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0.024 ppb is the annual average FIRST at 12.4% of chronic RfD for all infants pesticide manufacturer. Potentially concentration. To determine drinking (<1 year), and 21.2% of chronic RfD for affected entities may include, but are water exposure, drinking water levels of children 1 to 6 (most highly exposed). not limited to: comparison (DWLOCs) were calculated The calculated DWLOCs ranged from • Crop production (NAICS 111) and used as a point of comparison 213 to 892 ppb for all the population • Animal production (NAICS 112) against the model estimates of the • Food manufacturing (NAICS 311) subgroups. The surface water and • pesticide concentration in drinking ground water DWECs for acequinocyl Pesticide manufacturing (NAICS water. For acequinocyl, the acute and were estimated to be 0.024 ppb and 32532) chronic DWLOC values were greater 0.006 ppb, respectively. Since the This listing is not intended to be than the estimated concentration DWEC chronic DWECs are less than the exhaustive, but rather provides a guide in surface water and ground water for DWLOCs for all population subgroups for readers regarding entities likely to be each population group. Therefore, including infants, the chronic aggregate affected by this action. Other types of exposures to acequinocyl in drinking risk estimates are below the level of entities not listed in this unit could also water do not pose a significant human concern. be affected. The North American health risk. Industrial Classification System 2. Non-dietary exposure. There are no F. International Tolerances (NAICS) codes have been provided to residential uses for acequinocyl. To date, no Codex, Canadian or assist you and others in determining whether this action might apply to D. Cumulative Effects Mexican tolerances exists for acequinocyl. certain entities. If you have any There is no information available to [FR Doc. 04–3936 Filed 2–24–04; 8:45 am] questions regarding the applicability of indicate that toxic effects produced by this action to a particular entity, consult BILLING CODE 6560–50–S acequinocyl are cumulative with those the person listed under FOR FURTHER of any other compound. INFORMATION CONTACT. E. Safety Determination ENVIRONMENTAL PROTECTION B. How Can I Get Copies of this AGENCY 1. U.S. population. The acute dietary Document and Other Related food exposure to acequinocyl was [OPP–2004–0030; FRL–7344–6] Information? estimated at 2.21% of acute RfD for the 1. Docket. EPA has established an total U.S. population. The calculated Novaluron; Notice of Filing a Pesticide official public docket for this action DWLOCs ranged from 2,791 to 10,405 Petition to Establish a Tolerance for a under docket ID number OPP–2004– ppb for all the population subgroups. Certain Pesticide Chemical in or on 0030. The official public docket consists The surface water and ground water Food of the documents specifically referenced DWECs for acequinocyl were estimated AGENCY: Environmental Protection in this action, any public comments to be 1.561 ppb and 0.006 ppb, Agency (EPA). received, and other information related respectively. Since the acute DWECs are to this action. Although a part of the ACTION: less than the DWLOCs for all population Notice. official docket, the public docket does subgroups, the acute aggregate risk SUMMARY: This notice announces the not include Confidential Business estimates are below the level of concern. initial filing of a pesticide petition Information (CBI) or other information The chronic dietary food exposure to proposing the establishment of whose disclosure is restricted by statute. acequinocyl was estimated at 5.6% of regulations for residues of a certain The official public docket is the chronic RfD for total U.S. population. pesticide chemical in or on various food collection of materials that is available The calculated DWLOCs ranged from commodities. for public viewing at the Public 213 to 892 ppb for all the population Information and Records Integrity DATES: Comments, identified by docket subgroups. The surface water and Branch (PIRIB), Rm. 119, Crystal Mall identification (ID) number OPP–2004– ground water DWECs for acequinocyl #2, 1921 Jefferson Davis Hwy., 0030, must be received on or before were estimated to be 0.024 ppb and Arlington, VA. This docket facility is March 26, 2004. 