Due Diligence FAQ's
FAQ's by Topic
- Due Diligence
- Inactivated Bacillus anthracis
- Legislature, Regulation, and Guidelines
- Personnel Suitability
- Report of the Identification of a Select Agent or Toxin
- Responsible Official
- Restricted Experiments
- Security Risk Assessments
- Select Agents and Toxins
What is “due diligence”?
"Due diligence" is a measure of prudence, activity, or assiduity, as is properly to be expected from, and ordinarily exercised by, a reasonable and prudent person under the particular circumstances; not measured by any absolute standard, but depending on the relative facts of the specific case. In the case of DSAT regulation, this means ensuring that all individuals use best practices when handling, storing, and transferring select agents and toxins.
Does the "due diligence" provision required under Section 16 apply to only registered individuals or entities or does it apply to entities or individuals not registered with the Federal Select Agent Program?
The "due diligence" provision required under Section 16 applies to anyone (registered or unregistered individuals or entities) that transfers toxin listed under Section 73.3 in amounts that otherwise would be excluded from the select agent regulations. FSAP developed the provision to address the concern that someone might stockpile toxins by receiving multiple orders below the excluded amount. The "toxin due diligence" provision requires a person transferring toxins in amounts which would otherwise be excluded from the provisions to: (1) use due diligence to assure that the recipient has a legitimate need to handle or use such toxins; and (2) report to FSAP if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to the toxin.
Is a Principal Investigator who possesses a regulated amount of a select toxin able to transfer an unregulated amount of a toxin to fellow co-workers without getting prior approval?
Yes, but with these caveats:
- If the "fellow co-worker" is someone supervised by the Principal Investigator, the toxin remains under the control of the Principal Investigator and has not really been transferred. In such cases, the "fellow co-worker" would have to be SRA approved and the room where the toxin located registered.
- The Principal Investigator must maintain accurate inventory records of the select toxin, including the transfer of unregulated amounts of the toxin.
Is a company that manufactures and possesses regulated amounts of a toxin able to transfer less than regulated amounts to an unregistered entity without getting prior approval?
Yes, the company may transfer toxins in amounts which would otherwise be excluded from the provisions of the regulations as long as the company uses due diligence to determine that the recipient has a legitimate need to handle or use such toxins.
Are there any specific documents required to meet the "due diligence" provision under Section 16?
There are no federal forms that are required to be completed. The regulations require that the transferor “documents that the recipient has a legitimate need (e.g., prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use” the toxins being transferred. Information to be documented includes, but is not limited, to the recipient information (i.e., the individual’s name, institution name, address, telephone number and email address), toxin and amount transferred, date of transfer and declaration that the recipient has legitimate purpose to store and use such toxins.
How do I report a suspected violation of transfer regulations for select agents and toxins?
If the transferor detects a known or suspected violation of Federal law or becomes aware of suspicious activity related to the shipped toxin, the transferor should report to FSAP either by emailing to DSAT: LRSAT@cdc.gov or AgSAS: AgSAS@aphis.usda.gov or calling FSAP (DSAT: 404-718-2000 or AgSAS: 301-851-3300 option 3 (voice only)) the requested toxin and the information pertinent to the person requesting and using the toxins (e.g., name, institution name, address, telephone number, and e mail address).
How does a registered entity document due diligence for the transfer of select toxins?
The regulations require that documented information includes, but is not limited to:
- The recipient information (Individual’s name, institutions name address, telephone number, and email address).
- Intended use of the toxin.
- Date of transfer.
- Toxin and amount transferred.
- Declaration that the recipient has a legitimate purpose to store and use such toxins.
The transferor can document their knowledge of the recipient’s need for the toxins, require the recipient to complete documentation stating their need, or use both methods.
An entity possesses a select toxin in an aggregated amount that exceeds the excluded limit listed in the select agent regulations; but the select toxin is distributed among multiple Principal Investigators, none of whom individually controls an amount above the excluded limit. Does this entity have to register with the Federal Select Agent Program?
No, if the aggregate amount of the select toxin under the control of each Principal Investigator (i.e., individual who is designated by the entity to direct a project or program and who is responsible to the entity for the scientific and technical direction of that project or program) at the same entity, does not, at any time, exceed the select toxin amounts listed in 42 CFR 73.3(d)(7).
How do the select agent regulations apply to a Principal Investigator (PI) possessing a regulated amount of a select toxin who transfers an “unregulated amount” of a select toxin to another person? Note: An “unregulated amount” of a select toxin would be those amounts listed in 42 CFR § 73.3(d)(7).
A PI transferring (meaning the PI will no longer have control of the select toxin) an unregulated amount of a select toxin to another person is not required to obtain prior approval for the transfer using the APHIS/CDC Form 2. The PI will be required to exercise due diligence prior to the transfer and keep a record of the transfer. The PI will be required to note the amount of the transfer on the PI’s select toxin inventory. Please note that transfer of any amount of select toxins outside of the U.S. requires an export license from the Department of Commerce, Bureau of Industry and Security (See 15 CFR Supplement #1 to Part 774, Export Control Classification Number 1C351).
NOTE: If a PI moves any amount of a select toxin to someone the PI supervises at the same entity (i.e., a research assistant), such that the toxin is still under the control of the PI, then that movement is not considered a transfer within the meaning of the regulations. Therefore, the select toxin would not be excluded from the regulation and the individual and room where the toxin is used or stored would need to be listed on the registration and must meet all requirements of the select agent regulations. For example, the PI maintains two laboratories. One laboratory stores above the excluded amount of the toxin. The second laboratory is where the PI’s research assistant works with the excluded amount of toxin. Since the PI maintains control over both portions of the select toxin, both rooms must be listed on the registration and must meet all requirements of the select agent regulations.