EPA 730-N-98-002

       \                      WASHINGTON, D.C. 20460 ,
                                    January 15, 1998
                                                                          OFFICE OF
                                                                    PREVENTION, PESTICIDES AND
                                                                       TOXIC SUBSTANCES
                      PESTICIDE REGULATION (PR) NOTICE 98-2


  ATTENTION:       Persons Responsible for Registration of Antimicrobial Pesticides

  SUBJECT:          Liquid Chemical Sterilant Products
         This notice advises applicants/registrants of antimicrobial pesticide products of new
  FIFRA provisions for liquid chemical sterilant products that are intended for use on critical or
  semi-critical devices. As described in this notice, these products 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).  The statutory change in
  authority was effective on August'3,1996. EPA retains jurisdiction for liquid chemical sterilant
  products that are not intended for use on critical or semi-critical devices.

         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. The key provisions of
  this notice are as follows.

         o     Producers of liquid chemical sterilant products  that are now solely under
               FDA jurisdiction should remove all EPA references such as the Registration
               No. and the Establishment No. from their labels.

         o     Registrants of products that bear mixed FDA- and EPA-regulated claims
               must "split" their product labels to include only EPA-regulated claims for
               their pesticide products, and should state only FDA-regulated claims for
               their medical devices.

         o     Registrants of products that are solely under EPA jurisdiction, and that
               comply with EPA requirements for general purpose disinfectants covered
               under PR Notice 94-4, are not required to take any action under this notice.
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       In order to remain in compliance with FIFRA, as soon as ; possible but no later than 120
days after issuance of this notice, affected registrants with mixed FDA- and EPA-regulated
cl^fmust submit to EPA applications for amendment to delete ^FDA-reflated I clanns. Jhe
cutoff date for registrant sale or distribution of product currently labeled with botfi EPA- and
FDA- regulated claims is October 1, 1998. There is no cutoff date for products that are in
channels of trade as of October 1, 1998. However, EPA strongly encourages early submission of
applications and relabeling of products to minimize the confusion of products with mixed FDA-
and EPA- regulated claims in channels of trade.


       This notice applies to products that are liquid chemical sterilants, intended for use on
critical or semi-critical devices, and subordinate disinfectant claims for critical or semi-cntical
devices such as tuberculocidal or virucidal claims which support a high level disinfectant use
nattem  The terms "high level disinfectant" and "high level disinfection" are terms of art used by
die public health community and are recognized by FDA as a separate or subcategory of
Slants. Accordingly, the terms "high level disinfectant" or "high level disinfection" will be
used throughout this document in discussing FDA-regulated claims. For a discussion of these
and other relevant terms used throughout this document refer to PR Notice 94-4.

        This notice does not affect:

        A. Products not bearing sterilant claims, regardless of use site.

        B Any gaseous chemical sterilant, such as ethylene oxide, regardless of use site and any
  other type of chemical sterilant that is distributed and sold in non-liquid form, even if in use it
  will be hi liquid form.

        C Liquid chemical sterilants intended solely for use on surfaces other than critical or
  semi-critical devices, e.g., environmental surfaces or manufacturing and packaging processes
  TteZL critical and semi-critical devices are defined by FDA in terms of their use in or on the
  human body. Liquid chemical sterilants intended for sterilization of similar veterinary devices
  are regulated by EPA.


         To address the concurrent jurisdiction of EPA and FDA over cer^ liquid chemical
  fSS lot June 4, 1993. The MOU was amended on June 20, 1994. The MOU (1) provides that
  EPA would undertake rulemaking to permanently vest exclusive jurisdiction for certain
  cJtego^es ofTiquid chemical germicides with FDA, and FDA would exempt certain categories of
  Schemic J [germicides from premarket clearance, and (2) serves as interim guidance to
  minimize duplicate regulatory requirements until the rulemaking is complete.

       Under the MOU, each Agency was given lead responsibility over one of the two
categories of liquid chemical germicides considered to be devices.  FDA took primary
responsibility over certain liquid chemical sterilants, which also included responsibility over high
level disinfectant claims, such as subordinate tuberculocidal, virucidal, and fungicidal claims,
associated with the use of these products on critical or semi-critical devices.  EPA retained
primary responsibility over the general purpose disinfectants.

