Regulatory Interpretation: Gram Stained Slides Containing Select Agents
Date: June 23, 2017
Subject: Regulatory Interpretation regarding Gram stained slides containing select agents
This is in response to your request, dated May 26, 2017 for the following regulatory interpretations for the preparation of a Gram stain slide using Burkholderia pseudomallei inside the biosafety cabinet (BSC) located in a registered room that is read on the microscope on the benchtop within the same room.
- Is the select agent considered outside of primary containment if viewed on the benchtop microscope?No. The select agent is not considered a release outside of the primary barriers of the biocontainment area because the agent is fixed onto the slide or washed off during Gram staining procedure.
- If not wearing respiratory protection, is the staff member “potentially exposed” for just viewing the slide on the microscope outside of primary containment? No. A staff member viewing a Gram stain slide of B. pseudomallei on a microscope within the same registered room would not be considered exposed to the select agent.
Please note that:
- The regulatory interpretation applies to Gram staining of all bacterial select agents.
- If you want to remove Gram stained slides of select agents from registered space, you must validate in house that the Gram stained slides do not contain viable agent.
Page last reviewed: August 25, 2020, 11:15 AM
Content source: Division of Regulatory Science and Compliance