2018 SA Grams

Due to the absence of either an FY 2019 appropriation or Continuing Resolution for the Department of Justice, the Federal Bureau of Investigation’s Criminal Justice Information Services Division (CJIS) has initiated the process of orderly shutdown of operations. During the shutdown, CJIS will not be able to process any security risk assessments.

It should be noted that the Division of Select Agents and Toxins and Agriculture Select Agent Services are not be affected by the government shutdown.

Currently, the eFSAP Help Desk is experiencing intermittent difficulties with the telephone helpline (877-232-3322).  Until this issue has been resolved, you may try the phone again or email to request assistance at eFSAPsupport@cdc.gov.

Today, the Federal Select Agent Program (FSAP) published its annual report of aggregate program data, the 2017 Annual Report of the Federal Select Agent Program.

For the third year, this report continues to provide the American public with insight into the regulatory activities of the program.  The contents include a look at both the regulatory functions of FSAP, as well as compliance with the select agent regulations at laboratories across the nation.  Publication of this report reflects the program’s ongoing commitment to increasing transparency and understanding of the program.

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

The full report, along with an infographic, is now available here.

If you have any questions about the report, 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.

The Federal Select Agent Program (FSAP) recently posted presentations online from the August 15-17, 2018 in-person workshop for Responsible Officials held at the Centers for Disease Control and Prevention headquarters in Atlanta, GA. The workshop provided participants with information about the eFSAP information system portal, laboratory facilities engineering, biosafety risk assessment, common reported incidents, as well as an opportunity to network with colleagues. The presentations are now available here.

We are pleased to announce that today, the Federal Select Agent Program (FSAP) has published a joint FSAP Strategic Plan, which will guide FSAP program efforts from fiscal year (FY) 2018 through FY2021. The plan is now available here.

In September 2017, FSAP initiated development of this joint agency Strategic Plan with input from leadership at the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS), regulated entities, and FSAP staff. The content reflects FSAP’s intent to prioritize activities, placing emphasis on the strategies we believe will most effectively and efficiently support achievement of FSAP goals and objectives. The document outlines FSAP’s mission, vision, and four key goals, which encompass the following priority areas:

1. Ensure the recruitment, development, and retention of a knowledgeable and professional FSAP workforce
2. Harmonize FSAP organizational processes and inspections
3. Leverage data-driven, risk-based approaches to guide FSAP operations
4. Engage, increase transparency, and highlight program benefits with FSAP’s diverse stakeholders

This Strategic Plan reflects just one of the many ways that we are working to improve the program by focusing our efforts, increasing transparency, and clearly conveying our priorities.  We are pleased to share this document with you, and look forward to continuing to strengthen our efforts towards ensuring the safety and security of work with select agents and toxins at laboratories across the country.

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.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of a system update to the electronic Federal Select Agent Program (eFSAP) portal.

Beginning November 1, 2018, authorized SAMS account holders at all registered entities will notice the following updates:

APHIS/CDC Form 1 Section 4

Based on user feedback from the 2018 Federal Select Agent Program Responsible Official Workshop as well as from the series of regional workshops conducted this past summer, the following enhancements have been added to APHIS/CDC Form 1 Section 4:

• Toggle filters now include the option of Principal Investigator.
• The Section 4 default sort is ascending by Security Risk Assessment (SRA) expiration date.
• Unrestricted individuals expiring within 90 days have their expiration date shown in bold text.

APHIS/CDC Form 1 Section 6

Entities operating registered laboratory suites now have the ability to provide greater context to the activities conducted in rooms within the suite.  The Section 6 suite legend has been expanded from three options (lab, storage, and other) to four options (lab only, storage only, lab and storage, and other).  Self-service Section 6 amendments will be released to entities in early 2019.  In the interim, registered entities can review their Section 6 suite legends and work with their designated FSAP representative to make any desired changes.

APHIS/CDC Form 1 Sections 7a and 7c reformatting

Self-service Sections 7a and 7c amendments will be released to entities in early 2019.  In preparation for this and in order for these amendment types to be compatible with a diverse array of select agent and toxin activities, biosafety levels, and laboratory suite configurations, we have reformatted the way in which data relationships are managed between Section 6 and Sections 7a and 7c.

In November 2018, FSAP staff will be migrating current Sections 7a and 7c data to the new format on behalf of our registered entities.  In December 2018, entities will be asked to verify that the data was migrated correctly.

From now until the end of 2018, entities following the Form 1 View pathway from their main landing page will notice two navigation buttons to Sections 7a and 7c.  During the data migration, reformatted work and storage objectives will be available for viewing via the navigation button labeled Section 7a & 7c.  Current Section 7a and 7c data is available for viewing through the navigation button titled Section 7a & 7c (legacy version). 

