EPA has released an Interim Guidance for the Evaluation of Products for Claims Against Viruses (“Policy”) which creates a pathway for registrants to add viral claims to food contact and non-food contact sanitizing products for hard, non-porous surfaces in non-healthcare related use sites. This Policy is now available for use as a 10-year pilot program, which is scheduled to sunset in October 2034.
Background
Antimicrobial products may be classified as disinfectants, sanitizers, sterilants, etc., based on their ability to kill or inactivate certain organisms. Prior to the publication of this policy, EPA only allowed disinfectants and sterilants to make virucidal claims on hard surfaces.
Historically, EPA believed household consumers were more concerned about exposure to bacteria than viruses and considered viruses to mainly be a concern in professional spaces. Following the COVID-19 pandemic, EPA has recognized a broader desire and public health need for products with claims against viruses. This guidance is expected to provide consumers with more products effective against viruses with reduced contact times, and more products that are Design for the Environment (DfE) Certified.
Who Can Use this Guidance?
This guidance is available for food and non-food contact sanitizer products for use on hard, non-porous surfaces only. These claims cannot be made until a revised label and data are submitted and accepted by EPA. Residual hard surface, and soft surface/laundry uses are not considered under the current guidance. We are hopeful if the pilot is successful, EPA may expand it in the future to include other uses. Currently, neither food contact or non-food contact sanitizing towelettes are mentioned in the Policy. EPA has confirmed to SRC that sanitizing towelette products may also make viral claims.
Testing
The testing requirements under this guidance mirror the requirements for viral disinfection testing in ASTM E1053; however, the contact time cannot exceed those allowed for bacterial sanitizing claims (See table below). 
We are anticipating these shorter contact times may be challenging to achieve with the tougher non-enveloped viruses. We are surprised to see EPA require the halide-based chemistries to meet a 30 second contact time when they are currently allowed a 60 second contact time for bacterial testing, though this stance provides for an equivalent bar across the spectrum of chemistries.
The SRC Efficacy Team has reviewed the guidance in depth and is excited to begin supporting clients with testing or product reformulation to take advantage of this guidance. In some situations, it is possible that existing data on file with EPA could be used to add these claims such that no new data may be necessary. This will depend on the test conditions (product concentration and contact times) used in the original testing. SRC welcomes the opportunity to review the historical data for its utility to support these claims.
Updating Your Label
To add viral claims to a sanitizer only product, you must also add a separate section for “USE DIRECTIONS for VIRUCIDES ONLY”, and qualify “virus” per existing label requirements. EPA will not allow “Kills germs” claims under this guidance. While EPA will allow use in residential, institutional, commercial or industrial sites, the label must clearly state the product is “Not for use in patient care areas of hospital/healthcare facilities”.
Label updates may be submitted via a fast track amendment if existing data is being used to update an existing registration. If new data is being submitted, a PRIA amendment or initial application path will be required.
When filing a submission, registrants will be required to submit a signed Terms of Registration Letter to confirm they understand this is an interim guidance and agree to remove the claim at the end of the 10-year period if the policy is not extended or permanently adopted.
Emerging Viral Pathogens
There is not currently a pathway to make Emerging Viral Pathogens (“EVP”) claims for sanitizers, so adding viral claims to your product will not make it eligible for EVP claims. However, the EVP Policy is scheduled for update in 2025, and we expect to see sanitizers added to the EVP policy as well as many other exciting changes. With this upcoming change, SRC is available to discuss the submission timing strategy.
How Can SRC Help?
This policy creates some interesting new opportunities to meet the consumer appetite for “safer” and more environmentally friendly chemistries. The SRC team is ready to help you add claims to your label, conduct testing, and/or reformulate your product to achieve these viral sanitizer claims on reduced active/inert formulations. Contact your SRC consultant with any questions!
Rhonda Jones
CEO
Posted 10/15/2024