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@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.
• July 2019: Updated to include eFSAP information and update links.
• January 2025: Updated exclusion amount for short, paralytic alpha conotoxins containing the following amino acid sequence X₁CCX₂PACGX₃X₄X₅X₆CX₇

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.