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

If you experience errors or have questions related to the eFSAP system in general or 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 301-851-2070 or agsas@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) on its website in order to clarify the use of eFSAP to submit requests related to the transfer of a select agent or toxin (APHIS/CDC Form 2) and making amendments to an entity’s registration (APHIS/CDC Form 1).

The transfer FAQs can be found here and the amendment FAQs can be found at 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.

The new general email inbox for the Agriculture Select Agent Services (AgSAS), AgSAS@usda.gov, is now operational and accessible to AgSAS staff.  AgSAS can now be reached at this new email address.

If you have any questions regarding this email, please contact the Agriculture Select Agent Services at 301-851-2070, or via email at AgSAS@usda.gov.

The Federal Select Agent Program (FSAP) has finalized its policy on select agent contained in formalin-fixed paraffin-embedded tissue.  FSAP has determined that a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus contained in a formalin-fixed paraffin-embedded (FFPE) tissue has been effectively inactivated if the FFPE process used is a recognized method (e.g., a previously published method shown to be effective such that validation does not have to occur in-house for FFPE tissues) for that particular agent or regulated nucleic acids. It is therefore the policy of the FSAP that such material is not subject to the select agent regulations found in 7 C.F.R. Part 331, 9 C.F.R. Part 121, or 42 C.F.R. Part 73.

A draft version of the policy statement was previously shared with the regulated community for review and input prior to being finalized. The final document does not reflect any major changes from the draft version.

The policy is posted online at here.

Today, the U.S. Department of Agriculture/Animal and Plant Health Inspection Service (APHIS) published a technical amendment to the USDA select agent regulations, containing non-substantive changes, that:

• Reclassifies Phoma glycinicola (formerly Pyrenochaeta glycines) to Coniothyrium glycines based on recent molecular and phylogenetic studies.
• Removes bovine spongiform encephalopathy from the list of USDA select agents and toxins whose seizure by any Federal law enforcement agency must be reported within 24 hours by telephone, facsimile, or e-mail since the agent was previously removed from the list of Veterinary Services (VS) select agents and toxins set out in 9 CFR 121.3(b) on October 5, 2012.
• Corrects the reference in paragraph (d)(9) for pigeon paramyxovirus-1 since the current numerical suffix appears as “12” instead of  “1.”
• Corrects the name for the “Security Plan Guidance” from “Security Guidance for Select Agent or Toxin Facilities.”

This language was first included as part of a final rule published in the Federal Register on October 5, 2012, with the regulations amended again in January 2017.

The full technical amendment is available at https://www.federalregister.gov/d/2018-20694external icon.

If you have any questions regarding this email, please contact the Agriculture Select Agent Services at 301-851-2070 or AgSAS@usda.gov.

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) on its website in order to clarify eFSAP submissions related to reporting of a theft, loss, or release of a select agent or toxin.  The new FAQs (available here) are as follows:

• Can my immediate notification be sent by email and then the APHIS/CDC Form 3 be submitted in eFSAP?
  The immediate notification can be sent via phone, email, or directly through eFSAP.  Complete APHIS/CDC Form 3 in eFSAP within 7 days of the incident. If initial notification is made using eFSAP (APHIS/CDC Form 3), then the date of your immediate notification will appear in APHIS/CDC Form 3 Section B within eFSAP.
• How do I fill out an APHIS/CDC Form 3 Immediate Notification in eFSAP?
  Please see the Form 3 Immediate Notification Quick Reference Guide for detailed instructions.
• How do I initiate an APHIS/CDC Form 3 but not officially submit it?
  When you start an APHIS/CDC Form 3, you can save it as a draft without clicking Submit.  Log into eFSAP and click on Form 3. Click Create Form 3. After you have started filling out the form, you can click Save at the bottom of the page to save the APHIS/CDC Form 3 as a draft without submitting it to FSAP for review.
• Does the RO need to access the immediate submission to provide more detail or is a new APHIS/CDC Form 3 required?
  If the immediate notification was submitted by starting the APHIS/CDC Form 3, then complete the APHIS/CDC Form 3. If you sent an email or fax, you may upload the document as Supporting Documentation.
• Will entities be required to maintain hard copy printouts of the APHIS/CDC Form 3 for reports of a theft, loss or release of a select agent or toxin documented in eFSAP?
  The electronic documentation in eFSAP acts as the record required by the select agent regulations. If there is not electronic documentation within eFSAP, it is the entity’s responsibility to ensure there is a record available.
• Can an entity not currently registered with FSAP (non-registered entity or NRE) use eFSAP to submit an APHIS/CDC Form 3, Report of Theft, Loss or Release of a Select Agent or Toxin?
  At this time, an NRE must submit a report of theft, loss, or release of a select agent or toxin via email, fax, or mail.

