January 26, 2015 - NIH’s Dual Use Research of Concern (DURC) Expectations for Institution
On January 26, 2015, the NIH released the deadline of September 24, 2015 for establishing the necessary infrastructure to come into compliance with the federal Policy on Dual Use Research of Concern (DURC), including establishing a standing Institutional Review Entity (IRE). Starting on that date, an IRE must assess research conducted by the institution, identify DURC as described in the Policy, and assess the benefits and risks. If an IRE determines that NIH-funded research has DURC potential, the institution must notify the grants management official or contracting officer listed on the award within 30 days. Additionally, institutions and investigators will work with NIH to develop an appropriate risk mitigation plan to guide the conduct and communication of research determined to be DURC. For more information go to the Dual Use Research of Concern web page at: http://www.phe.gov/s3/dualuse/Pages/default.aspx.
October 27, 2014 - ASM Testifies Before the Federal Experts Security Advisory Panel on Issues Related to Biosafety and Biosecurity
Ronald Atlas, Ph.D., Chair of the Public and Scientific Affairs Board testified before the Federal Experts Security Advisory Panel. To strengthen US Government oversight for work with infectious agents, including (but not limited to) Biological Select Agents and Toxins (BSAT), the FESAP has undertaken a comprehensive federal review that will result in specific recommendations to strengthen the government's biosafety and biosecurity practices and oversight system for federally-funded activities, consistent with the need to realize the public health and security benefits of such work. The ASM will address the following tasks in its testimony: 1. Identify needs and gaps and make recommendat ions to optimize biosa fety , biosecurity, oversight , and inventory management and control for BSAT, 2. Identify actions and any regulatory changes necessary to improve biosafety and biosecurity, 3. Identify an approach to determine the appropriate number of high containment U.S. laboratories required to possess, use, or transfer BSAT.
October 17, 2014 - USG Launches Deliberative Process on Gain-of-Function Research
The White House Office of Science and Technology Policy announced that the U.S. government will undertake a deliberative process to assess the risks and benefits of certain gain-of-function (GOF) experiments with influenza, SARS, and MERS viruses in order to develop a new Federal policy regarding the funding of this research.
September 25, 2014 - United States Government Policy for Institutional Oversight of Life Sciences DURC
On September 24 the United States Government issued the final US Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC. The Office of Public Affairs sent a notice to ASM members about the Oversight document.
September 2, 2014 - USG Communications about Ensuring Biosafety in US Laboratories
The ASM sent an e-mail to ASM members regarding US Government communications about ensuring biosafety in US laboratories. The e-mail includes links to a White House memo and an NIH notice.
August 28, 2014 - White House Memo: Ensuring Biosafety and Biosecurity in US Laboratories
The Office of Science and Technology Policy sent a memo to all federal departments and agencies involved in life-sciences research urging them to take immediate and longer-term steps aimed at addressing the underlying causes of the recent laboratory incidents and strengthening overall biosafety and biosecurity at federal facilities. The Administration has asked these agencies to conduct a “Safety Stand-Down” in the near-term, during which senior leaders would review laboratory biosafety and biosecurity best practices and protocols, and would develop and implement plans for sustained inventory monitoring.
August 27, 2014 - NIH Announces National Biosafety Stewardship Month
August 25, 2014 - ASM Statement: What is in your Laboratory Freezer?
ASM sent a statement out to ASM members reminding them to practice safe "laboratory housekeeping."
July 31, 2014 - ASM Statement on Dual Use Research of Concern and Biosafety
The ASM sent a statement to ASM members on Dual Use Research of Concern and Biosafety.
July 30, 2014 - Historical Background Related to Select Agents
July 21, 2014 - ASM Statement on Recent Biosafety Lapses
The ASM sent the following statement to ASM members regarding the recent biosafety lapses.
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, 2012 - DHHS 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 14, 2011 - CDC Proposed Rule Changes for Importation of Etiologic Agents
The CDC published a Notice of proposed rulemaking in the October 14 Federal Register to revise regulations that cover the importation of etiological agents, hosts and vectors. The rule proposes changes to the Foreign Quarantine regulations, including section heading, terms and definitions (eg,“host”, “vector”); a requirement for appropriate biosafety measures as a prerequisite for a permit and a provision for CDC inspection authority to inspect an applicant’s facility for the conduct of research at the biosafety levels 3 and 4 if it has not been inspected by the select agent program; permit exemptions are described for select agents, diagnostic specimens, genomic material, and regulated products. The importer must be in compliance with all applicable laws concerning the packaging and shipment of infectious substances.
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 21, 2011 - ASM Participates in Conference on Emerging Technologies and Institutional Biosafety Committees
The NIH Office of Biotechnology Activities (NIH OBA) invited ASM to participate in and serve on the planning committee for their recent biennial conference that focused on biosafety issues and Institutional Biosafety Committee (IBC) oversight of laboratory research involving emerging technologies. The conference was intended to increase understanding of biosafety and biosecurity issues surrounding advances in select agent research, synthetic biology, nanotechnology, and the implications for institutional biosafety programs including IBCs. Presentations and panel discussions outlined strategies and resources for addressing program gaps, strengthening IBC risk assessment s for emerging technologies, developing comprehensive training programs, raising biosecurity awareness, and aspects of personnel reliability programs. The program was targeted towards IBC members and staff, biosafety professionals, research administrators, scientists, regulators and others involved in the conduct and oversight of research. Approximately 200 people attended the June 12-14 conference in San Diego. Claudia Mickelson, Ph.D., a member of the PSAB’s Committee on Biomedical Research represented ASM at the conference.
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.
May 11, 2011 - MMWR Special Supplement: Guidelines for Biosafety Laboratory Competency CDC and the Association of Public Health Laboratories
These guidelines for biosafety laboratory competency outline the essential skills, knowledge, and abilities required for working with biologic agents at the three highest biosafety levels (BSLs) (levels 2, 3, and 4). The competencies are tiered to a worker’s experience at three levels: entry level, midlevel (experienced), and senior level (supervisory or managerial positions). These guidelines are intended for laboratorians working with hazardous biologic agents, obtained from either samples or specimens that are maintained and manipulated in clinical, environmental, public health, academic, and research laboratories.
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."
August 13, 2010 – ASM Submits Comments to CDC on Draft Guidelines for Safe Work Practices in Human and Animal Clinical Diagnostic Laboratories
On August 13, the PSAB Committee on Laboratory Practices submitted comments to the Centers for Disease Control and Prevention on its draft Guidelines for Safe Work Practices in Human and Animal Clinical Diagnostic Laboratories.
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.
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. (Microbe Article)
May 3, 2005 - The CDC has posted an Interim CDC-NIH Recommendation for Raising the Biosafety Level for Laboratory Work Involving Noncontemporary Human Influenza (H2N2) Viruses. The recommendation is excerpted from the draft Biosafety in Microbiological and Biomedical Laboratories, 5th edition.
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