Controlled Toxins

Select Agents & Toxins

List Labs is registered with the Division of Select Agents & Toxins at the Centers for Disease Control and Prevention (CDC). This allows us to manufacture and transfer items that have been categorized as Select Agents & Toxins by the CDC and U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS). We comply with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Select Agents & Toxins Regulations, 7 CFR Part 331, 9 CFR Part 121 and 42 CFR Part 73.

A few of our products are considered Select Agents & Toxins, which include botulinum neurotoxins and enterotoxin type B from S. aureus. To order a Select Agent for the first time, follow the steps below:

  • Establish an account with List Labs, by submitting a New Customer Application.
  • Submit a signed Letter of Assurance.
  • Submit a purchase order on company letterhead or an official purchase order. Once approved, you will be notified and your order will be processed.

Larger purchases of Select Agents require permission from the CDC or APHIS. In this situation, a Form 2 is required. Entities that are registered for Select Agent and Toxins are familiar with this requirement. To begin the Form 2 process, see the link here. The above requirements also need to be met.

These toxins are not regulated and Form 2 is not required if the amount under the control of the Principal Investigator (PI), treating physician or veterinarian, or commercial manufacturer or distributor does not exceed, at any time, the amount indicated below:

  • Botulinum neurotoxin (BoNT): 0.5 mg
  • Staphylococcal enterotoxins (subtypes A-E): 5 mg

The PI is the person designated by the institution to direct a program or project, who is responsible for the scientific and technical direction of that program or project. A signed Letter of Assurance is required to document the recipient's eligibility and legitimate need to handle or use Select Agents and Toxins.

Botulinum neurotoxins and staphylococcal enterotoxins ship on a Dangerous Goods Declaration. A specific box is utilized to ensure that the item arrives intact. A special handling fee of $50.00 is added to each domestic shipment. List Labs completes the Dangerous Goods Declaration when preparing the package for shipment.

Further details regarding the shipping of Select Agents & Toxins can be found on our blog.
 

U.S. Export Controls

List Labs complies with the U.S. Export Controls, following the Bureau of Industry and Security and the U.S. Department of Commerce regulations (EAR), 15 CFR, part 774. These regulations require us to obtain an Export License when transferring items which are on the Control List (Section 1C351, Page 64). In order for List Labs to obtain the Export License, the following items are required to begin the application process.

Once the above items have been received, an application for an Export License will be submitted to the U.S. Department of Commerce. The license is usually issued within four to six weeks. The license is valid for four years, so the export of multiple shipments may be included on the application. There is a $50.00 fee added to each shipment on an Export License.