       On June 30, 1994, EPA issued PR Notice 94-4, which provided detailed guidance on
interim EPA registration procedures for liquid chemical sterilants and general purpose
disinfectant products affected by the June 4, 1993 MOU.  Registrants were reminded that FDA
approval of their products was needed. According to FDA, a product regulated by FDA that is
not in compliance with FDA requirements may not be sold or distributed in interstate commerce.


       Before either Agency was able to issue regulations under the MOU, the Food Quality
Protection Act of 1996 (FQPA) was enacted. Among other things, this law amended  section 2(u)
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to remove from the
definition of "pesticide" liquid chemical sterilants for use on critical or semi-critical devices (and
subordinate disinfectant claims on those products). The result is that such products and their
affected claims are no longer regulated as pesticide products. The relevant portion of sec. 2(u) is
as follows:

       The term "pesticide" does not include liquid chemical sterilant products (including any steriiaBt or
       subordinate disinfectant claims on such products) for use on a critical or semi-critical device, as
       defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). For purposes of
       the preceding sentence, the term "critical device" includes any device which is introduced directly into
       the human body, either into or in contact with the bloodstream or normally sterile areas of the body and
       the term "semi-critical device" includes any device which contacts intact mucous membranes but
       which does not ordinarily penetrate the blood barrier or otherwise  enter normally sterile areas of the

       This change in FIFRA vests exclusive jurisdiction for affected liquid chemical sterilants
with FDA.  EPA no longer needs to issue regulations to transfer authority, and will no longer
follow the procedures described in the MOU with respect to  these products.  After these products
no longer bear any EPA-regulated claims (as discussed in Section V), they will be subject solely
to the regulatory and enforcement requirements of FDA.  However, this does not affect
enforcement or regulatory actions against affected products that are based upon actions that took
place before August 3, 1996.

        EPA retains jurisdiction for all pesticide uses of non-liquid chemical sterilants including
 ethylene oxide and for liquid chemical sterilants which bear  claims for use on devices, surfaces,
 or objects other than critical or semi-critical devices. These  products include, but are not limited
 to:  sterilants used on veterinary instruments, environmental surfaces, and in manufacturing and
 packaging processes.


       Registrants should note that, since there are no channels of trade date (see Section V I),
existing stSf products bearing mixed claims that are sold or distributed by the registrant on
or SeStoWl, 1998, may remain in commerce after products have been  split" pursuant to
this notice. EPA retains jurisdiction over a product as long as any EPA-regulated
claim appears on the labeling.

       The interim measures outlined in the MOU and PR Notice 94-4 relating to general
purpose disinfectants remain in effect until FDA completes rulemaking to exempt these products
from FDA premarket clearance requirements.


       The following Agency policy pertains to all liquid chemical sterilant products for use on
critical or semi-critical devices.                                •      .

       A  New products.  EPA will not accept any application for registration of a liquid
       chemical sterilant which bears sterilant only.or sterilant and subordinant disinfectant
       claims for use on critical or semi-critical devices. Persons who wish to market new
       products with such claims should contact the FDA Liaison Officer listed in Section X. If
        any applications are currently pending with the Agency, EPA will administratively
        withdraw them as of the date of issuance of this notice without further notice to

        B  Registered products with finfe FDA-regulated claims.  As of August 3,1996,
        registered products bearing only sterilant and subordinant disinfectant claims for use on
        critical or semi-critical devices, which are regulated by FDA, were no longer required to
        be, and are no longer considered to be, registered under FIFRA. EPA will
        adrninistratively withdraw the registrations of such products effective as of the date of
        issuance of this notice. Registrants of these products are not required to request
        cancellation of registration for these products. Effective at the same time, EPA will also
        stop review of, and administratively withdraw, any pending actions  for these registrations.
        If a registrant or producer intends to continue to market these products under FDA_
        jurisdiction, he should remove all EPA references from the labeling, including the EPA
        Registration number and EPA establishment number (see Section V),

         C  Registered products with mixed claims. A liquid chemical sterilant regulated by
         EPA under FIFRA may not bear mixed claims (that is, claims for both. FDA-regulated
         critical or semi-critical devices, and general purpose disinfection or other use sites that
         are EPA-regulated). The registrant must modify the registration as  described in Section V
         in order to remain in compliance with FIFRA.


