EPA737-N-94-009
                UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                           WASHINGTON, D.C: 20460
                                                             OFFICE OF
                                                        PREVENTION, PESTICIDES AND
                                                           TOXIC SUBSTANCES
                           JUN 3 0 1994
                PESTICIDE REGULATION (PR). NOTICE 94-4

        NOTICE TO  MANUFACTURERS, FORMULATORS, PRODUCERS  AND
                 REGISTRANTS OF  PESTICIDE PRODUCTS
 ATTENTION:

 SUBJECT:





 I.   Purpose
Persons Responsible for Registration of Pesticides

Interim Measures  for the Registration of
Antimicrobial Products/Liquid Chemical Germicides
with Medical Device Use Claims Under the
Memorandum of Understanding Between EPA and FDA
  •<-,,      .        is  intended to provide the regulated  communitv
 with detailed guidance  on the interim EPA registration procedures
 for antimicrobial products affected by the June 4,  1993
 Memorandum of Understanding (MOU)  between the EnvironmeAtal
 ^™?Ctl°n A9encv (EPA) and the Food and Drug Administration

 included wTtfthis No?ice.°f *** "lgMd ** "* ±tS ~ "*»«* are

 II-   Applicability
^-rm-           u aPPlies to a11 registrants of liquid chemical
germicides which bear claims for use  on medical devices.  While
 u^  u  f!  re9ulatorY authority over all antimicrobial products
o5iS«r,bear1!.SitlmS^0,aCt a^alnst microorganisms on inanimate
surfaces,  FDA's regulatory purview extends  to liquid chemical
germicides which are used on medical  devices  and are therefore
considered to be medical devices themselves.   Because FDA's
regulatory concern focuses on the application of chemical
germicides to medical devices,  the MOU  is relevant only to those
antimicrobial pesticides with medical device  use claims.

     The manner in which FDA determines the required level of '
processing needed for a medical device  is based on Dr.  E.H.
                                                       Recycled/Recyclable
                                                       Pflnttd «rttti Soy/CMibla Ink on paper that
                                                       contain* at te«t 50% recycled fiber

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                                2

Spaulding's infection control classification system, as adapted
and recommended by the Centers for Disease Control and Prevention
(CDC).  In this system, medical devices are categorized according
to the relative risk associated with their intended use patterns.
The three primary categories are (1) critical surfaces which must
be sterilized, (2) semi-critical surfaces which should be
sterilized but must at least undergo high level disinfection, and
(3) non-critical surfaces including medical equipment surfaces
which should undergo intermediate or low level disinfection.
These definitions are discussed in detail in the MOU.

       The MOU divides antimicrobial pesticides into two
categories based on label claims and medical device use patterns.
The first category is liquid chemical germicides used as
sterilants to reprocess reusable critical and semi-critical
devices such as heat labile instruments, and endoscopes.  The
second category is general purpose disinfectants.  The products
in-this second category are used on non-critical surfaces and
dental and medical equipment surfaces such as wheel chairs,
dental chairs, and medical beds in hospitals and related
institutions.  These products can be used for pre-cleaning or
decontamination of critical or semi-critical surfaces as long as
the label clearly states that this is done prior to the surface
being sterilized or disinfected.  Because of their intended use
pattern, these two categories of antimicrobial pesticides are
considered to be medical devices and are thus subject to the
conditions of this Notice.

III. Background

     Liquid chemical germicides which bear claims for use on
medical devices are currently regulated both as pesticides under
the Federal Insecticide, Fungicide, and Rodenticide Act  (FIFRA)
and as medical devices under the Federal Food, Drug, and Cosmetic
Act  (FFDCA).  In an effort to resolve the confusion and burden of
dual regulation, a Memorandum of Understanding  (MOU) was signed
on June 4,  1993 between the Environmental Protection Agency  (EPA)
and the Food  and Drug Administration  (FDA).  The MOU was amended
on June 20, 1994.  The objectives of  the MOU are to  (1) provide a
framework under which both Agencies will undertake  rulemaking to
permanently vest  exclusive jurisdiction  for certain categories of
chemical germicides in one Agency or  the other, and  (2)  serve as
interim guidance  designed to minimize duplicate regulatory
requirements  in shared areas of  jurisdiction between the two
Agencies until the rulemaking  is complete.      .    ,

      To briefly summarize the MOU,  each  Agency  has  been  given
primary jurisdiction  over one  of the  two categories  of  liquid
chemical germicides considered to be  medical devices.;   FDA  has ;
primary responsibility over  liquid  chemical  sterilants,  which  .  ,.
includes responsibility  for  subordinate  claims^ on  sterilant
products such'as'tuberculocidal  or  virucidal claims  which  support

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 a high level disinfectant use pattern.  EPA has primary
 jurisdiction over the general purpose disinfectants.  The MOU
 calls for both EPA and FDA to initiate rulemaking to give each
 Agency sole jurisdiction over their designated categories.
 However, since rulemaking may involve a long term process, the
 MOU sets forth interim procedures in order to reduce the
 condition of dual regulatory oversight.

