FLUORIDE ACTION NETWORK PESTICIDE PROJECT
Return to FAN's Pesticide Homepage
Return to Cryolite Index Page
Cryolite. May 1993. Fluorine compounds. Pesticide Tolerance and Animal Feed Additive Regulation. Final Rule. Federal Register.
From: Cornell U. Pesticide Management Education Program
http://pmep.cce.cornell.edu/profiles/insect-mite/propetamphos-zetacyperm/sodium-alum-fluor/fluoride-tol.html
sodium aluminum fluoride (cryolite) Pesticide Tolerance and Animal Feed Additive Regulation 5/93
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 180 and 186 [PP 9F3739 and FAP 1H5604/R1190; FRL-4579-1] RIN 2070-AB78 Pesticide Tolerance and Animal Feed Additive Regulation for Fluoride Compounds AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 180 and 186 [PP 9F3739 and FAP 1H5604/R1190; FRL-4579-1] RIN 2070-AB78 Pesticide Tolerance and Animal Feed Additive Regulation for Fluoride Compounds AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. .. ------------------------------------------------------------ SUMMARY: This regulation establishes a 3-year time-limited tolerance for residues of cryolite and/or synthetic cryolite (sodium aluminum fluoride) in or on the raw agricultural commodity potatoes at 2.0 parts per million (ppm) and a 3-year time-limited feed additive regulation for residues of the insecticide cryolite and/or synthetic cryolite (sodium aluminum fluoride) in the commodity processed potato waste (wet or dry) at 22.0 ppm. These regulations to establish a maximum permissible level for residues of the insecticide compounds in or on the commodities were requested in petitions submitted by Atochem North America, Inc. (formally Pennwalt Corp.) EFFECTIVE DATE: These regulations become effective May 5, 1993. ADDRESSES: Written objections, identified by the document control number, [PP 9F3739 and FAP 1H5604/R1190], may be submitted to: Hearing Clerk (A-110), Environmental Protection Agency, rm. 3708, 401 M St., St., Washington, DC 20460. FOR FURTHER INFORMATION CONTACT: By mail: Robert A. Forrest, Product Manager (PM) 14, Registration Division, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 219, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6600. SUPPLEMENTARY INFORMATION: EPA issued notices as follows regarding petitions submitted by Atochem North America, Inc., 3 Parkway, rm. 619, Philadelphia, PA 19102: 1. PP 9F3739. Appearing in the Federal Register of March 23, 1989 (54 FR 12009), the petition requested that the Administrator, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(d)) propose to establish a tolerance for residues of cryolite and/or synthetic cryolite in or on the raw agricultural commodity (RAC) Irish potatoes at 1.5 ppm. EPA subsequently issued notice of filing of PP 1F3959 in the Federal Register of April 3, 1991 (56 FR 13643), stating that Atochem North America, Inc., proposed to increase the tolerance from 1.5 ppm to 2.0 ppm and change the RAC Irish potatoes to the more appropriate designation, potatoes. PP 1F3959 had been intended as an amendment to PP 9F3739, but was published as an initial filing. The April 3, 1991 notice reflects the current amendment. 2. FAP 1H5604. Appearing in the Federal Register of April 3, 1991 (56 FR 13643), the petition requested that the Administrator, pursuant to section 409(c)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 348(c)(1), propose to establish a tolerance for residues of cryolite and/or synthetic cryolite in the animal feed potato waste at 22.0 ppm resulting from the application of the compounds to growing potatoes. For consistency, the commodity potato waste is corrected to read potato waste (wet or dry) in the final rule. There were no comments received in response to these notices of filing. The data submitted in the petitions and all other relevant material have been evaluated. The pesticide is considered useful for the purposes for which the tolerances are sought and considered capable of achieving the intended physical or technical effect. The toxicological data considered in support of the tolerances include the following: 1. A 2-year rat bioassay conducted by the National Toxicology Program (NTP) using sodium fluoride as the test material in which mottling; dentine incisor dysplasia; and incisor odontoblast and ameloblast degeneration of teeth were observed at the lowest dose tested, 25 ppm (1.3 mg/kg/day). Levels tested were 0, 25, 100, and 175 ppm. Osteosarcoma of the bone was observed in one male in the 100-ppm group (mid-dose) and in three males in the 175 ppm group (highest dose tested). NTP considers this to be equivocal evidence of carcinogenicity in male F344/N rats. No evidence was seen in female rats. The currently available information does not support the regulation of cryolite insecticides as carcinogens at this time. The U.S. Department of Health and Human Servcies (USDHHS), Public Health Service, concluded in its 1991 "Review of Fluoride Benefits and Risks" that "Taken together, the two animal studies available at this time fail to establish an association between fluoride and cancer." The two studies examined by USDHHS consisted of the NTP study using male and female rats and mice and one conducted by Procter and Gamble. A total of eight individual sex/species groups (four sex/species groups from each study) were examined. The National Academy of Science is currently examining all available data on fluoride, including the NTP studies, with a report expected to be issued April 1993. The NTP study utilizing sodium fluoride as the test material in lieu of cryolite or synthetic cryolite satisfies the guideline study requirement 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 the available data show that these compounds act as free fluoride. Due to an abundance of data on the effects of fluoride on humans, additional data are not required to define a no-observed-effect-level (NOEL) in rats for the effects of fluoride on teeth. 