FLUORIDE ACTION NETWORK PESTICIDE PROJECT
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Fludioxonil (IR-4). March 29, 2000. Petition for Pesticide Tolerances. Federal Register.
Note from FAN:
We only include the petitions for the organofluorine pesticide Fludioxonil.
http://www.epa.gov/fedrgstr/EPA-PEST/2000/March/Day-29/p7740.htm
[Federal Register: March 29, 2000 (Volume 65, Number 61)] [Notices] [Page 16602-16608] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr29mr00-67] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [PF-924; FRL-6495-5] Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of certain pesticide chemicals in or on various food commodities. DATES: Comments, identified by docket control number PF-924, must be received on or before April 28, 2000. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-924 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, Registration Support Branch, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; 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 affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ------------------------------------------------------------------------ Examples of Categories NAICS codes potentially affected entities ------------------------------------------------------------------------ Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing ------------------------------------------------------------------------ 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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select ``Laws and Regulations'' and then look up the entry for this document under the ``Federal Register--Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number PF-924. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal [[Page 16603]] holidays. The PIRIB telephone number is (703) 305-5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-924 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805. 3. Electronically. You may submit your comments electronically by e-mail to: ``opp-docket@epa.gov,'' or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number PF-924. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified 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 control 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 certain pesticide chemicals in or on various food commodities under section 408 of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions contain data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports 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: March 15, 2000. James Jones, Director, Registration Division, Office of Pesticide Programs. Summaries of Petitions The petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of the petitions were prepared by the petitioners and represent the views of the petitioners. EPA is publishing the petition summaries verbatim without editing them in any way. 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. ... 2. Interregional Research Project Number 4 New Jersey Agricultural Station 8E5026 and 9E6049 EPA has received pesticide petitions (8E5026 and 9E6049) from the Interregional Research Project Number 4 (IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231, Rutgers University, New Brunswick, NJ 08903. The petitions propose, 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 fludioxonil 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H- pyrrole-3 carbonitrile). 1. PP 8E5026 proposes the establishment of tolerances for strawberries at 2.0 ppm; dry bulb onion; great-headed garlic; shallot; and welsh onion at 0.2 ppm; and green onion and leek at 7.0 ppm. 2 PP 9E6049 proposes the establishment of a tolerance for stone fruit group at 2.0 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 notice includes a summary of petitions prepared by Novaris Crop Protection, Inc. (Novartis), Greensboro, North Carolina, 27419. A. Residue Chemistry 1. Plant metabolism. The metabolism of fludioxonil is adequately understood [[Page 16607]] for the purpose of the proposed tolerances. 2. Analytical method. Novartis, has developed and validated analytical methodology for enforcement purposes. This method (Novartis Crop Protection Method AG-597B) has passed an Agency petition method validation for several commodities and is currently the enforcement method for fludioxonil. This method has also been forwarded to FDA for inclusion into PAM II. An extensive database of method validation data using this method on various crop commodities is available; acceptable method validation and concurrent method recovery data on stone fruits, strawberry, and onions were submitted. The validated limit of quantitation (LOQ) for residues of fludioxonil in/on stone fruit is 0.05 ppm and in/on strawberry and bulb vegetables is 0.02 ppm. For residues in/on representative rotational crop matrices is 0.01 ppm. 3. Magnitude of residues. The magnitude of residues for fludioxonil is adequately understood for the purpose of the proposed tolerances. B. Toxicological Profile 1. Acute toxicity. Fludioxonil and end use formulations have very low toxicity to the mammalian species by the oral, dermal, or inhalation route. The dose needed to kill 50% of animals was calculated to be greater than 5,000 mg/kg (oral), 2,000 mg/kg (dermal), and 2.6 milligrams/liter (mg/L) (inhalation) in these studies. The eye and skin irritations seen in animals upon acute exposure indicate that no more than transient and slight irritation. No sensitizing potential was noted with either the technical material or the formulated product. 2. Genotoxicity. Mutagenicity potential of fludioxonil was tested in several studies. In the Chinese hamster ovary (CHO) cell assay, some clastogenic and polyploidogenic effects were seen at or near the precipitating concentration of the test substance. However, results were negative in the Ames assay, CHO V79 cell assay, hepatocyte DNA repair assay, rat hepatocyte micronucleus test, mouse bone marrow test, and Chinese hamster bone marrow test. A dominant lethal test conducted in the mouse was also negative. 3. Reproductive and developmental toxicity. Fludioxonil is not a developmental toxicant and does not affect reproduction or fertility. No fetal toxicity was observed even at the HDT in both the rabbit (300 mg/kg) and the rat (1,000 mg/kg) developmental toxicity studies. In a 2-generation rat reproduction study, a reduction of pup body weight was seen at the highest feeding level of 3,000 ppm in the presence of maternal toxicity. The NOAEL was 300 ppm for both maternal and fetal toxicity in this study. 