Select Toxin Guidance
Contents
- Preface
- Introduction
- List of Select Toxins and Non-Regulated Amounts
- Tier 1 requirements for Botulinum neurotoxin and Botulinum neurotoxin producing species of Clostridium
- Regulatory Exclusions
- Regulatory Exemptions
- Inventory requirements
- Regulation if registered for a select toxin regardless of the quantity possessed
- Registration and Biosafety level
- Transfer requirements
- Importation requirements
- Identification of a select toxin requirements
- Proficiency Testing Identification
- Useful Links and Resources
- Appendix A
- Download PDF
Preface
The information in this guidance document is meant to provide additional information to regulated entities to assist them in meeting the requirements for select toxins.
Revisions: This is a living document subject to ongoing improvement. Feedback or suggestions for improvement from registered Select Agent entities or the public are welcomed. Submit comments directly to the Federal Select Agent Program at:
CDC: LRSAT@cdc.gov
APHIS: AgSAS@aphis.usda.gov
Revision History:
June 23, 2016: Initial posting
October XX, 2016: Updates include new regulatory requirements, revised List of Select Toxins and Non-Regulated Amounts, added section on food and clinical samples, revised section on toxin as a byproduct, revised section on documenting due diligence, and revised chart in Appendix A.