0.006 ppb, respectively. Since the open from 8:30 a.m. to 4 p.m., Monday chronic DWECs are less than the ADDRESSES: Comments may be through Friday, excluding legal DWLOCs for all population subgroups, submitted electronically, by mail, or holidays. The docket telephone number the chronic aggregate risk estimates are through hand delivery/courier. Follow is (703) 305–5805. below the level of concern. the detailed instructions as provided in 2. Electronic access. You may access 2. Infants and children. The acute Unit I. of the SUPPLEMENTARY this Federal Register document dietary food exposure to acequinocyl INFORMATION. electronically through the EPA Internet was estimated at 4.81% of acute RfD for FOR FURTHER INFORMATION CONTACT: under the ‘‘Federal Register’’ listings at all infants (<1 year), 6.33% of acute RfD Daniel C. Kenny, Registration Division http://www.epa.gov/fedrgstr/. for children 1 to 6 and 8.18% of acute (7505C), Office of Pesticide Programs, An electronic version of the public RfD for children 1 to 2 (most highly Environmental Protection Agency, 1200 docket is available through EPA’s exposed). The calculated DWLOCs Pennsylvania Ave., NW., Washington, electronic public docket and comment ranged from 2,791 to 10,405 ppb for all DC 20460–0001; telephone number: system, EPA Dockets. You may use EPA the population subgroups. The surface (703) 305–7546; e-mail address: Dockets at http://www.epa.gov/edocket/ water and ground water DWECs for [email protected]. to submit or view public comments, acequinocyl were estimated to be 1.561 access the index listing of the contents ppb and 0.006 ppb, respectively. Since SUPPLEMENTARY INFORMATION: of the official public docket, and to the acute DWECs are less than the I. General Information access those documents in the public DWLOCs for all population subgroups docket that are available electronically. including infants, the acute aggregate A. Does this Action Apply to Me? Although not all docket materials may risk estimates are below the level of You may be potentially affected by be available electronically, you may still concern. The chronic dietary food this action if you are an agricultural access any of the publicly available exposure to acequinocyl was estimated producer, food manufacturer, or docket materials through the docket

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facility identified in Unit I.B.1. Once in delivery/courier. To ensure proper addresses that are automatically the system, select ‘‘search,’’ then key in receipt by EPA, identify the appropriate captured by EPA’s e-mail system are the appropriate docket ID number. docket ID number in the subject line on included as part of the comment that is Certain types of information will not the first page of your comment. Please placed in the official public docket, and be placed in EPA’s Dockets. Information ensure that your comments are made available in EPA’s electronic claimed as CBI and other information submitted within the specified comment public docket. whose disclosure is restricted by statute, period. Comments received after the iii. Disk or CD ROM. You may submit which is not included in the official close of the comment period will be comments on a disk or CD ROM that public docket, will not be available for marked ‘‘late.’’ EPA is not required to you mail to the mailing address public viewing in EPA’s electronic consider these late comments. If you identified in Unit I.C.2. These electronic public docket. EPA’s policy is that wish to submit CBI or information that submissions will be accepted in copyrighted material will not be placed is otherwise protected by statute, please WordPerfect or ASCII file format. Avoid in EPA’s electronic public docket but follow the instructions in Unit I.D. Do the use of special characters and any will be available only in printed, paper not use EPA Dockets or e-mail to submit form of encryption. form in the official public docket. To the CBI or information protected by statute. 2. By mail. Send your comments to: extent feasible, publicly available 1. Electronically. If you submit an Public Information and Records docket materials will be made available electronic comment as prescribed in this Integrity Branch (PIRIB) (7502C), Office in EPA’s electronic public docket. When unit, EPA recommends that you include of Pesticide Programs (OPP), a document is selected from the index your name, mailing address, and an e- Environmental Protection Agency, 1200 list in EPA Dockets, the system will mail address or other contact Pennsylvania Ave., NW., Washington, identify whether the document is information in the body of your DC 20460–0001, Attention: Docket ID available for viewing in EPA’s electronic comment. Also include this contact Number OPP–2004–0030. public docket. Although not all docket information on the outside of any disk 3. By hand delivery or courier. Deliver materials may be available or CD ROM you submit, and in any your comments to: Public Information electronically, you may still access any cover letter accompanying the disk or and Records Integrity Branch (PIRIB), of the publicly available docket CD ROM. This ensures that you can be Office of Pesticide Programs (OPP), materials through the docket facility identified as the submitter of the Environmental Protection Agency, Rm. identified in Unit I.B.1. EPA intends to comment and allows EPA to contact you 119, Crystal Mall #2, 1921 Jefferson work towards providing electronic in case EPA cannot read your comment Davis Hwy., Arlington, VA, Attention: access to all of the publicly available due to technical difficulties or needs Docket ID Number OPP–2004–0030. docket materials through EPA’s further information on the substance of electronic public docket. your comment. EPA’s policy is that