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.

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) on its website in order to clarify requirements related to the reporting of the identification of a select agent or toxin in a clinical or diagnostic or proficiency testing specimen as outlined in Sections 5, 6, and 9 of the select agent regulations.

The following two new FAQs related to reporting can be found at https://www.selectagents.gov/compliance/faq/reporting.htm:

• 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 define which tests or procedures constitute positive identification of a select agent or toxin.
• A registered public health laboratory frequently identifies Francisella tularensis and Yersinia pestis presented in diagnostic samples, but the laboratory is not registered for these agents.  After the agent is identified and an APHIS/CDC Form 4 is submitted, the registered entity destroys all materials within 7 days except for fixed slides that are located in an unregistered laboratory.  With regard to the select agents identified in this scenario, does the registered entity fall under the clinical diagnostic exemption found section 73.5 (destroy by recognize inactivation process) or is the entity subject to the inactivation requirements found in section 73.3 (validated inactivation procedure)?
  In order to exclude an agent (for which it is registered) from the requirement of the select agent and toxin regulations, a registered clinical or diagnostic laboratory is required to use an in-house validated inactivation procedure [following the requirements found in section 3(d)(4) or 4(d)(4)].  To exclude an agent for which it is not registered but has identified in a diagnostic or verification sample, a registered clinical or diagnostic laboratory is allowed to “destroy” the agent on-site by a recognized sterilization or inactivation process as outlined in section 5(a)(3) or 6(a)(3).

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.

The Federal Select Agent Program (FSAP) has revised its guidance document on inactivation, Guidance on the Inactivation or Removal of Select Agents and Toxins for Future Use, to explain how a principal investigator may sign documents electronically.

The updated guidance is available on page 17 and states:

For an individual to sign a document electronically, the entity should incorporate a method that:

• Identifies and authenticates a person using at least two factors of authentication, including something the person knows (i.e., email password) and something the person has (e.g., a mobile phone with SMS text message access);
• Provides a means to preserve the integrity of the signed record that is (a) portable, (b) independently verifiable, (c) tamper-evident, (d) granular, and (e) verifiable in the long-term; and
• Meets the requirements of the Government Paperwork Elimination Act, the Electronic Signatures in Global and National Commerce Act (ESIGN, 15 U.S.C. ch. 96), and the Uniform Electronic Transactions Act. 

In addition, the electronic form of signature must be executed or adopted by a person with the intent to sign the electronic record (e.g., to indicate a person’s approval of the information contained in the electronic record). Not only must this intent be captured at the time of each signature, but it must also be captured for each individual signature and be provided as granular evidence within the electronic signature system’s audit trail.  Each signed document must be backed by an audit trail that captures intent to sign for each individual signature and provides granular, consistent, time stamped evidence as to every step in the entire signature process. The electronic form of signature must be attached to or associated with the electronic record being signed, and each signature should be produced according to established standards. The signature should be independently verifiable, without relying on the electronic signature service or website to be validated.

FSAP has also incorporated this information into a new frequently asked question posted on the website, now available at https://www.selectagents.gov/compliance/faq/ro.html.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of extensive additional functionality to the electronic Federal Select Agent Program (eFSAP) portal.

Beginning September 5, 2018, authorized SAMS account holders at all registered entities will be able to experience the following system-wide enhancements and additional functionality within eFSAP:

APHIS/CDC Form 1 Section 4, Section 7b, and Entity Amendment History Redesign

APHIS/CDC Form 1 Section 4 and Section 7b data tables, as well as entity amendment histories, have been redesigned to provide an enhanced user experience:

• Additional data columns have been added (e.g., Form 1 Section 4 status, Tier 1 status, SRA approved date, SRA expiration date, Form 1 Section 7b date added/withdrawn).
• Data table columns now have fixed column headers during scrolling.
• Data tables support filtering and sorting of each data column independently for rapid retrieval of pertinent information.

Email Notifications Update

Since March 2018, eFSAP has supported daily email notifications.  Unfortunately, entities have reported sporadic functionality of this feature.  With this release, our developers have reengineered the notification engine.  Once daily, Responsible Officials (ROs) and Alternate Responsible Officials (AROs) should receive an email notification if FSAP staff have performed any action generating a notification in an entity’s notification table.  The email will indicate that ROs and AROs should log into eFSAP at their earliest convenience to review the action.

