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Sulfuryl Fluoride; Notice of Filing a Pesticide Petition to Establish Tolerances for a Certain Pesticide Chemical in or on Food
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[Federal Register: March 4, 2005 (Volume 70, Number 42)] [Notices] [Page 10621-10625] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr04mr05-55] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-2005-0067; FRL-7701-8] Sulfuryl Fluoride; Notice of Filing a Pesticide Petition to Establish Tolerances 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 identification (ID) number OPP- 2005-0067, must be received on or before April 4, 2005. 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: Suku Oonnithan, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 703-605-0368; e-mail address: oonnithan.suku@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. [[Page 10622]] 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 ID number OPP-2005-0067. 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, 1801 S. Bell St., 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 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-2005-0067. 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-2005-0067. 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-2005-0067. 3. By hand delivery or courier. Deliver your comments to: Public Information [[Page 10623]] and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID Number OPP-2005-0067. 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 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 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: February 25, 2005. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Summary of Petition PP 3F6573 The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was 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. EPA has received a pesticide petition (PP 3F6573) from Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 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 tolerances for residues of: 1. Fluoride in or on the following raw agricultural commodities: Animal feed at 130 parts per million (ppm), beef, meat at 40 ppm; cheese, post harvest at 5 ppm; cocoa bean, post harvest at 12 ppm; coconut, post harvest at 40 ppm; coffee, post harvest at 12 ppm; cottonseed, post harvest at 13 ppm; egg at 850 ppm; ginger, post harvest at 13 ppm; grain, cereal, forage, fodder and straw group 16, post harvest at 130 ppm; grass, forage, fodder and hay group 17, post harvest at 130 ppm; ham at 20 ppm; herbs and spices group 19, post harvest at 50 ppm; milk at 3 ppm; nut, pine, post harvest at 10 ppm; other processed food at 70 ppm; peanut, post-harvest at 13 ppm; rice flour, post harvest at 98 ppm; and vegetable, legume, group 06, post harvest at 6 ppm. 2. Sulfuryl fluoride in or on the following raw agricultural commodities: Animal feed at 2.0 ppm; beef, meat at 0.01 ppm; cheese, post harvest at 0.5 ppm; cocoa bean, post harvest at 0.8 ppm; coconut, post harvest at 1.0 ppm; coffee, post harvest at 0.8 ppm; cottonseed, post harvest at 0.2 ppm; egg at 0.7 ppm; ginger, post harvest at 0.2 ppm; grain, cereal, forage, fodder and straw group 16, post harvest at 2.0 ppm; grass, forage, fodder and hay group 17, post harvest at 2.0 ppm; ham at 0.01 ppm; herbs and spices group 19, post harvest at 0.3 ppm; milk at 1.5 ppm; nut, pine, post harvest at 3.0 ppm; other processed food at 1.2 ppm; peanut, post-harvest at 0.2 ppm; rice flour, post harvest at 0.08 ppm; and vegetable, legume, group 06, post harvest at 0.02 ppm. EPA has determined that the petition contains 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 supports granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry 1. Plant metabolism. The metabolism of sulfuryl fluoride is adequately understood for the purposes of this tolerance. Potential residues of sulfuryl fluoride and its degradation product fluoride and sulfate were investigated. Residues of sulfuryl fluoride in treated commodities are transient and rapidly decrease to very low (parts per billion (ppb)) or non-detectable levels. Residues of fluoride and sulfate resulting from the fumigation of commodities with sulfuryl fluoride were measurable and predictable. Sulfate as a terminal residue of sulfuryl fluoride is not considered of toxicological significance due to its natural abundance and pervasiveness in living systems. 