In addition to data requirements that apply to all pesticides, pesticides designed to control microbial pests such as viruses and bacteria must have data proving their ability to kill these pests (known as efficacy).

Each of the guidance documents listed below provides a summary of current efficacy-related requirements and/or policy for a category of antimicrobial pesticide products, claims, or patterns of use. If more detailed guidance is needed, the Antimicrobials Division should be consulted. 

If any of the product's use patterns is classified as human-health-related, efficacy data must be submitted for review in order to support the inclusion of that use pattern in the product registration. Regardless of the use pattern, however, product efficacy data is required to be maintained in the registrant's files.

Requirements to develop data on product performance provide a mechanism to ensure that pesticide products will control the pests listed on the label and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. Specific performance standards are used to validate the efficacy data in the public health areas, including:

• disinfectants used to control microorganisms infectious to humans in any area of the inanimate environment; and
• those pesticides used to control vertebrates (such as rodents, birds, bats, and skunks) and invertebrates (ticks, mosquitoes, etc.) that may directly or indirectly transmit diseases to humans. 

The key set of documents directing efficacy testing is:

• Test Guidelines -- Series 810: Product Performance Guidelines
• Frequent Questions for the 2018 Series 810 – Product Performance Test Guidelines

In addition, the following documents also provide information relevant to the efficacy process:

• Methods and Guidance for Testing the Efficacy of Antimicrobial Products Against Biofilms on Hard, Non-Porous Surfaces
• Interim Guidance for the Efficacy Evaluation of Products for Claims against Candida auris
• Revisions to the Performance Standard for the AOAC Use-dilution Methods for Staphylococcus aureus (955.15) and Pseudomonas aeruginosa (964.02)
• Standardized Efficacy Study Report and Efficacy Study Summary
• Efficacy Testing Standards for Product Data Call-in Responses
• Fogger-Mister Final Signed Letter (guidance on data requirements for fogging claims)
• Methods and Guidance for Testing the Efficacy of Antimicrobial Products Against Spores of Clostridium difficile on Hard Non-Porous Surfaces (September 2017)
• Guidance for Efficacy Testing at the Lower Certified Limits
• Protocol for Evaluation of Bactericidal Activity of Hard, Non-porous Copper/Copper Alloy Surfaces
• Protocol for Room Sterilization by Fogger Application
• Protocols for Testing the Effectiveness of Disinfectants Against Hepatitis B Virus (HBV)
• Protocol for Residual Self-Sanitizing Activity of Dried Chemical Residues on Hard, Non-Porous Surfaces
• Using Bovine Viral Diarrhea Virus (BVDV) As Surrogate for Human Hepatitis C Virus
• Virucidal Efficacy Testing Using Feline Calicivirus as a Surrogate for Norovirus

Information about test protocols and related guidance can be found on the Pesticide Analytical Methods site.

Questions about the efficacy requirements? Contact the Antimicrobials Efficacy Team (AD_Efficacy@epa.gov).

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