      The MOU itself cannot change the statutory responsibilities
 granted under FIFRA and FFDCA.  Therefore, until rulemaking is
 finalized,  both Agencies will continue to share jurisdiction over
 all liquid chemical germicides used on medical devices and will
 continue to maintain separate registration and premarket approval
 procedures.  In addition, the June 1993 MOU and this PR Notice
 have no affect on EPA's authority to take actions based on test
 results from the ongoing EPA antimicrobial testing program.   EPA
 will still  act to remove inefficacious products from the market
 based on test results from that program.   Products so removed
 from the market,  however, must,  in addition to meeting other
 applicable  requirements,  follow the procedures outlined in the
 MOU and this PR Notice before they may return  to the market.

      Although both Agencies  must continue to fulfill their
 statutory responsibilities,  the  MOU attempts to alleviate the
 regulatory  burden that may be associated  with  submitting
 duplicate data packages  to both  EPA and FDA.   Essentially, the
 interim procedures state  that only one Agency  needs  to  review the
 product performance  (efficacy) data which are  required  to support
 both an EPA registration  and an  FDA 510(k)  premarket clearance.
 The  MOU states  that  the FDA  review and acceptance  of efficacy
 data submitted in support of a 510(k)  notice will  meet  EPA's
 product  performance  (efficacy) registration requirements  for   '
 liquid  chemical sterilant products.  Likewise,  the EPA  review of
 product  performance  (efficacy) data  submitted  for  a  general
 purpose  disinfectant  will  suffice  for  a 510(k)  premarket  approval
 notice.   Each Agency  will  continue  to  administer any other
 applicable  requirements.
IV.
Interim Procedures for Obtaining or Amending an EPA
Registration for Liquid Chemical Sterilant Products
     As stated in the previous section, FDA will ultimately be
responsible for the sole regulation of liquid chemical sterilant
products used to reprocess critical and semi-critical devices.
FDA will also be solely responsible for the subordinate claims on
particular sterilant product labels which support a high level
disinfectant use pattern including the hospital disinfectant,
tuberculocidal, and virucidal claims.   The FDA efficacy and
product performance requirements for 510(k) clearance are
comparable to EPA's FIFRA Section 3 efficacy registration
requirements as listed in the Product  Performance Guidelines
Subdivision G.  Therefore, under the interim provisions of the

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MOU, EPA will agree that the FDA review and acceptance of the
efficacy and product performance data will fulfill EPA's product
performance (efficacy) registration requirements under FIFRA,

     The following step-by-step procedure describes the EPA
interim registration process for liquid chemical sterilants and
additional product claims which support a high level disinfectant
use pattern for both new registrations and amendments to current
registrations.  The registrant will submit its registration
package to EPA and FDA at the same time so that both Agencies can
conduct concurrent reviews.

     1.   Registrant prepares the full EPA registration package
          including all toxicology, chemistry, ecological
          effects, and environmental fate data, proposed
          labeling, and associated administrative forms.
          Efficacy/product performance data should not be
          included in this package.

     2.   Registrant submits the EPA registration package to EPA
          for review.  EPA will review this application
          concurrent with FDA's assessment of the 510(k)
          premarket clearance package.     .

     3.   Registrant prepares the full FDA 510(k) premarket
          clearance package.  All efficacy/product performance
          data will be included in this package and reviewed by
          FDA.  Once the efficacy/product performance data have
          been reviewed and accepted by FDA, they will satisfy
          the EPA efficacy/product performance registration data
          requirements.  FDA may have additional requirements •
          beyond  EPA's current requirements.  These data
          requirements and label/label insert requirements are
          published in FDA's Guidance on the Content and Format
          of Premarket Notification  [510(k)] Submissions for
          Liquid  Chemical Germicides, January  31,  1992.

     4.   Registrant  submits the 510(k) premarket  clearance
          package to  FDA.  Once FDA  has completed  its review, a
          copy  of the  FDA  accepted labeling  and 510(k)  clearance
          will  be transmitted  by FDA to EPA.

     5.   Once  EPA  has  received a  copy of  the  510(k) clearance
           from  FDA  and has  completed the  review of the  FIFRA
          application package, the registration or amendment will
          be  granted  if  EPA determines that  registration or
           amendment is  appropriate.  EPA  will  include all
           comments  from EPA and/or FDA regarding  the proposed
           labeling  in the  acceptance letter  and all required
           corrections or additions must be incorporated into the
           final label before the  registered  product may be

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           legally released  for shipment or sold or distributed
           As currently required,  five copies of the final printed
           labeling must be  submitted to EPA.

 v-   Interim Procedures for Obtaining or Amending an EPA
      Registration for General Purpose Disinfectants	