EPA Such deliveries are only accepted For public commenters, it is will not edit your comment, and any during the docket’s normal hours of important to note that EPA’s policy is identifying or contact information operation as identified in Unit I.B.1. that public comments, whether provided in the body of a comment will D. How Should I Submit CBI to the submitted electronically or in paper, be included as part of the comment that Agency? will be made available for public is placed in the official public docket, viewing in EPA’s electronic public and made available in EPA’s electronic Do not submit information that you docket as EPA receives them and public docket. If EPA cannot read your consider to be CBI electronically without change, unless the comment comment due to technical difficulties through EPA’s electronic public docket contains copyrighted material, CBI, or and cannot contact you for clarification, or by e-mail. You may claim other information whose disclosure is EPA may not be able to consider your information that you submit to EPA as restricted by statute. When EPA comment. CBI by marking any part or all of that identifies a comment containing i. EPA Dockets. Your use of EPA’s information as CBI (if you submit CBI copyrighted material, EPA will provide electronic public docket to submit on disk or CD ROM, mark the outside a reference to that material in the comments to EPA electronically is of the disk or CD ROM as CBI and then version of the comment that is placed in EPA’s preferred method for receiving identify electronically within the disk or EPA’s electronic public docket. The comments. Go directly to EPA Dockets CD ROM the specific information that is entire printed comment, including the at http://www.epa.gov/edocket/, and CBI). Information so marked will not be copyrighted material, will be available follow the online instructions for disclosed except in accordance with in the public docket. submitting comments. Once in the procedures set forth in 40 CFR part 2. Public comments submitted on system, select ‘‘search,’’ and then key in In addition to one complete version of computer disks that are mailed or docket ID number OPP–2004–0030. The the comment that includes any delivered to the docket will be system is an ‘‘anonymous access’’ information claimed as CBI, a copy of transferred to EPA’s electronic public system, which means EPA will not the comment that does not contain the docket. Public comments that are know your identity, e-mail address, or information claimed as CBI must be mailed or delivered to the docket will be other contact information unless you submitted for inclusion in the public scanned and placed in EPA’s electronic provide it in the body of your comment. docket and EPA’s electronic public public docket. Where practical, physical ii. E-mail. Comments may be sent by docket. If you submit the copy that does objects will be photographed, and the e-mail to [email protected], not contain CBI on disk or CD ROM, photograph will be placed in EPA’s Attention: Docket ID Number OPP– mark the outside of the disk or CD ROM electronic public docket along with a 2004–0030. In contrast to EPA’s clearly that it does not contain CBI. brief description written by the docket electronic public docket, EPA’s e-mail Information not marked as CBI will be staff. system is not an ‘‘anonymous access’’ included in the public docket and EPA’s system. If you send an e-mail comment electronic public docket without prior C. How and to Whom Do I Submit directly to the docket without going notice. If you have any questions about Comments? through EPA’s electronic public docket, CBI or the procedures for claiming CBI, You may submit comments EPA’s e-mail system automatically please consult the person listed under electronically, by mail, or through hand captures your e-mail address. E-mail FOR FURTHER INFORMATION CONTACT.

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E. What Should I Consider as I Prepare pesticide chemical residues or an locations in the U.S. and Canada (2000– My Comments for EPA? explanation of why no such method is 2002). In view of the proposed use You may find the following needed. directions (maximum seasonal rate of 1 lb active ingredient per acre, up to 4 suggestions helpful for preparing your Makhteshim-Agan of North America, applications, pre-harvest-interval of 14 comments: Inc. 1. Explain your views as clearly as days), the maximum novaluron residue possible. PP 2F6430 found on apples was 0.876 ppm, which 2. Describe any assumptions that you EPA has received a pesticide petition is below the proposed tolerance of 1.0 ppm for pome fruit (excluding pears). used. (2F6430) from Makhteshim-Agan of The highest residues measured on pears 3. Provide copies of any technical North America, Inc. (MANA), 551 Fifth following 6 applications at a seasonal information and/or data you used that Avenue, Suite 1100, New York, NY rate of 2 lb active ingredient per acre support your views. 