2019 SA Grams

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

Beginning November 22, 2019, authorized SAMS account holders at all registered entities will notice the following system updates:

1. APHIS/CDC Form 1 Section 7 A/C Load Time Improvements
   Upon navigation to Form 1 Section 7A/C, work objectives now load substantially faster.
2. System-wide Data Table Enhancements
   Based on feedback from the regulated community, users now have the option of configuring data tables to show up to 500 rows of information at a time.
3. Amendment Flagging and Archiving
   User-requested enhancements previously added to the entity notification table have now been applied to the amendment table. Users are now able to flag and archive amendments.
4. Final Inspection Findings
   Also at the request of the regulated community, the eFSAP inspection module now allows the FSAP inspection team to indicate when all inspection findings have been released to an entity.  Activation of this feature prompts a notification to the entity’s home page.  It also generates a message on the inspection resolution page as well as on the printed version of the report indicating that the findings displayed represent the final inspection findings.
5. Inspection Histories
   Each entity inspection now contains an inspection history displaying the date upon which changes in inspection status occurred and by whom the change was executed.

FSAP would like to thank the regulated community for your continued feedback regarding 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 Centerpdf icon page.

If you experience errors, have questions, or have challenges 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) has posted several new Frequently Asked Questions (FAQ) to its website to clarify information about the steps required in order to obtain a CDC SAMS account to access eFSAP. The new FAQs can be found hereexternal icon.

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 first joint program analysis of inspection report timeliness data, the 2018 FSAP 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 timely feedback is essential so that FSAP can quickly get important information back to entities following an inspection.  The data show that nearly all inspection reports were sent to entities within the program’s goal of 30 business days, underscoring the program’s continued commitment to provide timely feedback.

Key findings include the following:

• FSAP issued 194 final inspection reports in 2018 – with 93 percent overall (181/194) issued within the 30 business day target
• Among reports issued by CDC’s Division of Select Agent and Toxins (DSAT), 95 percent met this goal, and among reports issued by APHIS’s Agriculture Select Agent Services (AgSAS), 84 percent met this goal.
• For the small number of reports that were delayed (13 total), analysis by inspection type found that the most common inspections conducted (verification inspections) were also the most commonly delayed report type.

Although previous analyses of inspection report timeliness have focused on data for CDC’S Division of Select Agents and Toxins, this is the first time data has been analyzed for both DSAT and AgSAS.  DSAT data continued to show high levels of timeliness, despite an increase in the number of final inspection reports issued. The analysis also includes an assessment of reasons for any delays; this information is necessary so that FSAP can continue to identify further opportunities for improvement.

For more information, please see the full reportpdf icon.

FSAP remains committed to issuing final inspection reports within the 30 business day target, as well as finding continued opportunities to increase transparency within the program.

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 developed a resource to assist entities with uploading documents in eFSAP. The new tool, posted in the eFSAP Resource Center and available directly at https://www.selectagents.gov/efsap/using/Document-Upload-Categories-Locations.pdfpdf icon, is titled Document Upload Categories and Locations in eFSAP and provides an overview of locations within eFSAP (e.g., forms, entity home page, inspection) where each type of document may be uploaded.  Additionally, the tool describes categories and subcategories for document classifications to assist users during the uploading process. We hope this resource is helpful to users.

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 added a Frequently Asked Question (FAQ) to its website in order to clarify the difference between a federal regulation, an FSAP regulatory interpretation, an FSAP policy statement, and an FSAP guidance document, and which have the force and effect of law.

The new FAQ is included below and can also be found at https://www.selectagents.gov/compliance/faq/legislature.htm:

What is the difference between a federal regulation, an FSAP regulatory interpretation, an FSAP policy statement, and an FSAP guidance document, and which have the force and effect of law?

• A federal regulation has the force and effect of law. The select agent and toxin regulations are 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331.  
• An FSAP regulatory interpretation is a written FSAP statement explaining the meaning of a section of the regulations or a regulatory phrase.  Although a regulatory interpretation is a response to a specific request for clarification of the meaning for a section of the regulations or a regulatory phrase, a regulatory interpretation is binding on FSAP for all entities.  The regulatory phrase being interpreted has the force and effect of law.
• An FSAP policy statement is a written FSAP statement explaining how the program reads (interprets) and will apply (enforce) a select agent and toxin regulation.  The regulation that is the subject of the FSAP policy statement has the force and effect of law. 
• An FSAP guidance document (e.g., FSAP’s Annual Inspection Guidance or FSAP’s Biosafety/Biocontainment Plan Guidance) is advice and information provided by FSAP to assist registered entities with achieving regulatory compliance.  It is a way to achieve compliance, not the way to achieve compliance.  A guidance document does not have the force and effect of law.