      Once rulemaking is complete, EPA will have sole jurisdiction
 for general purpose disinfectants.  The process and requirements
 to register general purpose disinfectants with the EPA will be
 the same as they are now, including the requirements for
 efficacy, toxicology, and chemistry data.   Current EPA label
 requirements remain in effect.  However,  in order to remain in
 compliance with FIFRA, the following restrictive label statement
 must be added to the label of any general  purpose disinfectant
 that is registered for any medical device  or medical equipment
 surface claims:                     '

      "This product is not to be used as  a  terminal
      sterilant/high level disinfectant on  any surface  or
      instrument that (1)  is  introduced directly into the
      human body, either into or in contact with the
      bloodstream or normally sterile areas of the  body,  or
      (2)  contacts intact  mucous membranes  but which  does not
      ordinarily penetrate  the  blood barrier or otherwise
      enter normally sterile  areas  of the body.   This product
      may  be  used to  preclean or decontaminate critical or
      semi-critical medical devices prior to sterilization or
      high level disinfection".
VI.
Label Revision Compliance Dates and Procedures
     For products bearing sterilization claims, existing EPA
labeling requirements remain in effect.  FDA will promulgate a '
final rule establishing sole jurisdiction over such products.
However, to comply with FDA's 510(k) requirements, registrants
generally will be required to develop a package insert which
clearly prescribes the steps to be followed in achieving high
intermediate, and low level disinfection, as well as provides
other appropriate information.  Registrants are reminded that
this package insert becomes labeling under FIFRA and must complv
with EPA labeling requirements at 40 CFR 156.10.

     For general purpose disinfectants, EPA has determined that
the incorporation of the label statement set forth in Section V
above must take place as described below.   Registrants of
affected products must comply with these label specifications and
deadlines in order to remain in compliance with FIFRA.
     1.
    Within  6 months of the date of this Notice each
    registrant of a general purpose, disinfectant product
    registered for use on any medical device or medical

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     equipment  surface  (an  "affected product") must  submit  a
     completed  amendment  (EPA  form number  8570-1) with  5
     copies  of  draft  labeling  which meets  the requirements
     of  #2(a) and (b) below.   In  order  to  expedite
     processing approval  of the amendment  application,
     registrants should clearly identify the submission in
     connection with  this PR Notice by  writing the words,
     "MOU COMPLIANCE  PER  PR NOTICE 94-  " in Section  II.  of
     the application  form.  Applications are to  be sent to
     the following address:

     For USPS Submissions:

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

     For Courier Deliveries:

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

2.   No later than October 1,  1995,  the labeling of
     each affected product sold or distributed by
     registrants and distributors must:

          bear the exact statement set  forth in Section V of
          this Notice and comply with the labeling
          requirements found in 40 CFR 156.10.

          have omitted or obliterated all specific claims of
          effectiveness, or directions  for use on critical
          or semi-critical surfaces or instruments.
a.
b.
3.   NO later than October 1, 1997, each affected product
     sold or distributed by any person other than
     registrants or distributors must bear labeling which
     meets the requirements of #2(a) and (b) above.

4.   At any time prior to the October 1, 1995 deadline,
     registrants may add the labeling statement in Section V
     of this Notice and may omit or obliterate the claims
     with respect to critical or semi-critical surfaces or
     instruments without waiting for approval of the
     amendment application submitted per #1 above.

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 VII.   Effective Date
      The  procedures  described  in  this  notice  for affected
products  are  effective  immediately.  All new  registration and
amendment applications  for products bearing medical device use
claims will be processed according to  the steps outlined in this
Notice.   Any  registrant not already in compliance with these
label specifications must, in  order to remain in compliance
with  FIFRA, submit appropriate registration and label amendments
for affected  products within the  time  periods specified in
Section VI.   Registrants must  also make required label changes to
affected  products by the deadlines specified  above in order to
remain in compliance with FIFRA.

VIII. For Further Information

     For  further information contact Michele Wingfield,
Microbiologist, Antimicrobial Program Branch,  Registration
Division  at (703) 305-6653.          ^       f
                                           hnson,  Director
                                           Division

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                    Memorandum of Understanding
                              Between
     The Food and Drug Administration, Public Health Service,
              Department of Health and Human Services
                                and
                The Environmental Protection Agency


 Notice Regarding Matters of Mutual Responsibility - Regulation of
 Liquid Chemical Germicides Intended for  Use on Medical Devices

 I.    PURPOSE

 This Memorandum of Understanding (MOU) between the Food and Drug
 Administration  (FDA)  and the Environmental  Protection  Agency
 (EPA)  clarifies jurisdiction between the two agencies  in the
 regulation of certain liquid chemical germicides.   These liquid
 chemical germicides are  devices under the Federal  Food.  Drug  and
 Cosmetic Act (FD&C  Act)  and pesticides under the Federal    '
 Insecticide, Fungicide and Rodenticide Act  (FIFRA).  This MOU
 also embodies the  agreement of  the two agencies to undertake
 certain rulemakings in order to eliminate duplicative  regulation
 of  certain types of liquid chemical germicides.  This  MOU
 includes the agencies' interim  agreement to simplify and
 coordinate their regulatory and enforcement activities in shared
 areas  of jurisdiction affecting these types of  products  pending
 the conclusion  of these  rulemakings.

