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Fenpyroximate; 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 11, 2003 (Volume 68, Number 133)] [Notices] [Page 41345-41349] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr11jy03-55] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-2003-0145; FRL-7314-8] Fenpyroximate; 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-2003-0145, must be received on or before August 11, 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 manufacturing (NAICS 311) ? Pesticide manufacturing (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-2003-0145. 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 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 [[Page 41346]] 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-2003-0145. 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-2003-0145. 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-2003-0145. 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-2003-0145. 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 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 pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities [[Page 41347]] 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 the elements 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 30, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs. Summaries of Petitions The petitioner summaries of the pesticide petitions are printed below as required by FFDCA section 408(d)(3). The summaries of the petitions were prepared by the petitioner and represent the views 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) PP 3E6519 EPA has received a pesticide petition (3E6519) 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 by establishing a tolerance for residues of combined residues of fenpyroximate benzoic acid, 4-[[[(E)-(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]amino] oxy]methyl]-, 1,1-dimethylethyl ester] and its z- isomer benzoic acid, 4-[[[[(Z)-(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]amino]oxy]methyl]-,1,1-dimethylethyl ester)]] in or on the raw agricultural commodity fruit, pome, group 11 at 0.3 parts per million (ppm). Nichino America, Incorporated. PP 2F6437 EPA has also received a pesticide petition (2F6437) from Nichino America, Inc., 4550 New Linden Hill Road, Wilmington, DE 19808 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances for residues of combined residues of fenpyroximate benzoic acid, 4-[[[(E)-(1,3- dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]amino] oxy]methyl]-, 1,1- dimethylethyl ester] and its z-isomer benzoic acid, 4-[[[[(Z)-(1,3- dimethyl- 5-phenoxy-1H-pyrazol-4-yl) methylene]amino]oxy]methyl]-,1,1- dimethylethyl ester)]] in or on the following raw agricultural commodities: Cotton, undelinted seed at 0.1 ppm, cotton, gin byproducts at 9.0 ppm, apple, fruit at 0.08 ppm, and grape at 0.3 ppm. Additionally, EPA has received request for tolerances for the combined residues of fenpyroximate benzoic acid, 4-[[[(E)-(1,3-dimethyl-5- phenoxy-1H-pyrazol-4-yl) methylene]amino] oxy]methyl]-, 1,1- dimethylethyl ester] and its z-isomer benzoic acid, 4-[[[[(Z)-(1,3- dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]amino]oxy]methyl]-,1,1- dimethylethyl ester)] and the acid metabolite ((E)-4-[(1,3-dimethyl-5- phenoxypyrazol-4-yl)-methyleneamino oxymethyl benzoic acid (M-3)], all expressed as fenpyroximate in or on milk at 0.01 ppm; meat at 0.02 ppm; fat at 0.8 ppm; kidney at 0.5 ppm; liver at 0.5 ppm; and meat byproducts at 0.01 ppm of cattle, goats, hogs, horses and sheep. 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 Nichino American, Inc., Wilmington, DE 19808, the registrant. A. Residue Chemistry 1. Plant metabolism. The metabolism of fenpyroximate and z- isomer has been studied in cotton, apples, grapes, and citrus and is adequately understood. 2. Analytical method. As a result an enforcement method has been developed which involves extraction of fenpyroximate from crops with acetone, filtration, partitioning and cleanup, and analysis by gas chromatography using a nitrogen/phosphorous detector. This method allows detection of residues at or above the proposed tolerances. The method has undergone independent laboratory validation as required by PR Notices 88-5 and 96-1. 