[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: mandula.barbara@epamail.epa.gov.
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
