[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]


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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.

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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