SELECT AGENTS AND TOXINS

The Department of Health and Human Services and the United States Department of Agriculture have released final rules for the registration of possession, use and transfer of select agents and toxins. The rules, which implement provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, have been in effect since February 7, 2003 (7 CFR PART 331, 9 CFR PART 121, 42 CFR PART 73).

The requirements for registration include a Department of Justice security risk assessment for individuals who have access to the listed agents and toxins. Individuals who are determined to meet the criteria of a "restricted person" as defined in the Act will not be approved for access. If you need more information on the use of select agents and toxins at Stony Brook University or have other questions about this new legislation, contact Environmental Health & Safety. Copies of the rules are available at the Federal Select Agent Program website.

View the list of HHS and USDA Select Agents and Toxins effective May 17, 2010.

Some exemptions continue to apply such as those agents contained in specimens for diagnosis. Contact Environmental Health & Safety for assistance in determining if materials are exempt or restricted.

Additional details on inspections, recordkeeping, required notifications to the RO of modifications of work and provisions for civil and criminal penalties may be found in the Final Rules.

Principal Investigators who possess select toxins (including de minimis quantities) are required to report their current inventory to EH&S using the Select Toxins Inventory Form or by using the Select Toxins Google Form.

Stony Brook University is a registered entity with the Federal Select Agent Program and is subject to periodic review by the Centers for Disease Control (CDC) for the possession, use and transfer of BSAT. SBU must also show "due diligence" that persons who possess select toxins are not exceeding legal amounts (see table below) and have a legitimate need to possess them.

Select toxins	Maximum permissible amount
Abrin	1000 mg
Botulinum neurotoxins	1 mg
Short, paralytic alpha conotoxins	100 mg
Diacetoxyscirpenol (DAS)	10,000 mg
Ricin	1000 mg
Saxitoxin	500 mg
Staphylococcal Enterotoxins (subtypes A, B, C, D and E)	100 mg
T-2 Toxin	10,000 mg
Tetrodotoxin	500 mg

*Any possession, use, or transfer of select toxins above the maximum permissible limits REQUIRES full Select Agent Program registration. Principal Investigators needing to exceed these permissible amounts must first contact EH&S for assistance with registration and authorization to possess these materials above the unregulated limits.

Additionally, Principal Investigators are required to:

• Maintain an accurate and up-to-date inventory of their select toxins and ensure that it stays below the maximum permissible limit.
• Obtain EH&S approval before transferring any select toxins to another PI / User and ensure that the recipient has a legitimate need to handle or use such toxins.
• Report to the Stony Brook University Police Department if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to a Select Toxin.
• Secure all select toxins against theft.
• Train laboratory staff in the security, safe handling and disposal requirements of these materials.

Regulatory background: Select Agents and Toxins are those biological agents and toxins that have the potential to pose a severe threat to public health and safety, animal health or to animal products. Select Agents and Toxins are regulated by the Department of Health and Human Services (DHHS), through the Centers for Disease Control and Prevention (CDC), and the United States Department of Agriculture (USDA) via the Animal Plant Health Inspection Service (APHIS).

The select toxin "due diligence" provision of the regulations requires a person transferring toxins in amounts which would otherwise be excluded from the provisions to: (1) use due diligence to assure that the recipient has a legitimate need to handle or use such toxins; and (2) report to Federal Select Agent Program if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to the toxin.

Severe penalties for non-compliance: There are severe penalties for non-compliance with the Federal Select Agent Program (FSAP) rules and it is imperative that each laboratory using and/or storing Select Agent and Toxins maintain accurate and current inventory information for these substances. Failure to register with the FSAP is potentially punishable by up to five years in prison and/or large monetary fines. (Public Health Security & Preparedness Response Act of 2002, Section 231(c), 18 USC 175(b), & Public Law (USA Patriot Act) 107-56 Sec. 817).

If you have any questions about the regulations or requirements, please contact Christopher Kuhlow, Biological Safety Officer at (631) 632-3717 or Christopher.Kuhlow@stonybrook.edu.