On August 28, 2019, the 2018 810 guidelines for 810.2000 General Considerations, 810.2100 Sporicidal Testing, and 810.2200 Disinfectant Testing were implemented with a new “Series 810 Guidelines FAQ” guidance. All efficacy testing must now comply with these documents though EPA will continue to accept studies conducted under the 2012 guidelines where the protocol was signed by the study director on or before August 28, 2019.
A summary of the changes and clarifications provided by the 2019 “Series 810 Guidelines FAQ” document follows:
810.2000 General Considerations
- The 2018 section will not be adopted. A standalone draft guidance will be developed/posted for comment. In the interim, consult EPA to confirm testing/submission requirements.
- EPA will implement the 2nd paragraph allowing no testing for changes in dye and/or fragrance at or below 1% in the formulation.
- When lots fall below the lower bound allowed on the LCL for efficacy testing, Registrants must confirm with EPA prior to testing they will accept the data.
- BEAD SOP MB30-01 is cited for water preparation for Concentrate dilution.
- EPA provided labeling examples in Appendix 1 to cover various scenarios of testing/labeling when mixed hardness levels have been used for Concentrate dilution:
- Concentrates diluted in sterile DI water for testing will have to revise use directions to require users to “Dilute with sterile DI water.” This change will occur with Amendments. It is unclear if Notifications may trigger this change.
- EPA is allowing “dilute with tap water” use directions when all testing has been conducted with >200ppm hardness.
- EPA is allowing use directions to “dilute with up to “x” water hardness” or water softened to that level based on the lowest level of hardness in testing. (e.g. Dilute in water with a minimum water hardness of 100ppm or dilute in water softened to 100ppm hardness).
- Where the method allows, EPA will accept neutralization performed in advance of testing.
- EPA is now allowing repeat neutralization controls following a study if the control was invalid due to high or low counts, or if contamination occurred in the control only.
- EPA clarified wetness testing is only required for towelette products seeking C. difficle or C. auris claims.
Performance Criteria for Batch Replication Policy
- When using the Batch Replication Policy to change water hardness, carrier type, soil or temperature claims, EPA has confirmed the revised UDM performance criteria may be used for testing if the two lots are tested on separate days.
EPA has offered new clarification including only two repeats are allowed under the same conditions:
- Passing testing may be repeated up to two times for each type of control failure. Where population controls exceed the upper limit and the product fails, you may repeat twice.
- Contamination in the Test System or Carrier Control – Testing may be repeated twice. EPA will not require separate staff, QA, or different labs for repeat tests.
- EPA will accept only one contaminated carrier in a 60 carrier study that meets the performance criteria. If more than 1 contaminated carrier is present in a 60 carrier study or any contaminated carriers are present in a 10 carrier test, up to two repeat tests may be conducted.
- EPA will no longer allow repeat testing (under the same test conditions) on 60 carriers when initial testing using 10 carriers resulted in one positive (1/10). Different test conditions are required to allow a repeat test.
- EPA added helpful information on repeating contaminated quantitative testing.
- EPA prefers Gram staining, colony morphology, and biochemical testing to confirm growth is contamination.
- EPA will no longer accept several control failure types and will require repeat testing.
- EPA has also noted product contamination must be immediately reported to EPA.
- EPA confirmed a tube with a contaminant and test organism is a failing tube.
810.2100 Sporicidal Testing
- EPA reiterated they will no longer allow vegetative claims for any sporeforming bacteria.
- EPA clarified the use of stainless steel penicylinders, porcelain penicylinders, and suture loops to support sporicidal claims for hard non-porous, porous, and soft surface use/claims, respectively. The registrant may test one or more carrier type as desired.
- EPA confirmed second lab verification testing for C. difficile claims is not required though it is required for general sporicidal claims.
810.2200 Disinfection Testing
- Towelette Wiping Technique – EPA offered confirmation of current wiping techniques allowing up to 6 passes, and to segment the large viral carrier for wiping.
- EPA has clarified “mechanical” expressing methods for towelette testing. They have omitted solvent extraction from this list. Registrants wishing to use other methods must contact EPA.
- EPA has provided sample virucidal calculations in Appendix IV.