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Office of Research Compliance and Assurance

 

 
biosafety
 
Public Health Security and Bioterrorism Preparedness
 
Act of 2002 - Public Law 107-877 - July 12, 2002
 
THIS NEW REGULATION COULD AFFECT YOUR RESEARCH
 
Management of the Select Agents Program at the University of South Alabama is accomplished through the Biosafety Office. The contact is Ms. Dusty Layton at 460-6041. This new regulation addresses the security of select infectious agents, toxins, and genetic elements (refer to attached list). The new law focuses on possession of materials that are not uncommon in biomedical research labs, and calls for the Department of Health and Human Services to be more aggressive in tracking individuals who have them. This new law takes the Patriot Act to the next level. The intensified concern over bioterrorism in the aftermath of September 11 have caused Congress to increase its scrutiny of potential sources of biological agents that could pose a risk to the public's health and safety, including the nation's university laboratories. On May 22, the US House and Senate approved House Rule 3448 and President Bush signed it into law on June 12, 2002 (Public Law 107-188).
 
BACKGROUND - Why is there a Select Agents Law? "The Antiterrorism and Effective Death Penalty Act of 1996," which became effective on April 15, 1997, and the "Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act) of 2001'' establish provisions that regulate the possession, usage, or transfer of hazardous agents, and required the Department of Health and Human Services to issue rules to implement these provisions. The Center for Disease Control proposed new regulations to meet the requirements of this statute. Specifically, the law was designed to (1) establish a system of safeguards to be followed when specific agents are transported; (2) collect and provide information concerning the location where certain potentially-hazardous agents are transferred (3) track the acquisition and transfer of these specific agents; and (4) establish a process for alerting appropriate authorities if an unauthorized attempt is made to acquire these agents. The directive also places additional shipping and handling requirements on facilities that transfer or receive select infectious agents.
 
The new law dictates that you must register with the CDC if you merely possess these infectious agents, toxins, and genetic elements. In the July 2nd Federal Register, the CDC published a proposed data collection system for notification of Select Agents possession. Section 202(a) of the Act requires that all persons in possession of a Select Agent notify the Secretary of Health and Human Services by September 10, 2002. Excerpt from the FR notice "In order to complete the application, the RFO will need to inventory its facility and consult with others (e.g., principal investigators) as necessary to obtain the information required for this application. The Responsible Facility Official (RFO) must review and sign the application and will be the point of contact if CDC has questions concerning the application or other matters related to the Public Law.
 
Select Agent/Toxin list as of March 18, 2005
 
NOTE: Please contact the Office of Research Compliance and Assurance at 460-6625 if you are in possession of or planning to use a select agent or toxin.
 
Summary of Regulatory Requirements:
 
USA PATRIOT ACT OF 2002
 
Public Health Security and Bioterriorism Preparedness and Response Act of 2002
 
Proposed Revision to the Select Agent List (Federal Register, August 23, 2002) (pdf file)
 
Facility Registration for Select Agents
 
Frequently Asked Questions on the Requirement for Notification of Possession
 
For information on the USDA/APHIS High Consequence Livestock Pathogens and Toxins
 
 
 
Updates
 
Biohazardous Activity Registration (BAR) form(Word template) (Updated 11/08/06)
 
 
 
rDNA - FAQs (7/12/05)
 
 
 
Biohazard Sign (Word document)
 
 
 
 

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Date last changed: April 1, 2014 3:23 PM
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