 Antimicrobials Division

Revised July 17, 2007

				

	

I.	Purpose

	

This guidance proposes to utilize an organism hierarchy to identify
effective products for use with emerging pathogens and to permit
registrants to make limited label statements against such pathogens. 
This document provides general guidance to EPA and to pesticide
registrants and applicants, and the public.  This guidance is not
binding on either EPA or any outside parties, and the EPA may depart
from the guidance where circumstances warrant and without prior notice.

II.	Limitations

Organisms to which this Guidance Applies

Microorganisms can be ranked with respect to their susceptibility to
inactivation by hard surface disinfection products.  The Spaulding
Classification model tiers microorganisms in accordance with the level
of difficulty to inactivate them using typical hard surface disinfectant
products. 1  The most difficult to inactivate using typical hard surface
disinfectant products are at the top of the model (i.e., bacterial
endospores); in contrast, the lowest tier includes those microorganisms
generally considered to be most susceptible to inactivation using
typical hard surface disinfectants (i.e., enveloped viruses).  The
guidance applies only to emerging enveloped and non-enveloped viruses.  

Application of the Guidance

The guidance may be implemented after the Centers for Disease Control
and Prevention (CDC) has identified the taxonomic genera of the emerging
enveloped or non-enveloped virus.  CDC typically provides notice to the
public of the identity of an emerging pathogen via its website.   



C.  Products Subject to this Guidance

Listed below are the criteria for antimicrobial products subject to this
guidance:  

     1) hospital and general disinfectant products registered with EPA; 

2) have acceptable efficacy data previously submitted to and reviewed by
the Agency for an enveloped and/or non-enveloped virus (e.g., HIV or
Rhinovirus, respectively); and, 

3) have at least one enveloped and/or non-enveloped public health virus
listed on the product label prior to the request to add a claim for the
emerging virus as identified by CDC, and be a member of the class of
products identified by CDC.

Note:  This guidance does not apply if there is a product already
registered with the pathogen of concern on its label.  Inclusion of the
pathogen of concern on labels for other registered products will be
subject to the amendment process as discussed in Agency regulations, not
to the process as defined by this guidance. 

III.	Definitions

An emerging pathogen may be defined as a newly appearing infectious
organism.2 A human pathogen is defined as "a species infectious to and
capable of causing disease in humans under natural transmission
conditions."3   For purposes of this document, the term “emerging”
includes both new and old, reappearing pathogens.

IV.	Label Recommendations 

Recommended Label Statement

The EPA considers the following examples of what might be acceptable
label statements for inclusion on products subject to this guidance: 

  

[Identify potential illness as stated by CDC] [state virus as identified
by CDC].  [State name of EPA registered product] is a broad-spectrum (or
hospital) disinfectant that has been shown to be effective against other
similar viruses.

Example:

Respiratory illnesses attributable to Severe Acute Respiratory Syndrome
(“SARS”) are caused by a Corona virus.  Product ABC is a
broad-spectrum hard surface disinfectant that has been shown to be
effective against other similar viruses.

Deviations from the above label language and format are not recommended,
but will be considered, if warranted, on a case-by-case basis. 
Submitting applications to the Agency with label statements that vary
from the above example, or similar statements may result in additional
review time by the Agency.

B.	Unacceptable Label Statements

The following label statements are generally expected to be unacceptable
and, if found to be unacceptable would likely lead to rejection by the
Agency.

Examples

1.	Any statements concerning efficacy of a product against an emerging
pathogen.

2.	Any claims regarding the emerging pathogen that in any way state or
imply a disease reduction (e.g. reduces the spread of SARS; reduces the
transmission of SARS; eliminates SARS cross contamination).

3.   	Any statement that a product is a “virucide” (or
“virucidal”) if the product has not been specifically approved to
bear claims as a “virucidal” product.

4.	“[Product name] kills SARS virus on contact.”

      “SARS Virucide”

       “Kills SARS virus.”

V.	Guidance Implementation

A.	Type of Application

Registrants desiring to add an emerging pathogen to the product label
should submit a request to the Agency to amend the existing product
label and include a statement certifying that only the portion of the
label relative to the emerging pathogen has been added, and no other
changes/additions have been made to the label.  The Agency will consider
the request a Food Quality Protection Act (FQPA) action and the
application will not be subject to Pesticide Registration Improvement
Act (PRIA) fees.  As noted above (Section II. C.), one of the criteria
for antimicrobial products subject to this guidance is that the Agency
already has acceptable efficacy data for at least one enveloped and/or
non-enveloped virus. Therefore, efficacy data do not have to support
initial submission of amendments subject to this guidance.  However, if
the applicant has efficacy data on the pathogen of concern, then the
applicant is encouraged to submit such data to the Agency for
evaluation.  If efficacy data are submitted with the applicant’s
request, then the application will not be subject to the reduced review
time period described below, and will be subject to PRIA requirements.  

