Due Diligence Instructions and Forms

Purpose

This document describes procedures for recording “due diligence” in instances where permissible amounts of select toxin are transferred from one Cornell University laboratory to another laboratory or institution. This form is required for the transfer of any select toxin amount, under the excluded amounts, as defined by select agent regulations. Following 42 CFR 73.3(d)(7) and  73.16(l), a registered entity transferring an amount of select toxin otherwise excluded under the provisions of 42 CFR 73.3(d) must:

1. Transfer the amounts only after the transferor uses due diligence and documents that the recipient has a legitimate need (e.g., prophylactic, protective, bona fide research, or other peaceful purposes) to handle or use such toxins. Information to be documented includes, but is not limited to, the recipient information, toxin and amount transferred, and a declaration that the recipient has a legitimate purpose to store and use such toxins.

2. Report to CDC if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to a toxin listed in § 73.3(d) of this part.

3. Finally, document those individuals who have a legitimate purpose to handle, and use select toxins, the transferor needs to document the recipient’s intended use of the toxins and document the legitimate need for the select toxins.

Instructions

1. Information on select toxin and date of transfer determined between Recipient and Cornell University-affiliated Sender. Note: Select Toxin Materials must be registered through the Institutional Biosafety Committee (IBC).

2. Recipient completes Section A of the Select Agent Toxin Transfer Due Diligence Form and submits the signed form to the Sender.

3. The Sender completes Section B of the Select Agent Toxin Transfer Due Diligence Form and submits the completed/signed form to Cornell University EHS Biosafety (ehsbiosafety@cornell.edu) for final review.

4. The completed form is provided (by the biosafety office) to Cornell University Principal Investigator and IBC to be recorded in monthly committee meeting minutes. Completed forms can be sent to askEHS@cornell.edu.

5. Cornell University Sender transfers toxin to the Recipient (in accordance with hazardous material shipping regulations) utilizing a shipping method that can be tracked. The shipper includes a copy of the form inside the shipment. The sender notifies the recipient of the tracking information and anticipated date of arrival.

6. Recipient notifies Sender upon receipt of shipment. Both shipper and recipient retain records for three years or as hazardous materials shipping requirements require.

Permissible Amounts

The following toxins do not require registration with the Federal Select Agent Program (but require due diligence and inventory) if the amount under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not exceed, at any time, the amounts indicated in the table below.