       A. Products bearing mixed claims. A registrant whose liquid chemical sterilant
product bears mixed claims for sterilant use, or sterilant and subordinant disinfectant claims, on
critical or semi-critical devices along with such claims on other sites, or general purpose or other
uses, and who wishes to retain his product registration under FIFRA, must amend the product
registration by deleting all claims for any use on critical or semi-critical devices. Because FIFRA
has been modified, EPA is allowing an additional period-of time to ensure that all EPA-regulated
products are in compliance.

       1.  Because critical or semi-critical device use sites on pesticide labeling are not always
       explicit, i.e., the unqualified term "hard surface" may be interpreted by the user to include
       critical or semicritical devices, EPA must approve the proposed deletion.  Therefore, a
       registrant may delete such claims only by amendment.  Amendment by notification is not

       2. Submit1 an application for amended registration (EPA Form 8570-1), together with 2
       copies of the current approved labeling, marked to indicate the critical or semi-critical
       device uses to be deleted. (Please do not simply highlight the marked text-highlighting
       does not photocopy). On the Application for Amendment, include in Section H, the
       statement:  "Amendment to remove claims for use as a sterilant on critical or semi-critical
       devices per PR Notice 98-2."                      !

       3. Submit applications for amendment as soon as possible, but no later than 120 days of
       issuance of this notice. Applications for deletion will be treated as "minor amendments,"
       with a decision time of 90 days. Once new labels are approved, EPA encourages
       registrants to begin promptly to relabel products with the new labels, even though
       products may continue to be sold or distributed by the registrant under the old label until
       October 1,1998.

       B. Liquid chemical sterilants bearing EPA references. For any liquid chemical
 sterilant that was previously registered by EPA but now is regulated solely by FDA which
 currently bears an EPA Registration number and EPA establishment number, the producer should
 revise the label to delete all such EPA references. No submission to EPA is required for this
 purpose.                                  .

        C. Registrants are reminded that they are responsible for ensuring that their
 (supplemental).distributor products, comply with the FIFRA requirements described in this
 notice.                                                 :
     1  the collection of information related to the registration of pesticide products has been approved by the Office of
  Management and Budget under the Paperwork Reduction Act under OMB Control Number 2070-0060. TTiis approval expms
  May 31, 1998.



      Applications should be sent to the following addresses:

      By US mail:

             Document Processing Desk (AMEND)
             Office of Pesticide Programs (7504C)
             U.S. Environmental Protection Agency
             401 M Street, S.W.
             Washington, D.C. 20460-0001

       Courier Deliveries Monday - Friday, 8:00 AM to 4:30 PM
       Excluding Holidays:

             Office of Pesticide Programs
             Document Processing Desk (AMEND)
             Room 266A, Crystal Mall 2
              1921 Jefferson Davis Highway
             Arlington, Virginia  22202


       The change of authority for liquid chemical sterilants for use on critical or semi-critical
 devices from mutual EPA and FDA authority to exclusive FDA authority is the result of changes
 in FIFRA. EPA's purpose in providing this guidance is to accomplish the transition in an orderly
 fashion without undue disruption in the marketing or use of these products.

       EPA recognizes a need to minimize confusion in the user community caused by this
 transition  Therefore EPA is establishing a final date after which registrants may no longer
 distribute or sell non-complying product into commerce. PR Notice 94-4 established a registrant
 compliance date of October 1,1995. In light of the FIFRA revision, EPA is extendrng the
 registrant compliance date until October 1,1998.

        Liquid chemical sterilants with both approved FDA labeling and approved EPA labeling
 will be in compliance with FIFRA until October 1,1998, except that this notice does not
 authorize distribution or sale of a product that currently may not be distributed or sold because of
 an existing EPA enforcement or regulatory action.