  		B.	Application Submission 

Hard copies of the application request should be submitted to the Agency
at the following mailing address: 

Document Processing Desk (AMEND) 		Courier Address

Office of Pesticide Programs (7504P)			Office of Pesticide Programs

U.S. Environmental Protection Agency			Potomac Yard South Building

1200 Pennsylvania Ave. NW				2777 South Crystal Drive

Washington, D.C. 20460				Arlington, VA  22202

     	C.	Application Review Period

The Agency generally expects to review the registrant’s application
and provide a written response to the registrant within 10 - 30 business
days from the Agency’s pin-punched date of receipt of the complete
application.  If requested by the applicant, the Agency will provide its
decision electronically to the applicant and subsequently send the
applicant a letter confirming the Agency’s decision.  The
applicant’s email address should be noted on the application, if an
electronic response is desired.  The Agency will strive to meet the 10 -
30 business day review period; however, the absence of Agency response
within that time period does not constitute an approval of the
application.

D.	Terms of Registration

Any amendment granted pursuant to this guidance would    

be a conditional registration generally subject to the following
conditions.  Specific statements made pursuant to this guidance, may
remain on the label for one year beginning with the date of the stamped
approved label.  

During the one year time period, the registrant is required to initiate
one of the following actions:

submit pathogen specific efficacy data to the Agency to support the
label claim;

If efficacy data are submitted to the Agency within the one-year time
period, these data will be evaluated, under the normal PRIA timeframes. 
The registrant may maintain the existing claim until Agency review of
the data is complete, and the Agency provides its determination. The
Agency’s decision and the appropriate course of action will be
communicated to the registrant via written correspondence.

If the submitted efficacy data are found to be acceptable by the Agency,
then the applicant may make claims against the specific enveloped or
non-enveloped virus, in accordance with existing antimicrobial labeling
guidelines.

 

If efficacy data are submitted and determined unacceptable by the
Agency, then the Agency will inform the registrant in writing that the
claim needs to be removed from the label and subsequently, hierarchy
associated statements may not be used in product advertisements,
technical bulletins, etc.  Correspondence provided to the registrant
will delineate the Agency’s concerns and the time period by which the
claim must be removed so that the product may be in compliance with
FIFRA.

submit a proposal for use of a surrogate virus to the Agency for review.
 The proposal should include a protocol and data to support the use of
the proposed virus as a surrogate for the emerging virus.  If the
registrant informs the Agency or the Agency determines that an
acceptable efficacy methodology or a proposed surrogate is available
less than 90 days prior to the end of one year from stamped approved
date of the original application, then the registrant may submit a
request for extension of the date for removal of the claim to allow time
for the Agency to make a determination on the acceptability of the
surrogate and for the registrant to generate the appropriate efficacy
data.  The time allotted to generate the data will be decided by the
Agency. Generally, if the methodology is new, the Agency may grant a 12
month time extension.  If an approved EPA surrogate is available using
existing methodology, then generally, a six-month time extension may be
granted.   A determination to extend the date for removal of the claim
will be at the Agency’s discretion.

If efficacy data or an extension request is not provided to the Agency
within one year from the date of the stamped approved label, then the
conditional registration will expire automatically.

E.	Product Eligibility Issues

 

Although a product may meet the criteria as outlined in the
“Limitations” section of this document, the Agency may reject
applications for which there is an enforcement action pending, or
pending evaluation of 6(a)2 data.  The Agency does not expect to approve
a request concerning a product for which a product failure is identified
by the Antimicrobial Testing Program (ATP).  The decision to reject an
application based on one of the concerns noted above generally would be
provided in writing to the registrant within 10 - 30 business days from
the Agency’s pin-punched date of receipt of application.  Also, if a
product failure is identified by the ATP, or 6(a)2 data or an
enforcement action becomes known after a product has been approved for
labeling in accordance with this guidance, then the Agency may
reevaluate its decision and will inform the registrant accordingly.  

VI.		References

Spaulding E.H.  1968.  Chemical disinfection of medical and surgical
materials.  Disinfection, Sterilization, & Preservation, 3rd Edition,
Block S (Ed), Lea & Febiger, Philadelphia, PA).

Medicine Net.Com.  October 2006.  Available from                 
HYPERLINK "http://www.medterms.com"  www.medterms.com .  

Woolhouse, M.E.J., Gowtage-Sequeria S. October 2006 [date cited].  Host
range and emerging and reemerging pathogens.    Emerging and Infectious
Diseases Volume 11, No. 12.  Available from
http://www.cdc.gov/ncidod/EID/vol11no12/05-0997.htm 

Prepared by:  Laura E. Bailey/OPP/AD

IMPLEMENTATION OF THE EMERGING PATHOGENS AND DISINFECTION HIERARCHY FOR
ANTIMICROBIAL PRODUCTS

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