Please continue to report to the eFSAP Help Desk if you believe entity email notifications are not functioning properly.

Historical Strains (APHIS/CDC Form 1 Section 7b) and Historical Buildings/Rooms/Suites (Section 6)

Starting with this release, any changes made to building/room/suite information in Form 1 Section 6 will be captured and displayed in the user interface as unique versions.  By selecting a history icon next to each building or room/suite, users will be able to view past information for that registered area.

In addition, select agent strains and select toxin serotypes that have been removed from an entity’s APHIS/CDC Form 1 Section 7b will be available in the user interface.  Users will be able to search past strains/serotypes by PI, date added, date withdrawn, etc.

FSAP Inspection Module (Version One)

FSAP is proud to bring to entities the first version of a new, interactive, electronic inspection module in eFSAP.  Over the next few months, FSAP will begin limited use of the inspection module during an initial pilot phase.  Features of the new eFSAP inspection module include the following:

• Entities will have awareness regarding the inspection team and inspection focus as soon as FSAP staffs the inspection and generates checklists for the inspection.
• As inspection findings are released for entity review, eFSAP generates automated entity notifications.
• Entities have the ability to respond to inspection findings on an individual basis as time and resources permit.
• Directly through the inspection module, FSAP has the ability to close inspection findings or ask for additional information.  Automated notifications are generated for these actions.
• Entities have the ability to print their inspection findings with or without all correspondence with FSAP regarding the inspection findings.

Available herepdf icon is a tutorial with screenshots of the new inspection module features.  In addition, you may reach out to your FSAP point of contact for assistance with these new features.  If you experience errors or have questions related to the eFSAP system in general or with SAMS access to the system, please continue to contact our excellent 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 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has posted to its website materials from the April 18, 2019 webinar.  The purpose of the webinar was to discuss and answer questions regarding the recently revised policy statement on entity annual internal inspections.  The materials, including the webinar presentation and a video recording, are available at https://www.selectagents.gov/resources/training.htm.

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 finalized a new policy statement and guidance document to assist entities in meeting the requirement regarding an annual internal inspection found in section 9(a)(6) of the select agent regulations (7 C.F.R. Part 331external icon, 9 C.F.R. Part 121external icon, and 42 C.F.R. Part 73external icon).

A draft version of the policy statement and guidance document was previously shared with the regulated community for review and input prior to being finalized.  The guidance document and policy statement do not reflect any major changes from the draft versions.

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.

The Federal Select Agent Program (FSAP) has finalized its policy on the registration and inspection of Effluent Decontamination Systems (EDS).  The policy states that an area containing an EDS is not required to be listed on an entity’s registration under the conditions prescribed in the policy.

A draft version of the policy statement was previously shared with the regulated community for review and input prior to being finalized.  The final document does not reflect any major changes from the draft version.

Please see the full policy for additional information. The policy is posted 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.

The Federal Select Agent Program (FSAP) has issued a revised inactivation policy that now addresses the requirements for a certificate used to document the inactivation of a select agent or material containing a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus (“inactivated material”).  See, for example, 42 CFR § 73.17(a)(8).

The revised FSAP policy clarifies that the purpose of the signature of the Principal Investigator, or designee, on the certificate is to certify that the information listed on the certificate is true, complete, and accurate.

The revised FSAP policy also clarifies that the certificate must be signed by the appropriate Principal Investigator, or designee, before “inactivated material” is removed from registered space or the biocontainment level required for that material before inactivation.

Please see the full policy for additional information. The policy is posted 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.

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) on its website in order to clarify eFSAP submissions related to reporting the identification of a select agent or toxin in a clinical, diagnostic, or proficiency testing specimen as outlined in sections 5, 6, and 9 of the select agent regulations.  The new FAQs are as follows:

• • What are the fields that need to be completed for a Form 4 Immediate Notification?
    Log into eFSAP and click on Form 4. Click Create Form 4. For an immediate notification you must provide the following:
    • Select Agent or Toxin identified from the dropdown menu (Section B, Field 1)
    • Date of the identification (Section B, Field 2)
    • Whether any of the samples containing the select agent or toxin may have led to an unintentional release and/or exposure (Section B, Field 9)
    • Click Immediate Notification. You will need to fill out the complete Form 4 within 7 days of identifying a select agent or toxin. See the Form 4 Quick Reference Guides for more information.

