Date: August 6, 2018
Subject: FSAP Policy Statement: Registration and Inspection of an Effluent Decontamination System
The Federal Select Agent Program (FSAP) is a collaboration between the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Service (APHIS), Agriculture Select Agent Services (AgSAS) to regulate the possession, use, and transfer of biological agents and toxins listed in 7 C.F.R. Part 331, 9 C.F.R. Part 121, and 42 C.F.R. Part 73 (select agents and toxins). The FSAP administers the select agent and toxin regulations in close coordination with the Federal Bureau of Investigation’s Criminal Justice Information Services Division (CJIS).
It is the policy of the FSAP that the room containing an Effluent Decontamination System is not required to be listed on an entity’s registration so long as:
- The room is not otherwise used for the storage of or work with a select agent or toxin, and
- The entity’s biosafety, security, and incident response plans address effluent with the potential to contain a select agent or toxin originating from a registered laboratory such that these plan procedures are sufficient to prevent the theft, loss, release, or unauthorized access to a select agent or toxin.
An Effluent Decontamination System is a system that sterilizes biohazardous liquid waste generated from a biocontainment laboratory or other facility prior to discharge from the entity.
FSAP considers the entire Effluent Decontamination System to be an extension of the registered space(s) where the effluent originates and therefore reserves the right to inspect the entire Effluent Decontamination System, including any section of an Effluent Decontamination System that may be located in an area not listed on an entity’s registration.
This policy statement is effective August 6, 2018.
HHS and USDA regulations require registration with either DSAT or AgSAS for the possession, use, and transfer of listed agents and toxins. See 42 C.F.R. §73.7, 9 C.F.R. §121.7, 7 C.F.R. §331.7. Completion of the APHIS/CDC Form 1 (Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins) is used to accomplish that registration. Information required to be listed on the APHIS/CDC Form 1 includes facility information including the listing of all areas where select agents and/or toxins are used or possessed.