Implementation of the Emerging Pathogens and Disinfection Hierarchy for Antimicrobial Products
Current as of April 3, 2008
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This guidance proposes to utilize an organism hierarchy to identify effective products for use with emerging pathogens and to permit registrants to make limited 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.
Organisms to which this Guidance Applies
The guidance applies only to emerging enveloped and non-enveloped viruses. 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.
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.
Products Subject to this Guidance
Listed below are the criteria for antimicrobial products subject to this guidance:
- hospital and general disinfectant products registered with EPA;
- 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);
- for an emerging small non-enveloped virus, have at least one small non-enveloped virus previously listed on the products label. Examples of small enveloped viral families include members of the Picornavide family (e.g. poliovirus, enterovirus, hepatitis A virus, rhinovirus), and Parvoviridae family (e.g., parvovirus);
- for an emerging large non-enveloped virus, have either one small or large non-enveloped virus previously listed on the product's label. Examples of large non-enveloped viral families include members of the Adenoviridae family (e.g. adenovirus), Reoviridae family (e.g. rotavirus), and Papillomaviridae family (e.g. papillomavirus);
- for an emerging enveloped virus, have at least one non-enveloped or enveloped virus previously listed.
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 which have been identified by CDC.
Recommended Statement for Product Master Label and Public Information
The goal of this policy is to provide timely information to the public regarding the effectiveness of disinfectant products against the emerging pathogen in question. The submission, review, production, and distribution of labels affixed to the product itself are lengthy processes not suited to emerging pathogen situations.
Under this Guidance, EPA will allow approved statements to be made for emerging pathogens on a product's master label and provided to the public through Web Sites, Technical literature, "1-800" consumer information services, and similar media.
Claims against emerging pathogens approved by EPA under this Guidance will not be allowed on the labels affixed to the product itself.
The EPA considers the following examples of what might be acceptable label statements for 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.
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.
- Any statements concerning efficacy of a product against an emerging pathogen.
- 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).
- 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.
- "[Product name] kills SARS virus on contact."
- "SARS Virucide"
- Kills SARS virus."
Type of Application
Registrants desiring to add an emerging pathogen statement to the product master label must 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.
Hard copies of the application request should be submitted to the Agency at the following mailing address:
Document Processing Desk (AMEND)
Office of Pesticide Programs (7504P)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave. NW
Washington, D.C. 20460
Office of Pesticide Programs
Potomac Yard South Building
2777 South Crystal Drive
Arlington, VA 22202
Application Review Period
The Agency generally expects to review the registrant's application and provide a written response to the registrant within 10 - 20 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 absence of Agency response within that time period does not constitute an approval of the application.
For applications containing a claim consistent with the example statement in Section IV of this Guidance, EPA will strive to review the application and provide a written response within 10-20 business days; however, the absence of Agency response within that time period does not constitute an approval of the application.
For applications deviating from the example statement of Section IV of this Guidance, EPA will strive to review the application and provide a written response within 20 business days; however, the absence of Agency response within that time period does not constitute an approval of the application.
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 master 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 master 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.
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 decision to reject an application based on one of the concerns noted above generally would be provided in writing to the registrant within 10 - 20 business days from the Agency's pin-punched date of receipt of application. Also, if 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.
1 Spaulding E.H. 1968. Chemical disinfection of medical and surgical materials. Disinfection, Sterilization, & Preservation, 3rd Edition, Block S (Ed), Lea & Febiger, Philadelphia, PA).
3 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 the Emerging and Infectious Diseases Web page about host range and emerging and reemerging pathogens.