2. Analytical method. Analytical methods have been developed and validated to determine the residues of sulfuryl fluoride and fluoride in the listed commodities. The sulfuryl fluoride method is based on gas chromatography/electron capture detector (GC-ECD) with a limit of quantitation (LOQ) of 8.0 ppb in grains and grain processed products and 4.0 [[Page 10624]] ppb in all other commodities. The fluoride method utilizes a fluoride ion specific electrode. The fluoride ion method was validated with an LOQ of 0.5 ppm in grains and grain processed products and 1.0 ppm in all other commodities. 3. Magnitude of residues. Cereal and small grains and their processed products were treated with sulfuryl fluoride at target doses ranging from 200 mg hr/L to 1500 mg hr/L. Sulfuryl fluoride dissipated rapidly with residues at less than the LOQ (with one exception), immediately following the 24-hr aeration. One sample (white corn) at the 1,500 mg hr/L dose showed a residue of 0.019 ppm after the 24-hr aeration interval. Fluoride ion residues measured in whole grains following the fumigations ranged from less than the LOQ to 1.8 ppm (200 mg hr/L dose level) and from 1.0 to 7.5 ppm (1,500 mg hr/L dose level). The processing of sulfuryl fluoride-fumigated whole grain wheat containing fluoride ion at 1.19 ppm yielded flour, shorts, bran, middlings, impurities, and germ containing fluoride ion at 0.446 ppm, 1.50 ppm, 3.05 ppm, 0.718 ppm, 1.07 ppm, and 5.74 ppm, respectively. The processing of fumigated whole grain corn containing fluoride ion at 1.76 ppm produced flour, meal, grits, impurities, containing fluoride ion at 1.29 ppm, 1.37 ppm, 0.826 ppm, and 9.67 ppm. Fluoride ion was below the LOQ (0.3 ppm) in corn oil (dry- and wet-milled) and wet- milled starch. Fluoride ion residues were consistently higher in processed products than in the whole grains. Fluoride ion residues in mill-fumigated processed products (germ, flour, meal) ranged from 7 to 90 ppm, with residues generally following the order of wheat germ being greater than wheat flour, being greater than corn flour, being greater than corn meal. Finished food products and key ingredients were fumigated with sulfuryl fluoride (SF) in controlled exposures to determine the magnitude of sulfuryl fluoride and terminal fluoride anion. Most of the finished food products were fumigated in their retail packaging and also in open configuration (removed from packages) to compare residue levels resulting from those two packaging configurations. Portions (typically 200 - 2,000g) of each commodity were exposed in single, 24-hr fumigations to a SF concentration of 62.5 mg/L (CT Product of 1,500 mg hr/L), at an exposure temperature of 30 C. Following fumigation and aeration, the commodities were analyzed to determine residue levels of sulfuryl fluoride and fluoride anion. The tested food commodities were exposed in a combination of packaged and open configuration. Sulfuryl fluoride was not present above the limit of quantitation (4 ppb) in twelve commodities fumigated in open configuration, nor in three commodities fumigated in packaged configuration. Only five of the fumigated commodities had SF residue levels that exceeded 1,000 ppb with the highest level being 1,864 ppb. The SF concentrations rapidly decayed in the tested commodities between post-fumigation Day 1 and Day 2. Fluoride ion was not present above the LOQ (1 ppm) in four commodities fumigated in open configuration, nor in seven commodities fumigated in packaged configuration. Thirty-five (of the 39) commodities fumigated with SF in the open configuration had quantifiable levels of fluoride which ranged from 1.03 to 754 ppm. The highest fluoride levels were 754 ppm in powdered eggs. Of the 20 commodities fumigated in packaged configuration, 13 had quantifiable fluoride levels, but the fluoride concentrations were less than 12 ppm for all package-fumigated commodities with one exception. The comparative results of fluoride residues in commodities fumigated under packaged versus open fumigation conditions indicate that the packaging in most cases does function as a barrier that isolates the contents of the package from external SF atmospheres or at least attenuates the inner-package concentration of SF to which the commodities are exposed. On the basis of the residues of fluoride and sulfuryl fluoride that were evaluated, the tolerances identified are supported for the listed commodities. B. Toxicological Profile 1. Acute toxicity. The acute LC50 for sulfuryl fluoride is 642 ppm 1,088 milligram/kilogram body weight (mg/kg/bwt) for CD-1 mice exposed for four hours. 