2020 SA Grams

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) to its website to clarify information about the regulatory requirements for when select agents and toxins are present or not present in registered laboratories.  The new FAQs can be found here and are also included below.

What are the regulatory requirements for a registered laboratory that has select agents and toxins present in the laboratory?

As a condition of registration, each entity is required to be in compliance 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 or not. With regard to toxins, the entity registered for possession, use or transfer of a toxin must be in compliance with the regulations regardless of the amount of toxin currently in its possession.

What are the regulatory requirements for a registered laboratory that has no select agents and toxins present in the laboratory?

As a condition of registration, each entity is required to be in compliance 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 or not.

The regulations do not require entities to:

1. Maintain information about all entries (e.g., the name of the individual and date and time of entry) into areas where no select agents or toxins are present.
2. Provide training for non-FSAP-approved individuals escorted into areas where no select agents or toxins are present.
3. Provide escorts for non-FSAP-approved individuals who enter areas where no select agents or toxins are present.

Based upon information provided to FSAP and reviewed by subject matter experts, the Brucella abortus strain S1119-3 has been characterized through genomic sequencing, molecular analysis, and biochemical analysis as originating from the previously excluded B. abortus live vaccine strain 19, and is therefore excluded from the select agent regulations.

Additional information regarding the excluded strains and toxins can be found at here.

The Federal Select Agent Program (FSAP) has posted a new Frequently Asked Question (FAQ) to its website to clarify information about the intentional inoculation of food samples with botulinum neurotoxin producing species of Clostridium.  The new FAQ can be found here and is also included below.

Is the intentional inoculation of food samples with botulinum neurotoxin producing species of Clostridium and the subsequent identification of botulinum neurotoxins in the inoculated samples considered diagnosis and does it meet the exemptions outlined in Section 5 of the select agent regulations?

No. This work would be considered experimental research. Botulinum neurotoxin producing species of Clostridium was introduced into the samples intentionally, and the toxin was created as a by-product of bacterial growth.  Therefore, the entity must be registered for botulinum neurotoxin producing species of Clostridium, and may have to be registered for the toxin to perform this type of work if the aggregate amount of toxin under the control of the entity or individual is over 1 mg.  Please note that Code of Federal Regulations Title 42 Part 73 Section 17 (Records) requires that an individual or entity registered with the Federal Select Agent Program must maintain complete records including an accurate and current inventory for each select agent and toxin held.

This is to notify you that the select agent forms listed below have expired.

• APHIS/CDC Form 1: Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
• APHIS/CDC Form 2: Request to Transfer Select Agents and Toxins
• APHIS/CDC Form 3: Incident Notification and Reporting (Theft, Loss, or Release)
• APHIS/CDC Form 4: Reporting the Identification of a Select Agent or Toxin
• APHIS/CDC Form 5: Request for Exemption of Select Agents and Toxins for an Investigational Product

These expired forms can continue to be used because the revision package is currently under review by Office of Management and Budget.

The Federal Select Agent Program (FSAP) wishes to share a preview of its new draft policy, Biosafety for Large Animal Study-Related Activities with B. abortus and B. suis Using Outdoor Containment Spaces, with the regulated community prior to posting the draft policy in the Federal Register.  FSAP is sharing this proposed policy with you for your review and to provide you with a heads up on the upcoming opportunity to provide feedback by submitting comments through the Federal Register process.

The draft policy states that biosafety plans for large animal B. abortus or B. suis outdoor containment studies within endemic areas of the agents should contain sufficient information for FSAP to determine that the study can be safely conducted in compliance with the select agent and toxin regulations.  Please click here to view the draft policy in its entirety.

FSAP will notify the regulated community once the draft policy is posted in the Federal Register so that comments can be provided through this process.  FSAP anticipates the draft policy will be officially published in the Federal Register in the coming weeks.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

Today, the Federal Select Agent Program (FSAP) published its fifth annual report of aggregate program data, the 2019 Annual Report of the Federal Select Agent Program, as part of the program’s continued efforts to provide the American public with insight into the regulatory activities of the program.  The annual publication of this report reflects FSAP’s continued commitment to increasing transparency and understanding of the program.

