Environmental Protection Agency (EPA).
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.
Comments, identified by docket control number PF-1068, must be received on or before March 18, 2002.
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-1068 in the subject line on the first page of your response.Start Further Info
FOR FURTHER INFORMATION CONTACT:
By mail: Dennis McNeilly, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-6742; and e-mail address: email@example.com.End Further Info End Preamble Start Supplemental 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:
|Categories||NAICS codes||Examples of potentially affected entities|
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” “Regulations and Proposed Rules,” 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-1068. 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 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-1068 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, 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: firstname.lastname@example.org, 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-1068. Electronic comments Start Printed Page 7157may 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 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 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.Start List of Subjects
List of Subjects
- Environmental protection
- Agricultural commodities
- Feed additives
- Food additives
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: February 5, 2002.
Richard P. Kiegwin, Jr.,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the petitioner and represents the view of the petitioner. EPA is publishing the petition summary verbatim without editing it 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.
EPA has received a pesticide petition (1F6312) from DowAgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of:
1. Fluoride in or on the following raw agricultural commodities: Date at 5 parts per million (ppm), fig at 5 ppm, plum, prune, dried at 5 ppm, grape, raisin at 5 ppm, fruit, dried at 5 ppm, almond at 10 ppm, pecan at 23 ppm, pistachio at 18 ppm, walnut at 30 ppm, beechnut; butternut; cashew; chestnut; chinquapin; filbert; nut, brazil; nut, hickory; and nut, macadamia at 30 ppm, barley, grain at 10 ppm, corn, field, grain; and corn, pop, grain at 7 ppm, oat, grain at 17 ppm, rice, grain at 10 ppm, wheat, grain at 25 ppm, millet, grain; rice, wild, grain; sorghum, grain; and triticale, grain at 25 ppm and on the processed products corn, field, flour at 26 ppm, corn, field, grits at 10 ppm, corn, field, meal at 28 ppm, corn, field, oil at 3 ppm, rice, brown at 14 ppm, rice, polished rice at 18 ppm, rice, bran at 31 ppm, rice, hulls at 35 ppm, wheat, bran at 40 ppm, wheat, flour at 10 ppm, wheat, germ at 98 ppm, wheat milled by products at 35 ppm, wheat, shorts at 38 ppm, corn, field, refined oil at 3 ppm.
2. Sulfuryl fluoride in or on the following raw agricultural commodities: Date at 0.03 ppm, fig at 0.05 ppm, plum, prune, dried at 0.01 ppm, grape, raisin at 0.01 ppm, fruit, dried at 0.05 ppm, almond at 0.2 ppm, pecan at 6.0 ppm, pistachio at 0.5 ppm, walnut at 6.0 ppm, beenut; butternut; cashew; chestnut; chinquapin; filbert; nut, brazil; nut, hickory; and nut, macadamia at 6.0 ppm, barley, grain at 0.01 ppm, corn, field, grain and corn, pop, grain at 0.04 ppm, oat, grain at 0.01 ppm, rice, grain at 0.04 ppm, wheat, grain at 0.05 ppm, millet, grain; rice, wild, grain; sorghum, grain; triticale, grain at 0.05 ppm and on the processed products corn, field, flour at 0.01 ppm, corn, field, grits at 0.01 ppm, corn, field, meal at 0.01 ppm, corn, field, refined oil at 9.0 ppm, rice, brown at 0.01 ppm, rice, polished rice at 0.01 ppm, rice, bran at 0.01 ppm, rice, hulls at 0.08 ppm, wheat, bran at 0.01 ppm, wheat, flour at 0.03 ppm, wheat, germ at 0.01 ppm, wheat milled byproducts at 0.01 ppm, wheat, shorts at 0.01 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 support 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 4.0 ppb in dried fruit, and tree nuts, and 8.0 ppb in grains, and grain processed products. Start Printed Page 7158 The fluoride method utilizes a fluoride ion specific electrode. The fluoride ion method was validated with a LOQ of 2.4 ppm in dried fruit, and tree nuts, and 0.5 ppm in grains, and grain processed products.
