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Pyridaben; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
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[Federal Register: July 3, 2003 (Volume 68, Number 128)] [Notices] [Page 39942-39947] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr03jy03-71] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-2003-0229; FRL-7315-4] Pyridaben; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP-2003-0229, must be received on or before August 4, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 308-3194; e-mail address: brothers.shaja@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: ? Crop production (NAICS 111) ? Animal production (NAICS 112) ? Food manufacturer (NAICS 311) ? Pesticide manufacturer (NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0229. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket [[Page 39943]] facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305- 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.regulations.gov/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select ``search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked ``late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select ``search,'' and then key in docket ID number OPP-2003-0229. The system is an ``anonymous access'' system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment. ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov, Attention: Docket ID Number OPP-2003-0229. In contrast to EPA's electronic public docket, EPA's e-mail system is not an ``anonymous access'' system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0229. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2003-0229. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or [[Page 39944]] CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding theelements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 26, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs. Summary of Petitions The petitioner summary of the pesticide petitions are printed below as required by FFDCA section 408(d)(3). The summary of the petitions were prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. Interregional Research Project Number 4 (IR-4) 0E6068, 1E6226, 1E6303, 2E6457, and 2E6460 EPA has received pesticide petitions (0E6068, 1E6226, 1E6303, 2E6457, and 2E6460) from IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.494 by establishing tolerances for combined residues of pyridaben, 2-tert-butyl-5-(4-tert-butylbenzylthio)-4- chloropyridazin-3(2H)-one in or on the following raw agricultural commodities: strawberry at 2.5 parts per million (ppm)(PP 0E6068); hop, dried cones at 10.0 ppm (PP 1E6226); tomato at 0.2 ppm (PP 1E6303); fruit, stone, group at 2.5 ppm (PP 2E6457), papaya, black sapote, canistel, mamey sapote, mango, sapodilla, and star apple at 0.1 ppm (PP 2E6460). Registration for tomato will be limited to greenhouse grown tomato based on the available residue data. The petitioner also proposes that established tolerances for nectarine, peach, plum, and prune at 2.5 ppm be deleted since they will be superceded by the tolerance for fruit, stone, group at 2.5 ppm. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on the petitions. This summary has been prepared by the BASF Corporation. A. Residue Chemistry 1. Plant metabolism. The nature of the residue in plants is adequately understood. The residue of concern is pyridaben per se as specified in 40 CFR 180.494. 2. Analytical method. The proposed analytical method involves extraction, partition, clean-up and detection of residues by gas chromatography/electron capture detector (gc/ecd). 3. Magnitude of residues. Field trials were carried out in order to determine the magnitude of the residue in the following crops: Strawberries, hops, cherries (to satisfy the requirements for a stone fruits group), and papaya. Two greenhouse tomato residue trials were conducted in Canada. Residue trials were carried out using the maximum label rate, the maximum number of applications, and the minimum pre- harvest interval for each crop or crop group. B. Toxicological Profile 1. Acute. In general, the acute toxicology studies conducted on technical grade pyridaben demonstrate that it has moderate to mild toxic effects. It was classified as Toxicity Category III based upon the acute oral lethal dose (LD)50 of 1,100 mg/kg in male rats and 570 mg/kg in female rats. The dermal LD50 in rabbits was greater than or equal to 2,000 mg/kg (Tox. Cat. III) and the inhalation lethal concentrations (LC)50 were 0.66 and 0.64 mg/kg in male and female rats, respectively (Tox Cat. III). The eye irritation study (rabbits) produced slight ocular irritation (Tox. Cat. III). Pyridaben was not a dermal irritant (Tox. Cat. IV) or sensitizer. 2. Genotoxicity. Genotoxicity studies including Ames testing, in vitro cytogenicity (chinese hamster lung cell), in vivo micronucleus assay (mouse) and DNA damage/repair (E. coli) showed no genotoxic activity associated with pyridaben. 