On July 17, 2023, EPA released for public comment its Draft Guidance for the Evaluation of Products for Claims Against Viruses. This draft guidance outlines the pathway and testing requirements for food and non-food contact sanitizer products to make claims against viruses. Historically, a sanitizer has not been eligible for virucidal claims unless it was also registered as a disinfectant. This guidance is an exciting development for the registration and marketing of sanitizer products.

Implementation

The public comment period for this guidance will be open until September 17, 2023 (60 days). It is not eligible for use until the final policy is posted, hopefully early in 2024. Oncefinalized, EPA intends to limit the use of this policy to 7 years from the implementation date. One year before the policy is set to expire, the agency will assess the benefits and concerns related to the program to determine whether the policy will be made permanent, changed, or discontinued.

Any product registered under this policy will be issued a conditional registration letter that includes the time limit for virucidal claims. If the guidance is terminated after the 7-year period, the Agency will work individually with each registrant to update product labels.

Claims

This draft guidance will allow virucidal claims for food contact and non-food contact sanitizer products used on hard, non-porous surfaces only. It does not have an allowance for residual, soft or porous surface, or laundry claims currently. EPA has indicated an interest in expanding the policy to those other uses in the future if this initial policy is well received.  However, the guidance does refer registrants to contact the Agency or review EPA’s Residual Efficacy Claims Guidance if they wish to add residual claims to their product. EPA is not allowing viral claims for the supplemental long lasting residual products, but it is unclear if residual self-sanitizers (RSS) might be included.  SRC has contacted the Agency to get clarification on whether RSS claims on hard, non-porous surfaces will be allowed under this policy.

Test Requirements

This guidance requires the test method, active ingredient (AI) level of the test lots, number of test lots, and performance criteria be the same as testing for virucidal disinfectant claims per EPA 810.2200. These requirements are:

  • Method: ASTM E1053
  • Number of Lots: 2 (worst case virus at LCL, all other viruses at NCL)
  • Performance Criteria: 99.9% reduction
  • Contact times are limited per the maximum time allowed in each category for the bacterial sanitization claim.
    • There is some confusion in the draft on this point for food contact surface sanitizers as the Table shows a 5-minute upper limit for both types of sanitizers.  During the recent Antimicrobial Workshop, EPA’s Antimicrobial Division Deputy Director Kristen Willis explained that this Table was in error and the bacterial testing maximums should be followed:
      • Non-food contact sanitizers: Up to 5 mins may be used.
      • Food Contact Sanitizers (FCS): There are two test methods for bacterial claims, and each has a different contact time to support a 1-minute label claim:
        • Halides: Testing is conducted with the AOAC Chlorine (Available) in Disinfectants 955.16 which uses a 60 second contact time.  There is a typographical oversight in the Table that shows the contact time as 30 seconds.
        • Non-Halides: Testing is conducted with the AOAC Germicidal & Detergent Sanitizing method 960.09 which uses a 30 second contact time.

SRC has contacted the Agency for clarification on the contact times to support viral claims for Food Contact Sanitizers.  We have further inquired if a 1-minute contact time for viral testing could be used to align with the 1-minute maximum label time so that all chemistries would be tested with the same parameters.

Labeling

EPA has provided detailed use direction and label claim recommendations to assure no consumer confusion occurs with these new viral claims.  A chief concern is that the viral claim might be interpreted by users as supporting use in patient care areas of healthcare facilities.  To avoid this concern, EPA proposes to require on products that are just food contact or non-food contact sanitizers the following statement “Not for use in patient care areas of hospital/healthcare facilities”.   To add clarity, EPA detailed allowed claims and those that would not be compliant:

  • Acceptable Claims:
    • Kills bacteria and viruses*
    • sanitizer
    • virucide*
    • virucidal*
    • “For residential, commercial and/or industrial use”
  • Not Acceptable:
    • Kills germs
    • For use in hospital/healthcare settings (Any use in a healthcare setting will have to state “non-patient care areas”.)

EPA may require label language to state where the product can be used. Examples are provided in the guidance document. Additionally, virucidal use sites and directions must be under a separate header on the label such as “USE DIRECTIONS for VIRUCIDES ONLY”.

SRC has reviewed the guidance and reached out to EPA on interpretation of the RSS inclusion and the food contact sanitizer contact time interpretation. EPA will review and may change the document based upon public comments so at this time it is not possible to make these claims as the guidance is not yet in its final form.  While the Agency is working to finalize it, we recommend Registrants review existing data to see what could be used to support future claims.  We will continue to monitor this guidance and update our clients as more information becomes available.  Public comments may be viewed at www.regulations.gov under Docket EPA-HQ-OPP-2023-0288.

EPA’s notice to industry on the guidance can be found here.

 

Rhonda Jones, RM (NRM)

Chief Executive Officer

Published July 24, 2023