• • Can I select more than one method of disposition in the APHIS/CDC Form 4?
    Yes. Select each method of disposition (Field 8) using the checkboxes as applicable to the situation.
    • Transferred – Indicate to whom the sample was sent and the date of the transfer.
    • Destroyed – Indicate method of destruction and date destroyed.
    • Retained – Indicate the Principal Investigator (PI) (from the dropdown menu of PIs approved to possess select agent and toxin).
    • Note: The “Retained” selection is not available for agents that you are not authorized by FSAP to possess.

• • Will entities be required to maintain hard copy printouts of the Form 4 for identifications of select agents or toxins documented in eFSAP?
    • The electronic documentation in eFSAP acts as the record required by the select agent regulations. If there is no electronic documentation within eFSAP, it is your responsibility to ensure a record is available for 3 years.

• • What are the deadlines regarding submitting an APHIS/CDC Form 4?
    • You must submit a completed APHIS/CDC Form 4A within 7 calendar days after identification of a select agent or toxin contained in a specimen presented for diagnosis or verification.

• A sample provider not registered with FSAP submitted a diagnostic sample containing a suspected select agent to a reference laboratory for identification. How will the sample provider know whether to complete APHIS/CDC Form 4?
  • FSAP will send an email with a link to the APHIS/CDC Form 4 to the sample provider. Once the sample provider completes the information, they mail, fax, or email it back to FSAP.

The FAQs can be found on the page titled Report of Identification of Select Agent or Toxin FAQs on the select agent website.

If you have any questions regarding this information, 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.

Over the last year, the Federal Select Agent Program (FSAP) has released extensive new functionality to the eFSAP system.

FSAP shared information in recent SA Grams that as a part of its continued effort to provide eFSAP training and gain input from the regulated community, this summer, FSAP staff directly involved in eFSAP development are conducting a series of regional trainings.

We have had such an overwhelming interest in our September date in the Washington D.C. area that the September 13, 2018 – Riverdale, MD training is full.  In order to accommodate all interested parties, FSAP is opening up registration for an additional training to be conducted in Riverdale the same week.  The new date and location will be as follows:

• September 12, 2018 – Riverdale, MD. 4700 River Rd, Riverdale, Maryland 20737

There is no need to attend both trainings as they are based in the same content.

In addition, the following regional eFSAP trainings remain open for registration at this time:

• July 31, 2018 – Madison, WI.  Madison Marriott West, 1313 John Q Hammons Dr, Middleton, WI 53562
• August 30, 2018 – Austin, TX.  Austin Marriott South, 4415 S IH 35 Frontage Rd, Austin, TX 78744
• September 18, 2018 – Hartford, CT. Hartford Marriott Farmington, 15 Farm Springs Rd, Farmington, CT 06032

Persons interested in attending one or more of the remaining regional trainings can register for the events by visiting the registration webpage.  Registration will be limited to 50 attendees at each training. Training agendas and additional information will be provided to attendees approximately one week before the start date of each event.

For awareness, these regional trainings are not limited to Responsible and Alternate Responsible Officials.  Anyone at your entity interested in receiving assistance with using eFSAP, previewing upcoming eFSAP features still currently in development, providing input on the current iteration of the system, and contributing ideas for desired functionality in future releases is more than welcome to attend.

We encourage those who are able to attend one of these regional trainings. If you have any questions regarding this email, please contact the Federal Select Agent Program at 404-718-2000 or LRSAT@CDC.gov.

Over the last year, the Federal Select Agent Program (FSAP) has released extensive new functionality to the eFSAP system.

FSAP shared information in a July 25, 2018 SA Gram that as a part of its continued effort to provide eFSAP training and gain input from the regulated community, this summer, FSAP staff directly involved in eFSAP development will conduct a series of regional workshops.

Earlier this week, FSAP completed its first eFSAP regional workshop in Irvine, California. Many thanks to all of the Responsible and Alternate Responsible Officials who drove and flew in to make the workshop a success. Workshop attendees were able to preview upcoming eFSAP features still currently in development, provide valuable input on the current iteration of the system, and contribute ideas for desired functionality in future releases. The eFSAP development team was also able to answer questions and resolve issues that some workshop attendees were currently experiencing with the system.

The following additional regional eFSAP workshops are now open for registration:

• July 31, 2018 – Madison, WI.  Madison Marriott West, 1313 John Q Hammons Dr, Middleton, WI 53562
• August 30, 2018 – Austin, TX.  Austin Marriott South, 4415 S IH 35 Frontage Rd, Austin, TX 78744
• September 13, 2018 – Riverdale, MD.  4700 River Rd, Riverdale, Maryland 20737
• September 18, 2018 – Hartford, CT. Hartford Marriott Farmington, 15 Farm Springs Rd, Farmington, CT 06032

Entity representatives interested in attending one or more of these additional regional workshops can register for the events by visiting the registration webpage. Registration will be limited to 50 attendees at each workshop.  Workshop agendas and additional information will be provided to attendees approximately one week before the start date of each event.

