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
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
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.
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:
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.
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"
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
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.
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 firstname.lastname@example.org.
of the Vice Provost for Research