Exclusion Guidance Document

Changes and Highlights

Revisions: This is a living document subject to ongoing improvement. Feedback or suggestions for improvement from registered select agent entities or the public are welcome. Submit comments directly to the Federal Select Agent Program at: 

CDC: LRSAT@cdc.gov    
APHIS: AgSAS@aphis.usda.gov   

Revision History:

March 27, 2013: Initial Posting
March 2017: Updates include new regulatory requirements, improved language and corrected errors, and changes to Regulatory Exclusions list.

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Introduction

The Federal Select Agent Program (FSAP) oversees the use, possession, and transfer of select agents and toxins at registered entities throughout the United States. The select agent regulations provide criteria for the exclusion of select agents and toxins (See 42 CFR §§ 73.3, 73.4; 9 CFR §§ 121.3, 121.4; 7 CFR § 331.3). This guidance document provides additional information to entities or individuals who request to exclude attenuated strains of select agents or select toxins modified to be less potent or toxic from the requirements of the select agent regulations.