10176 proposing, pursuant to section were 1.9 ppm, which is below the 4. If you estimate potential burden or 408(d) of the FFDCA, 21 U.S.C. 346a(d), proposed tolerance of 2 ppm. Residues costs, explain how you arrived at the to amend 40 CFR part 180 by in juice from apple processing were estimate that you provide. establishing a tolerance for residues of below 0.05 ppm, demonstrating that 5. Provide specific examples to novaluron in or on the raw agricultural there was no concentration in juice and illustrate your concerns. commodity pome fruits (excluding therefore no need for proposing a 6. Make sure to submit your pears) at 1.0 parts per million (ppm), comments by the deadline in this tolerance. The proposed tolerance for apple pomace at 6.0 ppm, pears at 2 apple pomace of 6 ppm is supported by notice. ppm, cottonseed at 0.3 ppm, cotton gin 7. To ensure proper receipt by EPA, using the highest average residues by-products at 17 ppm, tuberous and measured in the field (0.774 ppm) be sure to identify the docket ID number corm vegetables (Crop Subgroup 1–C) at assigned to this action in the subject multiplied by the established 0.05 ppm, cattle meat at 0.3 ppm, cattle concentration factor of 7.2 from the line on the first page of your response. meat-by-products at 6.0 ppm, cattle fat You may also provide the name, date, available apple processing study. at 6.0 ppm, cattle liver at 0.4 ppm, cattle ii. Cotton. Seventeen residue trials and Federal Register citation. kidney at 0.4 ppm, and milk at 0.4 ppm. were conducted in the U.S. over a 2-year II. What Action is the Agency Taking? EPA has determined that the petition period (2000–2002). The novaluron contains data or information regarding residues in cottonseed ranged from less EPA has received a pesticide petition the elements set forth in section as follows proposing the establishment than 0.05 to 0.23 ppm, and in cotton gin 408(d)(2) of the FFDCA; however, EPA by-products the residues ranged from and/or amendment of regulations for has not fully evaluated the sufficiency residues of a certain pesticide chemical 3.5 ppm to 14.8 ppm, following the of the submitted data at this time or proposed use directions. Therefore, in or on various food commodities whether the data support granting of the under section 408 of the Federal Food, tolerances of 0.3 ppm for cottonseed and petition. Additional data may be needed 17 ppm for cotton gin by-products are Drug, and Cosmetic Act (FFDCA), 21 before EPA rules on the petition. being requested. U.S.C. 346a. EPA has determined that A. Residue Chemistry iii. Tuberous and corm vegetable this petition contains data or subgroup (Crop Subgroup 1–C). A series information regarding the elements set 1. Plant metabolism. The qualitative of potato residue trials in support of the forth in FFDCA section 408(d)(2); nature of the residue of novaluron in tuberous and corm vegetable subgroup however, EPA has not fully evaluated plants is adequately understood based was conducted over a 2-year period the sufficiency of the submitted data at on acceptable apple, cabbage, cotton, (1999–2000) in Europe (Germany, this time or whether the data support and potato metabolism studies. These France, Spain, and Italy). Treatments granting of the petition. Additional data plant metabolism studies have were made twice at 0.022 lb active may be needed before EPA rules on the demonstrated that novaluron does not ingredient per acre with the last petition. metabolize and is non-systemic (does application 21 days before harvest, in List of Subjects not translocate within the plant). The addition to residue decline studies with results observed in the plant and sampling dates of 0, 3, 7, 14, and 21 Environmental protection, livestock metabolism studies show days after the last application. No Agricultural commodities, Feed similar metabolic pathways. The residue residues were detected above 0.01 ppm additives, Food additives, Pesticides of concern, which should be regulated, limit of quantitation (LOQ), even at and pests, Reporting and recordkeeping is the parent compound, novaluron, sampling dates right after the last requirements. only. application. Data from field trials Dated: February 12, 2004. 2. Analytical method. An adequate conducted in Oregon and Pennsylvania Lois Rossi, analytical method, gas chromatography/ (2002), using an exaggerated rate of 0.25 Director, Registration Division, Office of electron capture detector (GC/ECD), is lb active ingredient per acre at 21 and Pesticide Programs. available for enforcing tolerances of 7 days before harvest, also indicate that novaluron residues in or on plant and Summary of Petition no measurable residues were detected animal commodities. The amount of (LOQ = 0.05 ppm). Therefore, the The petitioner’s summary of the novaluron in most crop matrices is generated data set is in full support of pesticide petition is printed below as determined using GC with ECD. GC is the proposed tolerance of 0.05 ppm. required by FFDCA section 408(d)(3). also used to determine residues of The summary of the petition was novaluron in milk, bovine fat, kidney, B. Toxicological Profile prepared by the petitioner and liver, and meat. 1. Acute toxicity. In an acute oral represents the view of the petitioner. 3. Magnitude of residues—i. Pome toxicity study in rats, novaluron had a The petition summary announces the fruits. Field residue trials were lethal dose (LD)50 >5,000 mg/kg. A availability of a description of the conducted on pome fruits (total of 23 dermal toxicity study in rats resulted in analytical methods available to EPA for trials on apples including a processing an LD50 greater than 2,000 mg/kg. The the detection and measurement of the study, and 10 trials on pears), in several lethal concentration (LC)50 for acute