2. Genotoxicity. Genetic toxicity did not occur when sulfuryl fluoride was tested in multiple in vivo and in vitro tests. 3. Reproductive and developmental toxicity. Sulfuryl fluoride did not have any effects on reproductive parameters at dose levels that induced treatment related effects in parental rats and rabbits. In addition, a teratogenic potential for sulfuryl fluoride was not demonstrated in either rats or rabbits at dose levels that induced maternal toxicity. 4. Subchronic toxicity. Several 2-week repeated dose inhalation studies indicate for mice a no observed adverse effect level (NOEL) of 30 ppm; for rat, rabbit, and beagle dog a NOEL of 100 ppm. 5. Chronic toxicity. The lowest reported chronic NOEL for sulfuryl fluoride is 5 ppm based on a 2-year inhalation study with Fischer 344 rats and the parental NOEL in a two-generation rat reproduction study. There was no evidence of carcinogenicity in 2-year rat and 18-month mouse studies. 6. Animal metabolism. Rats fed a diet that had been fumigated by sulfuryl fluoride at a rate of 2 lb/1,000 cu ft (containing fluoride levels of 19 ppm above the control level of 36 ppm) for 66 days experienced an increase in the fluoride content of their bones. The National Research Council in their 1993 report on fluoride concluded that fluoride is readily absorbed by the gut and rapidly becomes associated with teeth and bones. The remaining fluoride is eliminated almost exclusively by the kidneys with the rate of renal clearance related directly to urinary pH. 7. Metabolite toxicology. Clinical symptoms of acute fluoride poisoning in humans are characterized by nausea, vomiting, diarrhea, abdominal pain, and paresthesia. The frequently cited ``probably toxic dose,'' the dose which should trigger therapeutic intervention and hospitalization, is 5 mg/kg/bwt calculated for the lowest third percentile of the infant population. Five to 10 grams of sodium fluoride (NaF) is considered the certainly lethal dose (CLD) for a 70 kg adult (32 to 64 mg fluoride per kg body weight). One-quarter of the CLD can be ingested without producing serious acute toxicity and is known as the safely tolerated dose, i.e., 8 to 16 mg of fluoride per kg of body weight. The Council on Dental Therapeutics of the American Dental Association recommends that ``no more than 264 mg of NaF (120 mg F) be dispensed at any one time'' in dental treatments to prevent the accidental poisoning of an infant weighing as little as 10 kilograms. The U.S. EPA (Cryolite Reregistration Eligibility Decision [RED], 8/96) determined a Maximum Concentration Limit Goal (MCLG) of 0.114 mg/kg/day for fluoride which provides protection from any known or anticipated adverse health effects. The MCLG has been reviewed and supported by the Surgeon General. The National Toxicology Program (NTP) has concluded that there was ``no evidence'' of carcinogenic activity in male or female mice administered sodium fluoride in drinking water for 2 years. 8. Endocrine disruption. There is no evidence from any studies to suggest that sulfuryl fluoride or fluoride are endocrine disrupters. [[Page 10625]] C. Aggregate Exposure 1. Dietary exposure. The Dietary Exposure Evaluation Model (DEEM), version 7.76, of Novigen Sciences, Inc. was used to estimate the dietary exposure to the U.S. population and critical sub-populations resulting from the use of sulfuryl fluoride under the conditions proposed. The highest potential chronic exposures to sulfuryl fluoride was to children ages 1 to 6 years resulting from the consumption of treated commodities totaling 0.00009 mg/kg/bwt/day. Likewise, the highest potential chronic exposure to fluoride was to children ages 1 to 6 years with a highest estimated exposure of 0.005 mg/kg/bwt/day. i. Food. Food tolerances as inorganic fluorine compounds exist to support the uses of Cryolite (insecticide) and ProFume on various food and feed commodities in the United States. The U.S. EPA, in the 2004 ProFume registration decision, conservatively estimates that the dietary exposures to fluoride due to all sources and routes (including the fluorination