2020 SA Grams

The Federal Select Agent Program (FSAP) has posted a new Frequently Asked Question (FAQ) to its website to clarify information about the intentional inoculation of food samples with botulinum neurotoxin producing species of Clostridium.  The new FAQ can be found at https://www.cdc.gov/selectagent/faq-general.html and is also included below.

Is the intentional inoculation of food samples with botulinum neurotoxin producing species of Clostridium and the subsequent identification of botulinum neurotoxins in the inoculated samples considered diagnosis and does it meet the exemptions outlined in Section 5 of the select agent regulations?

No. This work would be considered experimental research. Botulinum neurotoxin producing species of Clostridium was introduced into the samples intentionally, and the toxin was created as a by-product of bacterial growth.  Therefore, the entity must be registered for botulinum neurotoxin producing species of Clostridium, and may have to be registered for the toxin to perform this type of work if the aggregate amount of toxin under the control of the entity or individual is over 1 mg.  Please note that Code of Federal Regulations Title 42 Part 73 Section 17 (Records) requires that an individual or entity registered with the Federal Select Agent Program must maintain complete records including an accurate and current inventory for each select agent and toxin held.

Page last reviewed: November 23, 2020, 09:50 AM