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inhalation in rats was greater than 5.15 i. Two 13-week rat studies were ii. A reference dose (RfD) of 0.083 mg/ milligrams/Liter (mg/L). In rabbits, conducted. In one study, doses were kg/day has been established for novaluron is not a skin irritant but it is administered at 50, 100, 200, 400 ppm novaluron. The RfD is based on a a mild eye irritant. Novaluron is not a (3.52, 6.93, 13.83, 27.77 mg/kg/day and subchronic rat study with a NOAEL of sensitizer in guinea pigs. 4.38, 8.64, 17.54, and 34.39 mg/kg/day 8.3 mg/kg/day, based on 2. Genotoxcity. The mutagenic for males and females, respectively). histopathological parameters in the potential of novaluron was investigated The NOAEL was 400 ppm, the HDT spleen. An uncertainty factor (UF) of in several in vivo and in vitro studies. (27.77 and 34.39 mg/kg/day for males 100 is used. Results in two Ames assays, an in vivo and females, respectively). In the second iii. The proposed classification of mouse micronucleus assay, an in vitro 13-week rat study, doses were novaluron is Group E (not likely human unscheduled DNA synthesis (UDS) administered at 50, 100, 10,000, and carcinogen) due to results of assay, an in vitro cell mutation assay, 20,000 ppm (4.2, 8.3, 818.5, 1666.9 mg/ oncogenicity studies that show no and an in vitro human lymphocyte kg/day and 4.7, 8.9, 871, 1820.6 mg/kg/ evidence of carcinogenicity. clastogenicity test were negative. day for males and females, respectively). 6. Animal metabolism. Metabolism Novaluron is therefore considered to The NOAEL was determined to be 8.3 studies in rats and goats were conducted have no potential to induce mg/kg/day. The lowest observed adverse with the parent material labeled in both mutagenicity. effect level (LOAEL) of 818.5 mg/kg/ the difluorophenyl and chlorophenyl 3. Reproductive and developmental day, is based on histopathological moieties. toxicity—i. A 2-generation rat parameters in the spleen. Rats absorb little novaluron when it is administered orally. More than 90% of reproduction study was conducted with ii. A 13-week mouse study was the dietary administered chlorophenyl dose levels of 1,000, 4,000, and 12,000 conducted with dose levels of 30, 100, 14C(U) novaluron is recovered in the ppm (74.2, 297.5, 894.9 mg/kg/day, and 1,000, 10,000 ppm (4.2, 12.8, 135.9, feces. When the diflurophenyl ring of 84, 336.7, 1009.8 mg/kg/day for males 1391.9 mg/kg/day and 4.7, 15.2, 135.6, the molecule is labeled, the recovered and females, respectively). There were 1493.1 mg/kg/day, for males and 14C activity in the feces is lower but still no effects on fertility or pregnancy at females, respectively). The NOAEL was any dose. The no observed adverse above 75%. The difference is thought to determined to be 100 ppm (12.8 and effect level (NOAEL) was determined to reflect intestinal metabolism by 15.2 mg/kg/day, male and females, be 12,000 ppm (894.9 and 1009.8 mg/ microbial flora and the higher respectively). The LOAEL was 1,000 kg/day for males and females, absorption of the diflurophenyl ppm (135.9 and 135.6 mg/kg/day, males respectively). metabolites. and females, respectively) based on ii. Teratology studies were conducted The parent molecule as well as its increased body weight gain, low in the rat and rabbit. No treatment- degradates are absorbed from the erythrocyte counts, and secondary related mortalities were observed in gastrointestinal tract (GI). All parent splenic changes. There were no clinical either study. No effect on survival, material is metabolized either upon treatment-related signs noted. development or growth of fetuses was initial entry into the systemic noted in either species in either study. iii. Two 13-week dog studies were circulation or, if sequestered to the fat, The maternal and fetal NOAEL was conducted. One study resulted in an upon its depuration back to the systemic determined to be 1,000 mg/kg/day NOAEL of 100 mg/kg/day and a LOAEL circulation. There is no intact novaluron (highest dose tested (HDT)) in the rat of 300 mg/kg/day based on low found in the urine. Novaluron’s high study. In the rabbit study the maternal erythrocyte counts and secondary octanol-water partition coefficient is and fetal NOAEL was 1,000 mg/kg/day. splenic and liver changes. No clinical responsible for its preferential The fetal effect in the rabbit study was treatment-related signs were noted. movement to fat. The half-life in fat weight gain at 1,000 mg/kg/day. These Another study, was conducted using calculated from the rat metabolism two studies demonstrate that novaluron only one dose level of 10 mg/kg/day. study is approximately 55 hours. was not teratogenic in either rats or There were no clinical or Two groups of metabolites are formed rabbits based on the study results. histopathological treatment-related after oral administration of novaluron. 