We encourage those who are able to attend one of these regional workshops. If you have any questions regarding this email, please contact the Federal Select Agent Program at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) has developed two new reference guides to assist eFSAP users with the APHIS/CDC Form 3 features. The reference guides are to provide a quick reference on how to input data by each section into eFSAP regarding APHIS/CDC Form 3.

The new quick reference guides are available online in the eFSAP Resource Center, and include the following materials:

• APHIS/CDC Form 3 Quick Reference Guide
• APHIS/CDC Form 3 Quick Reference Guide – Submitting an Immediate Notification

We hope that this information is helpful to you. If you have any questions related to the eFSAP system in general or with SAMS access to the system (e.g., log in problems, system outage) please contact the 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 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

Over the last year, the Federal Select Agent Program (FSAP) has released extensive new functionality to the eFSAP system.

As a part of our continued effort to provide eFSAP training and gain input from the regulated community, over the coming months, FSAP staff directly involved in eFSAP development will be conducting a series of regional workshops. These workshops will provide hands-on training and eFSAP assistance to attendees. There will also be time dedicated to gaining input from the regulated community on additional desired features and functionality. Further, FSAP will provide attendees with a preview of upcoming releases and answer any questions or concerns from the regulated community.

The first workshop will be conducted on Monday July 9, 2018 in Irvine, California at the Anaheim Marriott Hotel, 700 West Convention Way, Anaheim, California 92802 from 9:00 – 3:00 pm Pacific Time. To register for the event, please visit the Training Registration Page.

FSAP is planning to conduct additional one-day regional workshops in late July through September at the following locations: Austin, TX; Hartford, CT; Madison, WI; and Riverdale, MD. Specific dates and locations for these additional workshops will be communicated by SA Gram in the coming weeks.

We encourage those who are able to attend one of these regional workshops. Registration will be limited to 50 attendees at each workshop.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 404-718-2000 or LRSAT@cdc.gov.

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 FMD-LL3B3D A24 Cruzeiro, foot-and-mouth disease vaccine virus strain is excluded from the requirements of the select agent regulations because it does not pose a severe threat to animal health or animal products.

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

The Federal Select Agent Program would like to announce a change in leadership at the Agriculture Select Agent Services (AgSAS). Effective May 30, Dr. Adis Dijab became the AgSAS National Director. To ensure program continuity, Drs. Dijab and Keith Wiggins (long-term Acting National Director for AgSAS) will coordinate the leadership transition through this month. By July 1, 2018, Dr. Dijab will assume full responsibility as the AgSAS National Director.

Dr. Dijab received his Doctor of Veterinary Medicine degree from Zagreb University, College of Veterinary Medicine in Croatia. After eight years in a small animal clinic in Kentucky, Dr. Dijab began his career at the United States Department of Agriculture (USDA)’s Animal and Plant Health Inspection Service (APHIS) in 2004. Since then, he has served the USDA under both the USDA’s Food Safety Inspection Service and APHIS’ Veterinary Services, as a supervisory veterinary medical officer (VMO), field VMO, area veterinarian-in-charge, and program director. Dr. Dijab most recently served as the National Director of Animal Product Permitting and Negotiation Services with the National Import Export Services.

If you have any questions regarding this email, please contact AgSAS at 301-851-2070 or AgSAS@usda.gov.

Today, CDC’s Division of Select Agents and Toxins (DSAT) published its third annual analysis of inspection report timeliness, the 2017 DSAT Inspection Report Processing Annual Summarypdf icon.

Inspection reports play a critical role in ensuring the safety and security of work with select agents and toxins, and the data show that DSAT continues to make substantial improvements in its ability to provide timely feedback to entities.  Key findings include the following:

• Nearly all inspection reports – 96 percent – issued by DSAT in 2017 were issued within DSAT’s target of 30 business days.  Only six reports out of 142 did not meet this goal.
• This reflects an improvement of 32 percent over 2016 data, even with an increase in the number of inspection reports issued, and a 50 percent improvement since 2015.
• Once again, improvements in report timeliness occurred across all inspection types, with particularly notable improvements in maximum containment inspections.

In addition, the analysis further examines the six delayed reports by looking closer at the timeframes and reasons for the delays.  Four of the six delayed reports were less than seven business days late; in all cases, administrative and/or workload reasons were the two reasons cited for delays.  For additional information, please see the full report (available herepdf icon).

