Archived Information

Chapare virus

On August 19, 2009, the U.S. Department of Health and Human Services (HHS) published in the Federal Register a notice proposing to add Chapare virus to the list of HHS select agents and toxins found at 42 CFR 73.3.

Chapare virus

Select Agents Workshop

On May 22, 2009, the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), published in the Federal Register a notice regarding a multi-agency informational meeting...

Select Agents Workshop

SARS-associated coronavirus

On July 13, 2009, the Department of Health and Human Services (HHS) published in the Federal Register a notice proposing to add SARS-associated coronavirus (SARS-CoV) to the list of HHS Select Agents and toxins found at 42 CFR 73.3.

SARS-associated coronavirus

Synthetic Genomics

The APHIS and CDC Select Agents Programs are pleased to announce the public release of guidance regarding the application of the current Select Agents regulations to those who create and use synthetic genomic products.

Synthetic Genomics

New OMB approved Select Agents Forms

The new OMB approved Select Agents Forms (expiration date 12/31/2011) are now available. All forms are available in both printable and fillable .pdf formats.

Forms

Select Agents Workshop

On November 5, 2008, APHIS published in the Federal Register, a notice regarding the Select Agents Workshop which was presented by APHIS and CDC Select Agents Programs on December 9, 2008. The one-day workshop covered information on entity registration, security risk assessments, biosafety requirements, and security measures.

Click here to view the agenda and presentation

2008 Biennial Review of Lists of Select Agents and Toxins

The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules in the Federal Register on October 16, 2008 that complete the biennial review and republication of the lists of Select Agents and toxins. The Final Rules published on October 16 become effective on November 17, 2008. CDC and APHIS will be working with those entities affected by the changes to the lists.

In addition, the Centers for Disease Control and Prevention (CDC) is issuing a Final Rule regarding a technical correction to the list of Select Agents and toxins regulated by the HHS published on October 16, 2008, in the Federal Register (73 FR 61363). This correction inserts "Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight segments (Reconstructed 1918 Influenza virus)" that was inadvertently omitted.

Click here for more information on the biennial review of the lists of Select Agents and toxins

Select Agents Workshop

On November 5, 2008, APHIS published in the Federal Register a notice regarding the Select Agents Workshop which will be presented by APHIS and CDC Select Agents Programs on December 9, 2008. The one-day workshop will include information on entity registration, security risk assessments, biosafety requirements, and security measures. Space will be limited. Details about this notice and the registration forms are available for download on this website.

Further Details & Registration Forms

Definition of variola virus in 18 U.S.C. 175c

On July 24, 2008, the Department of Justice concluded that the current definition of variola virus found in section 18 U.S.C. 175c applies only to viruses “produced, synthesized, or engineered from variola major virus or its components through human manipulation.”

Definition of variola virus in 18 U.S.C. 175c (6 MB)

Theft, Loss and Release Information

The Centers for Disease Control and Prevention (CDC and Animal and Plant Health Inspection Service (APHIS) Select Agents Programs have posted information relating to theft, loss and release (Form 3) reporting requirements of the Select Agents regulations.

Theft, Loss and Release Information

ABSA Pre-conference Course Materials

On October 7, 2007, the CDC and APHIS Select Agents Programs, conducted a pre-conference course at the American Biological Safety Association's 50th Annual Biosafety Conference. The one-day, interactive course, titled "Select Agents Compliance from a Federal Perspective" included formal presentations, group exercises, and case studies. The course materials are available for download on this website.

Course Materials

Inspection Videos Released

The Centers for Disease Control and Prevention and Animal and Plant Health Inspection Service Select Agents Programs are pleased to announce the release of two informational videos entitled “Facility Inspections under the Select Agents Regulations for Biosafety Level 3 and Toxin Laboratories”. The in-depth, informational videos address topics related to the inspection of biosafety level 3 Select Agents laboratories and Select Agents 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.

Facility Inspection Videos

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 Agents 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 Agents 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.

Inspection Checklists Released

The Centers for Disease Control and Prevention (CDC) and Animal and Plant Health Inspection Service (APHIS) Select Agents Programs have released inspection checklists to assist entities in complying with security, incident response, training and the records requirements of the Select Agents regulations.

Inspection Checklists

Security Plan Information Released

The Centers for Disease Control and Prevention (CDC) and Animal and Plant Health Inspection Service (APHIS) Select Agents Programs have posted guidance that will assist entities in complying with the security requirements of the Select Agents regulations.

Security Plan Information

Beta version of the National Select Agents 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 Agents 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 (55KB PDF) 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 Agents. 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.