3. Magnitude of residues--i. Magnitude of residues in crops field residue trials meeting. EPA study requirements have been conducted at the maximum label rate for cotton, grapes, and pome fruit. Results from these trials demonstrate that the highest fenpyroximate and z-isomer residues found will not exceed the proposed tolerances when the product is applied following the proposed use directions. ii. Magnitude of the residue in animals--a. Ruminants. Maximum residues of fenpyroximate, z-isomer, and acid metabolite in a cattle feeding study demonstrate that the highest fenpyroximate, z-isomer, and acid metabolite, combined as fenpyroximate, will not exceed the proposed tolerances in or on milk (0.01 ppm); meat (0.02 ppm), fat (0.8) ppm, kidneys and liver (0.5) ppm, and meat byproducts (0.01) ppm in cattle, goats, hogs, horses, sheep. b. Poultry. The maximum poultry dietary burden results from a diet composed of cotton meal for a total dietary burden that is significantly lower than the levels that would require the proposal of tolerances in poultry. This conclusion is based on the exaggerated rate field crop studies carried out on fenpyroximate and the z-isomer. Therefore, an exemption from tolerances in poultry meat, poultry meat by-products, fat and eggs under 40 CFR 180.6(a)(3) and (b) is proposed as it is not possible to establish with certainty whether finite residues will be incurred, but there is no reasonable expectation of finite residues. B. Toxicological Profile A full description of the studies describing the toxicity of fenpyroximate can be found in the posting for the import tolerances on hops and wine grapes in the Federal Register of April 10, 2001 (66 FR 18561) (FRL-6773-2). 1. Animal metabolism. The qualitative nature of the residues of fenpyroximate and z-isomer and acid metabolite, in animals is adequately understood. Fenpyroximate was not metabolized to volatiles to any significant degree. The majority of either benzyl or pyrazole labels (approximately 70% to 92%) is excreted in the feces. Urinary excretion accounts for less (approximately 9% to 18%) of the label. Thus, feces and urine are the major routes of excretion for fenpyroximate. Tissue did not accumulate fenpyroximate or its metabolites to any great extent. The greatest levels of label were in liver, kidneys, adrenals, and fat (to a lesser degree). In blood, nearly all the label is in the plasma. 2. Endocrine disruption. Chronic, lifespan, and multigenerational bioassays in mammals and acute and subchronic studies on aquatic organisms and wildlife did not reveal any endocrine effects for fenpyroximate. Any endocrine-related effects would have been detected in this [[Page 41348]] comprehensive series of required tests. The probability of any such effect due to agricultural uses of fenpyroximate is negligible. C. Aggregate Exposure 1. Dietary exposure. The potential dietary exposure to fenpyroximate has been calculated from the proposed tolerances for use on cotton, grapes, and pome fruit. These very conservative chronic dietary exposure estimates used the tolerance value for all the raw agricultural commodities. In addition, these estimates assume that 100% of the crops contain fenpyroximate residues. i. Food. Chronic dietary exposure to fenpyroximate was estimated on the basis of 100% crop treatment for cotton, grapes, and pome fruit and assuming tolerance level residues on these crops. These estimated exposures were compared to the chronic dietary RfD for fenpyroximate, which has already been established by EPA at 0.010 milligrams/kilogram/ day (mg/kg/day), in connection with the import tolerance on wine grapes and hops. ii. Drinking water. Laboratory and field data have demonstrated that fenpyroximate is immobile in soil and will not leach into ground water. Other data show that fenpyroximate is virtually insoluble in water. As a result, NAI concludes that residues reaching surface waters from field runoff will quickly adsorb to sediment particles and be partitioned from the water column. Further, a screening evaluation of leaching potential for other miticides was conducted using EPA's Pesticide Root Zone Model (PRZM) and Screening Concentration in Ground Water (SCI-GROW). Based on this screening assessment, the potential concentrations of fenpyroximate and z-isomer in water at depths of 1 and 2 meters are essentially zero (<1 part per trillion (ppt)). Surface water concentrations using PRZM and EXAMS were predicted in the simulated pond of 0.0242 part per billion (ppb). 2. Non-dietary exposure. There are no registered or proposed residential uses of fenpyroximate. Thus, a residential exposure assessment is not required. Exposure to fenpyroximate for the mixer/ loader/ground boom applicator was calculated using the Pesticides Handlers Exposure Data base (PHED). These PHED assessments were based on a 70 kg operator treating <50 acres per day using ground boom equipment on both apples and grapes and 80 acres per day on cotton by ground application with an operator treating at a maximum use rate of 0.1 lb active ingredient per acre. All mixer/loaders and workers/ operators were assumed to be wearing gloves, long pants and long- sleeved shirts. D. Cumulative Effects In consideration of potential cumulative effects of fenpyroximate and other substances that may have a common mechanism of toxicity, to our knowledge there are no currently available data or other reliable information indicating that any toxic effects produced by fenpyroximate would be cumulative with those of other