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DRAFT GUIDANCE TO REGISTRANTS: PROCESS FOR 

MAKING CLAIMS AGAINST EMERGING VIRAL PATHOGENS

NOT ON EPA-REGISTERED DISINFECTANT LABELS

March 29, 2016

In this document:

I. Background and Purpose

II. Viral Subgroup Classification

III. Product Eligibility Criteria

IV. Instructions for Using the Process

V. Outbreak Criteria Associated with Emerging Pathogens Process

VI References

Attachment 1 - Additional Terms of Registration

Attachment 2 - Process Example

I. Background and Purpose

Emerging pathogens are an increasing public health concern in the United States as well as 

globally. Many of the emerging pathogens of greatest concern are pathogenic viruses, and 

the ability of some of these viruses to persist on environmental surfaces can play a role in 

human disease transmission. Because the occurrence of emerging viral pathogens is less 

common and predictable than established pathogens, few if any EPA-registered disinfectant 

product labels specify use against this category of infectious agent. Also, the pathogens are 

often unavailable commercially, and standard methods for laboratory testing may not have 

been developed. Thus, it can be difficult to assess the efficacy of EPA-registered 

disinfectants against such pathogens in a timely manner and to add these viruses to

existing product registrations, which requires the submission of efficacy data for Agency 

review. As a result, the Agency is providing a voluntary, two-stage process to enable use of 

certain EPA-registered disinfectant products against emerging viral pathogens not identified 

on the product label. 

1) In the first stage, which may be performed prior to any outbreak, registrants with

an eligible disinfectant product may submit a request via label amendment to add a

designated statement (see Attachment 1) to the master label and additional terms to the 

product registration. If the product meets the eligibility criteria suggested in this Guidance, 

the Agency generally will approve the amendment. Approval of the amendment would 

include additional terms and conditions of registration regarding how the designated 

statement may be published and communicated.

2) The second stage of this process occurs during a human or animal disease 

outbreak caused by an emerging virus. In this stage, registrants of products with the 

previously mentioned label amendment and terms of registration would be allowed to use 

the designated statement in off-label communications intended to inform the user 

community/public that the disinfectant product(s) may be used against the specific 

emerging viral pathogen. These off-label statements can inform the public about the utility 

of these products against the emerging pathogen in the most expeditious manner and can 

be more easily removed once the outbreak has ended than statements on a label.
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Note that this document provides general guidance to EPA, pesticide registrants, applicants 

for pesticide registrations, and the public. This guidance is not binding on EPA or any 

outside parties, and EPA may depart from the guidance where circumstances warrant and 

without prior notice.

II. Viral Subgroup Classification

EPA and Centers for Disease Control and Prevention (CDC) recognize that certain 

microorganisms can be ranked with respect to their tolerance to chemical disinfectants. The 

Spaulding Classification model, used by CDC, tiers microorganisms in accordance with the 

level of resistance to being killed (inactivation) by typical disinfectant products.1 With this 

approach viruses are divided into three viral subgroups (small non-enveloped, large nonenveloped, and enveloped) based on their relative resistance to inactivation (see below). 

According to this hierarchy, if an antimicrobial product can kill a small, non-enveloped virus 

it should be able to kill any large, non-enveloped virus or any enveloped virus. Similarly, a 

product that can kill a large, non-enveloped virus should be able to kill any enveloped virus.

Small, Non-Enveloped Viruses (<50 nm): These small, non-enveloped viruses 

can be highly resistant to inactivation by disinfection. Despite the lack of a lipid 

envelope, these organisms have a very resistant protein capsid. The following are 

viral families in the small non-enveloped subgroup: (1) Picornaviridae, (2) 

Parvoviridae, (3) Caliciviridae, (4) Astroviridae, and (5) Polyomaviridae.

Large, Non-Enveloped Viruses: Compared to small, non-enveloped viruses, these 

viruses are less resistant to inactivation by disinfection. Although they have a 

resistant protein capsid, their larger size (50-100nm) makes them more vulnerable 

than their smaller viral counterparts. The following are viral families in the large 

non-enveloped subgroup: (1) Adenoviridae, (2) Reoviridae, and (3) Papillomaviridae.

