Select Agent

Select Agent Toxin Purchasing, Shipping, and Receiving Procedures

IMPORTANT NOTE: Viable select agents (including genetic elements), regardless of quantity, and select agent toxins in volumes over the exclusion limits, are subject to strict federal regulations under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. These regulations require individuals with access to any select agents, or toxins over the exclusion, to be background checked and approved by the U.S. Attorney General; the laboratory, activities, and individuals with access to be registered with HHS (or USDA, as applicable); and individual and institutional compliance with laboratory and container security, agent/toxin inventory, emergency, safety, training and other requirements. Failure to comply is subject to individual and institutional criminal and civil liabilities, and the Justice Department and FBI are taking an aggressive law enforcement approach to the requirements. See the attached list of regulated agents (including genetic elements) and toxins, with per PI toxin volume exclusion limits.
PURPOSE OF THIS SOP: This SOP will help MIT PIs and other personnel to avoid obtaining quantities of select agent toxins that will cause them to inadvertently exceed the per PI exclusion limits and become subject to and violate the federal regulations. The purchase or transfer of any quantity of viable select agents (including genetic elements), or of select agent toxins over per PI exclusion limits, requires the prior approval of the Institute’s Responsible Official, Dr. Claudia Mickelson or Alternate RO, Richard Fink, and HHS. In addition, an HHS Registration Certificate must be obtained and CDC Form EA101 must be used before any regulated transfer may occur. The Institute’s RO administers Certificates of Registration and EA101 forms. Contact Dr. Mickelson or Mr. Fink at 2-EHSS if you have questions.

1. Select agent toxins must be ordered through MIT’s EHS Office, Biosafety Program via the use of a paper requisition. All requisitions should be confidentially sent to the attention of the Biosafety Program in N52-470.).

2. The paper requisition must be signed and approved by the PI and include the following information:

• The Material Name
• The name and laboratory/location of the user and PI
• The current inventory of this select agent toxin in the laboratory (total of existing amount before the current order plus amount being ordered)
• Cost Object and account number for funds to pay for purchase

3. The MIT EHS Office will verify that the requisition is properly authorized and the order does not inadvertently put the laboratory and its personnel at risk of exceeding per PI toxin volume exclusions and of becoming subject to and violating the federal regulations. If the regulations will apply, the EHS Office will work with the PI to register and comply before acquiring the toxins.

4. Final approval and verification are contingent upon receipt of all requested information. Once all needed information has been obtained, approvals will be completed and orders placed with the vendor within two hours if submitted before 2:00 p.m. or by 10:00 a.m. on the next business day if received after 2:00 p.m. between Monday and Friday (except holidays). Please contact Dr. Mickelson or Mr. Fink if you have a special request and they will do their best to accommodate your needs.

5. The order will then be delivered to “EHS Office, BSP” at MIT Building N52-496

6. The order will be received, verified against the original order. The order will be delivered to your laboratory by EHS personnel on the same day as delivery, provided that someone is at the laboratory to receive it and sign off on delivery.

Last updated 6/25/03