4. Subchronic toxicity. Rats, mice, and signs and the NOAEL was determined to One group is typified by the aniline dogs all show the same toxicologic be 10 mg/kg/day. metabolite 3-chloro-4-(1,1,2-trifluoro-2- response. Generally, novaluron induces 5. Chronic toxicity—i. Chronic trifluoromethoxyethoxy) aniline, small increases in methemoglobin; red toxicity and oncogenicity was evaluated referred to as 3–TFA. The other group cells are sequestered; and, in the rat, mouse and dog. The rat of metabolites is typified by 2,6- compensatory hematopoiesis occurs. chronic toxicity and oncogenicity was difluorobenzoic acid is from the The severity of these changes is well conducted with dose levels of 25, 700, diflurophenyl moiety of the molecule. within the physiological capacity of the 20,000 ppm (1.25, 35, 1,000 mg/kg/day). Nearly all the metabolites are formed at animals and is judged not adverse. The no observed effect level (NOEL) was a level of 1% or less of the applied dose. Rats treated topically with novaluron 25 ppm (1.25 mg/kg/day) based on They are rapidly excreted. in a 28-day study at 0, 75, 400, and methemoglobin. There was no evidence The metabolism in goats mimics that 1,000 mg/kg/day did not show signs of of carcinogenicity in this study. A seen in rats. systemic toxicity. Small treatment- mouse chronic toxicity study was 7. Metabolite toxicology. Makhteshim- related increases in methemoglobin conducted with dose levels of 30, 450, Agan of North America Inc., has were seen in both sexes at 1,000 mg/kg/ 7,000 ppm (4.5, 67.5, 1,050 mg/kg/day). determined that there are no metabolites day and in females at 400 mg/kg/day. The NOEL was 30 ppm (4.5 mg/kg/day) of toxicological concern and therefore, The highest methemoglobin value seen based on methemoglobin. There was no metabolites need to be included in in females was 1.28% compared with also no evidence of carcinogenicity in the tolerance expression and require 0.86% in controls. Organ weights, this study. Chronic toxicity was regulation. macroscopic and microscopic investigated in dogs using dose levels of 8. Endocrine disruption. No special examination of organs and tissues did 10, 100, 1,000 mg/kg/day. The NOEL of studies investigating potential not reveal any treatment-related 100 mg/kg/day was based on estrogenic or other endocrine effects of changes. methemoglobin. novaluron have been conducted.

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However, inspection of in-life data from is made. If the DWLOC exceeds the developmental toxicity studies are toxicology studies does not indicate that DWEC value then there is reasonable designed to evaluate adverse effects on novaluron is an endocrine disruptor. certainty that no harm will result from the developing organism resulting from Specifically, endocrine organ weights the short-term or the intermediate-term pesticide exposure during prenatal (e.g., thyroid, testes, ovaries, pituitary aggregate exposure. There are no development. Reproduction studies from the 2-generation study) were not monitoring data for novaluron, so the provide information relating to adversely affected by novaluron. Food Quality Protection Act (FQPA) reproductive and other effects on adults Milestones of sexual development were Index Reservoir Screening Tool (FIRST) and offspring from prenatal and not affected by novaluron; and, model was used to estimate a surface postnatal exposure to the pesticide. reproduction was not adversely affected. water residue. Estimated DWLOC values FFDCA section 408 provides that EPA Based on these observations, there is no are 767 parts per billion (ppb) for may apply an additional safety factor for evidence to suggest that novaluron has children (1 to 2 years old), 2,470 ppb for infants and children to account for an adverse effect on the endocrine adult females, and 2,861 ppb for the prenatal and postnatal toxicity and the system. U.S. population. Since the calculated completeness of the data base. DWLOC values for the U.S. population Makhteskim-Agan of North America C. Aggregate Exposure and all its subgroups considerably Inc., concludes that the toxicology data Dietary exposure. Tolerances are exceed the modeled DWEC of 0.14 ppb base for novaluron regarding potential proposed for residues of novaluron in or in surface water, Makhteskim-Agan of prenatal and postnatal effects in on pome fruit (excluding pears), apple North America Inc., concludes that children is complete according to pomace, pears, cottonseed, cotton gin there is reasonable certainty that no existing Agency data requirements and by-products, tuberous, and corm harm will result from aggregate (food does not