[Federal Register Volume 63, Number 250 (Wednesday, December 30, 1998)] [Notices] [Pages 71924-71925] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-34292] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-00538A; FRL-6051-4] Announcement of the Availability and Request for Comments on Protocols for Testing the Efficacy of Disinfectants Used to Inactivate Hepatitis B Virus and Corresponding Label Claims AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: EPA is announcing the availability and requesting comments on two protocols for testing the efficacy of disinfectants against Hepatitis B Virus (HBV). The protocols use Duck Hepatitis B Virus (DHBV) in an in-vitro or an in-vivo assay system. These protocols were presented at an HBV workshop which was held on July 23 and 24, 1998 at the Double Tree Hotel, Crystal City, VA. As a result of the workshop EPA agreed to publish the testing protocols and proposed labeling claims in the Federal Register with a 45-day comment period before the Agency makes a final decision about the use of protocols. DATES: Comments, identified by the docket control number (OPP-00538A) should be received on or before February 16, 1999, to be given full consideration. ADDRESSES: Submit comments and other information identified by the docket control number OPP-00538A by mail to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW, Washington DC 20460. In person, bring comments directly to the OPP Docket Office which is located in Rm. 119 of Crystal Mall 2 (CM #2), 1921 Jefferson Davis Highway, Arlington, VA. Comments and data may also be submitted electronically to: opp- [email protected]. Follow the instructions under Unit III of this document. No Confidential Business Information (CBI) should be submitted through e-mail. 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 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. 119 at the Virginia address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: By mail: Ibrahim Barsoum, Antimicrobials Division (7510C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: 308W7, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. Tel. (703) 308-6417, Fax (703) 308- 6466, e-mail: [email protected]. SUPPLEMENTARY INFORMATION: I. Electronic Availability Electronic copies of this document and various support documents are available from the EPA home page at the Federal Register- Environmental Documents entry for this document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/). II. Background EPA held a workshop in July, 1998 to discuss alternative models for testing disinfectants against human HBV. The workshop was attended by representatives from academia, research centers, testing laboratories, and industry. Presentations were given by experts in hepatitis on various animal models of HBV infection followed by [[Page 71925]] technical presentations on in-vitro and in-vivo duck models of infection that might be used in testing disinfectants against HBV. Presentations were followed by a discussion on criteria to be used in decision making about surrogate model(s) and proposed labeling claims of registered products. It was proposed in the workshop to leave the label claim broad, such as ``Effective against HBV'' or ``Hepadnavirucidal'' and not to add information about the test organism. Submitted protocols were evaluated and discussed by all participants. At the end of the workshop an outline was presented, showing the agency's implementation plans for allowing products to be registered with HBV label claims using surrogate animal models. III. Public Record and Electronic Submissions A record has been established for this action under docket number ``OPP-00538A'' (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 Rm. 119 of the Public Information and Records Integrity Branch, Information Resources and Services Division, Office of Pesticide Programs, Environmental Protection Agency, CM #2, 1921 Jefferson Davis Highway, Arlington, VA. Comments and other information may also be submitted electronically by 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 or encryption. Comments will also be accepted on disks in WordPerfect in 5.1/6.1 or ASCII file format. All comments and data in electronic form must be identified by the docket number ``OPP-00538A.'' No CBI should be submitted through e- mail. Electronic comments on this document may be filed online at many Federal Depository Libraries. The official record for this action, 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 record which will also include all comments submitted in writing. The official record is the paper record maintained at the address in ADDRESSES at the beginning of this document. List of Subjects Environmental protection, Antimicrobials, Pesticides and pest, Efficacy testing, Hepatitis Virus B (HBV). Dated: December 17, 1998. Frank Sanders, Director, Antimicrobials Division, Office of Pesticide Programs. [FR Doc. 98-34292 Filed 12-29-98; 8:45 am] BILLING CODE 6560-50-F