2. A 2-year mouse bioassay conducted by the NTP utilizing sodium fluoride as the test material with mottling, discoloration, and attrition of teeth observed at the lowest dose tested, 25 ppm (2.4 mg/kg). The bioassay was negative for carcinogenic effects under the conditions of the study. Levels tested were 0, 25, 100, and 175 ppm. This study utilizing sodium fluoride in lieu of cryolite or synthetic cryolite as the test material satisfies the guideline study requirement for a mouse carcinogenicity study for the reason described above under item one. 3. A developmental toxicity study in rats with developmental and maternal no-observable-effect levels (NOELs) at greater than 3,000 mg/kg/day (highest dose tested). 4. A developmental toxicity study in mice with a developmental no-observable-effect level (NOEL) of 100 mg/kg/day with a lowest- effect level (LEL) of 300 mg/kg/day based on increased incidents of bent ribs and bent rib bones. The maternal NOEL was 30 mg/kg/day with a LEL of 100 mg/kg/day based on increased mortality and reddened mucosa in the glandular portion of the stomach. The guideline study requirement for a developmental toxicity study in a nonrodent species is waived. 5. A 28-day range-finding study in rats with the only compound- related effect being a change in coloration and physical property of the teeth. 6. A supplemental 90-day rat-feeding study at dose levels of 0, 50, 5,000, and 50,000 ppm in which stomach lesions were observed at the 5,000-ppm dose level. 7. A supplemental 90-day dog feeding study at dose levels of 0, 500, 10,000, and 50,000 ppm with systemic effects (fluoride accumulation in the bone) seen at the 500-ppm dose level. 8. Genotoxicity studies including an Ames test (negative), an in vitro assay in human lymphocytes (negative), and an unscheduled DNA synthesis in rat hepatocytes (negative). 9. Open literature studies showing that human and animal metabolism of cryolite and/or synthetic cryolite manifests itself as normal free fluoride metabolism, i.e., dissociation occurs, producing free fluoride ions which are assimilated into bone. Desirable toxicological data currently lacking and the projected dates for completion of these studies are as follows: (1) 1- year nonrodent feeding study, May 1994; (2) two-generation rat reproduction study, June 1993. Although there are significant data gaps for cryolite and/or synthetic cryolite, the available toxicity data are considered adequate to support the time-limited tolerance and feed additive regulation. The additional dietary exposure to fluoride resulting from the use of cryolite and/or synthetic cryolite on potatoes is considered negligible when compared to the total dietary exposure to fluoride from noninsecticidal sources such as drinking water, toothpaste, dental fluoride application, and the naturally occurring background levels in addition to that resulting from the current established pesticide tolerances for the compounds. The current established tolerances for the use of cryolite and/or synthetic cryolite provide for an exposure of 0.029 mg of fluoride per kg/day (.054 mg/kg/day of cryolite and/or synthetic cryolite), and the current maximum contaminant level (MCL) of 4.0 ppm established for the use of sodium fluoride in drinking water provides for an exposure of 0.266 mg of fluoride per kg/day (based on consumption of 2 liters of water per day by a 60-kg person) for a total of 0.285 mg/kg/day. As a result of this regulation, the total maximum estimated dietary exposure will be 0.2862 mg/kg/day of fluoride, or an increase of 0.0012 mg/kg/day (0.4 percent) fluoride. As stated in the Federal Register of May 11, 1979 (44 FR 27932-27954), the "Agency will generally consider as insignificant an increase in the theoretical maximum residue concentration of 1.0 percent or less." For purposes of this rule, this is interpreted to include the estimated dietary exposure resulting from nonpesticidal uses. This percent increase in the dietary exposure is even less when the background levels of fluoride are taken into consideration. Fluoride is ubiquitous and may be present in soils and foodstuffs that have not been treated with cryolite and/or synthetic cryolite. Data submitted in support of the subject petition show background levels of fluoride in untreated potatoes ranged from 0.14 ppm to 0.31 ppm and are consistent with the ranges reported in the open literature. Levels of fluoride found in the treated potatoes ranged from 0.18 ppm to 0.94 ppm. The residue analytical method used for enforcing the subject tolerance cannot distinguish between the naturally occurring fluoride and the fluoride resulting from use of cryolite and/or synthetic cryolite. The metabolism of the subject insecticides in plants and animals is adequately understood. The residue of concern in or on plants resulting from the application of these insecticides is cryolite and/or synthetic cryolite. Only surface