indicate any developmental or vegetables, cattle meat, fat, liver, kidney, and water) exposure to novaluron reproductive concerns. meat by-products, and milk. For the residues. ii. Developmental toxicity studies. In purpose of assessing the potential the rat developmental study, the dietary exposure for these proposed D. Cumulative Effects maternal NOAEL was determined to be tolerances, an exposure assessment was To Makhteskim-Agan of North 1,000 mg/kg/day based on slight conducted using Exponent’s Dietary America’s Inc., knowledge, there are increase in body weight gain and food Exposure Evaluation Model (DEEM) currently no available data or other consumption and the fetal NOAEL was software, consumption data derived reliable information indicating that any determined to be 1,000 mg/kg/day, the from the 1994–1998 United States toxic effects produced by novaluron HDT. There was no effect on survival, Department of Agriculture (USDA) would be cumulative with those of other development or growth of the fetuses. Continuing Surveys of Food Intake by chemical compounds; thus only the There were no developmental effects Individuals (CSFII), residue levels at potential risks of novaluron have been noted in the rabbit study, even at the proposed tolerance levels, and projected considered in this assessment of its limit dose level (1,000 mg/kg/day), percent crop treated for cotton and aggregate exposure. however, slight maternal toxicity (body pome fruit at market maturity, and E. Safety Determination weight effects) was observed at the limit assuming 100% crop treated for dose level. potatoes. 1. U.S. population. No acute dietary iii. Reproductive toxicity studies. 1. Food—i. Acute dietary exposure. assessment was conducted because There was no evidence of adverse No acute dietary assessments were there is no toxicological endpoint effects on reproductive capability, conducted since no toxicological attributable to a single exposure. A fertility or pregnancy, observed at any endpoint attributable to a single conservative chronic exposure analysis dose level in the rat 2-generation exposure was identified in the available was conducted, using tolerance level reproductive study. However, there was toxicology studies, including the rat and residues, with adjustments for percent increased bodyweight and spleen rabbit developmental studies. crop treated at product maturity (cotton weight, and hemosiderosis of the spleen ii. Chronic dietary exposure. The and pome fruits), and no adjustment for at the high dose. The NOAEL was 894.9 appropriate RfD value for novaluron is potatoes (100% treated). The chronic in males and 1009.8 mg/kg/day in 0.083 mg/kg/day, based upon the novaluron exposure is low, accounting females, the HDT. NOAEL of 8.3 mg/kg/day from the 13- for 0.8% to 7.6% of the RfD, depending iv. Conclusion. Based on the absence week oral rat study and an UF of 100. on the population subgroup. The of fetal effects and pup toxicity in any The chronic dietary exposure estimate chronic exposure for the U.S. of the reference studies, Makhteskim- for the overall U.S. population is 1.5% population is 0.001243 mg/kg/day, Agan of North America Inc., concludes of the RfD of 0.083 mg/kg/day. Children which uses 1.5% of the RfD. The most that reliable data support the use of the 1 to 2 years old, the most exposed sensitive population subgroup, children standard 100-fold UF, and that an population subgroup, utilize 7.6% of the 1 to 2 years old, has a chronic exposure additional UF is not needed to protect RfD. The chronic exposure estimates for of 0.006339 mg/kg/day, which utilizes the safety of infants and children. In the overall U.S. population and 32 only 7.6% of the RfD. Based on the lack addition, the RfD is based on a NOAEL population subgroups, including infants of acute toxicity and the chronic of 8.3 mg/kg/day (from a 13-week rat and children, were less than 8% of the exposure analyses, Makhteskim-Agan of study), which is already more than 120- RfD. Based on these exposure estimates, North America Inc., concludes that fold lower than the NOAEL in the rabbit Makhteshim-Agan of North America, there is reasonable certainty that no developmental toxicity study. Thus, the Inc., concludes that there is reasonable harm will result from acute and chronic proposed RfD of 0.083 mg/kg/day is certainty of no harm for the use of exposure to novaluron. considered to be appropriate for novaluron on pome fruit, cotton, 2. Infants and children—i. General. assessing potential risks to infants and tuberous, and corm vegetables. Data from rat and rabbit developmental children and an additional FQPA safety 2. Drinking water. A comparison of toxicity studies and a 2-generation rat factor is not warranted. As noted the calculated drinking water level of reproduction study have been used to previously, the aggregate chronic concern (DWLOC) value to the drinking assess the potential for increased exposure assessment utilizes less than water estimated concentration (DWEC) sensitivity of infants and children. The 8% of the RfD for the entire U.S.

