Web4 P a g e Inactivation Guidance Document Select agents and toxins excluded as an attenuated strain of a select agent or a select toxin modified to be less potent or toxic.1 See 7 CFR §331.3(e), 9 CFR §§121.3(e), 121.4(e), 42 CFR §§73.3(e), 73.4(e). Decontamination for waste disposal. WebSelect Agent Specialist Location: 1980 Denison Ave., Manhattan, KS. Duties ... Developing SOPs and WIs for entry/exit requirements, inactivation policies, Biosafety Plans, Security Plans, and ...
Guidance on the Inactivation or Removal of Select Agents and …
WebApr 19, 2024 · All categories for exclusion of material subjected to an inactivation or removal procedure from the select agent regulations require initially validating select agent inactivation or select agent removal procedures (using one of the two options listed below) and viability testing using appropriate positive, negative, and process controls, WebApr 6, 2024 · A “validated inactivation procedure” is defined by the select agent and toxin regulations as “a procedure, whose efficacy is confirmed by data generated from a viability testing protocol, to render a select agent non-viable but allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids ... products containing msg
Biological Toxins Guidance Biosafety Program
WebSep 9, 2024 · the date of inactivation or viable select agent removal, a written description of the validated inactivation or viable select agent removal method used, and; the name and … WebJan 19, 2016 · If there are strain-to-strain variations in resistance of a select agent to the inactivation procedure, then a specific kill curve must be developed for each strain that undergoes the inactivation procedure. A new kill curve must be created upon any change in procedure or inactivation equipment. (B) Develops site-specific standard operating ... WebDec 6, 2024 · The following pathology specimen types are considered inactivated and can be handled in accordance with BSL-2 guidelines: Fixed fluid or tissue smears for routine diagnostic staining and microscopic analysis Formalin-fixed biopsy or autopsy tissues Glutaraldehyde-fixed grids for electron microscopic study products containing nitric acid