 II.  STATUTORY  AUTHORITIES

 A.   FDA Authorities

 The FDSC Act grants FDA  authority to  regulate devices  as  defined
 in  21 U.S.C. §321(h).  Under  section  321(h), the term  "device"
 includes an  instrument,  apparatus,  implement, machine,
 contrivance, implant, in vitro  reagent,  or  other similar  or
 related article, including any  component, part, or accessory that
 is  intended to  cure, mitigate,  treat, or prevent disease  in man
 or  is intended  to affect the  structure or any function of the   '
body of man.  Liquid chemical germicides intended for use in
conjunction with a variety of articles that fit within the
statutory definition of  "device," such as operating instruments,
medical examining tables, hospital scales, and other hospital
equipment,  also fall within the definition of "device"  because
they are considered accessories to these devices.

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Unless liquid chemical germicides used in conjunction with
devices were commercially distributed prior to May 28, 1976,
manufacturers of these products, under 21 U.S.C. §360(k) [section
510 (k) of the FD&C Act] are required to submit a prema'rket
notification to FDA before they market their products.  Before
these products can be legally marketed, FDA must grant marketing
clearance by (1) issuance of an order in response to a section
510(k) submission which exempts the device from the FD&C Act's
premarket approval requirements, or (2) approval of a premarket
approval application.  In granting marketing clearance by
issuance of a section 510(k) order exempting a liquid chemical
germicide from premarket approval, FDA must find that the device
is "substantially equivalent," as the term is defined in 21
U.S.C.  §360c(i)(1)(A), to a predicate device that does not
require premarket approval.  Section 513 of the FD&C Act
authorizes FDA to exempt products from premarket notification
requirements for which there is a reasonable assurance of safety
and effectiveness.  At present, no chemical germicides that are
used with devices have been exempted from premarket notification
requirements.

In regulating liquid chemical germicides used with devices, FDA
is exercising its responsibilities under the FD&C Act  for
ensuring that devices  are safe and effective for their  intended
uses.  The FD&C Act provides enforcement authority to FDA to
pursue regulatory actions,  including seizure, injunction,
prosecution, and civil penalties.

B.    EPA Authorities

Liquid chemical  germicides,  including  those regulated as devices,
are also under  the  authority of the EPA under FIFRA.  Before  a
pesticide product may  be  lawfully sold or distributed in
commerce, the product  must  be registered by EPA pursuant to FIFRA
section 3, or otherwise exempted  from  the requirements  of FIFRA.
A registration  is  a license allowing a pesticide product to be
sold  and distributed for  specified uses  in accordance with
specified use instructions,  precautions, and other terms and
conditions.  Liquid chemical  sterilants  are  included among  the
various types of antimicrobial  products  that are currently
subject to  FIFRA.
 I/  Devices marketed prior to May 28, 1976 are grandfathered from
 the FD&C Act's premarket notification requirements.   Neither FDA
 nor EPA are aware of'any currently marketed products that are
 exempt under this grandfather provision.  Should any exist, they
 are not covered by this Memorandum of Understanding.

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 A pesticide product may be registered or remain registered only
 if_it meets the statutory standard for registration.  Among other
 things, a pesticide must perform its intended pesticidal function
 without causing "unreasonable adverse effects on the environment"
 (FIFRA section 3(c)(5)).  "Unreasonable adverse effects on the
 environment" is defined as "any unreasonable risk to man or the
 environment, taking into account the economic, social, and
 environmental costs and benefits of the use of [the] pesticide"
 (FIFRA section 2(bb)).

 The burden of demonstrating that a pesticide product satisfies
 the statutory criteria for registration is at all times on the
 proponents of initial  or continued registration.   FIFRA section 6
 provides EPA with various regulatory tools that the Administrator
 may use if it appears  that the product no longer satisfies the
 statutory criteria for registration.   If appropriate,  EPA may
 require modifications  to the terms and conditions of
 registration,  such as  deletion of particular uses or revisions to
 labeling,  as an alternative to regulatory outcomes such as
 cancellation,  suspension,  or emergency suspension.   FIFRA also
 provides enforcement authority to EPA to pursue actions,
 including issuance of  stop sale,  use,  or removal  orders when
 there is reason to believe a pesticide is in violation of FIFRA.
 Additionally,  EPA has  authority to seek the assessment of civil"
 administrative penalties as well  as institute seizure  and
 criminal actions for violations of FIFRA.