DSAT remains committed to meeting its 30-day target for issuing final inspection reports.  Overall, the substantial improvements in timeliness demonstrated in today’s report underscore DSAT’s continued commitment towards program improvement.  Today’s publication also reflects the program’s sustained pledge to increase transparency.

If you have any questions about the report, please contact DSAT at 404-718-2000 or LRSAT@cdc.gov.

The Federal Select Agent Program (FSAP) has noticed an increase in reports of failures involving the integrity of the positive pressure encapsulating suits used in BSL-4 laboratories. A significant portion of these suit failures were identified during the exit chemical decontamination shower. As a result of these recent reports, we recommend entities maintaining BSL-4 laboratories consider the length of time a suit at the entity has been in service and conduct a more thorough examination of all suits, especially the seams and high wear areas, prior to entry into the BSL-4 laboratories.

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.

The Federal Select Agent Program (FSAP) has posted a new Frequently Asked Question (FAQ) on its website in order to assist individuals with completing the FBI/Criminal Justice Information Services (CJIS) Division’s FD-961 form (Application for Security Risk Assessment). The new FAQ is as follows:

When completing question #6 (Position) in Section II (Individual Information) on the FD-961 form, what position should be listed?

Please select the one of the following roles that best describes the individual’s primary responsibilities:

• Administrative
• Alternate Responsible Official
• Animal Care Staff
• IT
• Laboratorian
• Janitorial
• Maintenance
• Owner/Controller
• Principal Investigator
• Responsible Official
• Safety
• Security
• Shipping/Receiving
• Other for individuals who do not fall under one of the roles noted above

The FAQ can be found at: https://www.selectagents.gov/compliance/faq/risk.htm.

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.

The Federal Select Agent Program (FSAP) has developed a series of reference guides to assist eFSAP users with the APHIS/CDC Form 2 and APHIS/CDC Form 4 eFSAP features. The reference guides are to provide a quick reference on how to input data by each section into eFSAP regarding APHIS/CDC Form 2 and APHIS/CDC Form 4.

The quick reference guides are available online in the eFSAP Resource Center, and include the following materials:

• APHIS/CDC Form 2 Quick Reference Guide – Completing Section 1
• APHIS/CDC Form 2 Quick Reference Guide – Completing Section 2
• APHIS/CDC Form 2 Quick Reference Guide – Completing Section 3
• APHIS/CDC Form 4 Quick Reference Guide – Immediate Notifications
• APHIS/CDC Form 4A Quick Reference Guide – Completing Sections A and B
• APHIS/CDC Form 4A Quick Reference Guide – Completing Sections C and D
• APHIS/CDC Form 4B Quick Reference Guide

We hope that this information is helpful to you. If you have any questions related to the eFSAP system in general or with SAMS access to the system (e.g., log in problems, system outage) please contact the 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 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) on its website in order to clarify requirements related to the reporting of the identification of a select agent or toxin in a clinical or diagnostic or proficiency testing specimen as outlined in sections 5, 6, and 9 of the select agent regulations. The new FAQs are as follows:

As part of a proficiency test, I identified a select toxin but in an amount below the excluded threshold amount listed in 42 CFR § 73. 3. Must I still report the identification using an APHIS/CDC Form 4?

Yes, regardless of the amount identified, a registered entity or a clinical or diagnostic laboratory is required to report the identification of a select toxin contained in a sample presented for proficiency testing using APHIS/CDC Form 4.

As part of a proficiency test, I identified an excluded attenuated strain of a select agent. Must I still report the identification on APHIS/CDC Form 4?

No. Any excluded attenuated strain of a select agent or toxin is excluded from the requirements of select agent regulations, including the reporting requirements set forth in sections 5 and 6 of the regulations. The list of excluded select agent strains can be found here.

If a diagnostic test only identifies a biological agent at the genus level, am I required to report the result if I only suspect that it is select agent?

No. but should further testing confirm that the specimen contains a select agent, the continued possession of that select agent is only exempt from the select agent regulations if the laboratory does the following:

• Unless directed otherwise by AgSAS or DSAT, within seven (7) calendar days after identification of the select agent or toxin, either transfer the select agent or toxin in accordance with Section 16 of the select agent regulations (requires prior approval by AgSAS or DSAT) or destroy the specimen on-site by a recognized sterilization or inactivation process.
• Before transfer or destruction, secure the select agent or toxin to prevent theft, loss, or release.
• Immediately report the identification of specific select agents and toxins listed in the regulations (See immediate notification list).
• Maintain copies of all APHIS/CDC Form 4A reports for a period of (3) three years.

