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Cryolite (Gowan). April 24, 2002. Proposed new and modified tolerances. Federal Register.
One of the weaknesses of the following petition is that there is no reference to EPA's September 5, 2001, updated risk assessment on inorganic fluoride.
EPA published this new risk assessment in the September 5, 2001, Federal Register in a petition for the first-time use of Sulfuryl fluoride as a fumigant for post-harvest food commodities. Because fluoride is the endpoint of toxicological concern for both Cryolite and Sufluryl fluoride, the September 5, 2001 fluoride assessment is a critical addition to the literature. It is also essential reading for understanding the risks associated with inorganic fluoride pesticides.
[Federal Register: April 24, 2002 (Volume 67, Number 79)] [Notices] [Page 20121-20124] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr24ap02-95] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-2002-0007; FRL-6832-1] 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 control number OPP-2002-0007, must be received on or before May 24, 2002. 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 OPP-2002-0007 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Marilyn Mautz, Registration Support Branch, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-6785; e-mail address: firstname.lastname@example.org. 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 OPP-2002-0007. 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 OPP-2002-0007 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: email@example.com, 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 OPP-2002-0007. 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 [[Page 20122]] 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. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 9, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. Summary of Petition The petitioner 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 Gowan Company, and represents the view of the Gowan Company. 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. Gowan Company EPA has received a pesticide petition from Gowan Company, P.O. Box 5569, Yuma, AZ, 85366-5569 proposing, pursuant to section 408(d) of FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by: (1) Modifying the tolerance expression in 40 CFR 180.145 (a) General. from ``Tolerances are established for combined residues of the insecticidal fluorine compounds cryolite and synthetic cryolite (sodium aluminofluoride) in or on the following commodities:'' to ``Tolerances are established for residues of fluoride arising from the use of the insecticidal fluorine compounds cryolite and synthetic cryolite (sodium aluminofluoride), in or on the following commodities:''; (2) renewing and removing the time limitations for potato and potato waste tolerances, as an amendment to petitions (December 5, 1997 62 FR 64294) (FRL-5756-5); (3) modifying the existing tolerances, for cucumber and kiwifruit to reflect the tolerance expression stated as residues of fluoride; (4) modifying existing tolerances for apricots, nectarines, kale, cranberry and plums (included in the tolerance modifications for plums is the relocation in 40 CFR 180.145 from (a)(1) to (a)(c)), as a followup to the Cryolite Reregistration Eligibility Decision, and as recommended by the Agency; and (5) establishing new tolerances for prunes and the berry group (Crop Group 13) as a follow-up to the Cryolite Reregistration Eligibility Decision, and as recommended by the Agency. The following specific actions are proposed: Modify existing tolerances: Apricots from 7 ppm to 10 parts per million (ppm) Cucumber from 7 ppm to 4 ppm Cranberry from 7 ppm to 2 ppm Kale from 7 ppm to 35 ppm Kiwi from 15 ppm to 8 ppm Nectarines from 7 ppm to 10 ppm Plums from 7 ppm to 2 ppm (tolerance with regional registration) Renew tolerances and remove time-limitation: Potatoes - 2 ppm Potatoes, waste from processing 22 ppm Establish new tolerances: Berries (crop group 13) - 0.5 ppm (replaces separate existing tolerances for blackberries, blueberries, boysenberries, dewberries, loganberries, raspberries and youngberries Prunes - 7 ppm (tolerance with regional registration) 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 cryolite in plants and animals was reviewed in the Cryolite Reregistration Eligibility Decision (RED) of 1996 and in the December 5, 1997 Federal Register. The nature of the residues in plants is understood. Plant residues are inorganic surface residues of cryolite, that are measured as total fluoride. Uptake and translocation of cryolite residues from soil is unlikely, due to the low water solubility of cryolite. 