chemical compounds; thus only the potential risks of fenpyroximate have been considered in this assessment of its aggregate exposure. E. Safety Determination 1. U.S. population--i. Acute. Using the 100% crop treatment scenario the acute population adjusted dose (aPAD) for the general population is 0.002309 mg/kg/day. Of the standard subgroups which are analyzed by the Dietary Exposure Evaluation Model (DEEM), the subgroup with the highest exposures is infants (<1 year) with an acute dietary exposure estimated at 0.006368 mg/kg/day (12.74% of the acute reference aRfD). For children in the age brackets 1-6 years and 7-12 years, the dietary exposures are approximately 0.004716 mg/kg/day (9.43% of the aRfD) and 0.002581 mg/kg/day (5.16% of the aRfD), respectively. Males and females aged 13 and older have an estimated acute dietary exposure of 0.001054 and 0.000911 mg/kg/day, respectively (2.11% and 1.82% of the aRfD, respectively). Even applying the Food Quality Protection Act (FQPA) factor of 10X to females aged 13 and older the percent aRfD utilization is only a modest 11.82%. All values for percentage utilization of the aRfD are well below 100% and no value exceeds 12.74%. ii. Chronic. Of the standard subgroups which are analyzed by the DEEM, and using the conservative estimates, of 100% crop treatment scenario, the chronic population adjusted dose (cPAD) for the general population, is approximately 0.0002579 mg/kg/day (which is 2.58% of the RfD). This value is based on the no observed adverse effect level (NOAEL) of 0.97 mg/kg/day observed in the chronic rat feeding study, the worse case estimate of chronic dietary exposure of fenpyroximate from cotton, grape, and pome fruit and a safety (uncertainty) factor of 100. 2. Non-dietary exposure--i. Acute. The margins of exposure relative to the acute dietary endpoint (5 mg/kg/day) are all in excess of 1,000. Therefore, there is a reasonable certainty that no harm will occur from acute exposure to crops treated at the maximum labeled use rates and minimum preharvest intervals for fenpyroximate. Worker exposure (mixer/ loader and applicator) estimates provide for margins of safety of >100 in all scenarios. Worker exposure is therefore expected, to a reasonable degree of scientific certainty, to be without harm. Based on the above, exposures of the U.S. population to fenpyroximate associated with the uses addressed in this reduced risk submission are expected, to a reasonable degree of scientific certainty, to be without harm. ii. Chronic. The margins of exposure relative to the chronic dietary endpoint are all in excess of 1,700. Therefore, there is a reasonable certainty that no harm will occur from chronic exposure to crops treated at the maximum labeled use rates and minimum preharvest intervals for fenpyroximate. 3. Infants and children--i. Acute. Using the 100% crop treatment scenario, the subgroup with the highest exposures is infants (<1 year) with an acute dietary exposure estimated at 0.006368 mg/kg/day (12.74% of the aRfD). For children in the age brackets 1-6 years and 7-12 years, the acute dietary exposures are approximately 0.004716 mg/kg/day (9.43% of the aRfD) and 0.002581 mg/kg/day (5.16% of the aRfD), respectively. Acute dietary exposure of infants and children is therefore expected, to a reasonable degree of scientific certainty, to be without harm. Based on the above, exposures of infants and children to fenpyroximate associated with the uses addressed in this reduced risk submission are expected, to a reasonable degree of scientific certainty, to be without harm. ii. Chronic. Using the 100% crop treatment scenario, infants (less than 1 year) have the highest chronic exposure (0.0009228 mg/kg/day, which is 9.23 % of the RfD). For children in the age brackets 1-6 years and 7-12 years, the dietary exposures are approximately 0.0005244 mg/ kg/day (5.24% of the RfD) and 0.0002733 mg/kg/day (2.73% of the RfD), respectively. Chronic dietary exposure of the infants and children is therefore expected, to a reasonable degree of scientific certainty, to be without harm. iii. Conclusion. There is a complete toxicity data base for fenpyroximate and exposure data are conservatively estimated based on data that reasonably account for potential exposures. Based on these risk assessments, Nichino America, Inc. concludes that, there is a reasonable certainty that no harm will result to infants and children from [[Page 41349]] aggregate exposure to combined residues of fenpyroximate. F. International Tolerances Codex Maximum Residue Levels (MRLs) have been established for residues of fenpyroximate and z-isomer on apples in Brazil at 0.1 ppm, France 0.2 ppm, Japan 1.0 ppm, Spain (pome fruits) 0.3 ppm, and Switzerland 0.2 ppm. Codex MRLs have been established on grapes in France at 0.2 ppm, Japan 2.0 ppm, Spain 0.3 ppm, and Switzerland 0.2 ppm. [FR Doc. 03-17617 Filed 7-10-03; 8:45 am] BILLING CODE 6560-50-S