Select Agent (SA) Grams
Previous SA Grams
9/5/14 - Enhancing Biosafety and Biosecurity in the United States "Safety Stand-Down"
On August 28, 2104, the White House released the Holdren-Monaco Memorandum and a statement of support from the White House calling for enhanced biosafety/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.
Recent reports of lapses in biosafety practices involving Federal laboratories have served to remind us of the importance of constant vigilance over our implementation of biosafety standards. As a measure toward preventing future lapses as well as promoting stewardship of the life sciences and biosafety awareness across Federal entities, the US Government is urging all state, public, university or private laboratories to do the same at the local level during the month of September. Promoting safe and secure practices in laboratory facilities protects workers and the public, and prevents potential damage to human, animal, and plant health.
The Holdren-Monaco memo calls on Federal agencies to take the following immediate actions:
- Conduct a comprehensive review of current biosafety and biosecurity protocols to ensure adequacy and appropriateness for today's infectious disease research
- Develop and implement plans for sustained inventory monitoring
- Initiate an immediate sweep of their facilities to identify biological select agents and toxins are not located in unregistered areas.
- Encourage extramural facilities which receive United States Government funding to hold similar events
The Federal Select Agent Program encourages all entities to highlight the importance of the requirements and activities that are already part and parcel of a robust biosafety program. We believe that it is also an opportunity for entities to further optimize biosafety oversight and strengthen their institutional safety culture by conducting activities that may include, but are not limited to:
- Conducting comprehensive reviews of current biosafety and biosecurity protocols and procedures to ensure they are adequate for today's research;
- Review procedures for biosafety, biosecurity, and inventory management;
- Identifying and rectifying any gaps in the institutional biosafety and biosecurity oversight programs
- Sweep areas used to store human, animal or plant infectious agents or toxins, especially areas containing historical collections to ensure that no unregistered select agents and toxins are present;
- Conduct facility biosafety/biocontainment training sessions; and
- Complete safety assessments or mock emergency response activities.
8/21/14 - Acceptance of FD-961 (Correction Notice)
As of August 1, 2014, the Federal Bureau of Investigation, Criminal Justice Information Services Division (CJIS) will no longer accept the form FD-961 that does not include the Entity Application Number for question #1 in Section 1. The Entity Application Number (referred to as "entity ID" (i.e., AGRxxxxxx or CDCxxxxxx) is included in letters used by the Federal Select Agent Program to issue a unique identifying number for an individual identified by an entity as requiring a security risk assessment. You may also ask your file manager for your entity application number. If you are unsure of who your file manager is, please contact the Federal Select Agent Program: APHIS/AgSAS, 301-851-3300 option 3 (voice only) or CDC/DSAT, 404-718-2000. If you have any questions regarding the FD-961 form, please contact CJIS at 304-625-4900.
8/1/14 - Acceptance of FD-961
This email is to notify you that the Federal Bureau of Investigation, Criminal Justice Information Services Division (CJIS) does not accept FD-961 form with digital signatures. If you have any questions regarding the FD-961 form, please contact CJIS at 304-625-4900.
3/26/14 - Registration Renewals
The Federal Select Agent Program is no longer requiring that the Responsible Official, Alternate Responsible Official(s), and any individual who owns or controls the entity, unless otherwise exempted, to undergo a security risk assessment at the time of the entity?s registration renewal, as long as each individual has a security risk assessment performed prior to the expiration date of your registration. In addition, a completed APHIS/CDC Form 1 must now be submitted at least 30 days prior to the scheduled renewal inspection or 90 days prior to the entity's expiration date, whichever occurs first. The self-certification form is no longer required to be completed.
3/15/13 - Use of “Lost in the crowd” concept for shipping select agent and toxin
The Federal Select Agent Program (FSAP) has amended the select agent regulations so regulated entities that maintain shipping and receiving facilities, and have procedures that are able to maintain select agent and toxin anonymity in shipping/receiving facilities, i.e., preserving "lost in the crowd," will not be required to register these areas if packages containing select agents or toxins will temporarily be stored in these areas awaiting transportation pickup. For entities preserving the "lost in the crowd" concept during shipping and receiving, the select agent regulatory oversight for recipients begins when a select agent or toxin package arrives at its ultimate destination for unpacking by an individual approved for access by the Department of Health and Human Services (HHS) Secretary or Animal and Plant Health Inspection Service (APHIS) Administrator. Select agent and toxin oversight for senders covers all use of a select agent and toxin up to the time that the materials are packaged for shipment, in compliance with Department of Transportation (DOT) hazardous materials regulations, by an individual approved for access by the HHS Secretary or APHIS Administrator. If packages are labeled as containing "Suspected Category A infectious substances" and temporarily stored in the shipping/receiving area, there is no need to develop and implement security practices (e.g., securing packages, registering the shipping/receiving area, and meeting Tier 1 requirements) for the area as the "lost in the crowd" concept is being preserved.
The FSAP approves and DOT recommends the use of "lost in the crowd" for all shipments of a select agent and toxin. To comply with this approach, “suspected Category A infectious substance” can be used as the technical name on the Shipper’s Declaration of Dangerous Goods in-lieu of identifying the select agent in the technical name, such as by listing the specific genus and species. Note: the technical name is included in parenthesis after the proper shipping name in the “Proper Shipping Name” section of the form. This approach will assist in maintaining anonymity for select agent and toxin packages during transit and avert additional security risks for couriers. Also, the technical name should not be placed on the package itself; instead the area for the technical name should be left blank.
In collaboration with DOT, the FSAP has developed guidance for the regulated community on the packaging and shipping of select agents and toxins. This guidance is available here and includes information on all applicable domestic and international shipping regulations.
7/19/12 - Verifying Inspectors and Confidentially Agreement Policy
The Federal Select Agent Program would like to make you aware of our policy for verifying Federal Select Agent Program Inspectors and an entity’s request to sign a confidentially agreement. The Federal Select Agent Program Inspectors have statutory authority (Public Health Security and Bioterrorism Preparedness and Response Act, 2002) to enter an entity in possession of biological select agents in toxins to perform inspections related to compliance with the HHS and USDA Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331).
A Federal Select Agent Program Inspector may show an entity his/her official government badge. The official government badge consists of the employee’s name, picture of the employee, the individual’s personal identifier number, and the government agency that the employee is affiliated. All Federal Select Agent Program Inspectors have undergone appropriate Federal background investigations and adhere to Federal Select Agent Program policy’s for safeguarding select agent information.
The Federal Select Agent Program Inspector is not allowed to give the entity his/her official government badge in exchange for the entity’s identification badge. In addition, the entity is not allowed to copy the badge. The Federal Select Agent Program Inspector will not provide the entity with any personal identification such as driver’s license, social security card, etc. The entity may request for the Federal Select Agent Program to provide the entity with an “Inspector Verification” letter prior to the arrival of the inspectors. However, a request for an “Inspector Verification” letter, or the absence of an “Inspector Verification” letter may not be used as grounds for delaying the start of an inspection.
The Federal Select Agent Program Inspector is not authorized to and may not sign a confidentiality agreement connected in any way to their duties as an inspector for the Federal Select Agent Program.