3. Reproductive and developmental toxicity. In a developmental toxicity study, Sprague-Dawley rats (22/group) from Charles River, U.K., received Pyridaben (98.0% pure) via gavage at dose levels of 0, 2.5, 5.7, 13.0, or 30.0 milligram kilogram day (mg/kg/day) from gestation day 6 through 15, inclusive. Maternal toxicity, observed at 13.0 and 30.0 mg/kg/day, consisted of decreased body weight/weight gain and food consumption during the dosing period. Based on these effects, the maternal toxicity lowest observed adverse effect level (LOAEL) is 13.0 mg/ [[Page 39945]] kg/day and the maternal toxicity no observed adverse effect level (NOAEL) is 4.7 mg/kg/day (82% of 5.7 mg/kg/day based on concentration analysis). The developmental toxicity NOAEL is 13.0 mg/kg/day based on observed decreased fetal body weight and increased incomplete ossification in selected bones at 30.0 mg/kg/day LOAEL. New Zealand white rabbits (19 or 20/group) were orally dosed with 0, 1.5, 5, or 15 mg/kg/day pyridaben from day 6 through 19 of gestation. Maternal toxicity was evidenced by a dose-dependent decrease in body weight gain and food consumption at all dose levels. There was also increased incidences of abortions and clinical signs (few feces) in the 15 mg/kg/day group. There was no evidence that the chemical had a developmental effect at any of the tested levels. The maternal NOAEL was <1.5 mg/kg/day and the Maternal LOAEL was 1.5 mg/kg/day based on decreases in body weight gain and food consumption at all dose levels. No developmental toxicity was observed at any dose level. Therefore, the NOAEL for developmental toxicity is greater than or equal to 15 mg/ kg/day. In a standard two-generation reproduction study, CD rats were administered pyridaben in the diet at doses of 0, 10, 28 or 80 ppm. The Parental/Systemic NOAEL is 28 ppm (2.20 and 2.41 mg/kg/day for males and females, respectively). The parental/systemic LOAEL is 80 ppm (6.31 and 7.82 mg/kg/day for males and females, respectively) based on decreased body weights, body weight gains and food efficiency. There was no effect on reproductive parameters on the dose levels tested. The reproductive NOAEL is >=80 ppm in males and females. The reproductive LOAEL is >80 ppm in males and females. 4. Subchronic toxicity. In a 21-day dermal study, rats received repeated topical applications of pyridaben (98% pure) to about 10% of the body surface area at dosages of 30, 100, 300 and 1,000 mg/kg for 21 days. The treatment produced body weight decreases in the 300 mg/kg/day females and in the 1,000 mg/kg/day males and females. The NOAEL was 100 mg/kg/day and the LOAEL was 300 mg/kg/day based on decreased body weight gain in females. The toxicology endpoints from this study were selected by the Agency for short- and intermediate-term dermal risk assessments. 5. Chronic toxicity. In a 12-month chronic feeding study in dogs pyridaben was administered in capsules at dosages of 0, 1.0, 4.0, 16.0 or 32.0 mg/kg/day. All animals survived until the end of the study and there were no treatment-related changes in hematology, clinical chemistry, or urinalysis parameters. The NOAEL was determined to be <1.0 mg/kg/day and the LOAEL was <=1.0 mg/kg/day based on increased incidences of clinical signs (thinness, dehydration, diarrhea, emesis, soft stool, ptyalism, and relaxed nictitans) in treatment groups of both sexes and decreased body weight gain in females at 1.0 mg/kg/day. In a follow-up study, Pyridaben was administered in capsules to beagle dogs at dosages of 0 and 0.5 mg/kg/day for 1 year. The NOAEL was determined to be <0.5 mg/kg/day for males and females and the LOAEL was <=0.5 mg/kg/day for males and females based on an increased incidence of clinical signs in both treated sexes and decreased weight gain in the treated females. Pyridaben was administered in the diet to CD-1 mice at dosages of 0, 2.5, 8.0, 25 or 80 ppm for 78 weeks. There was no evidence of a carcinogenic effect of the chemical. The NOAEL was determined to be 25 ppm (2.78 mg/kg/day) for males and females and a LOAEL of 80 ppm (8.88 and 9.74 mg/kg/day for males and females, respectively). The LOAEL was determined to be 80 ppm for males and females based on decreased body weight gain, decreased food efficiency and changes in organ weights and histopathology (males). Pyridaben was administered in the diet to groups of Wistar rats for 104 weeks at doses of 0, 4, 10, 28 or 80 ppm to assess carcinogenicity. Additional groups (35 animals/sex/dose) received doses of 0, 4, 10, 28 or 120 ppm for 104 weeks (with an interim sacrifice at 53 weeks) to assess chronic toxicity. There was no treatment-related neoplastic or non-neoplastic pathology in either phase of the study. The NOAEL was determined to be 28 ppm in males (1.13 mg/kg/day) and 28 ppm (1.46 mg/ kg/day) in females. The LOAEL was determined to be 120 ppm (5.00 mg/kg/ day) in males and 120 ppm (6.52 mg/kg/day) in females based on decreased body weight gain in males and females and decreased ALT levels in males in the chronic toxicity phase. There was no evidence of a carcinogenic effect of this chemical. 