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New Bioterrorism Legislation Affecting University Laboratories and Clinical Facilities

Before September 11, 2001, the transfer of certain infectious agents and biological toxins called "select agents" was regulated by The Antiterrorism and Effective Death Penalty Act of 1996 which mandated strict regulation of the use, transfer and disposal of these materials.

After September 11, 2001, the Bush administration proposed broad antiterrorism legislation that established additional controls over select agents. On October 26, 2001 the USA Patriot Act of 2001 was signed into law. The law criminalized the possession of select agents that had no legitimate purpose, banned the possession of select agents by a set of "restricted persons", and required the Secretary of Health and Human Services to establish additional standards and procedures governing the possession, use, and transfer of select agents.

The USA Patriot Act did not include a requirement to register laboratories for possession of select agents nor did it assign enforcement responsibility to a specific government agency. To rectify this, Congress passed and President Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 on June 12, 2002.

The Public Health Security And Bioterrorism Preparedness and Response Act of 2002 requires the US Department of Health and Human Services and the US Department of Agriculture to promulgate regulations by early December that:

1) maintain and establish a database of select agents that have the potential to pose a severe threat to the health and safety of the public; and review and republish the select agent list at least biennially.

2) establish safety procedures for the possession, use and transfer of select agents, including measures to ensure proper training for handlers of agents, proper containment facilities for use and disposal and appropriate safety and security measures to prevent access to agents by unauthorized persons.

In August, the Centers for Disease Control and Prevention (CDC) and the USDA initiated a notification process, whereby all possessors of select agents were required to self-identify. The Provost asked all faculty to comply with the process by reviewing the list of notifiable agents available at the Environmental Health and Radiation Safety (EHRS) web site (www.ehrs.upenn.edu) and responding to EHRS if they possessed agents. In addition, the CDC and the USDA sent out almost 200,000 "Notification of Possession of Select Agents or High Consequence Livestock Pathogens and Toxins" forms to individuals and institutions. EHRS notified form recipients at Penn to forward the forms to EHRS without completing them. EHRS coordinated Penn's response to the notification request and will continue to be the University focal point for future related efforts once the regulation is promulgated.

If you received a CDC/USDA "Notification of Possession of Select Agents or High Consequence Livestock Pathogens and Toxins" form and did not return it or forward it to EHRS, you will receive a reminder postcard asking you to report on what happened to the form. Please forward all forms and postcards to EHRS, 3160 Chestnut Street, Suite 400/6287.

If you have not already done so, consult the EHRS web site (www.ehrs.upenn.edu) for a list of select agents and the procedures to follow should you possess any of these materials.

If you intend to purchase or receive select agents, you must register your lab with the CDC. The director of EHRS must sign for each transfer and the CDC must be notified of each transfer. Contact EHRS at (215) 898-4453 for assistance.

In conjunction with the pending regulation, all possessors of biological agents and toxins on campus must register with EHRS. More information about the Biological Agent Registration Form will be provided to faculty by EHRS in the near future.

If you have any questions or concerns, contact EHRS at (215)898-4453 or ehrs@ehrs.upenn.edu.

--The Office of the Vice Provost for Research



Almanac, Vol. 49, No. 4, September 17, 2002

ISSUE HIGHLIGHTS:

Tuesday,
September 17, 2002
Volume 49 Number 4
www.upenn.edu/almanac/

The School of Veterinary Medicine invites the Penn community to celebrate 50 Years of Excellence with an Open House on September 21.
U.S. News & World Report ranks Penn #4 in it's annual Best national Universities survey.
The Penn Humanities Forum dedicates the 2002-2003 lectures, seminars, and exhibitions to the topic of The Book.
New Bioterrorism Legislation affects laboratories and clinical facilities.
Speaking Out about the conservation postcards.
Honors for faculty and staff
The 14th annual Career Conference for graduate students starts on September 17.
The 10th annual Penn Family Day is scheduled for October 5.
Research Roundup: Nurse Shortage; Alternate Tobacco Use; Immune Cells Fight Cancer; Head Start.
The Annual Crime Report from the Division of Public Safety.