Enveloped Viruses: Enveloped viruses are the least resistant to inactivation by 

disinfection. The structure of these viruses includes a lipid envelope, which is easily 

compromised by most disinfectants. Once the lipid envelope is damaged, the 

integrity of the virus is compromised, thereby neutralizing its infectivity. The 

following are viral families in the enveloped subgroup: (1) Arenaviridae, (2)

Bornaviridae, (3) Bunyaviridae, (4) Coronaviridae, (5) Filoviridae, (6) Flaviviridae, 

(7) Hepadnaviridae, (8) Herpesviridae, (9) Orthomyxoviridae, (10) Paramyxoviridae, 

(11) Poxviridae, (12) Retroviridae, (13) Rhabdoviridae, and (14) Togaviriedae.

Under the criteria outlined in Section III of this Guidance, this hierarchy is used to 

determine a product’s anticipated efficacy against an emerging viral pathogen.

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III. Product Eligibility Criteria

Registrants should use the following criteria to determine if an EPA-registered disinfectant 

product is eligible to use the process described in this Guidance. An eligible product should

meet both of the following criteria:

1. The product is an EPA-registered, hospital/healthcare or broad-spectrum disinfectant 

with directions for use on hard, porous or non-porous surfaces2.

2. The currently accepted product label (from an EPA registered product as described 

above in III.1) should have disinfectant efficacy claims against at least one of the 

following viral pathogen groupings:

a) A product should be approved by EPA to inactivate at least one large or one small 

non-enveloped virus to be eligible for use against an enveloped emerging 

viral pathogen.

b) A product should be approved by EPA to inactivate at least one small, nonenveloped virus to be eligible for use against a large, non-enveloped 

emerging viral pathogen.

c) A product should be approved by EPA to inactivate at least two small, nonenveloped viruses to be eligible for use against a small, non-enveloped 

emerging viral pathogen.

This approach, where disinfectant products registered for use against viral pathogens in one 

category of the Spaulding Classification model can be presumed effective against viral 

pathogens in less-resistant categories, is intended to serve as a conservative approach to 

identifying disinfectant products likely to be effective against emerging pathogens. However,

since there is no viral subgroup known to be more resistant than small, non-enveloped viral 

pathogen, a disinfectant product must be proven to be efficacious against at least two 

different small, non-enveloped viral pathogens in order to be eligible for emerging pathogen 

claims pursuant to this guidance in regard to an outbreak of an emerging small, nonenveloped viral pathogen.

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IV. Instructions for Using the Process

The following are instructions for registrants (with a product eligible under Section III 

above) who wish to use the process in this document for making claims against emerging 

viral pathogens. Registrants are encouraged to submit an FQPA (fast-track, non-PRIA) label 

amendment request (may also be submitted as part of a PRIA action) explaining why the 

product meets the criteria for use against one or more categories of emerging [enveloped 

/ large non-enveloped / small non-enveloped] viral pathogens as suggested in this 

guidance.

This label amendment request should include a request to amend the existing Terms of 

Registration for the product to add a product-specific version of the language in Attachment 

1, and include each of the conditions governing the use of such statements that appear in 

Attachment 1. If the registration amendment is approved, the registrant will be authorized 

to make the product-specific version of the statement(s) described in Attachment 1 in the 
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event of an applicable disease outbreak. The conditions stated in Attachment 1, which would 

be incorporated into the terms of registration, identify the allowable statements, the outlets 

through which the use statements may be communicated, and the time periods during 

which the use statements may be made. Use of the designated statements in 

circumstances other than those specified in the terms of registration would be a violation of 

FIFRA section 12(a)(1)(B), unless otherwise authorized by EPA.