        EPA sees no reason to require that product already in commerce be recalled or relabeled.
 Therefore, EPA is eliminating the October 1, 1997 channels of trade date established by PR
 Notice 94-4.

      Accordingly the following dates apply:

      ••After approval of amendment (but no later than October 1, 1998). A registrant may
      begin to sell or distribute an EPA-registered product that has been amended to delete
      FDA-regulated claims as soon as EPA has approved the deletion.

      »After October 1,1998:

      1. An FDA-regulated liquid chemical sterilant for use on critical or semi-critical devices
      should comply only with FDA requirements. The label should not bear any EPA
      references, such as an EPA Registration Number or establishment number.

      2. A registrant may not distribute or sell an EPA-registered product bearing FDA-
      regulated sterilant claims (or subordinant disinfectant claims).  Such a product may be
      deemed to be misbranded under FIFRA.

      3. Registrants must maintain a sales inventory of their products with mixed labeling
      claims to verify that products bearing mixed labeling claims in channels of trade after
      October 1,1998 were distributed or sold on or before October 1, 1998.
                                                      ,  !

Vffl. PR NOTICE 94-4

      A. Liquid  Chemical Sterilants For Use On Critical or Semi-critical Devices. This
notice supersedes all provisions of PR Notice 94-4 with respect to liquid chemical sterilants.
Section IV of that notice contained procedures for EPA registration of liquid chemical sterilants
for use on critical or semi-critical devices. Section VI of that notice stated that FDA package
inserts for liquid chemical sterilants for use on critical or semi-critical devices were required to
meet EPA labeling requirements. Those requirements no longer apply. Refer to PR Notice 94-4
for a discussion of these requirements.

       B. General Purpose Disinfectants. The provisions of PR Notice 94-4 that apply solely
to general purpose  disinfectants continue to apply. Moreoever, PR Notice 94-4 applies to
products that become general purpose disinfectants by deleting FDA-regulated sterilant claims
for use on critical or semi-critical devices. Sections V and VI of that notice required labeling
statements prohibiting use as a sterilant.  Registrants were required to amend their labels to
include this limitation and begin distributing and selling newly-labeled product no later than
October 1995. EPA believes that all products now entering channels of trade bear this limitation.
This limitation is and will continue to be in effect for all EPA-regulated products with label
directions for pre-cleaning critical or semi-critical devices.

       Section VI  of PR Notice 94-4 required that, as of October 1997, any general purpose
disinfectant that is registered for any medical device or medical equipment surface claim bear
the limitation that the product is not to be used as a terminal sterilant/high level disinfectant for

                                           -7-                 '               '

critical or semi-critical medical devices.  This notice eliminates that channels of trade date;
however, all EPA-regulated products with label directions for pre-cleaning critical or semi-
critical devices must continue to bear this limitation.


       Although liquid chemical sterilants (and subordinant disinfectant claims) on critical or
semi-critical devices have been removed from EPA jurisdiction under FEFRA, many States
continue to regulate these products as pesticides. The authority of the States to regulate such
liquid chemical sterilant products may not have been affected by the change in FIFRA.
Companies should consult with individual States to determine the regulatory status of their liquid
chemical sterilant products under State law.


       If you do not understand this notice, or what you should do to comply, please contact-one
of the following people:

At the Environmental Protection Agency:

              Michele E. Wingfield
              Office of Pesticide Programs
              Antimicrobials Division (7510W)
              401 M Street, S.W.
              Washington, D.C. 20460

              Phone: (703)308-6349
              E-mail: wingfield.michele@epamail.epa.gov

 At the Food and Drug Administration:

              Dr. ChiuS.Lin
              Center for Devices and Radiological Health (HFZ-480)
              Food and Drug Administration
              9200 Corporate Boulevard,
              Rockville, MD 20850

              Phone: (301)443-8913
              E-mail:  cxl@fdadr.cdrh.fda.gov
                                                     . SaKoers, Director
                                              Antimicrobials Division
                                              Office of Pesticide Programs