As in previous years, 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.  In addition, the report highlights FSAP’s efforts to engage with the regulated community throughout the year to help ensure regulatory compliance.

The findings underscore that overall, most laboratories registered with the program are compliant with the regulations, and none of the relatively small number of reported incidents during the year resulted in a risk to public or agricultural health.

The report summarizes aggregate program data in areas such as:

• Numbers and types of registered entities, as well as amendments to registrations
• Top registered select agents or toxins
• Security risk assessments performed
• Number of inspections conducted
• Key observations related to inspection findings and compliance with the select agent regulations
• Reported thefts, losses, and releases of select agents or toxins
• Identifications and transfers of select agents or toxins
• Publications and outreach activities

The full report, along with an infographic summarizing the key findings, is now available here.

If you have any questions about the report, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) to its website to clarify information about the steps required to obtain a CDC SAMS account to access eFSAP.  The new FAQs can be found here.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of another update to the electronic Federal Select Agent Program (eFSAP) Information System.

Beginning September 10, 2020, eFSAP users will notice the following system updates:

• Discussion Enhancements
  • eFSAP now automatically tags discussion messages with information regarding the subject of the message and provides a link to the area of the system from which the message originated.
• APHIS/CDC Form 1 Section 7A/C Enhancements
  • Upon approval of amendments, FSAP personnel will add additional notes to each work objective (e.g., large volume >10L, small animal, non-human primate).
    • This additional information will show on the Section 7A/C summary page allowing users to see more context regarding the work being performed without having to open each work objective.
• Updates to APHIS/CDC Form 2
  • Users now have the ability to request a one-time extension to their transfer authorization.

For more information, please review the with screenshots of the new features here.

The Centers for Disease Control and Prevention published a Federal Register Notice seeking public comment on the request for continued approval by the Office of Management and Budget to collect information through use of the Federal Select Agent Program’s key reporting forms:

• Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1)
• Request to Transfer Select Agents or Toxins (APHIS/CDC Form 2)
• Incident Notification and Reporting (Theft, Loss, or Release) (APHIS/CDC Form 3)
• Reporting the Identification of a Select Agent or Toxin (APHIS/CDC Form 4)
• Request for Exemption of Select Agents and Toxins for an Investigational Product (APHIS/CDC Form 5)

The Federal Register Notice and information on how to submit public comments is located here. The public comment period ends on August 20, 2020.

If you have any questions regarding this email, please contact CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) will host a multi-agency public webinar on September 23, 2020 from 11 a.m. to 3 p.m. EDT to provide guidance and information regarding the submission of APHIS/CDC Form 2, APHIS/CDC Form 3 and APHIS/CDC Form 4.  Representatives from the U.S. Department of Transportation and the Minnesota Department of Health will have additional presentations.  All stakeholders from the FSAP-registered and non-registered communities are invited to attend the event.

The webinar agenda and registration instructions can be found on the FSAP website here. Registration is limited to the first 1000 participants.

Registration will be confirmed by email and registrants will receive a link to enter the meeting one week prior to the date of the webinar.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

Today, the Federal Select Agent Program (FSAP) is pleased to announce the publication of its annual analysis of inspection report timeliness data, the 2019 FSAP Inspection Report Processing Annual Summary.

The analysis finds that FSAP continues to send nearly all inspection reports to entities within the program’s goal of 30 business days following an inspection, underscoring the program’s continued commitment to provide timely feedback.

Key findings include the following:

• FSAP issued 193 final inspection reports in 2019 – with 97 percent overall (188/193) issued within the target timeframe of 30 business days.  The average was 21 days.
• Among reports issued by CDC’s Division of Select Agent and Toxins (DSAT), 98 percent met this goal, and among reports issued by APHIS’s Agriculture Select Agent Services (AgSAS), 95 percent met this goal.
• All 7 immediate action reports were issued within the target timeframe of 10 business days. The average was 8 days.
• For the small number of reports that were delayed (5 total), analysis by inspection type found that the most common inspections also continue to be the most commonly delayed report types (verification and renewal inspections).

FSAP will continue to assess this information on an annual basis, including looking at reasons for any delays in order to identify potential opportunities for improvement.  The program remains committed to issuing final inspection reports within the target timeframe of 30 business days.

For more information, please see the full report.

