Regulatory Interpretation

Date:June 17, 2019

Subject: Regulatory interpretation regarding transfer of excluded toxin

This is in response to your request, dated June 3, 2019, for a regulatory interpretation for transferring excluded amounts of toxins.  Specifically, you requested information explaining whether approval from the Federal Select Agent Program is required to transfer less than 1.0 mg botulinum neurotoxins. 

An entity that possesses regulated amounts of a toxin may transfer the toxin in an amount which excludes it from the provisions of the select agents and toxins regulations (e.g., less than 1.0 mg botulinum neurotoxins)(See 42 CFR §73.3) without use of a APHIS/CDC Form 2 authorization as long as the entity uses due diligence to determine that the recipient has a legitimate need to handle or use such toxins.  For a shipment of a toxin where the amount of the toxin is not known, the toxin will not be excluded from the requirements of select agents and toxins regulations until the entity is able to confirm that the amount is within the exclusion limit.