[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