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 Frequently Asked Questions (FAQs) regarding inactivation that are posted on the program’s website in order to increase clarity of the information provided. Please visit https://www.selectagents.gov/compliance/faq/inactivation.htm for more information.

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 completed a system update to the electronic Federal Select Agent Program (eFSAP) information system. Entities are encouraged to sign up for our upcoming webinars covering the new “super-admin” user role and the new “Principal Investigator Replacement” amendment type. Several additional minor system updates will also be covered.

Sessions will be held at the following dates/times:

• Thursday, September 19: 10:00-11:30 am EDT
• Thursday, September 19: 1:00-2:30 pm EDT
• Friday, September 20: 10:00-11:30am EDT

To register for a session, please visit the Training Registration 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 following information is being sent on behalf of the FBI, Criminal Justice Information Services Division (CJIS), Bioterrorism Risk Assessment Group (BRAG).

BRAG is currently reviewing the reasons for delays in security risk assessment (SRA) processing, which are often due to the individual not completing the FD-961 correctly. Some of the most common reasons for delays include:

• Not completing Question 20 (Driver’s License Number and Issuing State) correctly. The individual will provide the license number, but not the issuing state.
• Leaving Questions 7e [Aliases/Maiden Name (Last, First, Middle)] and 7f (Nicknames) blank instead of entering the names or putting “none.”
• Missing or outdated signatures of the Responsible Official on the FD-961 form or the individual’s signature on fingerprint cards.

BRAG has also noted delays because fingerprints were rejected due to the quality of the images or new fingerprints needed.

It is important to note that security risk assessments for foreign born individuals require additional time to process.

We wish to share this information with you so that you can proactively avoid delays related to these issues in the future.

As a reminder, section 10 of the select agent regulations (Restricting access to select agents and toxins; security risk assessments) states a written request from the Responsible Official to the Federal Select Agent Program (FSAP) is required to expedite an individual’s security risk assessment. These requests should be sent directly to FSAP using the eFSAP portal. The request must show good cause (e.g., public health or agricultural emergencies, national security, or a short-term visit by a prominent researcher) to expedite the SRA. In response, FSAP will provide a written decision granting or denying the request to expedite the SRA.

Questions concerning completion of the FD-961 form can be directed to BRAG at 304-625-4900 or fd961@leo.gov

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of the 10th major update to the electronic Federal Select Agent Program (eFSAP) Information System.

Beginning September 6, 2019, authorized SAMS account holders at all registered entities will notice the following significant updates:

• • Super-admin Users
    Registered entities now have the ability to designate one or multiple “super-admin” users.  These individuals are able to log into eFSAP and draft, but not submit, the following:
    • APHIS/CDC Form 1 technical amendments
    • APHIS/CDC Form 2
    • APHIS/CDC Form 3
    • APHIS/CDC Form 4
    • Responses to inspection findings

• • Simple Principal Investigator (PI) Replacement
    eFSAP now includes a new type of administrative amendment, simple PI replacement. If a PI needs to be removed, eFSAP is able to automatically assign the following to another
    unrestricted PI:
    • all of their approved work objectives
    • all of their personnel
    • all of their strains and serotypes

This new feature negates the need to submit APHIS/CDC Form 1 Section 7A/C technical amendments, as well as Section 4 and 7B administrative changes, if the removed PI’s work objectives, personnel, and strains/serotypes need to be retained.

In addition to the major features listed above, eFSAP users will also notice the following enhancements:

• Work Objective Histories – Changes to work objectives over time are able to be tracked in APHIS/CDC Form 1 Section 7A/C.
• APHIS/CDC Form 1 Section 4 Enhancements – 1) APHIS/CDC Form 1 Section 4 now defaults to show an entity’s unrestricted personnel when the page is initially loaded or upon page refresh.  2) APHIS/CDC Form 1 Section 4 now also displays the “BRAG-received” date (the date that FBI/CJIS began the individual’s background check).
• Amendment Numbers – Unique amendment numbers are assigned to each technical amendment in the amendment grid table for easier reference, search, and retrieval.
• APHIS/CDC Form 3 Case Identifiers and Agents – 1) Unique case identifiers are assigned to APHIS/CDC Form 3s for easier reference, search, and retrieval. 2) APHIS/CDC Form 3 data tables show the agent or toxin involved.