3. Magnitude of residues. Residue data in support of the proposed temporary tolerances for sulfuryl fluoride and the degradate of interest, fluoride, in the listed commodities have been generated. Tree nuts (walnuts, pistachios, pecans, and almonds), and dried fruits (dates, figs, dried plums, and raisins) were treated with sulfuryl fluoride at target doses ranging from 200 milligrams hour/liter (mg hr/L) to 1,500 mg hr/L. At the completion of a 24 aeration interval, following the single fumigation at 200 mg hr/L, sulfuryl fluoride residues were observed only in walnuts, pecans, and figs with average residues of 0.072 μg/g, 0.046 μg/g and 0.005 μg/g, respectively. The effect of multiple fumigations at 1,500 mg hr/L per fumigation on residue levels indicated presence of sulfuryl fluoride residues in all of the commodities tested except in dried plums (no detectable residue). At the completion of a 24 aeration interval following each fumigation, sulfuryl fluoride average residue levels in the commodities were in the following order: Pecans (2.27-5.16 μg/g) >pistachios (0.036-0.29 μg/g) >almonds (0.036-0.13 μg/g) >figs (0.012-0.0141 μg/g) >dates (ND-0.007 μg/g) >dried plums ND. Fluoride ion residues were measured after dissipation of sulfuryl fluoride residues (<LOQ). In general, the fluoride ion levels resulting from the single fumigation with concentration x time (CT) product of 200 mg hr/L were either not detected or ≤LOQ for both tree nuts and dried fruits. Only almonds contained measurable levels of fluoride ion with an average of 3.4 μg/g. For multiple fumigations (2-5 times) at 1,500 mg hr/L each fumigation, average fluoride ion levels in dried fruits were either not detected or <LOQ, except for dried plums indicating an average residue (2.6 μg/g) near the LOQ. Fluoride ion residues were detected in tree nuts after each fumigation (3 fumigations). After the first fumigation, the average fluoride ion residues were approximately 4 μg/g, 5 μg/g, and 9 μg/g in pistachios, almonds, and pecan, respectively. After the last fumigation, the fluoride ion levels increased to approximately 10 μg/g, 16 μg/g, and 21 μg/g in almonds, pistachios, and pecans, respectively. Vacuum fumigation of tree nuts (4-hour exposure, target CT product of 200 mg hr/L) resulted in higher SF levels in the commodity than from fumigations at NAP, however, fluoride levels remained low following vacuum fumigation, less than the method LOQ (2.4 μg/g commodity).
Cereal and small grains and their processed products were treated with sulfuryl fluoride at target doses ranging from 200 mg hr/L to 1,500 mg hr/L. Sulfuryl fluoride dissipated rapidly with residues at <LOQ (with one exception), immediately following the 24-hour aeration, one sample (white corn) at the 1,500 mg hr/L dose showed a residue of 0.019 μg/g after the 24-hour aeration interval. Fluoride ion residues measured in whole grains following the fumigations ranged from <LOQ to 1.8 μg/g (200 mg hr/L dose level) and from 1.0 to 7.5 μg/g (1,500 mg hr/L dose level). The processing of sulfuryl fluoride-fumigated whole grain wheat containing fluoride ion at 1.19 μg/g yielded flour, shorts, bran, middlings, impurities, and germ containing fluoride ion at 0.446 μg/g, 1.50 μg/g, 3.05 μg/g, 0.718 μg/g, 1.07 μg/g, and 5.74 μg/g, respectively. The processing of fumigated whole grain corn containing fluoride ion at 1.76 μg/g produced flour, meal, grits, impurities, containing fluoride ion at 1.29 μg/g, 1.37 μg/g, 0.826 μg/g, and 9.67 μg/g. Fluoride ion was below the LOQ (0.3 μg/g) 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 μg/g, with residues generally following the order of wheat germ >wheat flour >corn flour >corn meal.
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 4 hours.
2. Genotoxicty. 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 (NOAEL) of 30 ppm for rat, rabbit, and Beagle dog a NOAEL of 100 ppm.
5. Chronic toxicity. The lowest reported chronic NOAEL for sulfuryl fluoride is 5 ppm based on a 2-year inhalation study with Fischer 344 rats and the parental NOAEL in a 2-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 cubic/feet (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 is considered the certainly lethal dose (CLD) for a 70 kg adult (32 to 64 mg fluoride per kg bwt). 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. EPA (cryolite RED decision, August 1996) 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 Start Printed Page 7159that sulfuryl fluoride or fluoride are endocrine disrupters.
C. Aggregate Exposure
1. Dietary exposure. The Dietary Exposure Evaluation Model (DEEM), version 7.73, 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 0.000106 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 0.002419 mg/kg/bwt/day.
i. Food. Food tolerances as inorganic fluorine compounds exist to support the uses of cryolite (insecticide) on various food and feed commodities in the U.S. EPA, in the 1996 cryolite RED document, conservatively estimates that the “high-end” 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) are approximately 0.085 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 ppm 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 ppm 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 0.002419 mg/kg/bwt/day) are considerably lower than EPA's 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 80,000 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 EPA's 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 (0.002419 mg/kg/day) is much lower than 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 0.002419 mg/kg/day for a child age 1 to 6 years. This value is much lower than EPA's 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.End Supplemental Information
[FR Doc. 02-3661 Filed 2-14-02; 8:45 am]
BILLING CODE 6560-50-S