6. Animal metabolism. In an acceptable rat metabolism study by the oral route, pyridaben was mainly eliminated in the feces where 80-97% of the administered dose was excreted regardless of the dose or site of label (pyridazinone or benzyl ring). Nearly 20% of the excreted residue in the feces was unmetabolized parent compound and there was some evidence of glucoronide conjugate(s) in the bile. The plasma levels following a single low oral dose (3 mg/kg) peaked at 23 hours while peak levels at the high dose (30 mg/kg) were at approximately 24 hours post-dose due, at least in part, to enterhepatic circulation (nearly 22-30% of an administered radioactive dose is excreted in bile within a period of 24 hours). Residual radioactivity was at or near background levels for most tissues by 72 to 168 hours. Generally, there seemed to be increased distribution to fat over time and, compared to other tissues, fat seemed to have relatively more residual radioactivity. Several metabolites, totaling up to 20-30, were resolved in urine and feces and some were structurally identified. 7. Metabolite toxicology. The nature of the residue in animals is adequately understood. The residue of concern is pyridaben and its metabolites PB-7, 2-tert-butyl-5-[4-(1-carboxy-1- methylethyl)benzylthio]-4-chloropyridazin-3(2H)-one and PB-9, 2-tert- butyl-4-chloro-5-[4-(1,1-dimethyl-2-hydroxyethyl) benzylthio]- chloropyridazin-3(2H)-one as specified in 40 CFR 180.494. 8. Endocrine disruption. The most common toxicity endpoint across the various studies and test species was decreased body weight/ decreased body weight gain followed by decreased feed consumption and/ or feed efficiency. These effects were observed in the 13-week feeding study in mice, in a 13-week rat study, in two 13-week dog studies, in a 21-day rat dermal study, in a 28-day inhalation toxicity study in rats, in two 1-year feeding studies in dogs, in a 78-week feeding/ carcinogenicity study in mice, in a developmental toxicity study in rats, in two developmental studies in rabbits, and in a 2-year feeding carcinogenicity study in rats. The LOAELs were always based on decreases in body weight gain/body weight decreases or decreases in food consumption. Other effects were sporadic and involved changes in certain clinical chemistry values or increases or decreases in organ weights. Thus, there is no indication that effects on the endocrine system were responsible for any of the observed effects. C. Aggregate Exposure 1. Dietary exposure. Assessments were conducted to evaluate the potential risk due to chronic and acute dietary exposure of the U.S. population to residues of pyridaben (BAS 300 I). Commodities (crops and animal products) specified in 40 CFR 180.494 and all new/updated crop tolerances were included in the dietary assessment (citrus, pome fruit, stone fruit, grapes, [[Page 39946]] cranberries, tree nuts, pistachio, papaya and similar fruit, strawberries, hops, green house tomatoes, and secondary residues in animal products meat, meat byproducts, fat - from cattle, goat, hog, horse, sheep). i. Food. Specific inputs and default values were considered in the pyridaben dietary assessment. Anticipated residue values from the raw agricultural commodities and the residue tolerances utilized in the assessment were multiplied by a factor of 2.3 to include all organosoluble residues of pyridaben. Tolerance values were assumed for pistachios, tree nuts, and secondary residues in meat, meat byproducts, fat, and milk. The 2.3 multiplication factor was not used for these animal commodities since the residues of concern (pyridaben and its metabolites), as specified in 40 CFR 180.494 are well understood in animals. Default processing factors were used for all commodities except for those specified in Table 1 below. In addition, percent crop treated (% CT) values of 23, 5.8, and 11.4% were utilized for pome fruit, grapes, and citrus, respectively. These percent crop treated values were based on the 2000 to 2002 pyridaben peak sales year and peak acreage year. All other crops were considered to have 100% crop treated. Table 1.--Process Factors Used in the Pyridaben Dietary Assessment ------------------------------------------------------------------------ Process Commodity Process Factor ------------------------------------------------------------------------ Citrus washed 0.48 juice................. 0.096 ------------------------------------------------------------------------ Apples/Pears washed 0.68 juice................. 0.09 ------------------------------------------------------------------------ Grapes juice 0.04 dried................. 0.94 ------------------------------------------------------------------------ * Default processing factors were used for all other commodities. ii. Drinking water. There are no established maximum contaminant levels or health advisory levels for residues of pyridaben (BAS 300 I) or its metabolites in drinking water. The PRZM/EXAMS and SciGrow models were used to estimate the maximum concentrations in surface and ground water, respectively. Pyridaben is immobile and thus unlikely to leach to groundwater. Results of environmental modeling indicate an estimated 0.215 ppm (acute) and 0.020 ppm (chronic) of pyridaben in surface water. 