[Federal Register Volume 63, Number 16 (Monday, January 26, 1998)]
[Notices]
[Pages 3742-3743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1766]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00521; FRL-5767-4]


Liquid Chemical Sterilant Products; Notice of Availability of PR 
Notice

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: EPA is announcing the availability of Pesticide Regulation 
(PR) Notice 98-2, entitled ``Liquid Chemical Sterilant Products.'' The 
PR Notice advises applicants and registrants of new FIFRA provisions 
related to liquid chemical sterilants intended for use on critical or 
semi-critical medical devices. Interested parties may request a copy of 
this PR Notice and obtain further information as set forth in the 
Addresses unit of this notice.

ADDRESSES: The PR Notice is available from, by mail: Barbara Mandula, 
Antimicrobials Division (7510W), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
The public record is filed in OPP's Docket Office under docket control 
number ``OPP-00521'', located in Room 119 of the Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Mandula (7510W), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: Sixth Floor, Crystal Station #1, 
2800 Crystal Drive, Arlington, VA, (703) 308-

[[Page 3743]]

7378, fax: (703) 308-8481; e-mail: <a href="/cdn-cgi/l/email-protection#bed3dfd0dacbd2df90dcdfccdcdfccdffedbcedfd3dfd7d290dbcedf90d9d1c8"><span class="__cf_email__" data-cfemail="deb3bfb0baabb2bff0bcbfacbcbfacbf9ebbaebfb3bfb7b2f0bbaebff0b9b1a8">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Electronic Availability:

Internet
    Electronic copies of this document and the PR Notice 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/).


Fax on Demand
    Using a faxphone call 202-401-0527 and select item (6107) for a 
copy of the PR Notice.


I. Purpose

    The purpose of the PR Notice is to announce that liquid chemical 
sterilant products intended for use on critical or semi-critical 
medical devices are no longer regulated as ``pesticides'' by the 
Environmental Protection Agency (EPA), but as ``medical devices'' under 
the regulatory authority of the Food and Drug Administration (FDA). For 
the affected liquid chemical sterilants, EPA will no longer follow the 
procedures described in the Memorandum of Understanding (MOU) between 
EPA and FDA signed on June 4, 1993 and amended on June 20, 1994. The 
goal of this notice is to clarify the authorities of FDA and EPA as 
they apply to liquid chemical sterilants, thereby increasing the 
efficiency of regulatory processes affecting these products.

II. Applicability

    The PR Notice applies to all manufacturers, formulators, producers, 
and registrants of liquid chemical sterilant products intended for use 
on critical or semi-critical medical devices, and to products with 
subordinate disinfectant claims, such as tuberculocidal or virucidal 
claims, which support a high level disinfectant use pattern for 
critical or semi-critical devices.

III. Contents of the PR Notice

    This notice informs registrants of liquid chemical sterilant 
products how to ensure that their products remain in compliance with 
FIFRA requirements where FIFRA still applies, and how products no 
longer regulated under FIFRA will be treated by EPA. In particular, the 
affected products will no longer be permitted to bear both FDA- and 
EPA-regulated claims. This notice supersedes all provisions of PR 
Notice 94-4 with respect to liquid chemical sterilants, but retains the 
provisions of PR Notice 94-4 that apply solely to general purpose 
disinfectants.

List of Subjects

    Environmental protection, Antimicrobials, Liquid chemical 
sterilants.

    Dated: January 15, 1998.

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

[FR Doc. 98-1766 Filed 1-23-98; 8:45 am]
BILLING CODE 6560-50-F


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