Risk analysis approaches for microbial ingredients in microbial-based cleaning products.

Microbial-based cleaning products (MBCPs) are an emerging class of cleaning products that contain viable microorganisms, often bacteria or bacterial endospores, as intentionally added formulation ingredients for cleaning and/or odor control. Although several well-established methodologies exist to support risk analysis for conventional chemical-based cleaning products, at present there are no widely recognized methods or commonly utilized frameworks to support risk analysis for use of microbial ingredients present in MBCPs, specifically. The purpose of this work is to provide information to MBCP manufacturers and regulators that can be used to assist in developing their own approaches to MBCP risk assessment. As part of this assessment, potential hazards associated with use of bacterial or bacterial endospore ingredients of MBCPs can be adequately characterized, assessed, and managed as part of both product development and ongoing product stewardship. Accordingly, this document summarizes potential approaches to support strain-level identification of microbial ingredient(s), evaluate their hazards and potential for human exposure, and assess their potential effects following such exposures to different human populations. Recommendations for both hazard and risk characterization are discussed. Additionally, guidance is provided to support decision-making by risk managers, including guidance for the development of risk communication strategies, where appropriate, to mitigate the identified risks. Properly applied, the conceptual approaches described herein may facilitate the standardization and more consistent application of appropriate risk analysis procedures tailored to suit microbial ingredients present in MBCPs. Beyond their utility in assessing microbial ingredients commonly used in MBCPs today, these same approaches may help companies and regulators consider and manage risks for new microbial ingredients that may be utilized in future MBCP formulations.