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Cryolite. May 8, 1996. Pesticide Tolerance and Feed Additive Regulation. Federal Register.
[Federal Register: May 8, 1996 (Volume 61, Number 90)] [Notices] [Page 20816-20817] >From the Federal Register Online via GPO Access [wais.access.gpo.gov] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 180 and 186 [PP 9F3739 FAP 1H5604/P654; FRL-5362-6] RIN 2070-AC18 Fluorine Compounds; Pesticide Tolerance and Feed Additive Regulation AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: EPA proposes to establish a pesticide tolerance for residues of the insecticidal fluorine compounds 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 feed additive regulation for the animal feed commodity, potato waste resulting from the processing of treated potatoes at 22.0 ppm. The proposed tolerance and regulation to establish maximum permissible levels for residues of the pesticide in or on the commodities were requested in petitions submitted by Attochem North America, Inc. DATES: Comments, identified by the docket control number [PP 9F3739 and FAP 1H5604/P654], must be received on or before June 7, 1996. ADDRESSES: Submit written comments by mail to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring comments to: Public Docket, Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. Comments and data may also be submitted electronically by sending electronic mail (e-mail) to: email@example.com. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in WordPerfect in 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket number (PP 9F3739 and FAP 1H5604/P654). No Confidential Business Information (CBI) should be submitted through e-mail. Electronic comments on this proposed rule may be filed online at many Federal Depository Libraries. Additional information on electronic submissions can be found below in this document. Information submitted as a comment concerning this document may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures as set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential will be included in the public docket by EPA without prior notice. The public docket is available for public inspection in Rm. 1132 at the above address, from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: By mail: Robert A. Forrest, Product Manager (PM) 14, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: Rm. 219, CM #2, 1921 Jefferson Davis Highway, Arlington, VA, (703) 305-6600, e-mail: firstname.lastname@example.org. SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the Federal Register of May 5, 1993 (58 FR 26687), which announced the establishment of a 3-year time-limited tolerance for residues of the insecticidal fluorine compounds cryolite and synthetic cryolite (sodium aluminum fluoride) on potatoes and the establishment of a 3-year time- limited feed additive regulation for residues of these compounds in processed potato waste (wet or dry). These regulations were established for a period extending to May 6, 1996, to cover residues existing from the conditional registration of the insecticidal compounds on potatoes extending to September 30, 1995. The Agency limited the period of time the conditional registration and the regulations were to be in effect because of the lack of a chronic dog feeding study and a two-generation rat reproduction study. These two studies have been received and have been found to be acceptable. Pesticide petition 9F3739 requests that the Administrator, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), amend 40 CFR 180 by establishing a tolerance for residues of the insecticidal fluorine compounds in or on the raw agricultural commodity potatoes at 2.0 ppm with no time limitations. Food additive petition 1H5604 requests that the Administrator, pursuant to section 409(b) of the FFDCA (21 U.S.C. 348), amend 40 CFR part 186 by establishing a feed additive regulation for residues of the insecticidal compounds in or on the processed animal feed commodity processed potato waste (wet or dry) at 22.0 ppm with no time limitations. To meet the current definition, the commodity, "processed potato waste (wet or dry)" is corrected to read as follows: potatoes, waste from processing. I. Background Information Fluoride has been identified as the residue of toxicological concern in cryolite and synthetic cryolite and the available data show that these compounds which are approximately 52.8% fluoride, act as free fluoride. Fluoride is ubiquitous and may be present at low levels in air, soils and in foodstuffs that have not been treated with cryolite and/or synthetic cryolite as well as in drinking water. The atmospheric levels of fluoride and incidental dietary exposures to fluoride as a toothpaste additive or as a dental treatment contribute relatively little to the average level of dietary fluoride exposure and are not further considered in the exposure estimate. 