of water and the potential for fluoride residues resulting from the uses of Cryolite) could be as high as 0.0397 mg/kg/ bwt/day. No toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on sulfuryl fluoride or inorganic fluoride that would be applicable for an acute dietary exposure. ii. Drinking water. There is no anticipated exposure of sulfuryl fluoride to drinking water. As a public health tool to aid in the prevention of dental caries, fluoride is added to some domestic water supplies at generally 0.8 to 1.0 ppm. 2. Non-dietary exposure. Sulfuryl fluoride (as Vikane specialty gas fumigant) is presently used to fumigate homes and other structures to control wood infesting insects. The existing Vikane use patterns and exposed populations are not expected to overlap with the intended post- harvest uses of ProFume. D. Cumulative Effects The primary degradation product of sulfuryl fluoride is fluoride. The toxicity of fluoride in various forms has been extensively reviewed and is used as an additive in treated water supplies, toothpastes, mouth rinses, and other treatments for the prevention of dental caries. It is also prescribed in therapeutic amounts for the treatment of osteoporosis. Fluoride is naturally present in both food and water in varying amounts, and has been added to public water supplies to fight dental caries. The recommended concentration of fluoride (usually as fluorosilicic acid) in treated water supplies is 0.8 to 1.0 ppm. The Third Report on Nutrition Monitoring in the United States says that ``Food contributes only small amounts of fluoride and monitoring the diet for fluoride intake is not very useful for current public health concerns. The sub-population most susceptible to fluoride is children. For this reason a number of studies have attempted to quantify the fluoride intake from a variety of sources. The total daily intake of fluoride from water (used to prepare formula, juices, and other foods) for infants ages birth to 9 months ranged to 1.73 mg with means from 0.29 to 0.38 mg. Assuming a body weight of 10 kg, these amounts are equivalent to 0.03 to 0.04 mg/kg/day. These levels of dietary exposure in combination with the potential dietary exposures that the proposed uses of ProFume would represent (chronic dietary exposures of 0.005 mg/ kg/bwt/day) are considerably lower than the U.S. EPA MCLG for fluoride of 0.114 mg/kg/bwt/day. E. Safety Determination 1. U.S. population. Aggregate risk from exposure to sulfuryl fluoride would be minimal because of its rapid dissipation from any fumigated commodity and because it is not expected to be present at the time of food consumption. The sulfuryl fluoride residues in fumigated foods are expected to be non-detectable at the point of food consumption. Furthermore, if residues were considered as high as what is found immediately following the 24 hour aeration period, the Margin of Exposure to the most sensitive population (children) is estimated to be greater than 150,000-fold for chronic exposures. Exposure to fluoride, the residue of interest for sulfuryl fluoride, can occur from foods, water, and dental treatments. The additional fluoride residues in some commodities fumigated with sulfuryl fluoride are indistinguishable from the natural levels of fluoride already present and would therefore also fall within the U.S. EPA Threshold of Regulation Policy. Alternatively, fluoride in other commodities are expected to contribute to the fluoride that is ingested, but at levels far below other sources, especially treated water and dentrifices. Chronic exposure to fluoride resulting from the proposed uses of ProFume (0.005 mg/kg/day) is much lower than the U.S. EPA's MCLG of 0.114 mg/kg/bwt/day calculated for exposure to fluorinated water. In addition, there is no directly applicable scientific documentation of adverse medical effects at levels of fluorine below 0.23 mg/kg/day. 2. Infants and children. Chronic exposure to fluoride from the consumption of ProFume treated commodities would be approximately 0.005 mg/kg/day for a child age 1 to 6 years. This value is much lower than the U.S. EPA MCLG of 0.114 mg/kg/bwt/day calculated for exposure to fluorinated water. F. International Tolerances There is no Codex maximum residue level established for residues of fluoride on any food or feed crop. [FR Doc. 05-4281 Filed 3-3-05; 8:45 am BILLING CODE 6560-50-S