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V. Outbreak Criteria Associated with Emerging Pathogens Process

As stated above, the process described in this Guidance is for use with emerging pathogens 

associated with certain human or animal disease outbreaks. Thus, registrants whose 

registrations have been amended as described in Section IV above may publish the 

approved statements only upon a disease outbreak that meets all the following criteria:

1. The causative organism should be a virus that causes an infectious disease that 

has appeared in a human or animal population for the first time, or that may 

have existed previously but is rapidly increasing in incidence or geographic range

("emerging viral pathogen").3 It includes both new and re-emerging viral 

pathogens listed by either the Centers for Disease Control and Prevention (CDC) 

or the World Organization for Animal Health (OIE) in one of the publications 

below. 

a. For human disease, the outbreak is listed in one of the following CDC 

publications: 

i. CDC Current Outbreak List for “U.S. Based Outbreaks”

(www.cdc.gov/outbreaks),

ii. CDC Current Outbreak List for “Outbreaks Affecting International 

Travelers” with an “Alert” or “Advisory” classification

(www.cdc.gov/outbreaks) (also released through the CDC’s Health 

Alert Network (HAN) notification process)

iii. Healthcare-Associated Infections (HAIs) Outbreaks and Patient 

Notifications page (www.cdc.gov/hai/outbreaks)

b. For animal disease, the outbreak is identified as an infectious disease 

outbreak in animals within the United States of America on the OIE 

Weekly Disease Information page

(www.oie.int/wahis_2/public/wahid.php/Diseaseinformation/WI).

2. The CDC or OIE has identified the taxonomy, including the viral family and/or 

species, of the pathogen and provides notice to the public of the identity of the 

emerging virus that is responsible for an infectious disease outbreak. Based on 

the taxonomy of the outbreak pathogen identified by CDC or OEI, the pathogen's 

viral subgroup (small non-enveloped, large non-enveloped, enveloped) should be 

determined. See OIE technical disease cards (www.oie.int/animal-health-in-theworld/technical-disease-cards/).

3. The virus can be transmitted via environmental surfaces (non-vector 

transmission), and environmental surface disinfection has been recommended by 

the CDC or OIE to control the spread of the pathogen.
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An example of how both the application and outbreak process might work is presented in 

Attachment 2.

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VI. References

1 Spaulding E.H. 1968. Chemical disinfection of medical and surgical materials. Disinfection, 

Sterilization, & Preservation, 3rd Edition, Block S (Ed), (Lea & Febiger, Philadelphia, PA).

2 Product Performance Test Guidelines: OCSPP 810.2200 Disinfectants for Use on Hard Surfaces –

Efficacy Data Recommendations [EPA 712-C-07-074]

3 World Health Organization (WHO). 2015. Emerging Diseases. Available from: 

http://www.who.int/topics/emerging_diseases/en/

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Attachment 1

Example Terms of Registration Associated with the Guidance for 

Making Claims against Emerging Viral Pathogens Not on EPARegistered Disinfectant Labels

The following are examples of additional Terms of Registration that EPA anticipates resulting 

from a request to amend a registration for the reasons addressed in EPA's 2016 Guidance to 

Registrants: Process for Making Claims against Emerging Viral Pathogens Not on EPARegistered Disinfectant Labels:

1. The statements shall be made only through the following communications outlets: 

technical literature, "1-800" consumer information services, social media sites and company 

websites (non-label related). These statements shall not appear on marketed (final print) 

product labels.

2. Statements shall adhere to one or both of the following formats:

[Product name] has demonstrated effectiveness against viruses similar to [name 

of emerging virus, which must be a small non-enveloped, large nonenveloped, or enveloped virus] on [eligible surface type(s)]. Therefore,

[product name] can be used against [name of emerging virus, which must be 

a small non-enveloped, large non-enveloped, and/or enveloped virus] when 

used in accordance with the directions for use against [name of supporting 

virus(es)] on [hard, porous/non-porous surfaces]. Refer to the [CDC or OIE] 

website at [pathogen-specific website address] for additional information.