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 and regulation cannot distinguish between the naturally occurring fluoride and the fluoride resulting from use of cryolite and/or synthetic cryolite. Fluoride levels in public drinking water are regulated under the Safe Drinking Water Act. EPA has established a Maximum Concentration Limit (MCL) at 4.0 mg/L [0.114 mg/kg/day] to protect against crippling skeletal fluorosis (51 FR 11396, April 2, 1986). The MCL established on April 2, 1986, finalizes interim regulations set in November 14, 1985 (50 FR 47142), and proposed in the Federal Register of May 14, 1985 (50 FR 20164). In addition, these FR notices established a Secondary Maximum Contaminant Level (SMCL) at 2.0 mg/L [0.057 mg/kg/day] for cosmetic effects (objectionable dental fluorosis) which are not considered to be adverse health effects by the Surgeon General. The EPA Office of Drinking Water issued a Drinking Water Criteria Document on Fluoride (October 21, 1985) which presents summaries of experimental and clinical data on the health effects of fluoride in animals and humans. In general, the health effects of fluoride include dental fluorosis and skeletal fluorosis. At the request of the EPA, the U.S. Surgeon General examined the nondental health aspects associated with fluoride in drinking water. The Surgeon General concluded that he did not consider changes in bone density to be an adverse health effect and that adverse effects (arthralgias) are not likely to occur at human dose levels below 20 mg F/day (10 mg F/L for an adult consuming 2 L water/day [0.29 mg/ kg/day]). The ad hoc committee concluded that four times the optimal fluoride concentration (approximately 4 mg F/L [0.114 mg/kg/day]) in drinking water should provide an adequate margin of safety for preventing adverse health effects which were not documented to occur in the U.S. population below 8 mg F/L [0.23 mg/kg/day]. (Water Criteria Document p. IX-21). II. Toxicological Data The scientific data submitted in the petitions and other relevant material have been evaluated. The toxicological data considered in support of the proposed tolerance and regulation include: 1. A 2-year rat bioassay 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 only observed in one male in the 100 ppm group and in three males in the 175 ppm group. NTP considers this to be equivocal evidence of carcinogenicity in male F344/N rats. The NOEL is less than 25 ppm (1.3 mg/kg/day). The LOEL is 25 ppm (1.3 mg/ kg/day) based on 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. There was "equivocal evidence" of carcinogenic activity in male rats and "no evidence" of carcinogenic activity in female rats. 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. 2. A 2-year mouse bioassay conducted by the NTP utilizing 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 NOEL is less than 25 ppm (2.4 mg/kg/day). The LOEL is 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. There was "no evidence" of carcinogenic activity in male and female mice. 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 1-year chronic dog feeding study 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 1139 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 NOEL (in terms of cryolite) is less than 3,000 ppm (95 mg/kg/ day in males and 105 mg/kg/day in females). The LOEL is 3,000 ppm (95 mg/kg/day) based on increases in emesis, nucleated cells in males, renal lesions and a decrease in urine specific gravity in females. 4. A two-generation reproduction study conducted with cryolite in the diet of rats at dose levels of 0, 200, 600, and 1,800 ppm (representing 0, 14, 42, and 128 mg/kg/day for males and 0, 16, 49, and 149 mg/kg/day for females, respectively, during premating). The systemic toxicity NOEL was not determined. The LOEL for systemic toxicity was 200 ppm (15 mg/kg/day) based on dental fluorosis. The NOEL and LOEL for reproductive toxicity were 600 and 1,800 ppm, respectively (46 and 138 mg/kg/day) based on decreased pup body weights. 5. A developmental toxicity study conducted with cryolite in rats at dose levels of 0, 750, 1,500, and 3,000 mg/kg/day (gavage). The NOEL for both developmental and maternal toxicity is 3,000 mg/kg/day. At this dose level, the only observation was whitening of the teeth of dams. 6. A developmental toxicity study conducted in female mice with cryolite at dose levels of 0, 30, 100 and 300 mg/kg/day (gavage). The NOEL for maternal toxicity is 30 mg/kg/day and the LOEL is 100 mg/kg/day based on the occurrence of dark red contents of the stomach. Fetuses at 300 mg/kg/day exhibited bent ribs and bent limb bones. The NOEL for developmental toxicity is 100 mg/kg/day. The LOEL is 300 mg/kg/day based on an increase in bent ribs and bent limbs. 7. A range-finding developmental toxicity study conducted in female rabbits with cryolite at dose levels of 0, 10, 30, 100, 300 and 1,000 mg/kg/day (gavage). The NOEL for maternal toxicity is 10 mg/kg/day and the LOEL is 30 mg/kg/day based on an increased incidence of soft stool and dark colored feces and decreased defecation and urination. The NOEL for developmental toxicity is 30 mg/kg/day. The LOEL could not be assessed due to excessive toxicity at dose levels of <gr-thn-eq>30 mg/kg/day. This study suggested that severe maternal toxicity occurred at lower doses than external developmental toxicity. However, following an extensive literature evaluation, the National Research Council (National Academy of Sciences Subcommittee of Health Effects of Ingested Fluoride) (NAS) determined that, There have been reports of adverse effects on reproductive outcomes associated with high levels of fluoride intake in many animal species. In most of the studies, however, the fluoride concentrations associated with adverse effects were far higher than those encountered in drinking water. . . . Based on these findings, the subcommittee concludes that the fluoride concentrations associated with adverse reproductive effects in animals are far higher than those to which human populations are exposed. Consequently, ingestion of fluoride at current concentrations should have no adverse effects on human reproduction. Therefore, an additional developmental study in rabbits is not required. 