Publication of Amendments to the HHS and USDA Select Agent Regulations
On January 19, 2017, HHS and USDA published parallel amendments to federal regulations for work with select agents and toxins. The regulatory amendments include critical changes to the requirements that must be followed by those working with select agents and toxins, and aim to increase the safety and security of work with these materials.
The changes include the addition of specific requirements that must be followed for the inactivation of select agents, changes to the permissible amounts for toxins, and new provisions in the biosafety sections. The regulations also clarify the regulatory language regarding security, training, incident response, and records.
HHS Federal Register Notice
USDA Federal Register Notice
Interim Final Rule on Bacillus cereus biovar anthracis
On September 14, 2016, CDC published an Interim Final Rule adding B. cereus biovar anthracis to the list of HHS select agents and toxins to be regulated as Tier 1 agent. The regulation was published in the Federal Register and CDC will be accepting public comment on the addition of the agent for the next 60 days.
B. cereus biovar anthracis is an emerging pathogen that has properties very similar to Bacillus anthracis (which is currently regulated as a Tier 1 agent). The agent has been isolated from great apes with anthrax-like disease in several countries in Africa.
This Interim Final Rule amends the HHS list of select agents and toxins, while simultaneously undertaking a public comment period. Given the potential for safety and security concerns due to its similarities to Bacillus anthracis, CDC believes that it is important to regulate this agent now while it appears to be limited in distribution.
The Federal Experts Security Advisory Panel (FESAP) also provided policy and technical input for the recommendation to list B. cereus biovar anthracis as an HHS select agent and regulated as Tier 1 agent. The FESAP recommended listing B. cereus biovar anthracis as a select agent.
Summary of FESAP deliberations
White House Memorandum on Biosafety and Biosecurity Measures
On October 29, 2015, the White House released a memorandum from Assistants to the President John Holdren and Lisa Monaco on the next steps to enhance biosafety and biosecurity in the United States. The memo highlights the conduct of parallel federal and broad stakeholder reviews to generate specific recommendations to strengthen the U.S. government's biosafety and biosecurity practices and oversight system. Federal departments and agencies have now developed the implementation plans and timelines to address these recommendations. The White House Office of Science and Technology Policy (OSTP) also published a supporting blog post to further emphasize the importance of the recommendations and the work being done by departments and agencies to enhance national biosafety and biosecurity. The October 2015 memorandum addresses implementation of actions to enhance biosafety and biosecurity as described in the August 18, 2014 memorandum from the Assistants to the President John Holdren and Lisa Monaco to federal departments and agencies.
Federal Experts Security Advisory Panel and Fast Track Action Committee on the Select Agent Regulations
On October 29, 2015, the United States government released these two sets of recommendations as well as the implementation plans, one from the Federal Experts Security Advisory Panel (FESAP), which conducted an internal U.S. Government review of biosafety and biosecurity practices, and another from the Fast Track Action Committee on Select Agent Regulations (FTAC-SAR), which conducted an external review that focused on the effects of the select agent regulations on researchers and laboratories. Recommendations made by both the FESAP and FTAC-SAR address the culture of responsibility, oversight, outreach and education; applied biosafety research; incident reporting; material accountability; inspection processes; and regulatory changes and guidance to improve biosafety and biosecurity. In addition, an approach was identified to determine the appropriate number of high-containment U.S. laboratories required to possess, use, or transfer biological select agents and toxins. More information is available on the FESAP website.
Implementation of the Recommendations
The U.S. Government has developed a plan to implement the FESAP’s and FTAC-SAR’s recommended actions. The U.S. Government expects that implementing the FESAP and FTAC-SAR recommended actions will strengthen biosafety and biosecurity practices and oversight activities. The Administration is committed to fostering progress in the life sciences, including peaceful research involving Biological Select Agents and Toxins (BSAT) as well as non-BSAT, while at the same time ensuring that work is conducted in a safe and secure manner. Read the fact sheet that summarizes the report recommendations and implementation plan.
White House Memorandum Calling for Enhanced Biosafety and Biosecurity Measures
On August 28, 2014, the White House released a memorandum from John Holdren, Assistant to the President for Science and Technology, and Lisa Monaco, Assistant to the President for Homeland Security and Counterterrorism, calling for enhanced biosafety and biosecurity measures. The memorandum acknowledges the importance of life science research for combating natural disease outbreaks and deliberate acts of bioterrorism, but stresses the U.S. Government’s responsibility to ensure infectious disease research is conducted safely and securely.
The Holdren-Monaco memo calls on Federal agencies to take three immediate actions:
- Conduct a comprehensive review of current biosafety and biosecurity protocols to ensure adequacy and appropriateness for today’s infectious disease research
- Inventory and document culture collections
- Increase attentiveness throughout research community to ensure the safety of laboratory workers and the America public
A copy of the Holdren-Monaco Memorandum is available online. The White House also issued a statement about the memorandum.
Additional guidance on biosafety and biosecurity as well as pertinent regulations can be found on the Biosafety and Biocontainment FAQs page and the U.S. Government Laws, Regulations and Guidance page.