VerDate jul<14>2003 16:15 Feb 24, 2004 Jkt 203001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 8654 Federal Register / Vol. 69, No. 37 / Wednesday, February 25, 2004 / Notices

population and various population • Crop production (NAICS 111) Certain types of information will not subgroups, including the most sensitive • Animal production (NAICS 112) be placed in EPA’s Dockets. Information subgroup, children 1 to 2 years old. • Food manufacturing (NAICS 311) claimed as CBI and other information • Therefore, Makhteskim-Agan of North Pesticide manufacturing (NAICS whose disclosure is restricted by statute, America Inc., concludes that there is 32532) which is not included in the official reasonable certainty that no harm will This listing is not intended to be public docket, will not be available for result to infants and children from exhaustive, but rather provides a guide public viewing in EPA’s electronic aggregate exposure to novaluron for readers regarding entities likely to be public docket. EPA’s policy is that residues. affected by this action. Other types of copyrighted material will not be placed entities not listed in this unit could also in EPA’s electronic public docket but F. International Tolerances be affected. The North American will be available only in printed, paper There are no Canadian, Mexican, or Industrial Classification System form in the official public docket. To the Codex maximum residue limits (NAICS) codes have been provided to extent feasible, publicly available established for novaluron. Therefore, assist you and others in determining docket materials will be made available international harmonization is not an whether this action might apply to in EPA’s electronic public docket. When issue at this time. certain entities. If you have any a document is selected from the index questions regarding the applicability of [FR Doc. 04–3937 Filed 2–24–04; 8:45 am] list in EPA Dockets, the system will this action to a particular entity, consult BILLING CODE 6560–50–S identify whether the document is the person listed under FOR FURTHER available for viewing in EPA’s electronic INFORMATION CONTACT. public docket. Although not all docket ENVIRONMENTAL PROTECTION B. How Can I Get Copies of this materials may be available AGENCY Document and Other Related electronically, you may still access any Information? of the publicly available docket [OPP–2004–0025; FRL–7345–5] materials through the docket facility 1. Docket. EPA has established an identified in Unit I.B.1. EPA intends to Gamma-Cyhalothrin; Notice of Filing a official public docket for this action work towards providing electronic Pesticide Petition to Establish a under docket ID number OPP–2004– access to all of the publicly available Tolerance for a Certain Pesticide 0025. The official public docket consists docket materials through EPA’s Chemical in or on Food of the documents specifically referenced electronic public docket. in this action, any public comments AGENCY: Environmental Protection For public commenters, it is received, and other information related Agency (EPA). important to note that EPA’s policy is to this action. Although a part of the that public comments, whether ACTION: Notice. official docket, the public docket does submitted electronically or in paper, not include Confidential Business SUMMARY: This notice announces the will be made available for public initial filing of a pesticide petition Information (CBI) or other information viewing in EPA’s electronic public proposing the establishment of whose disclosure is restricted by statute. docket as EPA receives them and regulations for residues of a certain The official public docket is the without change, unless the comment pesticide chemical in or on various food collection of materials that is available contains copyrighted material, CBI, or commodities. for public viewing at the Public other information whose disclosure is Information and Records Integrity restricted by statute. When EPA DATES: Comments, identified by docket Branch (PIRIB), Rm. 119, Crystal Mall identifies a comment containing identification (ID) number OPP–2004– #2, 1921 Jefferson Davis Hwy., copyrighted material, EPA will provide 0025, must be received on or before Arlington, VA. This docket facility is a reference to that material in the March 26, 2004 open from 8:30 a.m. to 4 p.m., Monday version of the comment that is placed in ADDRESSES: Comments may be through Friday, excluding legal EPA’s electronic public docket. The submitted electronically, by mail, or holidays. The docket telephone number entire printed comment, including the through hand delivery/courier. Follow is (703) 305–5805. copyrighted material, will be available the detailed instructions as provided in 2. Electronic access. You may access in the public docket. Unit I. of the SUPPLEMENTARY this Federal Register document Public comments submitted on INFORMATION. electronically through the EPA Internet computer disks that are mailed or FOR FURTHER INFORMATION CONTACT: under the ‘‘Federal Register’’ listings at delivered to the docket will be William G. Sproat, Jr., Registration http://www.epa.gov/fedrgstr/. transferred to EPA’s electronic public Division (7505C), Office of Pesticide An electronic version of the public docket. Public comments that are Programs, Environmental Protection docket is available through EPA’s mailed or delivered to the docket will be Agency, 1200 Pennsylvania Ave., NW., electronic public docket and comment scanned and placed in EPA’s electronic Washington, DC 20460–0001; telephone system, EPA Dockets. You may use EPA public docket. Where practical, physical number: (703) 308–8587; e-mail address: Dockets at http://www.epa.gov/edocket/ objects will be photographed, and the [email protected]. to submit or view public comments, photograph will be placed in EPA’s access the index listing of the contents SUPPLEMENTARY INFORMATION: electronic public docket along with a of the official public docket, and to brief description written by the docket I. General Information access those documents in the public staff. docket that are available electronically. A. Does this Action Apply to Me? Although not all docket materials may C. How and to Whom Do I Submit You may be potentially affected by be available electronically, you may still Comments? this action if you are an agricultural access any of the publicly available You may submit comments producer, food manufacturer, or docket materials through the docket electronically, by mail, or through hand pesticide manufacturer. Potentially facility identified in Unit I.B.1. Once in delivery/courier. To ensure proper affected entities may include, but are the system, select ‘‘search,’’ then key in receipt by EPA, identify the appropriate not limited to: the appropriate docket ID number. docket ID number in the subject line on

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