Also, the EPA lists anything that kills an organism as a pesticide unless of course you file a 5-10k with the FDA at which time it can bear the claim that it kills 99.9% of viruses or bacteria and meets medical standards. In addition, you could also file to be considered a sanitizer but must be able to kill germs in under 5 minutes:
The summary information below was assembled by National Antimicrobial Test Laboratories. It is believed to be more current (as of publication) than EPA's own 810 series of guidance documents.
Product testing requirements change over time, so please check with EPA or a good consultant to verify the accuracy of these testing requirements as they pertain to your sanitizer or disinfectant.
Note: a "carrier" is just an individual inoculated and dried test surface and LCL stands for "lower certified limit."
Sanitizer (Non-Food Contact)
ASTM E1153
Staphylococcus aureus and either Enterobacter aerogenes or Klebsiella pneumoniae
3 lots (batches), each at LCL
3 control, 5 test carriers per lot, per microorganism
Contact time less than 5 minutes
>99.9% reduction
Sanitizer (Food Contact)
AOAC 960.09, or AOAC 955.16 if a halide like chlorine or iodine
Staphylococcus aureus and Enterobacter aerogenes (non-halide)
Staphylococcus aureus or Salmonella typhi (halide)
3 lots (batches), each at LCL
Contact time varies by method
Performance requirement varies by method
Sanitizing Towelette (Non-Food Contact)
Modification of ASTM E1153
Staphylococcus aureus and either Enterobacter aerogenes or Klebsiella pneumoniae
3 lots (batches), each at LCL
3 control, 5 test carriers per lot, per microorganism
Contact time less than 5 minutes
>99.9% reduction
Sanitizing Towelette (Food Contact)
EPA interim towelette guidance
Staphylococcus aureus and Escherichia coli
3 lots (batches), each at LCL
Contact time of 30 seconds
>99.9% reduction
Residual Self-Sanitizer
EPA residual self-sanitization test method
Staphylococcus aureus and Enterobacter aerogenes
3 lots (batches), each at LCL
Contact time less than 5 minutes
>99.9% reduction
Laundry Pre-Soak Sanitizer
ASTM E1153
Staphylococcus aureus and either Enterobacter aerogenes or Klebsiella pneumoniae
3 lots (batches), each at LCL
3 control, 5 test carriers per lot, per microorganism
Contact time less than 5 minutes
>99.9% reduction
Sanitizing Laundry Additive
ASTM E2274 and ASTM E2406
Staphylococcus aureus and Klebsiella pneumoniae
3 lots (batches), each at LCL
Contact time less than 5 minutes
>99.9% reduction
Carpet Sanitizer
Custom method required by EPA, typically includes...
Staphylococcus aureus and either Enterobacter aerogenes or Klebsiella pneumoniae
3 lots (batches), each at LCL
3 control, 5 test carriers per lot, per microorganism
Two carpet types
Contact time less than 60 minutes
>99.9% reduction
Surface Sanitizer for Fabrics and Textiles
Modification of ASTM E1153
Staphylococcus aureus and either Enterobacter aerogenes or Klebsiella pneumoniae
3 lots (batches), each at LCL
3 control, 5 test carriers per lot, per microorganism
Contact time less than 5 minutes
>99.9% reduction
Disinfectant (Residential Use)
Use Dilution (AOAC 955.14 and 955.15) or Germicidal Spray Test (AOAC 961.02)
Staphylococcus aureus and Salmonella enterica
3 lots (batches), each at LCL
60 carriers per lot, per microorganism
Each lot tested on separate day if S. aureus is the test organism.
Contact time less than 10 minutes
Performance criteria depend on test method and test organism(s)
Disinfectant (Hospital Use)
Use Dilution (AOAC 955.15 and 964.02) or Germicidal Spray (AOAC 961.02)
Staphylococcus aureus and Pseudomonas aeruginosa
3 lots (batches), each at LCL
60 carriers per lot, per microorganism
Each lot tested on separate day for both test microorganisms
Contact time less than 10 minutes
Performance criteria depend on test method and test organism(s)
Fungicidal Disinfectant
All requirements for basic disinfectant, plus....
AOAC Fungicidal Test (955.17) or Use-Dilution Test modified for fungi
Trichophyton mentagrophytes
Two lots (batches), each at LCL
10 carriers per lot
Contact time less than 10 minutes
Performance criteria depend on test method used
Virucidal Disinfectant
All requirements for basic disinfectant, plus....
ASTM E1053 or Germicidal Spray Products Test Modified for Viruses
Virus claimed on the label or suitable surrogate
Two lots (batches), at LCL if "main" virus
1 10 square inch test surface per lot
Contact time less than 10 minutes
Complete inactivation or >99.9% when cytotoxicity is evident
Tuberculocidal Disinfectant
All requirements for basic disinfectant, plus....
AOAC 965.12 or AOAC Germicidal Spray Products modified for Tuberculocides
Mycobacterium bovis BCG
Two lots (batches) at LCL
10 carriers per lot or 4 replicates per lot, depending on method
Contact time less than 10 minutes
Complete inactivation on all carriers
Fungicidal Disinfectant Towelette
All requirements for basic disinfectant, plus....
Germicidal Spray Test modified for towelettes and fungi
Trichophyton mentagrophytes
Two lots (batches), each at LCL
10 carriers per lot
Contact time less than 10 minutes
Performance criteria depend on test method used
Virucidal Disinfectant Towelette
All requirements for basic disinfectant, plus....
ASTM E1053 or Germicidal Spray Products Test Modified for Viruses and Towelettes
Virus claimed on the label or suitable surrogate
Two lots (batches), at LCL if "main" virus
1 10 square inch test surface per lot
Contact time less than 10 minutes
Complete inactivation or >99.9% when cytotoxicity is evident
Tuberculocidal Disinfectant Towelette
All requirements for basic disinfectant, plus....
AOAC 965.12 or AOAC Germicidal Spray Products modified for Tuberculocides
Mycobacterium bovis BCG
Two lots (batches) at LCL
10 carriers per lot or 4 replicates per lot, depending on method
Contact time less than 10 minutes
Complete inactivation on all carriers
Laundry Pre-Soak Disinfectant
Use Dilution (AOAC 955.14 and 955.15)
Staphylococcus aureus and Salmonella enterica
60 carriers per lot, per microorganism
Contact time less than 10 minutes
Performance criteria depend on test method and test organism(s)
Disinfectant Laundry Additive
ASTM E2274 and ASTM E2406
Staphylococcus aureus and Klebsiella pneumoniae
3 lots (batches), each at LCL
Complete inactivation of all test organisms
