[Federal Register Volume 62, Number 38 (Wednesday, February 26, 1997)] [Notices] [Pages 8734-8735] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-4626] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [PF-706; FRL-5585-7] Bioxy, Inc.; Pesticide Tolerance Petition Filing AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of filing. ----------------------------------------------------------------------- SUMMARY: This notice annonces the filing of a pesticide petition proposing the exemption from the requirement of a tolerance for sodium chlorite residues in or on meat and meat byproducts of cattle, sheep, hogs, goats, horses, and poultry when applied as a bactericide for the generation of chlorine dioxide in livestock drinking water. DATES: Comments, identified by the docket control number PF-706, must be received on or before, March 28, 1997. ADDRESSES: By mail, submit written comments 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 Rm. 1132, CM #2. 1921 Jefferson Davis Highway, Arlington, VA 22202. Comments and data may also be submitted electronically be sending electronic mail (e-mail) to: [email protected]. 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 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by docket control number PF-706. Electronic comments on this notice may be filed online at many Federal Depository Libraries. Additional information on electronic submissions can be found in Unit II. of this document. Information submitted as comments concerning this document may be claimed confidential by marking any part or all of that information as ``Confidential Business Information'' (CBI). CBI should not be submitted through e-mail. Information marked as CBI will not be disclosed except in accordance with procedures 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 may be disclosed publicly by EPA without prior notice. All written comments will be available for public inspection in Rm. 1132 at the address given above, from 8:30 a,.m. to 4 p.m., Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: Vivian A. Turner, Acting Product Manager (PM) 32, Registration Division (7505C), Rm., 237, Crystal Mall #2, Jefferson Davis Highway, Arlington, VA. 703-305-7460. e-mail: [email protected]. SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition (PP 6F4783) from Bioxy, Inc. proposing, pursuant to section 408(d) of the Federal Food, Drug and Cosmetic Act, (FFDCA) 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing an exemption from tolerance for residues of sodium chlorite and its hydrolysis by-product, chlorine dioxide, in or on meat and meat byproducts of cattle, sheep, goats, horses and poultry when such residues result from the use of sodium chlorite to generate the bactericide, chlorine dioxide, in poultry drinking water and livestock drinking water at a concentration of up to 18.34 parts per million (ppm). The proposed analytical method is ultraviolet spectrophotometric analysis. Pursuant to the section 408(d)(2)(A)(i) of the FFDCA, as amended, Bioxy, Inc. has submitted the following summary of information, data and arguments in support of their pesticide petition. This summary was prepared by Bioxy, Inc. and EPA has not fully evaluated the merits of the petition. EPA edited the summary to clarify that the conclusions and arguments were the petitioner's and not necessarily EPA's and to remove certain extraneous material. I. Petition Summary This section has been arranged to provide a justification for this tolerance exemption and a summary of available data. The request is to exempt from the requirement of a tolerance, residues of sodium chlorite and its hydrolysis product, chlorine dioxide, in or on meat and meat byproducts of cattle, sheep, hogs, goats, horses, and poultry, and milk and eggs when such residues result from the use sodium chlorite to generate the bactericide, chlorine dioxide in poultry drinking water and livestock drinking water. EPA has exempted sodium chlorite from the requirement of a tolerance when used as a seed-soak treatment of the raw agricultural commodities (RACs) crop group Brassica (cole) leafy vegetables and radishes (40 CFR 180.170). Sodium chlorate is chemically similar to sodium chlorite, and sodium chlorate is exempt from the requirement of a tolerance when used as a defoliant, desiccant, or fungicide on various RACs (40 CFR 180.1020). Chlorine gas is exempted from the requirement of a tolerance when used pre- or post-harvest in solution on all RACs (40 CFR 180.1095). Calcium hypochlorite is exempted from the requirement of a tolerance when used harvest or postharvest on all RACs and in or on grapes when used as a fumigant [[Page 8735]] postharvest by means of a chlorine generator pad (40 CFR 180.1054). The Agency has determined previously (as stated in the proposal for exemption from the requirement of a tolerance