4. Subchronic toxicity. In a 90-day dietary toxicity study the kidney and liver have been identified as target organs. In a subchronic study in rats, the NOAEL was 10 ppm based on liver toxicity. In a subchronic study in mice, the NOAEL was 100 ppm based on blue urine (a metabolite); the maximum tolerated dose was 7,000 ppm. In a subchronic study in dogs, the NOAEL was 200 ppm based on clinical observations; the maximum tolerated dose was 8,000 ppm. 5. Chronic toxicity. In an 1-year chronic toxicity study in dogs, the NOAEL was 100 ppm based on body weight effects; the maximum tolerated dose was 8,000 ppm. Two 18-month dietary carcinogenicity studies were performed in mice. While a NOAEL of 1,000 ppm was clearly established in the first study, its highest feeding level (3,000 ppm) did not meet the criteria for a maximum tolerated dose. In the second 18-month study, the maximum tolerated dose was determined to be 5,000 ppm based on kidney effects. There were no treatment-related increases in neoplasia at any dose level tested in either study. In a combined chronic toxicity/carcinogenicity study in rats, the incidence of liver tumors in top-dose females (3,000 ppm) was marginally higher than the concurrent controls but within historical control range. The NOAEL for chronic toxicity was 1,000 ppm in both sexes. 6. Animal metabolism. The metabolism of fludioxonil in rats is adequately understood. 7. Metabolite toxicology. The residues of concern for tolerance setting purposes is the parent compound. Consequently, there is no additional concern for toxicity of metabolites. 8. Endocrine disruption. Fludioxonil does not belong to a class of chemicals known for having adverse effects on the endocrine system. No estrogenic effects have been observed in the various short- and long- term studies conducted with various mammalian species. C. Aggregate Exposure 1. Dietary exposure--i. Food. For purposes of assessing the potential dietary exposure under the proposed tolerance, Novartis has estimated aggregate exposure based on a Tier I assessment from the proposed tolerance level of 2.0 ppm in or on stone fruit and strawberry and 8.0 ppm in or on bulb vegetables including in these petitions, a pending 1.0 ppm grape tolerance, and all the currently established fludioxonil tolerances. This is deemed a worse case estimate of dietary exposure since it is assumed that 100% of all crops for which tolerances are proposed or established are treated except for strawberry and bulb vegetables where 50% and 28% market share estimates were utilized. Further, it was assumed that pesticide residues are present at the tolerance levels. ii. Drinking water. Exposure of the general population to residues of fludioxonil from drinking water is considered unlikely since field dissipation studies demonstrate the movement of fludioxonil into ground water does not occur. In addition, EPA has not established a maximum contaminant level for residues of fludioxonil in drinking water. 2. Non-dietary exposure. Non-occupational exposure for fludioxonil has not been calculated since the current registration for fludioxonil is limited to commercial crop production. Since the chemical is not used in or around the home, Novartis considers the potential for non- occupational exposure to the general population to be non-existent. D. Cumulative Effects Consideration of a common mechanism of toxicity is not appropriate at this time since Novartis is unaware of any reliable information that indicates that toxic effects produced by fludioxonil would be cumulative with those of any other chemical compounds. Consequently, Novartis is considering the potential risks of only fludioxonil in its aggregate exposure assessment. E. Safety Determination 1. U.S. population--i. Acute risk. The risk from acute dietary exposure to fludioxonil is considered to be very low. Using an acute reference dose (RfD) of 0.1 mg/kg taken from the maternal toxicology NOAEL from a rabbit teratology study and a 100 fold safety factor and highly conservative exposure assumptions, 43.4% of the aRfD is utilized for the general U.S. population. ii. Chronic risk. Based on the available chronic toxicity data, EPA has set the RfD for fludioxonil at 0.03 mg/kg/day. This RfD is based on a 1-year feeding study in dogs with a NOAEL of 3.3 mg/kg/day (100 ppm) and an uncertainty factor of 100. No additional uncertainty factor was judged to be necessary as body weight was the most sensitive indicator of toxicity in that study. Based on the highly conservative exposure assumptions described above, only 7.5% of the RfD will be utilized by the U.S. general population. Therefore, [[Page 16608]] based on the completeness and reliability of the toxicity data supporting these petitions, there is a reasonable certainty that no harm will result from aggregate exposure to residues of fludioxonil as a result of these requested tolerances. 2. Infants and children. Infants and children are not expected to show any particular sensitivity to fludioxonil. This can be demonstrated by referencing several data points, including the equivalence of the maternal and fetal toxicity NOAEL in the fludioxonil 2-generation rat study. i. Acute risk. The risk from acute dietary exposure to fludioxonil is considered to be very low. Under the highly conservative exposure assumptions of residue levels being at tolerance level and 100% market share for the majority of crops with proposed and established fludioxonil registrations, the utilization of the acute RfD of the most exposed group is 83.4% (children, 1-6 years). ii. Chronic risk. Using highly conservative aggregate exposures 23.0% and 19.2% of the RfD were obtained for the most sensitive sub- populations, non-nursing infants ( 1-year old) and children (1-6 years), respectively. Therefore, a reasonable certainty exists that no harm will result from aggregate exposure to fludioxonil if the proposed uses are registered. F. International Tolerances There are no Codex maximum residue levels established for residues of fludioxonil in or on strawberrry, dry bulb onion, green onion, and stone fruit crop fruit. [FR Doc. 00-7740 Filed 3-28-00; 8:45 am] BILLING CODE 6560-50-F