```
[Federal Register Volume 63, Number 108 (Friday, June 5, 1998)]
[Notices]
[Pages 30747-30748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15011]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-00538; FRL-5792-8]

Announcement of a Workshop to Develop a Protocol for Testing the 
Efficacy of Disinfectants Used to Inactivate Hepatitis B Virus

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA is announcing a public workshop to be held July 23 and 24, 
1998, in the Washington DC area. The purpose of this workshop is to 
allow all interested parties to have input in developing a new and 
usable protocol, using a surrogate test species such as ``Duck'', for 
testing the efficacy of disinfectants used to inactivate Hepatitis B 
Virus (HBV). The Agency is requesting that interested parties send in 
any protocols and other information that they would want to be included 
in the deliberations of the workshop. A package of pertinent 
information, including the workshop agenda, will be sent to the 
participants before the workshop. The workshop will be structured to 
allow the participants to discuss all issues that are germane to the 
development of a workable test protocol.

DATES: Protocols, other information, and comments, identified by the 
docket number [OPP-00538], should be received on or before July 6, 1998 
to be given full consideration.

ADDRESSES: Submit protocols and other information identified by the 
docket control number OPP-00538 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, 1921 Jefferson Davis Highway, Arlington, VA.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
Confidential Business Information (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 may be disclosed publicly by EPA without prior notice.

FOR FURTHER INFORMATION CONTACT: By mail: Ibrahim Barsoum, 
Antimicrobials Division (7510W), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: 6W23, Crystal Station #1, 2800 
Crystal Drive, Arlington, VA, (703) 308-6417, fax: 703-308-6466, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    EPA has the authority through FIFRA to register antimicrobial 
pesticides. For public health pesticides, OPP reviews the submitted 
data for efficacy as well as safety. Guidelines have been developed for 
methods and performance standards which are used to test the efficacy 
of the various types of antimicrobial products that need to be 
registered.

II. Hepatitis Virus B Testing

    The Agency has approved registrations for products that have 
Hepatitis Virus B claims based on a method using chimpanzees as the 
test subject. The continued use of the chimpanzee test is in doubt 
because the test is very expensive, which means that only one animal 
can be economically used for each test. An OPP Scientific Advisory 
Panel Meeting in September 1997 recommended that EPA look at 
alternative test systems, such as tests using Duck Hepatitis Virus B, 
in order to produce a new method to replace the chimpanzee test. EPA 
has decided to conduct a workshop in order to develop a new protocol 
for HBV efficacy testing. The workshop is being planned to include all 
parties interested in this issue. The group's goal will be to provide 
information that will aid EPA's development of a workable protocol. The 
Agency will be responsible for developing the actual protocol suitable 
for testing and validation.

III. Workshop Process

    The two-day workshop will concentrate on producing an effective 
protocol that will replace the chimpanzee test. EPA anticipates that 
individuals from academia, industry, health care facilities, other 
federal agencies and public health advocacy groups will attend the 
workshop. The Agency is requesting that all interested parties submit 
any information that would be relevant for developing a new protocol. 
Submissions could include protocols developed by the submitters and 
those found in the open literature. EPA requests that submitters not 
claim the materials as confidential because the Agency would like to 
disseminate the materials to the public. Any confidential information 
sent into the Agency for the workshop would be used internally by EPA 
scientists in identifying appropriate topics to be discussed, but would 
not be included in the information that would be provided to the 
participants. Any other pertinent information that interested parties 
feel would be helpful to the Agency in setting the workshop agenda, 
especially scientific issues that need to be discussed and names of 
individuals who should specifically be invited to attend, should be 
sent to the Agency as indicated under ADDRESSES or Unit V. The goal of 
the workshop will be for EPA to develop a draft protocol for 
validation.

IV. Workshop Follow up

    Once EPA produces a protocol, it will be disseminated to the 
public, including the regulated community, and to testing laboratories 
for immediate use. If an applicant submits data using the new protocol, 
and EPA decides to register the product based on the results of the 
study along with the other required information, the registration will 
be time limited. This approach allows products to be registered and 
used during the time it takes for the AOAC validation. However, the 
registration will automatically expire, if the test protocol does not 
pass the validation process. EPA anticipates allowing a two year 
registration that may be renewed if

[[Page 30748]]

more time is needed to complete the validation process.

V. Public Record and Electronic Submissions

    A record has been established for this action under docket number 
``OPP-00538'' (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, Crystal Mall 
#2, 1921 Jefferson Davis Highway, Arlington, VA.
    Protocols and other information may also be submitted 
electronically by sending electronic mail (e-mail) to: opp-[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-00538.'' 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, Efficacy testing, 
Hepatitis Virus B (HBV), Pesticides.

    Dated: June 1, 1998.

Frank T. Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.

[FR Doc. 98-15011 Filed 6-4-98; 8:45 am]
BILLING CODE 6560-50-F
```