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***THIS NEW REGULATION COULD AFFECT YOUR RESEARCH***
July 12, 2002
If you conduct biomedical research, you need to know about this new regulation that addresses 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 DHHS 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 and the subsequent anthrax incidents 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).
ACTION ITEM – Oversight of the Select Agents Program at the University of Michigan is accomplished through the Department of Occupational Safety and Environmental Health (OSEH). The contact is Michael Hanna at 7-2318. Please scour your memories, inventories, and Ultralow’s to determine if you are in possession of any of these regulated materials. Internal DEADLINE is August 30. If you suspect you’ve located a Select Agent, call OSEH and we’ll assist you in working through the required registration.
BACKGROUND – Since 1996 when Select Agents were first listed as more heavily regulated research materials by the CDC, OSEH has assisted the research community in dealing with these new regulations. In conjunction with the Office of the Vice President for Research (OVPR), the effort has been to alert and brief researchers on shipping restrictions for Select Agents. However, 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 (FR), 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.
Appendix A
Select Agents List as of January 1, 2002
[42CFR 72, Appendix A – October 24, 1996]
Viruses
Bacteria
Rickettsiae
INSTRUCTION FROM UM-OSEH TO RESEARCHERS - CDC AND USDA HAVE ADDED NEW AGENTS TO THE LIST. IF YOU HAVE ALREADY DONE A REVIEW OF YOUR COLLECTION FOR SELECT AGENT POSSESSION, REVIEW THE FINAL BLOCK AND RE-CHECK YOUR COLLECTION. IF ANY ARE IDENTIFIED, CONTACT OSEH AT 7-2318.
HHS Select Agents