 FIFRA section  25(b) authorizes the Administrator  to exempt
 pesticides from FIFRA  through regulation if the Administrator
 determines that the pesticide is  "adequately regulated by another
 Federal  agency" or is  "of  a character  which it is unnecessary to
 be  subject to  this Act in  order to carry out the purposes of  this
 Act. "

 III-  REGULATORY RESPONSIBILITIES AND DEFINITIONS

 For the  purposes of this agreement, liquid  chemical germicides
 that are used  in conjunction  with  medical devices are  divided
 into two product categories:   (1)  sterilants  and  (2) general
 purpose  disinfectants.   Sterilants, for purposes of this
 agreement, means those chemical germicides used to reprocess
 reusable critical  and semicritical devices2.  Critical  devices
 are  devices that are introduced directly into the human body,
 either into or  in  contact with the bloodstream or normally
 sterile  areas of the body.  These critical devices must be
 sterile.
2/ This definition is consistent with the definition of these
terms used by the Centers for Disease Control and .Prevention
(CDC).  Block, S.S. 1991.  Disinfection, 'Sterilizaton,  and
Preservation. 4th Edition.  Philadelphia, Lea Sc Febiger.

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Semicritical devices are those which contact intact mucous
membranes but which do not ordinarily penetrate the blood barrier
or otherwise enter normally sterile areas of the body.  For these
devices, sterilization is desirable but not mandatory.  These
devices must be subjected at least to a high level disinfection3
process using a sterilant, but for a shorter time than that
required for sterilization.

The second category of liquid chemical germicides are general
purpose disinfectants.  General purpose disinfectants, for
purposes of this agreement, means those chemical germicides used
to reprocess noncritical devices and medical equipment surfaces .
Noncritical devices and medical equipment surfaces must be
subjected to intermediate or low level disinfection5.

FDA's priority is to confirm the efficacy and safety of
sterilants used to reprocess critical and semicritical devices
which pose the greatest risk of disease transmission.  This
includes assuring that they do not adversely affect device
performance or pose a hazard to the patient/user.  Historically,
EPA has assessed the effective performance of all chemical
germicides and addressed health and safety issues presented by
their use.

The FD&C Act and FIFRA have overlapping regulatory schemes for
liquid chemical germicides used on devices.  The objective of
this MOU is to minimize redundant regulation of these products by
PDA and EPA while assuring that the safety and efficacy
requirements of both statutes are met.  This affects three areas:
data requirements for obtaining approval, procedures for
obtaining approval, and compliance.
 3/   "High  level  disinfectant"  and  "high  level disinfection" are
 terms  of art used by the public health community.  FDA recognizes
 "high  level disinfectant"  as a separate  or  subeategory of
 sterilants.  EPA does not  register "high level' disinfectants" as
 separate antimicrobial pesticides,  but instead may register uses
 of  germicides  that  correspond  with uses  in  FDA's  "high level
 disinfection"  category.,

 4/   This definition is consistent  with the  definition of the term
 used by CDC.

 5/   "Low and intermediate  level disinfectants" are terms of art
 used by the public  health  community.  FDA recognizes "low  and
 intermediate level  disinfection" as subcategories of general
 purpose disinfectants. EPA does not register low level and
 intermediate level  disinfectants,  but has corresponding germicide
 classes.

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 In determining whether the FD&C-Act's and FIFRA's statutory and
 regulatory requirements are met, EPA and FDA will utilize the
 data requirements and performance standards referenced in FDA's
 current Guidance on the Content and Format of Premarket
 Notification Submission for Liquid Chemical Germicides  FDA
 premarket notification regulations at 21 CFR Part 807, Subpart E
 EPA data requirements regulations at 40 CFR Part 158, and EPA's '
 Subdivision G, Product Performance Guidelines.

 Since the EPA registration requirements for general purpose
 disinfectants parallel the requirements necessary to receive
 marketing clearance for general purpose disinfectants under
 section 510(k) of the FD&C Act, fulfillment of EPA's registration
 requirements fulfills FDA's section 510(k)  requirements for those
 products.

 The EPA efficacy data requirements for liquid chemical
 sterilants,  including those with high level disinfectant uses
 are fulfilled by FDA's section 510(k)  requirements or premarket
 approval requirements.   Therefore,  premarket clearance by FDA
 fulfills certain EPA registration requirements for liquid
 chemical sterilants,  insofar as efficacy and product performance
 are concerned.  FDA premarket clearance does not satisfy EPA's
 chemistry,  toxicology,  and ecological  effects requirements.

 IV.   AGREEMENT

 The Administrator of the Environmental  Protection Agency and  the
 Commissioner  of  the Food and Drug Administration agree that until
 exemptions  referred to  in  Section V occur,  the following division
 of  responsibility will  govern the activities of the  agencies  in
 the regulation of liquid chemical germicides that are intended
 for use  on devices:
A.

1.
Regulatory Responsibilities

FDA will be primarily responsible for the premarket review
of safety and efficacy requirements for liquid chemical
germicides that are sterilants6 intended for use on critical
or semicritical devices.  Examples of critical devices are
laparoscopes, surgical instruments, heart-lung oxygenators
and transfer forceps.  Examples of semicritical devices are
gastrointestinal endoscopes, endotracheal tubes,
cystoscopes, anesthesia breathing circuits, and vaginal
specula.  FDA will also be primarily responsible for
premarket review of contact lens solutions.
6/ If a liquid chemical sterilant product has subordinate claims
such as tuberculocidal or virucidal, these claims also will be
regulated by FDA.