2. Non-dietary exposure. Pyridaben (BAS 300 I) is a plant protection product used to control insects. This product is not considered for residential use and therefore the aggregate exposure is a result of pyridaben residues in food and water. D. Cumulative Effects The cumulative exposure to substances with common mechanism of toxicity must be considered. Currently at this time there is not available data to determine whether pyridaben has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, pyridaben does not appear to form a toxic metabolite produced by other substances. As a result, for the purposes of this tolerance action, it is assumed that pyridaben does not have a common mechanism of toxicity with other substances. E. Safety Determination 1. Acute. Exposure estimates for the pyridaben acute dietary assessment were well under 100% of the aPAD at the 99.9th percentile. The overall general population and the most sensitive subpopulation (females 13-49 years) utilized <11% and 14.5% of the acute population adjusted dose (aPAD), respectively. Results from a Tier I dietary assessment of pyridaben residues in cranberries indicates the percent aPAD for children 1-6 years old and females 13-49 years old were <3%. Therefore considering all current and pending commodities, including cranberries, the percent chronic reference dose (%cRfD) and percent chronic population dose (%cPAD) will be below 20% for all population subgroups. Further refinements including additional percent crop treated, processing factors, cooking factors, actual residue values for the remaining commodities (where default values and tolerance levels were used for this assessment) would further reduce the exposure estimates. Table 2. Acute Dietary Exposure Assessment for for Pyridaben (BAS 300 I) ------------------------------------------------------------------------ Exposure Estimate Population Subgroups (mg/kg b. w. / %aRfD %aPAD day) ------------------------------------------------------------------------ Birth to 1 year 0.04488 8.98 8.98 ------------------------------------------------------------------------ 1-2 years 0.0509 10.18 10.18 ------------------------------------------------------------------------ 3-5 years 0.04339 8.68 8.68 ------------------------------------------------------------------------ 1-6 years 0.03382 6.76 6.76 ------------------------------------------------------------------------ 6-12 years 0.0300 6.00 6.00 ------------------------------------------------------------------------ 13-19 years 0.01327 2.65 2.65 ------------------------------------------------------------------------ Females 13-49 years 0.01885 14.50 14.50 ------------------------------------------------------------------------ Males 20-49 years 0.01101 2.20 2.20 ------------------------------------------------------------------------ Adults 50+ years 0.01591 3.18 3.18 ------------------------------------------------------------------------ [[Page 39947]] 2. Chronic. The estimated chronic dietary exposure for all current and pending commodities (except cranberries) ranged from 15.6 to 77.3% for the cRfD and cPAD for all subpopulations. Results from a Tier I dietary assessment of pyridaben residues in cranberries indicates the percent cPAD for children 1-6 years old and females of childbearing years (13-49 years old) were 7.1% and 12.9%, respectively. Therefore considering all current and pending commodities, including cranberries, the %cRfD and %cPAD will be below 100% for all population subgroups. Further refinements including additional percent crop treated, processing factors, cooking factors, actual residue values for the remaining commodities (that used default values and tolerance levels) would further reduce the exposure estimates. Table 3.--Chronic Dietary Exposure Assessment for pyridaben (BAS 300 I) ----------------------------------------------------------------------- Exposure Population Subgroups Estimate(mg/kg %cRfD %Cpad b.w./day) ----------------------------------------------------------------------- Birth to 1 year 0.00371 74.2 74.2 ----------------------------------------------------------------------- 12 years 0.003867 77.34 77.34 ----------------------------------------------------------------------- 35 years 0.002752 55.04 55.04 ----------------------------------------------------------------------- 16 years 0.0031 62 62 ----------------------------------------------------------------------- 6-12 years 0.002541 50.82 50.82 ----------------------------------------------------------------------- 13-19 years 0.0009618 19.236 19.236 ----------------------------------------------------------------------- The aggregate exposure (food and drinking water) of pyridaben will not exceed the U.S. EPA's level of concern (100% of RfD). Overall, we can conclude with reasonable certainty that no harm will occur from either acute or chronic aggregate exposure of pyridaben residues as a result of use on citrus, pome fruit, stone fruit, grapes, cranberries, tree nuts, pistachio, papaya (and similar fruit), strawberries, hops, and green house tomatoes. F. International Tolerances Maximum residue levels (MRLs) have been established for pyridaben in Canada. No MRLs have been established by the Codex Alimentarius Commission. [FR Doc. 03-16930 Filed 7-2-03; 8:45 am] BILLING CODE 6560-50-S