For more information, please review the tutorial.

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 Centerpdf icon page.

If you experience errors, have questions, or have challenges 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.

In order to prevent the unnecessary termination of an individual’s approval to access select agents and toxins and to allow the appropriate time for processing approval renewals, the Federal Select Agent Program (FSAP) recommends that any individual needing the renewal of their access approval should email a new FD-961 form to the Bioterrorism Risk Assessment Group (BRAG)/Criminal Justice Information Services Division (CJIS) at FD961@leo.gov between 90 and 180 days prior to the date of their access approval expiration.

Should an individual fail to take the necessary steps to have their access approval renewed, FSAP will note the expiration of the access approval after the access approval expiration date [See 42 CFR 73.10(a), 9 CFR 121.10(a), and 7 CFR 331.10(a)].  This will be reflected as an ‘Expired’ status in eFSAP.  Should this happen, the entity must immediately deny that individual access to select agents and toxins.  If the entity still wants the individual to have access approval and a new FD-961 has been submitted to BRAG/CJIS, the entity may leave the individual on the registration with the ‘Expired’ status in eFSAP until a determination on the renewal for access approval has been made.

It is the responsibility of each Responsible Official to monitor the status of the access approvals for individuals in their entity and ensure submission of the appropriate renewal paperwork in a timely manner.

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) would like to announce the selection of a permanent Agriculture Select Agent Services (AgSAS) Director. Effective June 24, Dr. Jacek (Jack) Taniewski became the AgSAS Director. Dr. Taniewski and Dr. Lisa Dixon, previous Acting AgSAS Director, will coordinate and complete a leadership transition by July 1, 2019. The FSAP wishes to thank Dr. Dixon for her services as Acting Director since May 19.

Dr. Taniewski is a graduate of the Academy of Agriculture and Technology (Olsztyn, Poland) with more than 30 years of veterinary expertise. After several years in private practice, Dr. Taniewski joined the USDA in 1998, and APHIS in 2003. He has supported the USDA mission to provide leadership on agriculture issues through a variety of regulatory enforcement, policy development, and program administration roles, ranging from an inspector with the Food Safety and Inspection Service to the Animal Export Director in Veterinary Services. Before his selection as the AgSAS Director, Dr. Taniewski led the development of policies for international animal movement as the National Director for Live Animal Import/Export.

The Federal Select Agent Program (FSAP) recently received a request for a regulatory interpretation regarding the requirements surrounding the transfer of excluded amounts of toxins.  The FSAP response is as follows:

An entity that possesses regulated amounts of a toxin may transfer the toxin in an amount which excludes it from the provisions of the select agents and toxins regulations (e.g., less than 1.0 mg botulinum neurotoxins) (See 42 CFR §73.3) without use of an APHIS/CDC Form 2 authorization as long as the entity uses due diligence to determine that the recipient has a legitimate need to handle or use such toxins.  For a shipment of a toxin where the amount of the toxin is not known, the toxin will not be excluded from the requirements of select agents and toxins regulations until the entity is able to confirm that the amount is within the exclusion limit.

You can find the full regulatory interpretation on this topic at https://www.selectagents.gov/regulations/interpretations/excluded-transfer.htm.

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

The Federal Select Agent Program (FSAP) has developed a new mobile application in order to assist laboratory managers and biosafety personnel in performing internal laboratory inspections. The Federal Select Agent Program Laboratory Examination Tool, or FSAP-LET, contains checklists that are based on federal regulations and biosafety standards used by FSAP inspectors. The checklists cover a variety of areas such as biosafety, security, training, and incident response.

The app is available to download for the following devices:

• On your Android mobile device through the Google Play Store: Google Play Storeexternal icon
• On your Apple device through the App Store: App Storeexternal icon
• On your Windows device through the Microsoft Store: Microsoft Storeexternal icon

Please note that, while the tool is intended to assist laboratories in meeting federal regulations and biosafety standards, it is not all-inclusive. The responsibility to fully adhere to applicable federal regulations remains with the entity using the tool.

For more information, please visit: https://www.selectagents.gov/resources/checklistapp.htm.

As previously announced, the Agriculture Select Agent Services (AgSAS) National Director position became vacant on April 1, 2019. Leaders from the Veterinary Services program will serve in the position – re-titled AgSAS Director (removing “National”) – on an acting basis until it is permanently filled.

The Federal Select Agent Program (FSAP) wishes to thank Dr. Narda Huyke, whose detail ended on May 18, 2019, for her service as AgSAS Director over the past months.