The FAQs can be found at: https://www.selectagents.gov/compliance/faq/reporting.htm.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of additional functionality to the eFSAP system.

Beginning May 7, 2018, authorized SAMS-account holders at all registered entities will be able to enjoy the following system-wide enhancements and additional functionality within eFSAP:

System-wide data table redesign

Data tables within eFSAP (e.g., amendment summary table, APHIS/CDC Form 2, 3, and 4 tables, document tables) have been completely redesigned to provide additional information and an enhanced user experience. Changes include:

• Additional data columns have been added (e.g., APHIS/CDC Form 2 approval and expiration dates, APHIS/CDC Form 3 incident type).
• Data table columns now have fixed column headers during scrolling.
• Data tables support filtering and sorting of each data column independently for rapid retrieval of specific documents, amendments, and APHIS/CDC Forms 2, 3 and 4.

File upload enhancements and additional functionality

The file upload feature of eFSAP has been redesigned to aid in subsequent search and retrieval, organization and version control, and to provide transparency regarding the status of FSAP review.

• eFSAP file upload now supports close to 700 different file types (e.g., .pdf, .doc, .rtf).
• Entities are now able to add text descriptors and assign files to predefined categories during the upload process to aide in future file search and retrieval.
• eFSAP now automatically generates unique versions of entity files with the same title to prevent overwrite and assist in keeping track of the most up-to-date copy of a file.
• After file upload, entity users are able to see the status of FSAP review (e.g., not yet reviewed, under review by FSAP, review complete).

Attached to this message is a tutorial with screenshots of the new features. In addition, you may reach out to your FSAP point of contact for assistance with these new features. If you experience errors or have questions related to the eFSAP system in general or with SAMS access to the system (e.g., log in problems, system outage) please continue to contact the eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.

The Federal Select Agent Program (FSAP) wishes to remind the regulated community that FSAP will not accept any information related to the FD-961 form (Application for Security Risk Assessment). The FD-961 form and photos required by the FBI must be sent as a pdf directly to the FBI’s Criminal Justice Information Services (CJIS) Division at FD961@leo.gov. An FD-961 form and/or photos submitted through eFSAP, to FSAP directly, or to any email except FD961@leo.gov will be deleted.

Additional information regarding the security risk assessment is found at https://www.fbi.gov/services/cjis/bioterrorism-security-risk-assessment-formexternal icon.

FSAP appreciates your assistance in ensuring that any documentation related to the FD-961 form and appeals to restricted person notifications are sent appropriately.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

This email is being sent on behalf of the Federal Bureau of Investigation, Criminal Justice Information Services Division (CJIS) to notify you that the newly revised OMB-approved FD-961 form [OMB No. 1110-0039 (Exp. 4-30-2021)] has been posted online and is now available for use. The FD-961 form and the instructions can be found on the FBI’s website at www.fbi.govexternal icon (search FD-961).

If you have any questions regarding the FD-961 form, please contact CJIS at 304-625-4900.

In the coming days, the Federal Select Agent Program (FSAP) will be releasing extensive new functionality to the eFSAP system. This update brings users the ability to categorize files during the upload process and track the review status of documents that have been uploaded for FSAP review. Users will also be able to maintain, view, and retrieve multiple versions of their documents that have been uploaded over time. In addition, the pending update brings a redesign of data tables throughout the system, giving users the ability to filter and sort each table column independently for rapid retrieval of information.

We have scheduled upcoming online training opportunities to assist you with using the new features. Online training sessions will be held between May 7-18, 2018. We encourage you to attend one of these training sessions.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) is committed to providing the regulated community with an optimal eFSAP system user experience. In order to address and help troubleshoot log on issues that have been reported by some users, FSAP developed a reference guide containing reported issues and solutions. The guide is attached to this email and can be found online in the eFSAP Resource Center. We hope that this information is helpful to you in case you should experience one of the identified issues.

If you have any questions related to the eFSAP system in general or with SAMS access to the system (e.g.,log in problems, system outage) please continue to contact the 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 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) would like to ensure eFSAP users are aware that they can now submit immediate notifications for APHIS/CDC Form 3 and APHIS/CDC Form 4A directly to FSAP via the system.

Attached to this message are tutorials with screenshots detailing these features. (Available here).

eFSAP users may access the system at https://efsap.selectagents.gov/external icon.  If you experience errors or have questions related to the eFSAP system in general or with SAMS access to the system (e.g.,log in problems, system outage) please continue to contact the eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.   You may also wish to visit our online eFSAP Resource Center.

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.