1/19/17 - Publication of Amendments to the HHS and USDA Select Agent Regulations

Today, HHS and USDA have 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. 

Key components include:

• Changes to the toxin permissible limits
• Addition of specific requirements that must be followed for the inactivation of select agents
• New provisions to the biosafety sections
• Clarifications to the regulatory language regarding security, training, incident response, and records
• Clarification that each registered entity must comply with the regulations for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin 

No changes are being made to the list of select agents and toxins at this time.

The amendments take effect 30 days from the date of publication and are available at the following links:

• HHS: Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements
• USDA: Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations

The publication of these amendments reflects the culmination of an extensive process, and includes input received from public comments and federal advisory bodies.  Elements are also responsive to recommendations received through recent program reviews.

Multiple efforts are underway by the Federal Select Agent Program (FSAP) to help registered entities comply with the regulations.  FSAP is updating current guidance documents, as well as developing new guidance, and will be holding an upcoming webcast to address the changes and provide an opportunity to ask questions about the regulations.

1/12/17 - Select Agent Program Webcast Postponed

Due to a scheduling conflict, the Federal Select Agent Program (FSAP) webcast — originally scheduled for February 8, 2017 from 12:00 PM to 4:00 PM EST — has been postponed. Details on a new date will be forthcoming once confirmed. An announcement will also be published in the Federal Register.

Participants that have already registered for the webcast will not need to re-submit registration requests for the new date.

9/14/16 - Publication of Interim Final Rule - B. cereus biovar anthracis

Today, CDC published an Interim Final Rule adding B. cereus Biovar anthracis to the list of HHS select agents and toxins to be regulated as a Tier 1 agent.  The regulation, available at https://www.federalregister.gov/d/2016-22049, 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.

Once the 60-day public comment period has closed, CDC will consider the comments received and then publish a Final Rule.  In the meantime:

• Within 30 days of publication of the notice in the Federal Register, any individual or entity that possesses B. cereus Biovar anthracis must provide notice to CDC regarding their possession of this agent.
• By 180 days after the publication date, any individual or entity that intends to continue to possess, use, or transfer this agent will be required to either register in accordance with the select agent regulations (42 C.F.R. part 73) or amend their current registration and meet all of the requirements of the select agent regulations.

Comments on the regulations should be submitted via the regulations.gov website; a direct link is available here.

9/07/16 - Welcome Dr. Edwin to CDC!

Please join us in welcoming Samuel S. Edwin, Ph.D. to the CDC!

This week, Dr. Edwin begins his new position as director of the agency's Division of Select Agents and Toxins (DSAT).

Dr. Edwin comes to CDC after serving as the responsible official and biological surety officer at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, MD. In all, he has been associated with biomedical research for over 30 years.

Dr. Dan Sosin has returned to his job as deputy director and chief medical officer of CDC's Office of Public Health Preparedness and Response.

6/30/16 - Federal Select Agent Program first annual report released

The Federal Select Agent Program (FSAP) released today its first annual report of data on the regulation and oversight of laboratories that work with biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products (select agents and toxins). The report aims to improve public understanding of the work performed by these unique laboratories and how the federal government ensures this work is done as safely and securely as possible.

Click here for media advisory.

1/16/16 - Federal Notice

The Departments of Health and Human Services (HHS) and Agriculture (USDA) published in the following Federal Register notices of proposed rulemaking regarding the select agents and toxins regulations:

HHS Notice of Proposed Rulemaking
USDA Notice of Proposed Rulemaking 

In the notices, HHS and USDA are considering whether to amend the select agent list by removing the following biological agents:

• Coxiella burnetii
• Rickettsia prowazekii
• Bacillus anthracis Pasteur strain
• Brucella abortus and B. suis
• Peronosclerospora philippinensis (Peronosclerospora sacchari)
• Phoma glycinicola (formerly Pyrenochaeta glycines)
• Sclerophthora rayssiae

HHS is considering whether to amend the select agent list by removing B. melitensis, which means this select agent would be identified as “USDA-only” select agent.
All comments should be submitted by March 21, 2016.