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     EPA will be primarily responsible for premarket review of
     liquid chemical germicides that are general purpose
     disinfectants7  intended for use on  devices  other than
     critical or semicritical  devices.  Examples of noncritical
     devices are wheel chairs, medical beds,  stands, certain
     operating room surfaces,  medical lamps,  dental units,  and
     stethoscopes.

     FDA marketing clearance through the section 510(k)  process
     or approval through the premarket approval process  of
     sterilants will satisfy certain requirements for
     registration under FIFRA Section 3.  Upon submission to EPA
     by the applicant of an order issued by FDA granting
     marketing clearance or approval for a liquid chemical
     germicide that is a sterilant, EPA will consider the
     efficacy data requirements for registration to be satisfied,
     and will promptly determine whether the other requirements
     for registration are satisfied.

     EPA registration of liquid chemical germicides that are used
     as disinfectants for devices, except sterilants,  will
     satisfy the criteria necessary to establish substantial
     equivalence as defined in 21 U.S.C. §360c(i)(1)(A).  For
     this category of liquid chemical germicides, submission by
     the manufacturer to FDA of a copy of the EPA correspondence
     granting registration will satisfy FDA's requirement for a
     premarket notification under 21 U.S.C. §360(k).  Upon
     receipt of this information from the manufacturer of a
     liquid chemical germicide in this category, FDA will issue
     an order finding the product substantially equivalent to a
     predicate device that does not require premarket approval.
     This order will allow the device to be legally marketed
     without an approved FDA premarket approval application.
2/ Procedures described in Paragraph 4 only apply to liquid
chemical germicide products that do not contain any sterilant
claims.  If a liquid chemical germicide product contains
both sterilant and general purpose disinfectant claims,
registration will proceed according to the procedures described
in Paragraph 3.  If the registrant of a general purpose
disinfectant product registered by EPA subsequently appl-ies for
registration of a sterilant claim, registration of that product
must proceed under procedures described in Paragraph 3 and the
existing EPA registration will become void upon FDA's clearance
of the product.

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B.

1.
2.
 As part of the EPA registration process, EPA will require
 registrants of liquid chemical germicides, other than
 sterilants that have received FDA premarketing clearance or
 approval, to put the following statement on their product
 labels:

      "This product is not to be used on any surface or
      instrument that (1) is introduced directly into the
      human body,  either into or in contact with the
      bloodstream or normally sterile areas of the body, or
      (2)  contacts intact mucous membranes but which does not
      ordinarily penetrate the blood barrier or otherwise
      enter normally sterile areas of the body."

 Compliance Responsibilities

 FDA will  be responsible for all sampling and all efficacy
 testing of liquid chemical sterilants intended for use on
 critical  and semicritical devices and for instituting
 appropriate enforcement and/or regulatory action against any
 products  that do  not comply with the FD&C Act.

 Upon request,  EPA will  provide FDA with copies  of the latest
 accepted  labeling and the name and location of  the
 production site for each product FDA intends to sample.

 To the  extent allowed under 21 U.S.C.  § 331j, 21 U S  C
 §360(j)(c),  42 U.S.C. §263g(d),  42 U.S.C.  263i(e),  and 21
 C.F.R.  Part 20, FDA will share all safety and efficacy test
 results,  labeling changes,  and upon EPA request,  any  other
-information obtained during FDA enforcement/regulatory
 actions, relating  to liquid chemical sterilants.   EPA  may use
 this information  to determine  whether  the registrant  has
 complied  with  FIFRA.  On the basis of  this information,  EPA
 may determine  that further regulatory  action under FIFRA,
 including cancellation  of the  product's registration   is'
 warranted.

 EPA will  be  responsible  for the  sampling and  efficacy
 testing of all general purpose chemical .germicides that  are
 intended  for use  on devices other  than  critical and
 semicritical devices, and for  instituting  appropriate
 enforcement  and/or regulatory  action against "any  such
 chemical  germicide that  does not comply with FIFRA.   EPA
 will.refer labels  and other evidence concerning
 inefficacious  liquid chemical  germicides  intended for use on
 medical devices other than  critical or  semicritical to FDA
 for  complementary  action  under the FD&C Act.

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                                8

3.   Each agency will provide assistance upon request to support
     compliance activities and litigation by the other Agency in
     cases involving liquid chemical germicides that are intended
     for use on devices.  Assistance will be requested in
     accordance with applicable procedures, statutory and
     regulatory requirements, including compliance with
     regulations of 21 CFR Part 20, through the liaison officers
     listed below.  Assistance may include provision of sampling,
     inspection and audit data, expert witnesses, certified
     statements, and affidavits.

