Select Toxin Guidance
- List of Select Toxins and Non-Regulated Amounts
- Tier 1 requirements for Botulinum neurotoxin and Botulinum neurotoxin producing species of Clostridium
- Regulatory Exclusions
- Regulatory Exemptions
- Inventory requirements
- Regulation if registered for a select toxin regardless of the quantity possessed
- Registration and Biosafety level
- Transfer requirements
- Due diligence
- Importation requirements
- Identification of a select toxin requirements
- Proficiency Testing Identification
- Useful Links and Resources
- Appendix A
- Download PDF
“Due diligence” is a measure of prudence, activity, or assiduity exercised by a reasonable and prudent person under the particular circumstances. It is not measured by any absolute standard, but depends on the relative facts of the specific case.
It is the entity’s responsibility to document how it has conducted its due diligence.
Sections 42 CFR §§ 73.3(d)(7)(i) and 73.16(l) require the transferor to use “due diligence” when transferring an amount of a HHS select toxin otherwise excluded under the provisions of §73.3(d). This provision requires a transferor to take reasonable actions to ensure that the recipient:
- Is eligible to receive the select toxin (principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor).
- Has a legitimate need (i.e., reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such select toxins.
The SAR also requires the transferor to report to FSAP immediately if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to the select toxin. FSAP developed this provision to address the concern that someone might stockpile select toxins by receiving multiple orders below the excluded amount.
Documenting Due Diligence
The transferor can document how they have determined that an individual has a legitimate purpose to handle and use such select toxins in a few ways:
- The transferor can require the recipient to complete documentation stating their intended use of the select toxin.
- The transferor can document their own knowledge of the recipient's legitimate need for the select toxin.
Information pertinent to the person requesting and using the select toxins must include, but is not limited to:
- The recipient identity information, including the recipient's name, institution name, address, telephone number, and email address.
- The name of the toxin and total amount transferred.
- The legitimate need claimed by the recipient.
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 select toxin, the transferor should report to FSAP the requested select toxin and the pertinent information of the person requesting and using the select toxins (e.g., name, institution name, address, telephone number, and email address). A transferor can contact FSAP either by emailing to CDC: LRSAT@cdc.gov or APHIS: AgSAS@usda.gov or calling FSAP (CDC: 404-718-2000 or APHIS: 301-851-3300 (option 3) (voice only)).
Toxin Due Diligence FAQs
- Question: My entity has prepared three vials that each contain less than the regulated amount of select toxin but in combination contain greater than the regulated amount of select toxin, and packaged them into one transfer. Can this transfer occur without the use of an APHIS/CDC Form 2?
Answer: No. The total amount transferred, regardless of how many vials it is distributed into, has exceeded the regulatory threshold amount and must be shipped via an APHIS/CDC Form 2 to a registered recipient.
- Question: My entity has prepared three vials that each contain less than the regulated amount of select toxin and packaged them into three separate transfers that are shipped on the same day to the same recipient. Can these transfers occur without the use of an APHIS/CDC Form 2?
Answer: No. The total amount transferred, regardless of how many vials or packages are separately shipped, will result in the recipient possessing greater than the regulatory threshold amount. Therefore, these transfers must be shipped using an APHIS/CDC Form 2 to a registered recipient.
- Question: My entity sent a transfer that contains select toxin below the regulatory threshold amount after performing due diligence. A week later the same recipient requests another shipment for an amount of select toxin below the regulatory threshold and states they have used up the select toxin from the first transfer. Can my entity send this second transfer?
Answer: It depends. If the transferor detects a known or suspected violation of Federal law or becomes aware of suspicious activity related to the shipped select toxin, the transferor should report to FSAP and not ship the select toxin. However, if the transferor believes the recipient has a legitimate need to handle or use such select toxins within a week of sending the first shipment and does not have concerns about the recipient stockpiling select toxin then the entity can send the second transfer.
- Question: How do the select agent regulations apply to a 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) and the exclusion is limited to select toxin under the control of a bona fide principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor.
Answer: A PI transferring (meaning the PI will no longer have control of the select toxin) an unregulated amount of a select toxin to the control of a bona fide principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor is not required to obtain prior approval for the transfer using the APHIS/CDC Form 2. However, the PI will be required to exercise due diligence prior to 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 (e.g., a research assistant), such that the toxin is still under the control of the PI, then that movement is not considered a transfer. Therefore, the select toxin would not be excluded from the regulations 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 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.
More information on due diligence requirements can be found in the Due Diligence FAQs.