Effective May 19, 2019, Dr. Lisa Dixon has assumed the duties of the AgSAS Director through August 17, 2019.

Dr. Dixon graduated from Tuskegee University School of Veterinary Medicine, and also holds a Master’s degree in Public Health from Walden University. After completing an equine internal medicine internship at Oklahoma State University, followed by many years of private practice, she entered the federal workforce in 2008.

Dr. Dixon served as a Supervisory Public Health Veterinarian and Enforcement Investigation and Analysis Officer with the Food Safety and Inspection Service, prior to joining the Animal and Plant Health Inspection Service (APHIS) as a Veterinary Medical Officer in 2013.

Since 2017, Dr. Dixon has served as the Director of Animal Product Imports, within Veterinary Services. As such, she oversees the program responsible for permitting, negotiation, and policymaking for animal product imports. She is also integrally involved in the USDA Approved Establishment Program for Restricted Products, the Cross Functional Working Group for Regulated Garbage, and the Veterinary Services’ National Civil Rights and Diversity Advisory Council.

FSAP will continue to inform the regulated community of further changes to the Acting AgSAS Directors via the FSAP website and by SA Gram.

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

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) recently announced the deployment of a major system update to the electronic Federal Select Agent Program (eFSAP) information system. Entities are encouraged to sign up for our upcoming webinars covering: APHIS/CDC Forms 2, 3, and 4 printing; APHIS/CDC Form 1 Section 4 and Section 7B data export; notification table enhancements; and file archiving.

Sessions will be held at the following dates/time:

• May 20: 10-11 am ET
• May 22: 1-2 pm ET
• May 30: 3-4 pm ET

To register for a session, please visit the 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.

In 2017, the Federal Select Agent Program (FSAP) issued a regulatory interpretation regarding the requirement for inactivation certificates and intra-entity transfers.  FSAP has updated that regulatory interpretation to clarify that a certificate must be generated every time material is inactivated, regardless of whether the material is transferred or not.  The updated regulatory interpretation reads as follows:

A copy of an inactivation certificate must accompany the inactivated material when the inactivated material is transferred externally (from your entity to another entity). It is recommended that an inactivation certificate also accompany the transfer of inactivated material internally (from one PI to another PI at the same registered entity).  Additionally, regardless of whether a transfer is made, an entity remains responsible for the record keeping requirements found in section 17(a)(8) of the select agents and toxins regulations.  An original certificate must be generated for every sample inactivated regardless of future transfer.

FSAP recommends that entities maintain the certification of inactivation as long as the material is in their possession.

The updated regulatory interpretation was posted online today (May 16, 2019) and replaces the previous response dated June 16, 2017.  It is now available at https://www.selectagents.gov/regulations/certificates.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) is pleased to announce the deployment of another major system update to the electronic Federal Select Agent Program (eFSAP) Information System.  Based on feedback from the regulated community, we believe these new features will provide a better user experience.

Beginning May 16, 2019, authorized SAMS account holders at all registered entities will notice the following significant updates:

• • APHIS/CDC Forms 2, 3, and 4 printing
    Responsible Officials (ROs), Alternate Responsible Officials (AROs), and entity “read-only” users now have the ability to print all sections of Forms 2, 3, and 4.

• • APHIS/CDC Form 1 Section 4 and Section 7B data export
    ROs and AROs now have the ability to export Section 4 data.  In addition, read-only users as well as ROs and AROs have the ability to export Section 7B data.  The data is exported into a .csv file that is compatible with common spreadsheet applications.

• • Notification table enhancements
    Numerous enhancements have been made to the notification tables found at the top of the entity home page and inspection details page.  Entities now get the following notifications:
    • When a person is approved by FSAP for access to select agents and toxins
    • When a person’s FSAP approval for access to select agents and toxins is 45 and 90 days from approval expiration
    • When a person’s FSAP approval for access to select agents and toxin has expired

    In addition, ROs, AROs, and read-only users now have the ability to flag notifications for follow up and to archive notifications.

• File archiving
  ROs and AROs now have the ability to archive previously uploaded files.  The archiving feature is available system-wide from the grid tables at the bottom of the entity landing page, inspection details page, and at the bottom of each section of Forms 1-4.

In addition to the major features listed above, eFSAP users will also notice the following minor enhancements:

• APHIS/CDC Form 1 Section 7A/C now includes a keyword search feature that filters information down to the requested search term.
• The Inspection Module has been updated to allow additional response time when FSAP requests subsequent information related to an inspection finding.
• The APHIS/CDC Form 1 interface has been optimized, making all sections landscape-oriented.

