolerances are established government and the States or tribal Cattle, meat byproducts ...... 10.0 for residues of etofenprox, [2-(4- governments, or on the distribution of Egg ...... 0 .40 ethoxyphenyl)-2-methylpropyl 3- power and responsibilities among the All food commodities (includ- phenoxybenzyl ether], in or on food various levels of government or between ing feed commodities) not commodities at 5.0 ppm; feed the Federal Government and Indian otherwise listed in this sub- section ...... 5 .0 commodities at 5.0 ppm; eggs at 0.40 tribes. Thus, the Agency has determined Goat, fat ...... 10 .0 ppm; hog fat at 4.0 ppm; hog meat at that Executive Order 13132, entitled Goat, meat ...... 0 .40 0.20 ppm; hog, meat byproducts at 4.0 ‘‘Federalism’’ (64 FR 43255, August 10, Goat, meat byproducts ...... 10 .0 ppm; fat of cattle, goat, horse, and sheep 1999) and Executive Order 13175, Hog, fat ...... 4 .0 at 10.0 ppm; meat of cattle, goat, horse, entitled ‘‘Consultation and Coordination Hog, meat ...... 0.20 and sheep at 0.40 ppm; meat byproducts with Indian Tribal Governments’’ (65 FR Hog, meat byproducts ...... 4 .0 of cattle, goat, horse, and sheep at 10.0 67249, November 9, 2000) do not apply Horse, fat ...... 10.0 ppm; milk at 0.60 ppm; poultry, fat at to this final rule. In addition, this final Horse, meat ...... 0.40 1.0 ppm; poultry, meat at 0.01 ppm; and rule does not impose any enforceable Horse, meat byproducts ...... 10.0 duty or contain any unfunded mandate Milk ...... 0 .60 poultry, meat byproducts at 1.0 ppm. Poultry, fat ...... 1.0 as described under Title II of the Poultry, meat ...... 0.01 VI. Statutory and Executive Order Unfunded Mandates Reform Act of 1995 Reviews Poultry, meat byproducts ...... 1.0 (UMRA) (2 U.S.C. 1501 et seq.). Rice, grain ...... 0 .01 This final rule establishes tolerances This action does not involve any Sheep, fat ...... 10 .0 under FFDCA section 408(d) in technical standards that would require Sheep, meat ...... 0.40 response to a petition submitted to the Agency consideration of voluntary Sheep, meat byproducts ...... 10 .0 Agency. The Office of Management and consensus standards pursuant to section Budget (OMB) has exempted these types 12(d) of the National Technology * * * * * of actions from review under Executive Transfer and Advancement Act of 1995 [FR Doc. 2013–28517 Filed 11–26–13; 8:45 am] Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note). BILLING CODE 6560–50–P

VerDate Mar<15>2010 16:16 Nov 26, 2013 Jkt 232001 PO 00000 Frm 00031 Fmt 4700 Sfmt 9990 E:\FR\FM\27NOR1.SGM 27NOR1 emcdonald on DSK67QTVN1PROD with RULES