This document outlines the University of Iowa's institutional requirements for possession of exempt quantities of Select Toxins regulated by the Center for Disease control and Prevention (CDC)
These requirements have been established to ensure:
- Safe laboratory handling, use, and storage procedures.
- Effective tracking and security of the regulated toxins.
- Compliance with federal regulations.
As per the federal regulations, each principal investigator (PI) may possess up to a specified amount of toxin and not be required to register with the CDC. Following is a list of the Select Toxins and the maximum quantities that are allowed in order to remain exempt from federal registration.
Max. Allowable per PI for Exemption
|Botulinum neurotoxin||1 mg|
|Short, paralytic alpha conotoxins||100 mg|
|Diacetoxyscirpenol (DAS)||10,000 mg|
|Staphylococcus enterotoxins (Subtypes A-E)||100 mg|
|T-2 Toxin||10,000 mg|
The following toxins are also exempt:
- Any toxin that is in its naturally occurring environment provided it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
- Nonfunctional toxins.
It is important to ensure that the total amount of toxin per PI is maintained below these limits at all times in order to remain exempt from registration with the CDC and the attendant restrictive requirements. Due to the severe penalties associated with non-compliance with the Select Agent Regulations, it is imperative that each laboratory using and storing toxins maintains current inventory information for these substances. (Failure to register a Select Toxin is now a criminal offense, punishable by up to five years in prison and/or $500,000 in fines. (Public Health Security & Preparedness Response Act of 2002).
II. UI Requirements for Possession of Exempt Quantities of CDC Select Toxins:
The Principal Investigator is responsible for ensuring the following:
- Standard Operating Procedures (SOPs): Prepare written SOPs for toxin-involved research processes and include these SOPs as an attachment in the laboratory’s Chemical Hygiene Plan.
- Personnel Training: Provide initial lab-specific safety training to staff for all toxin-involved processes, with updates as necessary.
- Ensure documentation of training is maintained. Training topics should include:
- Toxin-associated hazards
- Engineering controls used to minimize exposure (e.g., fume hood use)
- Personal protective equipment (PPE) to be used when handling the toxin
- Safe handling and storage
- Proper decontamination and disposal
- Administrative requirements (recordkeeping, inventory, security)
- In addition to lab specific training, EHS’s online training course, Toxins, Select Agent Quantity, must be completed by all laboratory staff involved in toxin-related research.
- Proper PPE: Appropriate personal protective equipment must be provided (e.g., gloves, safety goggles, lab coat or disposable lab coat). Note: if respirators are necessary, contact Justin Newnum (335-9554) for required respirator use approval and compliance documentation.
- Engineering Controls: Ensure proper use of the fume hood, biosafety cabinet, or glove box with toxin-associated procedures.
- Inactivation: Use the Toxin Inactivation procedures prior to disposal of remaining stock and/or empty containers
- Disposal: After inactivation, dispose of residual wastes (liquids/solids) as follows:
- Liquids: can be disposed of in a biohazard waste container, provided there is no other characteristic of the waste that makes it a hazardous waste, such as heavy metals, flammability, etc.
- Stock vials and other materials: Deface container labeling. Collect in a leak-proof container and place in biohazard waste container, with the same conditional statement as above.
- Storage/Security: Items must be
- Stored with compatible materials within secondary containment; and
- Provided one layer of physical security (e.g., toxin secured within a locked freezer or secured within a permanently fixed lockbox).
- Used only by approved staff: Before becoming an approved user, the PI must ensure that each person has received training as described above. Maintain a list of PI-approved toxin users (include those having access to toxin materials). The lab must keep track of who uses the stock (and who has access to the freezer), recording each use.
- Inventory Maintenance: Inventory of toxins must be kept current. To ensure that the exempt quantity limits are not inadvertently surpassed, inventories are to be promptly updated after every container of toxin is:
- Acquired (by purchase/intra-campus transfer)
- Depleted (by consumption /intra-campus transfer)
- Print out the Select Toxin Inventory Record Template that must be kept current within the laboratory. This form is designed to track specific toxin use and personnel access.
- Current toxin inventories may also be kept in the online EHS Assist system. However, use of the EHS Assist system cannot be used in lieu of the Select Agent Toxin Inventory Record Form noted above.
- Transfer of an exempt quantity of select toxin(s): PIs wishing to transfer an exempt quantity of a select toxin to another user must use due diligence and document that the receiver has a legitimate need to handle or use the toxin(s).
- An Exempt Quantity Transfer Form has been developed by EHS for this purpose.
- The transfer form must be retained by the transferor as the HHS Secretary retains the right to inspect or request the submission of the due diligence documentation to the CDC.
- Security Inspection: Each laboratory with select agent toxins will be audited annually by EHS. The inspection will include:
- Review of approved users list to verify authorized access to toxins.
- Verification of appropriate labeling, storage, secondary containment, and security measures.
- Comparison of physical inventory with what is accounted for in the records. A copy of the current recorded inventory signed and dated by the PI, will be collected at the time of the audit by EHS safety advisors.
III. Possession of Select Toxins Above the Exempt Quantities:
Prior to possessing select toxins in quantities above the exempt limits, a Principal Investigator must contact the Responsible Official (RO) (Nyree Mortensen, Biosafety Officer, 353-5679) in order to submit all appropriate information to the CDC and the FBI, and receive CDC approval to conduct the work in an approved facility.
For any questions regarding the Select Agent Program at the University of Iowa, contact Nyree Mortensen, Biological Safety Officer/RO at 353-5679 or Norma Miller, Assoc. Biological Safety Officer/Alternate RO at 467-1123.