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 updates to the notifications table, the general discussion page, and APHIS/CDC Form 1, Sections 6, 7A/C and B, as well as APHIS/CDC Form 2.

Sessions will be held via webinar at the following dates/times:

• July 7: 1-2:30 pm EDT
• July 8: 1-2:30 pm EDT
• July 9: 1-2:30 pm EDT

To register for a session, please visit the eFSAP updates 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 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

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 June 24, 2020, eFSAP users will notice the following system updates:

• Redesigned APHIS/CDC Form 1 Section 7B
  • Section 7B has been redesigned to support bulk-editing and bulk-deleting of strains/serotypes.
  • Upon addition or modification of a strain/serotype, detailed information is no longer required.  Rather, users are provided with a simple drop-down list of the most common strains/serotypes for the agent/toxin that is being added or modified.
  • If the entity has multiple entries of the same strain/serotype, the new 7B table automatically groups those rows together in an expandable/collapsible configuration to make the 7B table more compact and easier to navigate.
• APHIS/CDC Form 1 Sections 4, 6, and 7A/C Updates
  • Section 4 now supports the withdrawal of expired personnel and also provides the user with a drop-down list of common reasons for withdrawal.
  • Section 6 now allows for the administrative editing of buildings, rooms, or suites that are not currently on an approved work objective.
  • Section 7A/C now permits the modification or removal of suspended work objectives. Enhancements have also been made to work objective histories and Section 7A/C notifications.
• Ability to Cancel APHIS/CDC Form 2 Transfer Requests
  • The recipient entity of a Form 2 transfer request has the ability to cancel the transfer from Form 2 Section 1.
• General Discussion Updates
  • The general discussion window now features pagination for faster loading times.
  • General discussion now has a search feature to find messages by date, keyword, or user.
• Notifications Table Updates
  • The Notifications table now includes a selectable filter to quickly find notifications related to either amendments, inspections, or APHIS/CDC Forms 1, 2, 3, or 4.

For more information, please review the tutorial [PDF – 2 MB] 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.

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.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) has updated the Guidance on the Transfer of Select Agents and Toxins to include electronic Federal Select Agent Program (eFSAP) information, update links, and remove appendices.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) has determined that the ASFV-G-ΔI177L strain of African swine fever virus is excluded from the requirements of the select agent regulations. We made our decision based upon information provided by the entity requesting the exclusion, consultations with subject matter experts and review of published studies. After completion of our review, FSAP concluded that the ASFV-G-ΔI177L strain does not pose a threat to animal health or animal products.

Additional information regarding the specific excluded strain can be found here.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

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 following attenuated strains and modified toxin are not subject to the requirements of the select agent regulations:

• Burkholderia pseudomallei strain PBK001 (ΔtonB Δhcp1)
• Clostridium botulinum Beluga Ei strain
• Yersinia pestis CO92 strain ΔlppΔmsbBΔpla
• Catalytically inactive Botulinum neurotoxin (ciBoNT)/D

In addition, the exclusions were revised for clarity for Anhydrotetrodotoxin (a derivative of wild-type tetrodotoxin), South American genotypes of Eastern Equine Encephalitis virus, and Burkholderia pseudomallei strain 576mn.

Additional information regarding the excluded strains and toxins can be found here.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) has updated its Frequently Asked Questions (FAQs) regarding security risk assessments.  See https://www.selectagents.gov/compliance/faq/risk.htm for the updated FAQs.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

A notice has been published in the Federal Register to seek public comment on the Federal Select Agent Program’s request for continued approval by the Office of Management and Budget to collect select agent and toxin information through the use of:

• Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1)
• Request to Transfer Select Agents or Toxins (APHIS/CDC Form 2)
• Incident Notification and Reporting (Theft, Loss, or Release) (APHIS/CDC Form 3)
• Reporting the Identification of a Select Agent or Toxin (APHIS/CDC Form 4)
• Request for Exemption of Select Agents and Toxins for an Investigational Product (APHIS/CDC Form 5)

The Federal Register notice and information on how to submit public comments can be found here. The public comment period ends on June 2, 2020.

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.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

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.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

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 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

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.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

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

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

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.

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.

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.

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.

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.

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.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

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.

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

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 301-851-2070 or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.