     Each Agency may consult with the other at any time to
     determine if the initiation of regulatory and/or enforcement
     action against a liquid chemical germicide in lieu of or
     concurrently with the other agency's action is appropriate.

     This Memorandum of Understanding has no effect on any
     pending investigations or enforcement or regulatory, actions
     undertaken by EPA pursuant to FIFRA or by FDA pursuant to
     the FD&C Act.

C.   Coordination of Activities

To ensure the continued coordinated regulatory, compliance, and
enforcement activities for liquid chemical germicides intended
for use on devices, an EPA/FDA interagency committee is
established.  The Directors of the EPA's Registration Division
and the Compliance Division, Office of Prevention, Pesticides,
and Toxic Substances, and of FDA's Center for Devices and
Radiological Health, Office of Compliance and Surveillance, will
serve as joint chairpersons who will designate their respective
agency members of the committee.  The committee will meet at a
minimum of twice each fiscal year.

V.   FUTURE RULEMAKINGS TO ELIMINATE DUPLICATIVE AGENCY REVIEW

EPA will initiate a rulemaking proceeding under section 25(b) of
FIFRA to exempt liquid chemical sterilant products from
regulation under FIFRA.  EPA believes that the efficacy data
requirements and product performance standards for liquid
chemical sterilants are fulfilled by FDA's section 510(k)
requirements or premarket approval requirements.  When such
exemption becomes effective, FDA and EPA will cease to follow
procedures described in Paragraph IV, A.3. and these products
will be subject solely to the regulatory and enforcement
requirements and procedures of FDA, and EPA will no longer
register such products.  To the extent EPA receives information
regarding such products, it will share such information with FDA.

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 FDA will  initiate  a  rulemaking proceeding  to  classify liquid
 chemical  germicides  used  on  devices under  section  513 of  the FD&C
 Act.•  FDA believes that EPA's  requirements under FIFRA for liquid
 chemical  germicides  that  are intended  for  use on medical  devices
 that are  not critical  or  semicritical  devices parallel the FD&C
 Act's  requirements under  section  510(k) of the Act.
 Accordingly, FDA will  recommend to its classification advisory
 panel  that liquid  chemical germicides  intended for use on devices
 that are  not critical  or  semicritical  devices be exempted from
 premarket notification requirements under  section  510(k)  of the
 FD&C Act.  When any  such  exemption becomes effective,  FDA and EPA
 will cease to follow the  procedures in paragragh IV.  A. 4.   To
 the extent FDA obtains any information regarding such products,
 it will share the  information  with EPA.
VI.
NAME AND ADDRESS OF PARTICIPATING PARTIES

A.   Food and Drug Administration
     5600 Fishers Lane
     Rockville, MD  20857
     B.
     Environmental Protection Agency
     401 M Street, S.W.
     Washington, D.C.  20460
VII. LIAISON OFFICERS

     A.   For the Food and Drug Administration:

          Sterilization and Toxicology Project Officer
          (currently:  Dr. Virginia Chamberlain)
          Office of Compliance and Surveillance
          Center for Devices and Radiological Health
          1390 Piccard Drive
          Rockville, MD  20850
          Telephone:  (301)  427-1131

     B.   For the Environmental Protection Agency:

          Antimicrobial Program Branch Chief
          (currently:  Juanita Wills)
          Registration Division
          Antimicrobial Program Branch (H7505C)
          401 M Street,  S.W.
          Washington, DC  20460
          Telephone:  (703)  305-6661

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                                 10
VIII.   PERIOD OF AGREEMENT
     This agreement: becomes effective upon acceptance by both
     parties.   It may be modified by mutual written consent or
     terminated by either party upon a thirty (30)  day advance
     written notice to the other party.   The par-ties agree to
     evaluate the agreement every three  (3)  years,  at which time
     either party would have the option  of renewing, modifying,
     or canceling the agreement.
APPROVED AND ACCEPTED FOR THE
ENVIRONHENTAL PROTECTION AGENCY
APPROVED AND ACCEPTED FOR THE
FOOD AND DRUG  ADMINISTRATION
By
                _   ,

Title Acting Assistant fld]njn.f.atrator

Date   June 4, 1993 _
      Associate Commissioner for Regulatory
                      :         Affairs
Date    June k, 1993 _

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     Amendment to the June 4,  1993 Memorandum of Understanding
                             Between
      The Food and Drug Administration,  Public Health Service
             Department of Health and Human Services
                               and
               The Environmental Protection Agency
 Amendment to Notice Regarding Matters  of  Mutual  Responsibility -
 Regulation of Liquid Chemical Germicides  Intended  for  Use  on
 Medical  Devices

 I.   PURPOSE

     This amendment  to the  June 4,  1993 Memorandum  of
 Understanding (MOU)  between  the Food and  Drug Administration
 (FDA) and the Environmental  Protection Agency (EPA) revises  the
 disclaimer statement required to appear on the labels  of all
 liquid chemical germicides,  other  than sterilants  that have
 received FDA premarket clearance or approval.