2. Analytical method. Analytical methodology was reviewed in the Cryolite Reregistration Eligibility Decision of 1996 and in the December 5, 1997 Federal Register. An adequate analytical method (fluoride specific electrode) is available for enforcement purposes for plant and animal residues. The limit of quantitation is 0.05 ppm. EPA has previously concluded that, because cryolite is an inorganic ionic compound, the requirement for data using the multi-residue protocols in the Pesticide Analytical Manual (PAM) Vol. I is not applicable. 3. Magnitude of residues. Magnitude of the residue studies have been reviewed in the 1996 cryolite RED, and in the December 5, 1997 Federal Register. Magnitude of the residue studies have been conducted at the maximum label rates for the commodities. Results from the studies demonstrate that the highest fluoride [[Page 20123]] residues will not exceed the proposed tolerances, when the insecticide is applied following the label use directions. B. Toxicological Profile The cryolite RED concluded that the toxicological data base was adequate for a reregistration eligibility decision. No additional toxicology requirements were specified in the RED. The cryolite residue of toxicological concern is fluoride; and health effects identified for fluoride in humans and animals are skeletal and dental fluorosis. Dental fluorosis (mottling of tooth enamel) is not considered to be an adverse effect. Further, the Agency has determined that although, fluoride accumulation is demonstrated in a number of studies, the accumulation itself is not considered an adverse effect. 1. Acute toxicity. A rat acute oral toxicity study (MRID 00138096) showed an LD50 greater than 5,000 milligrams/kilogram (mg/ kg). A rabbit acute dermal toxicity study (MRID 00128107) demonstrated an LD50 of 2,100 mg/kg. An LC50 > 2.06 milligrams per liter( mg/L) and < 5.03 mg/L was seen in an acute inhalation study with rats (MRID 00128107).Technical cryolite is a moderate eye irritant in rabbits (MRID 00128106). Cryolite is not a skin irritant to rabbits (MRID 00128106) and is not a dermal sensitizer to guinea pigs (MRID 00138097). 2. Genotoxicty. Cryolite was negative in an Ames reverse mutation test (MRID 41838401) using Salmonella typhimurium with and without activation at dose levels of 167, 500, 1,670, 5,000, 7,500, and 10,000 microgram/plate (µg/plate). Cryolite was tested in an in vitro chromosome aberration assay (MRID 41838402) using human lymphocytes at 100, 500, and 1,000 microgram milliliter (µg/ml), with and without activation. The results were negative. Cryolite was also negative in an unscheduled DNA synthesis study (MRID 41838403) with rat hepatocytes at dose levels up to and including 50 µg/mL. 3. Reproductive and developmental toxicity--i. Reproductive toxicity. A two-generation rat reproduction study (MRID 43387501) was conducted with cryolite at dietary dose levels of 0, 200, 600, and 1,800 ppm (representing 0, 14, 42, and 128 milligrams/kilogram/day (mg/ kg/day) for males and 0, 16, 49, and 149 mg/kg/day for females, respectively, during premating). The systemic toxicity no observed adverse effect level (NOAEL) was not determined. The lowest observed adverse effect level (LOAEL), for systemic toxicity was 200 ppm (15 mg/ kg/day) based on dental fluorosis. The NOAEL and LOAEL for reproductive toxicity were 600 and 1,800 ppm, respectively (46 and 138 mg/kg/day) based on decreased pup body weights. ii. Developmental toxicity. A developmental toxicity study was performed with cryolite in rats (MRID 00128112) at dose levels of 0, 750, 1,500, and 3,000 mg/kg/day (gavage). The NOAEL for both developmental and maternal toxicity was 3,000 mg/kg/day. At this dose level, the only observation was whitening of the teeth of dams. A developmental toxicity study was conducted in female mice (MRID 42297902) with cryolite at dose levels of 0, 30, 100, and 300 mg/kg/day (gavage). The NOAEL for maternal toxicity was 30 mg/kg/day and the LOAEL was 100 mg/kg/day, based on a single mortality in this group. Fetuses at 300 mg/kg/day exhibited bent ribs and bent limb bones. The NOAEL for developmental toxicity was 100 mg/kg/day. The LOAEL was 300 mg/kg/day based on an increase in bent ribs and bent limbs. A range-finding developmental toxicity study in female rabbits (MRID 42297901), tested cryolite at dose levels of 0, 10, 30, 100, 300, and 1,000 mg/kg/day (gavage). The NOAEL for maternal toxicity was determined to be 10 mg/kg/day and the LOAEL was 30 mg/kg/day based on an increased incidence of soft stool and dark colored feces and decreased defecation and urination. The NOAEL for developmental toxicity was 30 mg/kg/day. The developmental