Biosecurity

August 29, 2013 - Revised NIH Policy: Mitigating Risks of Life Sciences Dual Use Research of Concern (DURC)
The NIH published its revised policy on “Mitigating Risks of Life Sciences Dual Use Research of Concern (DURC).” The notice reflects the federal government’s 2012 policy for the oversight of life sciences DURC, which is defined as “research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.” Mitigation plans will be required for projects determined to be DURC, based on an administrative review.

April 5, 2013 - Summary of Recent Dual Use/Biosafety Research Policies
The ASM has compiled a summary of recent Dual Use/Biosafety Research Policy responses.

March 27, 2013 - ASM Comments on Dual Use Research Policy
ASM sent comments to the Office of Science and Technology Policy regarding the February 22, 2013 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern

March 25, 2013 - ASM Comments on NIH Recombinant DNA Molecules Guidelines
The ASM sent comments to the NIH's Office of Biotechnology Activities regarding changes to the NIH Guidelines for Research Involving Recombinant DNA Molecules.

February 21, 2013 - U.S. Government Releases Proposed Policy for Dual Use Research of Concern
The Office of Science and Technology Policy (OSTP) released for public review and comment the proposed policy for institutional oversight of life sciences dual use research of concern.

December 14, 2012 - ASM Comments on Influenza Viruses Containing the Hemagglutinin from the Goose/Guangdong/1/96 Lineage
The ASM submitted comments in response to the Federal Register Notice, "Influenza Viruses Containing the Hemagglutinin from the Goose/Guangdong/1/96 Lineage."

October 17, 2012 - CDC Requests Comments Concerning Highly Pathogenic Avian Influenza (HPAI) H5N1
The Centers for Disease Control and Prevention (CDC) has published a notice in today’s Federal Register announcing the opening of a docket to obtain information and comments from the public to questions concerning highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety.

October 9, 2012DHHS and APHIS Revised Select Agent Final Rules Published
The DHHS and APHIS published regulatory changes to the Select Agent and Toxin rules in the October 5, 2012 Federal Register.

April 26, 2012 - National Select Agent Registry Website Change of Address
On May 1, 2012, the http://www.selectagent.gov web address will no longer be available and its presence will be eliminated from the World Wide Web.  Please remove or update any personal links, bookmarks or favorites you may have saved for this site.  To access the Federal Select Agent Program, you will need to use the following website link http://www.selectagents.gov.

April 19, 2012 - Dual Use Research of Concern Update
Congressman Jim Sensenbrenner released a response from Dr. Holdren, Director of the Office of Science and Technology policy regarding the Administration’s safeguards for dual use research, in response to his concerns that the current ad hoc approach was inadequate to balance the priorities of national security and the free flow of academic ideas. The link above contains both Rep. Sensenbrenner's original letter and Dr. Holdren's response.

March 30, 2012 - Now Available: US Government Issues Policy on Oversight of Life Science Dual Use Research of Concern
The purpose of this Policy is to establish regular review of United States Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern (DURC) in order to: (a) mitigate risks where appropriate; and (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

December 1, 2011 - ASM Comments on Proposed Changes to the CDC List of Biological Agents and Toxins
The ASM sent comments to the Department of Health and Human Services (DHHS) on the October 3 Notice of Proposed Rulemaking which requested input on the proposed changes to the DHHS list of biological agents and toxins that have potential as severe threats to public health and safety.

December 1, 2011 - ASM Comments on Proposed Changes to the APHIS List of Biological Agents and Toxins
The ASM sent comments to the Animal and Plant Health Inspection Service (APHIS) on the October 3 Notice of Proposed Rulemaking which requested input on the proposed changes to the USDA list of biological agents and toxins that have potential as severe threats to public health and safety.

October 3, 2011 - CDC and APHIS Release Biennial Review and Republication of the Select Agent and Toxin List
In the Federal Register, the Centers for Disease Control and Prevention (CDC) and Animal and Plant Health Inspection Service (APHIS) have published the Biennial Review and Republication of the Select Agent and Toxin List.

June 14, 2011 -
Federal Experts Security Advisory Panel Releases Recommendations on Select Agents and Toxins The Federal Experts Security Advisory Panel (FESAP) released its recommendations concerning the Select Agent Program.

August 31, 2010 - ASM Invited to Testify before Federal Biosecurity Panel
The ASM Public and Scientific Affairs Board was invited to present comments on August 31 at the meeting of the Federal Experts Security Advisory Panel (FESAP).

August 30, 2010 - ASM Comments on the Proposed Changes to the APHIS List of Select Agents and Toxins
The ASM sent comments to APHIS on the Federal Register notice, "Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Reorganization of the Select Agent and Toxin List."

August 19, 2010 - ASM Comments on the Changes to the HHS List of Select Agents and Toxins
The ASM sent comments to the Centers for Disease Control and Prevention responding to the July 21, 2010 Federal Register Notice, "Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List."

July 7, 2010 - President's Executive Order on Optimizing the Security of Biological Agents and Toxins in the United States
On July 2, the President  released an Executive Order on Optimizing the Security of Biological Agents and Toxins in the United States.  The  Executive Order directs federal agencies to institute changes in the current implementation of the Select Agent Program (SAP) and Regulations (SAR) within their existing statutory authorities.

September 8, 2009 - ASM Comments on the Proposed Addition of SARS-CoV to the List of Select Agents and Toxin
ASM commented on the proposal to add SARS associated Coronavirus (SARS-CoV) to the list of HHS select agents and toxins, published in the July 13, 2009, Federal Register, Vo. 74, No. 132.

December 19, 2005 - ASM Comments on Possession, Use, and Transfer of Select Agents and Toxins--Reconstructed Replication Competent Forms of the 1918 Pandemic Influenza Virus Containing Any Portion of the Coding Regions of All Eight Gene Segments
ASM commented on the interim final rule published in the October 20, 2005 Federal Registered on the reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments.

May 10, 2009 -Meeting of the Working Group on Strengthening the Biosecurity of the United States

September 9, 2005 - Survey for Determining the Location, Capacity, and Status of Existing and Operating BSL-3 Laboratory Facilities within the United States
In October 2004, the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), in partnership with ASM, conducted a survey of academic, biotechnology, and pharmaceutical--but not federal--entities in the United States regarding the location, capacity, and status of domestic laboratories with biosafety level 3 (BSL-3) containment facilities and equipment. BSL-3 containment is used in clinical, diagnostic, teaching, research, and production facilities in which work is done with microbial agents that may cause serious or lethal disease.

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