The EPA continues to focus on method development to address industry’s request for biofilm claims and efficacy guidance. The regulatory strategy for this effort hinges on method validation and the data generated through collaborative performance studies. The EPA is currently assessing multiple disinfectant chemistries using the Single Tube Method (ASTM E2871) with a focus on data reproducibility.
Although official test guidelines have not been established, the agency will likely require testing against Pseudomonas aeruginosa and Staphylococcus aureus with biofilm claims limited to EPA registered hospital-use disinfectants. Unlike the Use-Dilution Test or Germicidal Spray Test methods, biofilm disinfection will be quantitatively assessed with a 99.999% reduction requirement currently under consideration. The EPA is also considering whether specific use-sites will determine the performance criteria. Claims such as, Kills-, Reduces- and Penetrates and Kills Biofilms are being evaluated and will likely depend on set performance standards.
Antimicrobial Test Laboratories is a contributing test facility for this EPA endeavor and will continue to work collaboratively with the agency to address test method concerns. Customers seeking biofilm claims are encouraged to contact the lab and speak to a scientist regarding questions related to the information above or other biofilm projects.