LOAEL could not be assessed due to excessive maternal toxicity at dose levels of >30 mg/ kg/day. 4. Subchronic toxicity. Cryolite was tested in a 28-day range- finding feeding study in rats (MRID 00128109), at dose levels of 0, 250, 500, 1,000, 2,000, 4,000, 10,000, 25,000, and 50,000 ppm in the diet (representing approximately 0, 25, 50, 100, 200, 400, 1,000, 2,500, and 5,000 mg/kg/day). The only compound-related effect seen in this study was a change in coloration and physical property of the teeth. A NOAEL was not determined in this study. The LOAEL is 250 ppm (25 mg/kg/day) based on dental fluorosis. In a 90-day rat feeding study (MRID 00158000), cryolite was tested at dose levels of 0, 50, 5,000, and 50,000 ppm (corresponding to 0, 3.8, 399.2 and 4,172.3 mg/kg/day in males and 0, 4.5, 455.9, and 4,758.1 mg/kg/day in females). The NOAEL was 50 ppm (3.8 mg/kg/day) for effects other than fluoride accumulation. The LOAEL was 5,000 ppm (399.2 mg/kg/day) based on lesions observed in the stomach. Cryolite was tested in a 90-day dog feeding study (MRID 00157999) at dose levels of 0, 500, 10,000, and 50,000 ppm (corresponding to 0, 17, 368, and 1,692 mg/kg/day). The NOAEL was 10,000 ppm (368 mg/kg/ day). The LOAEL was 50,000 ppm (1,692 mg/kg/day) for effects other than fluoride accumulation. 5. Chronic toxicity. The Agency concluded in the cryolite RED that the available information does not support the regulation of cryolite insecticides as carcinogens. The Agency has classified cryolite as a Group ``D'' chemical not classifiable as to human carcinogenicity. Further, EPA has noted that fluoride has been the subject of a comprehensive review by the National Research Council (National Academy of Sciences Subcommittee of Health Effects of Ingested Fluoride) who concluded that, `` . . .the available laboratory data are insufficient to demonstrate a carcinogenic effect of fluoride in animals.'' and that `` . . . the weight of evidence from more than 50 epidemiological studies does not support the hypothesis of an association between fluoride exposure and increased cancer risk in humans.'' As stated in the cryolite RED, the Agency is in agreement with the conclusions reached by the National Academy of Science (NAS). The following specific chronic/oncogenicity studies are included in the cryolite toxicology data base: A 2-year bioassay in B6C3F1 mice (HED DOC No. 009682) was conducted by the National Toxicology Program (NTP) using sodium fluoride as the test material at dose levels of 0, 25, 100, and 175 ppm, in water, representing 0, 2.4, 9.6, and 16.7 mg/kg/day in males and 0, 2.8, 11.3, and 18.8 mg/kg/day in females. The NOAEL was less than 25 ppm (2.4 mg/kg/day). The LOAEL was 25 ppm (2.4 mg/kg/day) based on attrition of the teeth in males, discoloration and mottling of the teeth in males and females and increased bone fluoride in both sexes. NTP considered that, there was ``no evidence'' of carcinogenic activity in male and female mice. A 2-year bioassay in F344/N rats (HED DOC No. 009682) also was conducted by the National Toxicology Program (NTP) using sodium fluoride as the test material at dose levels of 0, 25, 100, and 175 ppm, in water, representing 0, 1.3, 5.2, and 8.6 mg/kg/day in males and 0, 1.3, 5.5, and 9.5 mg/kg/day in females. Osteosarcoma of the bone was observed only in 1 male of 50 (1/50) in the 100 ppm group and in 3 of 80 (3/80) males in the 175 ppm group. The NOAEL was less than 25 ppm (1.3 mg/kg/day). The LOAEL was 25 ppm (1.3 mg/kg/day) based on [[Page 20124]] mottling of teeth, dentine incisor dysplasia, increased serum, urine and bone fluoride levels in males and females and incisor odontoblast and incisor ameloblast degeneration in males. EPA concluded in the cryolite RED, that the NTP studies utilizing sodium fluoride in lieu of cryolite satisfy the guideline study requirements for both the rodent chronic feeding study and the rat carcinogenicity study. Fluoride has been identified as the residue of toxicological concern in cryolite and synthetic cryolite, and these compounds act as free fluoride. A 1-year chronic dog feeding study (MRID 42575101) was conducted with cryolite at dose levels of 0, 3,000, 10,000, and 30,000 ppm, representing 0, 95, 366, and 1,137 mg/kg/day in males and 0, 105, 387, and 1,139 mg/kg/day in females (in terms of fluoride the doses are 0, 51, 198, and 614 mg F/kg/day for males and 0, 57, 209 and 615 mg F/kg/ day for females). The NOAEL was less than 3,000 ppm (95 mg/kg/day in males and 105 mg/kg/day in females). The LOAEL was 3,000 ppm based on increases in emesis, nucleated cells in males, renal lesions and a decrease in urine specific gravity in females. 