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Pesticide Registration (PR) Notice 98-2: Liquid Chemical Sterilant Products
Resources
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
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.
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 claims must submit to EPA applications for
amendment to delete FDA-regulated claims. The cutoff date for registrant sale
or distribution of product currently labeled with both 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.
I. WHAT PRODUCTS ARE AFFECTED?
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-critical devices such as tuberculocidal
or virucidal claims which support a high level disinfectant use pattern. The
terms "high level disinfectant" and "high level disinfection" are terms of art
used by the public health community and are recognized by FDA as a separate or
subcategory of sterilants. 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 in 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. The terms 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.
II. BACKGROUND
To address the concurrent jurisdiction of EPA and FDA over certain liquid
chemical germicide products, a Memorandum of Understanding (MOU) between EPA and
FDA was signed on 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 categories of liquid chemical germicides with FDA, and
FDA would exempt certain categories of liquid chemical 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.
III. FOOD QUALITY PROTECTION ACT OF 1996
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 sterilant 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 body."
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 VII), existing stocks of products bearing mixed claims that are
sold or distributed by the registrant on or before October 1, 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.
IV. POLICY
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
applicants.
B. Registered products with only 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 administratively
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.
V. RESPONSE TO THIS NOTICE
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
acceptable.
2. Submit(*1) 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 II, the statement:
"Amendment to remove claims for use as a sterilant on critical or semi-
critical devices per PR Notice 98-2."
(*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. This approval expires May 31, 1998.
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.
VI. ADDRESS FOR SUBMISSIONS
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
VII. SALE OR DISTRIBUTION DATE
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 extending 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.
VIII. 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 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.
IX. STATE REGULATION
Although liquid chemical sterilants (and subordinant disinfectant claims)
on critical or semi-critical devices have been removed from EPA jurisdiction
under FIFRA, 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.
X. FOR FURTHER INFORMATION
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. Chiu S. 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
Frank T. Sanders, Director
Antimicrobials Division
Office of Pesticide Programs