Does FDA recommend any specific experimental methods?
FDA recognizes it is impractical to design a standard experimental protocol that addresses all relevant safety issues for every antimicrobial agent. However, there are a number of resources specific to microbiological methods that the agency recommends. FDA publishes an online version of its Bacteriological Analytical Manual which presents useful laboratory procedures for microbiological analyses of foods and cosmetics. Furthermore, FDA maintains a website with numerous links to related resources on Microbiological Methods. Also, FSIS maintains a Microbiology Laboratory Guidebook of current protocols for analytical tests required by FSIS in its regulatory activities on meat, poultry and egg products; these test procedures may be useful in the experimental design of technical effect studies. However, a petition or notification will not be treated differently simply because an alternative study design was chosen.