residues of the insecticides per se may be expected to occur on the treated plants. The residue of concern in animals is total fluoride. An adequate analytical method (fluoride-specific electrode) is available for enforcement purposes for the RAC potatoes and potato waste. Because the subject compounds are inorganic compounds, the requirement for data using the multiresidue protocols in PAM Vol. I is not applicable. Because of the long lead time from establishing these tolerances to publication of the enforcement methodology in the Pesticide Analytical Manual, Vol. II, the analytical methodology is being made available in the interim to anyone interested in pesticide enforcement when requested from: Calvin Furlow, Public Information Branch, Field Operations Division (H7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 1128, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703-305- 5232). There is no reasonable expectation of finite residues of cryolite or synthetic cryolite occurring in the meat, milk, poultry, and eggs of animals fed potato waste processed from the treated potatoes and 40 CFR 180.6(a)(3) applies. Thus, secondary tolerances are not necessary at this time in meat, milk, poultry, and eggs. Because of the lack of a chronic dog feeding study, and a two-generation rat reproduction study, the Agency is limiting the period of time that the regulations are to be in effect. Should the Agency find that these data are acceptable, it will reassess the tolerance for potatoes, and if appropriate, will establish a permanent tolerance for potatoes and a permanent feed additive regulation for processed potato waste (wet or dry). There are no regulatory actions pending against the continued registration of these insecticidal compounds. Based on the above information, the Agency concludes that the establishment of the section 408 regulation will protect the public health, and use of the pesticide in accordance with the section 409 regulation will be safe. Based on the currently available information, there has been shown no association between fluoride and cancer and thus the pesticide has not been found to induce cancer in man or animals. Therefore, the tolerance and feed additive regulation are established as set forth below. Residues not in excess of 2.0 ppm remaining in or on the raw agricultural commodity potatoes and 22.0 ppm remaining in or on the processed animal feed potato waste after expiration of the time-limited tolerances will not be considered actionable if the pesticide is legally applied during the term of, and in accordance with, provisions of the tolerance and the feed additive regulation. Any person adversely affected by these regulations may, within 30 days after publication of this document in the Federal Register, file written objections with the Hearing Clerk, at the address given above (40 CFR 178.20). The objections submitted must specify the provisions of the regulations deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fees provided by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, and the requestor's contentions on each such issue, and a summary of the evidence relied upon by the objection (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). The Office of Management and Budget has exempted these rules from the requirements of section 3 of Executive Order 12291. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950). List of Subjects in 40 CFR Parts 180 and 186 Administrative practice and procedure, Agricultural commodities, Animal feeds, Pesticides and pests, Recording and recordkeeping requirements. Dated: April 22, 1993. Douglas D. Campt, Director, Office of Pesticide Programs. Therefore, chapter I of title 40 of the Code of Federal Regulations is amended as follows: PART 180-[AMENDED] 1. In part 180: a. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371. b. In . 180.145, by adding new paragraph (c), to read as follows: . 180.145 Fluorine compounds; tolerances for residues. * * * * * (c) A time-limited tolerance to expire May 6, 1996 is established for residues of the insecticidal fluorine compounds cryolite and synthetic cryolite (sodium aluminum fluoride) in or on the raw agricultural commodity as follows: --------------------------------------------------------------+--------------- Commodity | Parts per | million --------------------------------------------------------------+--------------- | Potatoes..................................................... | 2.0 --------------------------------------------------------------+--------------- PART 186-[AMENDED] 2. In part 186: a. The authority citation continues to read as follows: Authority: 21 U.S.C. 348. b. By adding new . 186.3375, to read as follows: . 186.3375 Fluorine compounds. A time-limited tolerance to expire on May 6, 1996, is established for residues of the insecticidal fluorine compounds cryolite and synthetic cryolite (sodium aluminum fluoride) in the following processed animal feed resulting from application of the compounds to growing crops: ------------------------------------------------------------------------------ Commodity Parts per million ------------------------------------------------------------------------------ Potato waste, process (wet or dry)............................. 22.0 ------------------------------------------------------------------------------ [FR Doc. 93-10578 Filed 5-4-93; 8:45 am] BILLING CODE 6560-50-F