Info Board
Important news, events and announcements from the National Select Agent Registry.
Theft, Loss and Release Information
The Centers for Disease Control and Prevention (CDC and Animal and Plant Health Inspection Service (APHIS) Select Agent Programs have posted information relating to theft, loss and release (Form 3) reporting requirements of the select agent regulations.
ABSA Pre-conference Course Materials
On October 7, 2007, the CDC and APHIS Select Agent Programs, conducted a pre-conference course at the American Biological Safety Association's 50th Annual Biosafety Conference. The one-day, interactive course, titled "Select Agent Compliance from a Federal Perspective" included formal presentations, group exercises, and case studies. The course materials are available for download on this website.
Inspection Videos Released
The Centers for Disease Control and Prevention and Animal and Plant Health Inspection Service Select Agent Programs are pleased to announce the release of two informational videos entitled “Facility Inspections under the Select Agent Regulations for Biosafety Level 3 and Toxin Laboratories”. The in-depth, informational videos address topics related to the inspection of biosafety level 3 select agent laboratories and select agent toxin laboratories. The videos describe how to prepare for an inspection and what transpires during and after an inspection.The videos can serve as a valuable educational tool for entities or individuals who currently possess, store, or transfer Select Agents and those who are planning to begin work with select agents or toxins. These informational videos can be used in various ways including as a complement to a comprehensive training program for staff or as a tool in developing a training program.
ABSA Pre-conference Course Announced
The Animal and Plant Health Inspection Service (APHIS) and Centers for Disease Control and Prevention (CDC) will be presenting a pre-conference course titled "Select Agent Compliance from the Federal Perspective" at the 2007 American Biological Safety Association's (ABSA) Annual Meeting on Saturday, October 6, 2007 from 8am- 5pm. This session will inform participants of the requirements regarding the select agent regulations including containment, security, incident response, access control, and recordkeeping. This will provide an excellent forum for the Responsible Officials and Alternate Responsible Officials to ask questions and seek guidance from CDC and APHIS. To register for this course, please complete the registration document located on the ABSA website.
Inspection Checklists Released
The Centers for Disease Control and Prevention (CDC) and Animal and Plant Health Inspection Service (APHIS) Select Agent Programs have released inspection checklists to assist entities in complying with security, incident response, training and the records requirements of the select agent regulations.
Security Plan Information Released
The Centers for Disease Control and Prevention (CDC) and Animal and Plant Health Inspection Service (APHIS) Select Agent Programs have posted guidance that will assist entities in complying with the security requirements of the select agent regulations.
Beta version of the National Select Agent Registry web site is released.
This release provides resources and downloadable application packages but does not include all functionality pursuant to the goals of the National Select Agent Registry.
Addition of Reconstructed 1918 Influenza virus to the list of HHS select agents and toxins.
The U.S. Department of Health and Human Services (HHS) published an interim final rule
(PDF format)
in the Federal Register on October 20, 2005 to add
"Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions
of all eight gene segments" to the list of HHS select agents and toxins.
The addition of the reconstructed 1918 pandemic influenza virus to the HHS select agents and toxins list is effective on October 20, 2005. Entities that intend to possess, use, or transfer this agent will be required to either register in accordance with 42 C.F.R. part 73, or amend their current registration in accordance with § 73.7(h).
In addition, the entity may be required to submit additional information involving the proposed work with this select agent. The "Interim CDC-NIH Recommendation for Raising the Biosafety Level for Laboratory Work Involving Noncontemporary Human Influenza Viruses" excerpted from the draft CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5th edition will be used as the minimum containment for such experiments. However, in some cases supplemental biosafety measures may be deemed appropriate after review of the proposed experiments.
Final Rule published in the Federal Register.
The final rule updates the interim final rule (IFR) originally issued by the CDC in December 2002 and amended in November 2003. The Final Rule takes into consideration hundreds of comments on the initial interim final rule from experts and the general public.