Select Agent (SA) Grams
2020 SA Grams
4/3/20 - Updated eFSAP Amendment Instructions
The Federal Select Agent Program (FSAP) has updated its electronic Federal Select Agent Program (eFSAP) Resource Center to include two new tools to assist users in requesting APHIS/CDC Form 1 registration changes. The new resources include a full instruction document, as well as an appendix highlighting the most frequently requested changes. Updates have also been made to other materials throughout the page to reflect screen shots of the current eFSAP system.
4/2/20 - Web Posting of Inspection Checklists
In June 2019, the Federal Select Agent Program (FSAP) introduced the Federal Select Agent Program Laboratory Examination Tool (FSAP-LET) app. The app is designed as a tool to assist laboratory managers and biosafety personnel with performing internal laboratory inspections and is available as a download for mobile devices at the link above. The app contains checklists that are used by FSAP inspectors. The checklists cover a variety of areas such as biosafety, security, training, and incident response.
In addition, FSAP is making the inspection checklists available for download as individual PDF files here.
3/19/20 - Electronic Federal Select Agent Program (eFSAP) information system – training on update just released
The Federal Select Agent Program (FSAP) recently announced the deployment of major system updates to the electronic Federal Select Agent Program (eFSAP) information system. eFSAP information system users are encouraged to sign up for one of our upcoming training webinars covering recent updates to the system. During the webinars we will discuss new and redesigned features such as: the principal investigator user role, entity admin center, redesign of the landing page, and printable entity registration certificate.
Sessions will be held via webinar at the following dates/times:
- March 23: 1-2 pm ET
- March 25: 1-2 pm ET
- March 26: 1-2 pm ET
To register for a session, please visit the eFSAP updates March 2020 training registration page.
Please note: as with every eFSAP system update, users must clear their internet browser cache in order for the system to function properly. Instructions can be found on the eFSAP Resource Center page.
If you experience errors, have questions, or have issues with SAMS access to the system, please continue to contact our eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.
If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or firstname.lastname@example.org, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.
3/18/20 - eFSAP System Update Just Released: 1) Principal Investigator User Role, 2) Entity Admin Center, 3) Landing Page Redesign, and 4) Printable Registration Certificate
The Federal Select Agent Program (FSAP) is pleased to announce the deployment of another major update to the electronic Federal Select Agent Program (eFSAP) Information System.
Beginning March 18, 2020, eFSAP users will notice the following system updates:
Principal Investigator User Role
- Responsible Officials (ROs) can now request system access for their Principal Investigators (PIs).
- Upon accessing eFSAP, PIs are able to view limited information in Form 1 Section 7A/C and 7B (PIs can only see strains/serotypes and work objectives to which they are currently assigned).
- PIs are able to view, edit, and save (but not submit) Form 1 Section 7A/C amendments (provided they are listed as a PI on the work objective the amendment is adding or modifying).
Entity Admin Center
- RO/ARO users now have access to a dedicated entity admin center.
- Within the admin center, the RO/AROs will see a list of all users with access to their select agent and toxin information.
- Each user's role is also displayed; read-only and super-admin user's roles can be modified directly.
Redesigned Landing Page
- Navigation links have been moved to the page header.
- The names and contact information of the entity’s primary and secondary FSAP points of contact have been added.
Printable Registration Certificate
- Your Certificate of Registration is now available for instant viewing/downloading/printing.
For more information, please review the tutorial with screenshots of the new features attached to this message.
FSAP would like to thank the regulated community for its continued feedback regarding eFSAP system functionality. We look forward to delivering continued improvements based upon your suggestions.
Please note: as with every eFSAP system update, users must clear their internet browser cache/cookies in order for the system to function properly. Instructions can be found on the eFSAP Resource Center page.
If you experience errors, have questions, or have challenges with access to the system, please continue to contact our eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.
3/17/20 - Advance Notices of Proposed Rulemaking – Biennial Review
Today, the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published Advance Notices of Proposed Rulemaking (ANPRM) in the Federal Register regarding the biennial review and republication of the list of select agents and toxins. Public comments are being accepted for the next 60 days.
Please visit the following links for more information:
- HHS: Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review
- USDA: Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
2/26/20 - Revised security plan guidance
The Federal Select Agent Program (FSAP) has revised the Security Plan Guidance to update inventory language to match the Inventory Guidance and to correct editorial errors from the previous version.
2/25/20 - Further clarification on which SARS viruses are regulated under the select agent regulations
On February 18, 2020, the Federal Select Agent Program (FSAP) sent a notice to clarify that viruses identified as SARS-CoV are regulated by the select agent regulations, while viruses identified as SARS-CoV-2 are not currently regulated.
FSAP wishes to further clarify that the positive strand RNA genome of SARS-COV is also a select agent because this genomic material represents nucleic acids capable of generating infectious virus, SARS-CoV.