6. Animal metabolism. As noted in the RED, cryolite behaves toxicologically as free fluoride. That is, dissociation produces free fluoride ions which are assimilated into bone. There are numerous references in the open literature concerning the metabolism of cryolite and other fluoride salts. The National Research Council concluded in their 1993 comprehensive report titled Health Effects of Ingested Fluoride, 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. The active moiety of cryolite is free fluoride, which does not further metabolize. 8. Endocrine disruption. No effects similar to those produced by naturally occurring estrogens, or other endocrine effects have been noted. C. Aggregate Exposure 1. Dietary exposure. A tier 3, partially refined, chronic DEEMTM analysis has been conducted for cryolite. In this assessment, the most highly exposed population subgroup was determined to be children 1-6 years old, at 0.0067 mg/kg/day, or 5.9% of the toxicological endpoint used for risk assessment. The estimated dietary exposure in this assessment for cryolite is below EPA's level of concern for chronic exposure for all population subgroups. Grapes and grape products are the largest contributors to dietary exposure estimates for all population subgroups. Lettuce was also a significant source of exposure for adult populations. i. Food. No acute endpoints have been identified for cryolite. For the chronic dietary exposure assessment, EPA has determined that the dose to be used for risk assessment for exposure to fluoride is 0.114 mg F/kg/day, per the 1996 Cryolite RED. This value is used for all population subgroups, and is derived from a maximum acceptable amount of fluoride in drinking water recommended to the EPA by the Surgeon General as providing an adequate margin of safety for avoiding skeletal fluorosis (1996 Cryolite RED). Tolerance level residues were assumed in this assessment for all crops. The tolerance expression currently used in the Code of Federal Regulations (40 CFR 180.145) for all cryolite tolerances is described as ``the combined residues of the insecticidal fluorine compounds cryolite and synthetic cryolite (sodium aluminum fluoride) in or on the following agricultural commodities.'' For this assessment, the cryolite tolerances have all been converted into ppm as fluoride and the toxic endpoint is also expressed as ppm fluoride. Estimates of percent crop-treated data were incorporated into the assessment where they were available, or could be reasonably translated from related crops, but 100% crop-treated (%CT) was assumed for cranberries, mint, and berries. The estimates of percent crop-treated were taken from BEAD estimates in the 1996 RED. Experimental processing factors were used for mint, oil, grape raisins, grape juice, juice concentrate; and for citrus juices, juice concentrates, and citrus peel. For all other commodities DEEMTM default process factors were used. ii. Drinking water. The cryolite RED concludes that use of cryolite should have negligible impacts on fluoride levels in ground and surface water. However, fluoride is intentionally supplemented to drinking water for prevention of dental caries, and may also be present at natural background levels. Levels of fluoride in/on food from the agricultural use of cryolite plus fluoride levels in U.S. drinking water supplies, results in a daily intake of fluoride of approximately 0.064 mg/kg/day for the most highly exposed population subgroup, children 1-6 years old. This is 56% of the dose used for chronic risk assessment (0.114 mg/kg/day), which represents a level, which provides no known or anticipated adverse health effect as determined by the Surgeon General. For the U.S. population, the exposure estimate is 0.060 mg/kg/day (53% of the dose used for risk assessment). 2. Non-dietary exposure. Non-dietary exposure to cryolite is anticipated to be negligible. D. Cumulative Effects EPA has not determined, that any pesticidal substance has a common mechanism of toxicity with cryolite. E. Safety Determination 1. U.S. population. For the U.S. population, the combined exposure estimate to fluoride from the agricultural use of cryolite plus drinking water is 0.060 mg/kg/day. 2. Infants and children. Levels of fluoride in/on food from the agricultural use of cryolite plus fluoride levels in U.S. drinking water supplies results in a daily intake of fluoride of approximately 0.064 mg/kg/day for the most highly exposed population subgroup, children 1-6 years old. F. International Tolerances No Canadian, Codex or other international tolerances currently exist for cryolite. [FR Doc. 02-9655 Filed 4-23-02; 8:45 am] BILLING CODE 6560-50-S
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