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
-------
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
-------
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
-------
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
-------
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
-------
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.
-------
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
-------
-------
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.
-------
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.
-------
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.
-------
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.
-------
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.
-------
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.
-------
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.
-------
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.
-------
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
-------
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 _
-------
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.
-------
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."
-------
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
-------
------- |