 II.  BACKGROUND

     On June  4, 1993,  a MOU was  signed between FDA  and  EPA as an
 interim  measure to  abolishing dual regulation of liquid chemical
 germicides.   Under  the MOU liquid chemical germicides, considered
 to !be medical  devices, are divided into two product categories:
 (1)  sterilants and  (2) general  purpose disinfectants.  FDA has
 primary  jurisdiction  over germicides with sterilant claims.  This
 jurisdiction  includes  sterilant products which also bear
 subordinate tuberculocidal or virucidal claims supporting their
 use  pattern as a high  level disinfectant.  EPA has primary
 jurisdiction  over the  general purpose disinfectants.  Under-the
 MOU, both  FDA  and EPA  are required to initiate rulemaking so as
 to give  each Agency sole jurisdiction over its assigned category.
 Until the  rulemakings  take effect, the MOU sets forth interim
 procedures designed to ease any possible regulatory burden that
was  associated with the submission of duplicate data packages to
 the Agencies.

     Among other things,  the MOU specified label language to be
placed on  labels of certain liquid chemical germicides.  For the
reasons explained below,  this amendment substitutes new language
 for that originally specified in the MOU.

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III. AMENDMENT

     A.  Background

     The existing label language specified in Paragraph IV(A)(5)
of the MOU, which must appear on the labels of liquid chemical
germicides other than sterilants that have received FDA
premarketing clearance or approval, is:

     "This product is not to be used on any surface or instrument
     that  (1) is introduced directly into the human body, either
     into or in contact with the bloodstream or normally sterile
     areas of the body, or (2) contacts intact mucous membranes
     but which does not ordinarily penetrate the blood barrier or
     otherwise enter normally sterile areas of the body."

     Since the MOU was signed, it has been brought to EPA's and
FDA's attention that the present label disclaimer does not allow
for the use of general purpose disinfectants as a precleaner for
the removal of gross filth on medical devices prior to their
sterilization.  Included under the "DIRECTIONS FOR USE" on the
label of sterilant products, is a statement requiring the
thorough cleaning, rinsing, and drying of medical instruments and
equipment prior to disinfection and sterilization.  This
amendment only serves to revise the disclaimer statement
currently required on the labels of all liquid chemical
germicides, other than sterilants.  The revised label disclaimer
statement will allow the use of general purpose disinfectants on
medical devices, as a precleaner, prior to sterilization.

     B.  Amended Language

     Paragraph IV(A)(5) of the June 4, 1993 Memorandum of
Understanding between the Food and Drug Administration, Public
Health Service, Department of Health and Human Services, and the
Environmental Protection Agency is amended by striking the entire
text of Paragraph IV(A)(5) and replacing it with the following:

     As part of the EPA registration process, EPA will require
registrants of liquid chemical germicides, other than sterilants
that have  received FDA premarketing clearance or approval, to put
the following statement on their product labels:

     "This product is not to be used as a terminal
     sterilant/high-level disinfectant on any surface or
     instrument that  (1) is introduced directly into the human
     body, either into or in contact with the bloodstream or
     normally sterile areas of the body, or  (2) contacts intact
     mucous membranes but which does not ordinarily penetrate the
     blood barrier or otherwise-enter normally sterile areas of
     the body.  This product may be used to preclean or
     decontaminate critical or semi-critical medical devices
     prior to sterilization or high-level disinfection."

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  IV.
      NAME AND ADDRESS  OF PARTICIPATING  PARTIES

      A.   Food and Drug Administration
           5600 Fishers  Lane
           Rockville, MD   20857
       B
           Environmental Protection Agency
           401 M Street, S.W.
           Washington, B.C.  20460
      B.
 V.    LIAISON OFFICERS1

      A.   For the Food and Drug Administration:
           Sterilization and Toxicology Project Officer
           (currently:  Dr. Virginia Chamberlain)
           Office of Compliance and Surveillance
           Center for Devices and Radiological Health
           1390 Piccard Drive
           Rockville, MD   20850
           Telephone:  (301)  594-4618

           For the Environmental Protection Agency:
           Antimicrobial Program Branch Chief
           (currently:   Juanita Wills)
           Registration Division
           Antimicrobial Program Branch (7505C)
           401 M Street,  S.W.
           Washington,  DC  20460
           Telephone:   (703)  305-6661

VI.,  EFFECTIVE DATE  of AMENDMENT"

     This  amendment  to the June  4,  1993 MOU becomes  effective
upon acceptance  by both  parties.                     «a-j-eutive
APPROVED AND ACCEPTED FOR THE
ENVIRONMENTAL_PBpTECT^GN AGENCY
                                    APPROVED AND ACCEPTED FOR THE
                                    FOOD AND DRUG ADMINISTRATION
       Daniel M.  Barolo

Title: Director

Date:
         JUN 2- 1994
       Ronald 'M.<

Title: Director

Date:
                           Updates  certain mail code and teiepfcone

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