8. A 28-day range-finding feeding study conducted with cryolite in rats 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) with the only compound related effect being a change in coloration and physical property of the teeth. The NOEL was not determined. The LOEL is 250 ppm (25 mg/kg/day) based on dental fluorosis. 9. A 90-day rat feeding study conducted with cryolite 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 NOEL is 50 ppm (3.8 mg/kg/day) for effects other than fluoride accumulation. The LOEL is 5,000 ppm (399.2 mg/kg/day) based on lesions observed in the stomach. Fluoride accumulated at all dose levels. 10. A 90-day dog feeding study conducted with cryolite at dose levels of 0, 500, 10,000, and 50,000 ppm (corresponding to 0, 17, 368 and 1,692 mg/kg/day). The NOEL is 10,000 ppm (368 mg/kg/day). The LOEL is 50,000 ppm (1,692 mg/kg/day) for effects other than fluoride accumulation. Fluoride accumulation occurred at all dose levels. 11. Genotoxicity studies including an Ames test (negative) at dose levels of 167, 500, 1,670, 5,000, 7,500 and 10,000 ug/plate; an in vitro assay in human lymphocytes (negative) at 100, 500, and 1,000 ug/ ml; and an unscheduled DNA synthesis study in rat hepatocytes (negative) at dose levels up to and including 50 ug/ml. 12. Open literature studies showing that human and animal metabolism of cryolite and/or synthetic cryolite manifests itself as normal free fluoride metabolism. That is, dissociation occurs, producing free fluoride ions which are assimilated into bone. The available toxicity data are considered adequate to support the proposed regulations to establish maximum permissible levels for residues of the insecticidal fluorine compounds in or on potatoes and in processed potato waste. The available information does not support the regulation of the cryolite insecticides as carcinogens. 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." EPA is in agreement with the conclusions reached by the National Academy of Science (NAS). Rather than the establishment of the traditional Reference Dose (RfD), a weight-of-the-evidence risk assessment was determined by the Agency to be a more appropriate approach for the assessment of the dietary exposure to fluoride residues as a result of agricultural uses of cryolite for the following reasons: -- National and international regulatory organizations (U.S. EPA Office of Water, U.S. DHHS, the Canadian Government, and the World Health Organization) have assessed potential health risks from exposure to fluoride. The endpoints and estimated effect levels documented by these organizations are similar. -- The U.S. Surgeon General (Koop, 1984 and Elders, 1994) has recommended a guideline level of exposure that should provide an adequate "margin of safety" based on a large amount of human data, including epidemiology studies. -- Animal data considered in evaluating the proposed regulations are consistent with human data with respect to dose-related skeletal effects. The weight-of-the-evidence dietary risk assessment was conducted utilizing the following factors. All calculations are based on 2 L/day water consumption and 70 kg adult. -- There exists no directly applicable scientific documentation of adverse medical effects at levels of fluoride below 8 mg/L [0.23 mg/kg/day]. (U.S. EPA. 1985. National Primary Drinking Water Regulations; Fluoride. Proposed Rulemaking. (50 FR 20166, May 14, 1985). -- Less than 0.4% of the U.S. population (on public water supplies) is exposed to greater than 2 mg/L fluoride [0.057 mg/kg/day] in the public water supply. (U.S. EPA. 1985. Drinking Water Criteria Document on Fluoride. U.S. EPA Office of Drinking Water, Washington, D.C. TR-832-5. pg. IV-3, Table IV-1.) -- Dietary exposure estimates using reassessed tolerances including the subject proposed tolerance and regulation for potatoes and percent of crops treated are approximately 0.029 mg/kg/day for the U.S. population and 0.038 mg/kg/day for the highest exposed subgroup (females 20 years old and over). Therefore, it can be concluded that 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 dietary intake of fluoride of approximately 0.095 mg/kg/day. This is less than the Maximum Concentration Limit (MCL) of 4.0 mg/L [0.114 mg/kg/day], a level which provides no known or anticipated adverse health effect as determined by the Surgeon General. The estimated dietary exposure resulting from the subject proposed tolerance on potatoes is approximately 0.00016 mg/kg/day. The metabolism of the subject insecticides in plants and animals is adequately understood. Plant residues are inorganic surface residues of cryolite which are measured as total fluoride. Cryolite metabolism in animals manifests itself as free fluorine