|Last Updated: Friday, May 03, 2013|
Federal Select Agent Program Policy Statement on the Toxin Due Diligence Provision in Sections 3 and 16
Section 42 CFR § 73.3(d)(3) specifies the select toxin amounts under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor that are excluded from the requirements of the select agent regulations. The Federal Select Agent Program 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 Federal Select Agent Program if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to the toxin.
"Due diligence" is generally understood to be such 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.
Documenting Due Diligence
To document those individuals who have a legitimate purpose to handle and use such toxins, the transferor can either require the recipient to complete documentation stating their intended use of the toxins or the transferor can document their knowledge of the recipient's legitimate need for the toxins. Information pertinent to the person requesting and using the toxins includes the individual's name, institution name, address, telephone number, and e-mail address.
Reporting Suspected Violation of Federal Law or Suspicious Activity
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 Federal Select Agent Program either by emailing to CDC: LRSAT@cdc.gov or APHIS: ASAP@aphis.usda.gov or calling the Federal Select Agent Program (CDC: 404-718-2000 or APHIS: 301-851-3300 (option 1) (voice only)) the suspected 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).
The Federal Select Agent Program has established a confidential means for reporting safety and security issues associated with the possession, use and transfer of select agents and toxins. The Department of Health & Human Services, Office of Inspector General (OIG) maintains a hotline that allows individuals to anonymously report fraud, waste and abuse in all departmental programs. This hotline is now available to anonymously report safety or security issues related to select agents and toxins. When reporting these issues to OIG, please ensure that you indicate it is a "Select Agent Program" issue.
|*Website is being revamped based on Revised Select Agent regulations.
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