[Name of illness/outbreak] is caused by [name of emerging virus, which 

must be a small non-enveloped, large non-enveloped, and/or enveloped 

virus]. [Product name] kills similar viruses and therefore can be used against 

[name of emerging virus, which must be a small non-enveloped, large nonenveloped, and/or enveloped virus] when used in accordance with the directions 

for use against [name of supporting virus(es)] on [hard, porous/non-porous 

surfaces]. Refer to the [CDC or OIE] website at [website address] for additional 

information.

3. The registrant may begin communications of these statement(s), upon notification on the 

CDC or OIE website identified under Section V of the Guidance of an outbreak of an 

emerging [small non-enveloped, large non-enveloped, and/or enveloped] viral 

pathogen. The registrant shall cease and remove all such communications no later than 24 

months after the original notification of the outbreak on the CDC or OIE website unless the 

Agency provides guidance to the contrary due to continued public health concerns.

4. The registrant agrees that paragraphs 1 through 3 above shall become immediately void 

and ineffective if registration for use against [name of supporting virus(es)] is 

suspended or cancelled or no longer meets the criteria for a disinfectant claim (see EPA 

Product Performance Test Guideline 810.2200). In addition, evidence of ineffectiveness 

against any pathogen in a less-resistant Spaulding category would also be grounds for 

voiding paragraphs 1 through 3.
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Attachment 2 

Example of the Process

The following is a hypothetical scenario for how registrants and EPA could use the process 

identified in this Guidance, using an Enterovirus D68 outbreak as an example.

Before an outbreak occurs:

- Prior to the occurrence of an outbreak, registrants interested in using this process apply 

for registration amendments as suggested in this Guidance to allow claims of anticipated 

efficacy against small non-enveloped viruses. Once EPA has approved the amendments, the 

subject products’ registrations will indicate that certain claims specified in the registration 

may be made regarding use against emerging small non-enveloped viral pathogens, subject 

to the products’ Terms of Registration as described in Attachment 1. For example, a 

registrant whose product is registered for use against two small non-enveloped viral 

pathogens might request the following product-specific statement:

Product Z has demonstrated effectiveness against viruses similar to [name of emerging 

virus, which must be either a small non-enveloped, large non-enveloped, or 

enveloped virus] on hard non-porous surfaces. Therefore this product can be used against 

[name of emerging virus, which must be either a small non-enveloped, large nonenveloped, or enveloped virus] when used in accordance with the directions for use 

against Virus X and Virus Y on hard, non-porous surfaces. Refer to the [CDC or OEI]

website at [website address] for additional information.

- EPA would review the claims and, if approved, add this statement to the product’s master 

label as a non-label claim permitted only when certain emerging viral pathogen conditions 

are met. 

After an outbreak occurs:

- In the event of an Enterovirus D68 public health outbreak, the Centers for Disease Control 

and Prevention would communicate the outbreak threat via its website 

(www.cdc.gov/outbreaks), identify the viral pathogen taxonomy, and indicate that surface 

disinfection is recommended. 

1. With the viral pathogen information provided by CDC, registrants would determine 

that the pathogen, Enterovirus D68 (a member of the Picornaviridae family), is a small nonenveloped virus.

2. At this point, registrants with products whose registrations have been amended to 

allow certain claims of anticipated efficacy against two or more small non-enveloped viral 

pathogens would be allowed to make those claims specified in the terms of registration as 

illustrated in Attachment 1 regarding use of the products against Enterovirus D68 without 

further submissions to, or review by, EPA. For example, a registrant whose registration was 

previously amended to include the product-specific language in the example above would 

now be allowed to include the following statement in its technical literature, non-label 

related websites, consumer information services, and social media sites:
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Product Z has demonstrated effectiveness against viruses similar to Enterovirus D68 on 

hard non-porous surfaces. Therefore, this product can be used against Enterovirus D68 

when used in accordance with the directions for use against Virus X and Virus Y on hard, 

non-porous surfaces. Refer to the CDC website at www.cdc.gov/... for additional 

information.