metabolism and 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 the animal feed, 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 this tolerance and regulation 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., 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 resulting from the processing of 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. There are presently no actions pending against the continued registration of these insecticidal compounds. The pesticide is considered useful for the purpose for which the tolerance is sought and capable of achieving its physical or technical effect. Based on the information and data considered, the Agency has determined that the tolerance established by amending 40 CFR part 180 would protect the public health, and the establishment of a feed additive regulation by amending 40 CFR part 186 would be safe. Therefore, it is proposed that they be established as set forth below. Any person who has registered or submitted an application for registration of a pesticide, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, which contains any of the ingredients listed herein, may request within 30 days after publication of this notice in the Federal Register that this rulemaking proposal as it relates to the section 408 tolerance be referred to an Advisory Committee in accordance with section 408(e) of the FFDCA. Interested persons are invited to submit written comments on the proposed regulation. Comments must bear a notation indicating the document control number, PP 9F3739 and FAP 1H5604/P. All written comments filed in response to this petition will be available in the Public Response and Program Resources Branch at the above address from 8 a.m. to 4:30 p.m., Monday through Friday, except legal holidays. A record has been established for this proposal under docket number (PP 9F3739 and FAP 1H5604/P654) (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The public record is located in Room 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. Electronic comments can be sent directly to EPA at: email@example.com Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. The official record for this proposal, as well as the public version, as described above will be kept in paper form. Accordingly, EPA will transfer all comments received electronically into printed, paper form as they are received and will place the paper copies in the official rulemaking record which will also include all comments submitted directly in writing. The official rulemaking record is the paper record maintained at the address in ADDRESSES at the beginning of this document. Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is "significant" and therefore subject to all the requirements of the Executive Order (i.e., Regulatory Impact Analysis, review by the Office of Management and Budget (OMB)). Under section 3(f), the order defines "significant" as those actions likely to lead to a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also known as "economically significant"); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of this Executive Order, EPA has determined that this rule is not "significant" and is therefore not subject to OMB review. In addition, this action does not impose any enforceable duty, or contain any "unfunded mandates" as described in Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as specified by Executive Order 12875 (58 FR 58093, October 28, 1993), entitled Enhancing the Intergovernmental Partnership, or special consideration as required by Executive Order 12898 (59 FR 7629, February 16, 1994). 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, or establishing or raising food additive regulations 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 Environmental protection, Administrative practice and procedure, Agricultural commodities, Animal feed, Food additive, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 30, 1996. Stephen L. Johnson, Director, Registration Division, Office of Pesticide Programs. Therefore, it is proposed that chapter I of title 40 be 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 Sec. 180.145, by adding a commodity to paragraph (a) in the table therein and deleting paragraph (c) to read as follows: Sec. 180.145 Fluoride compounds; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Commodity Parts per million ------------------------------------------------------------------------ * * * * * Potatoes 2.0 * * * * * ------------------------------------------------------------------------ * * * * * PART 186--[AMENDED] 2. In part 186: a. The authority citation for part 186 continues to read as follows: Authority: 21 U.S.C. 348. b. Section 186.3375 is revised to read as follows: Sec. 186.3375 Fluorine compounds. A tolerance is established for residues of the insecticidal fluorine compounds cryolite and synthetic cryolite (sodium aluminum fluoride) in the following ready-to-eat animal feed resulting from application of the compounds to growing crops: ------------------------------------------------------------------------ Commodity Parts per million ------------------------------------------------------------------------ Potatoes, waste from processing 22.0 ------------------------------------------------------------------------