for calcium hypochlorite chlorine gas in the Federal Register of January 11, 1991 (56 FR 1153; FRL-3686-5), that there is no reasonable expectation that residues of these compounds will remain in eggs, meat, milk or poultry in accordance with 40 CFR 180.3. The residues which do remain are not of toxicological significance. A. Residue Chemistry Residues of sodium chlorite are not expected in livestock because it converts to chlorine dioxide in the drinking water and is consumed by biological activity. Because sodium chlorite is highly reactive with minerals, bacteria and other contaminants, the reaction is complete within a few minutes consuming most, if not all of the sodium chlorite. Because there are many active Federal pesticide registrations for sodium chlorite and chlorine dioxide as well as existing tolerance exemptions for both compounds, the Agency has determined that the residue chemistry for these compounds is understood. Adequate analytical methodology is available through spectrophotometric analysis to determine the amounts of sodium chlorite in livestock drinking water. B. Toxicological Profile The acute and chronic toxicity of sodium chlorite and chlorine dioxide have been tested extensively. Adverse effects are not expected when used in the proposed manner. C. Aggregate Exposure There are no established U.S. tolerances for sodium chlorite or chlorine dioxide; however, there are several tolerance exemptions for theses compounds. The addition to aggregate exposure or sodium chlorite or chlorine dioxide as described in this petition is minimal. The estimated non-occupational exposure to sodium chlorite and chlorine dioxide has been evaluated based on its proposed use pattern. The potential for non-occupational exposure under the proposed use to the general population is unlikely. Sodium chlorite and its hydrolysis product, chlorine dioxide, is proposed to be used only on poultry and livestock farms and is not to be used in or around the home. There is no maximum contaminant level for residues of sodium chlorite in drinking water; however, there is a proposed maximum residual disinfectant level (MRDL) for chlorine dioxide of 0.8 milligrams per liter (mg/L) and a MRDL goal of 0.3 mg/L. The MRDL was part of a proposed EPA rulemaking on disinfectants on drinking water on July 29, 1994; however, this rule is not yet finalized. D. Cumulative Effects Sodium chlorate is chemically similar to sodium chlorite, and sodium chlorate is exempt from the requirements of a tolerance when used as a defoliant, desiccant, or fungicide on various RACs (40 CFR 180.1020). Chlorine gas is exempted from the requirement of a tolerance when used preharvest or postharvest in solution on all RACs (40 CFR 180.1095). Calcium hypochlorite is exempted from the requirement of a tolerance when used preharvest or postharvest on all RACs and in or on grapes when used as a fumigant postharvest by means of a chlorine generator pad (40 CFR 180.1054). The agency has determined previously that there is no reasonable expectation that residues of these compounds will remain in eggs, meat, or poultry in accordance with 40 CFR 180.3. The residues which do remain are not of toxicological significance. E. Safety Determination Because sodium chlorite and chlorine dioxide are not expected to accumulate in poultry or livestock tissues and their food byproducts, exposure to the U.S. population and the subgroup infants and children does not pose a significant risk. In addition, chlorine dioxide (the byproduct from the reaction during the proposed use of sodium chlorite) is already present in many municipal drinking water systems, therefore, the exposure to any chlorine dioxide that may be present in animal food products as a result of the proposed use is not expected to cause any additional risk to the general population and the subgroup of infants and children. F. International Tolerances The petitioner understands that there are no current established Maximum Residue Levels for sodium chlorite or chlorine dioxide. II. Public Record Interested persons are invited to submit comments on the this notice of filing. Comments must bear a notation indicating the docket control number, PF-706. A record has been established for this notice under docket control number PF-706 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 8:30 a.m. to 4 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: opp-D[email protected] 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 rulemaking, 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 Virginia address in ``ADDRESSES'' at the beginning of this document. List of Subjects Environmental Protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 13, 1997. Peter Caulkins, Acting Director, Registration Division, Office Pesticide Programs. [FR Doc. 97-4626 Filed 2-25-97; 8:45 am] BILLING CODE 6560-50-F