2/18/20 - Clarification on which SARS viruses are regulated under the select agent regulations
On February 11, 2020, the International Committee on Taxonomy of Viruses (ICTV) announced that taxonomically, what has previously been referred to as 2019-nCoV should now be referred to as SARS-CoV-2. The “Severe acute respiratory syndrome-related coronavirus: The species and its viruses – a statement of the Coronavirus Study Group” indicates that SARS-CoV-2 is not a descendent of SARS-CoV, but is genetically closely related.
The select agent regulations currently regulate viruses identified as SARS-CoV and not viruses identified as SARS-CoV-2.
As the Federal Select Agent Program gains more information about the SARS-CoV-2, we will reassess the select agent status as needed. Any changes in the select agent status of SARS-CoV-2 will be published in the Federal Register.
2/14/20 - Revised policy statement regarding regulated genomes and guidance regarding the regulation of select agent and toxin nucleic acids
The Federal Select Agent Program (FSAP) has issued a revised policy statement regarding laboratory work with genomes capable of producing infectious virus of regulated Risk Group 3 and 4 (RG3 and RG4) select agents and Veterinary Services select agents (VSsa) at one containment level lower than the infectious virus without RNA inactivation. The policy was revised to allow entities that work with RG3 and VSsa genomic material in a BSL2 laboratory under biosafety and security requirements dictated by a risk assessment.
The revised policy replaces the previous FSAP policy statement on the subject (issued August 13, 2014) and is posted here.
In addition, FSAP has revised the Guidance on the Regulation of Select Agent and Toxin Nucleic Acids to correct editorial errors, improve clarity and update the information related to a policy posted on our website.
2/13/20 - Updated Responsible Official Knowledge Check
The Federal Select Agent Program (FSAP) has updated the Knowledge Check Self-Exam (available here) for the Responsible Official (RO). The self-exam serves as a tool for ROs and Alternate ROs to familiarize themselves with the regulatory responsibilities of an RO. Additionally, while updating this tool, FSAP incorporated feedback received from the regulated community.
2/12/20 - Exclusion of African swine fever viruses, ASFV-G-Δ9GL/ΔUK and ASFV-G-ΔMGF
Based upon consultations with subject matter experts and a review of relevant published studies and information provided by the entities requesting the exclusions, the Federal Select Agent Program has determined that the ASFV-G-Δ9GL/ΔUK and ASFV-G-ΔMGF strains of African swine fever virus are excluded from the requirements of the select agent regulations because they do not pose a severe threat to animal health or animal products.
Additional information regarding the specific excluded strain can be found here.
1/27/20 - Update to Frequently Asked Question (FAQ) regarding positive identification of select agents
In response to a recent request, the Federal Select Agent Program (FSAP) is clarifying the below Frequently Asked Question (FAQ) on whether a sample that has been serologically identified as suspect/positive for antibodies is considered to be a select agent. FSAP does not consider a test result identifying the presence of antibodies to select agent antigen(s) in a sample as positive identification of the select agent.
The newly updated FAQ is as follows:
What test or procedure determines whether a select agent or toxin is contained in a specimen presented for diagnosis or verification?
The test or procedure used to determine whether a select agent or toxin is contained in a specimen presented for diagnosis or verification will depend on the select agent or toxin, and whether the agent is identified at the genus or the genus/species level. A particular test or procedure used by an accredited laboratory, and/or disease program approved laboratory, and/or reference laboratory will have a recognized capability to make either a tentative or positive identification depending on the exactness of the identification needed. In some cases, an agent may need to be cultured for confirmatory test purposes and may also require specific disease program testing requirements. The Federal Select Agent Program (FSAP) does not consider a test result identifying the presence of antibodies to select agent antigen(s) in a sample as positive identification of the select agent. FSAP does not define which tests or procedures constitute positive identification of a select agent or toxin.
The updated FAQ can be found on the FSAP website.
1/21/20 - Publication of the 2018 Annual Report of the Federal Select Agent Program
Today, the Federal Select Agent Program (FSAP) published its annual report of aggregate program data, the 2018 Annual Report of the Federal Select Agent Program.
Now in its fourth year, this report continues to provide the American public with insight into the regulatory activities of the program. The content includes a look at both the regulatory functions of FSAP, as well as compliance with the select agent regulations at laboratories across the nation. The report also highlights FSAP’s efforts to engage with the regulated community throughout the year in order to ensure regulatory compliance.
As in previous years, the report summarizes aggregate program data in areas such as:
- Numbers and types of registered entities
- Security risk assessments performed
- Number of inspections conducted
- Top registered select agents or toxins, by agency
- Key observations related to inspection findings and compliance with the select agent regulations
- Identifications and transfers of select agents or toxins
- Thefts, losses, and releases of select agents or toxins
- Publications and outreach activities
The annual publication of this report reflects the program’s ongoing commitment to increasing transparency and understanding of the program.
The full report, along with an infographic summarizing the key findings, is now available online.
If you have any questions about the report, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or email@example.com, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.