For more information, please review the tutorialpdf icon with screenshots of the new features attached to this message.

If you experience errors, have questions, or have challenges 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.

This a reminder that section 18 of the select agents and toxins regulations provides that, without prior notification, representatives of the HHS Secretary and the APHIS Administrator (FSAP inspectors) shall be allowed to inspect any site at which activities regulated by the federal select agents and toxins regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331) are conducted and shall be allowed to inspect and copy any records relating to the activities covered by said regulations.

• All FSAP inspectors will, where required, have the appropriate security clearance for the entity to be inspected.  For those entities requiring pre-access verification, FSAP will have shared with the entity confirmation of the security clearance prior to the beginning of the inspection.
• All FSAP inspectors will have undergone the appropriate medical clearance for the entity to be inspected.  Each inspector has been certified to not have any underlying medical conditions which would interfere with their performing his/her duties.  Each individual also maintains a copy of his/her immunization records and his/her respirator fit testing card.  The inspectors are not allowed to participate in any entity medical surveillance program.
• All FSAP inspectors will adhere to FSAP’s policy for safeguarding select agent and toxin information.
• The FSAP inspector will identify himself or herself by their personal identity verification (PIV) card (his/her official government identification card).
• The FSAP inspector is not allowed to surrender his/her PIV card to the entity or exchange the PIV card for the entity’s identification badge.
• An entity is not allowed to copy the PIV card.
• The FSAP inspector will not provide an entity with any personal identification (e.g., a driver’s license, social security number).
• The FSAP inspector is not authorized to sign and will not sign any type of an entity confidentiality agreement.
• The FSAP inspector is not authorized to sign and will not sign any type of document releasing the entity from any liability.

The failure to allow an FSAP inspector access to a registered entity to conduct an inspection is a violation of federal regulations that may result in the imposition of civil penalties. Such failure may result in the immediate suspension or revocation of the entity’s approval to possess and use select agents and toxins.

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) congratulates Dr. Adis Dijab, previous National Director of the Agriculture Select Agent Services (AgSAS), on his recent appointment as Executive Director of Field Operations in Veterinary Services. As pleased as we are for Dr. Dijab, this means that the AgSAS National Director position became vacant effective April 1, 2019. Leaders from the Veterinary Services program will serve as National Director on an acting basis until the position is filled permanently.

Most immediately, Dr. Narda Huyke will provide coverage as acting AgSAS National Director through May 18, 2019. Dr. Huyke received her Bachelor of Science and Doctor of Veterinary Medicine degrees from the University of Illinois. She worked in veterinary pathology, laboratory animal medicine, and research compliance before joining APHIS in 2006. Since then, she has served as a Veterinary Medical Officer in the Diagnostic Virology Laboratory of the National Veterinary Services Laboratories and the Professional Development Services staffs before joining AgSAS in 2016. Most recently, Dr. Huyke served as the acting Technical Unit Director for AgSAS.

FSAP will continue to inform the regulated community of changes to the Acting National Directors via the FSAP website and by SA Gram. Coverage of this position is expected to rotate as outlined below:

April 1 – May 18, 2019
Dr. Narda Huyke
Narda.Huyke@usda.gov
301-851-3376

May 19 – August 17, 2019
Dr. Lisa Dixon
Lisa.M.Dixon@usda.gov
301-851-3373

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

The Federal Select Agent Program (FSAP) regulates laboratories working with select agents and toxins and helps to ensure that lifesaving research conducted with these potentially dangerous materials is done as safely and securely as possible.  While there is always some risk in working with select agents and toxins, our goal is to get as close to zero risk as possible.  Unfortunately, incidents do occur, and sometimes serious deficiencies in biosafety or security measures are identified at the laboratories that work with these materials.

The good news is that the vast majority of laboratories are doing well in following the select agent regulations. However, when issues do arise, systems are in place to deal with those situations.  Importantly, FSAP can take action in order to protect public, animal, and plant health, using a number of available options to address any potential risks and bring the entity back into compliance with the regulations.

The Federal Select Agent Program has developed a new series of infographics in order to describe these processes in more detail.  Posted to the FSAP website here, you will find new infographics covering the following topics:

• How the Federal Select Agent Program Addresses Serious Biosafety or Security Concerns
• Theft or Loss of a Select Agent or Toxin
• Release of a Select Agent or Toxin
• About the Federal Select Agent Program

We hope that these materials are useful references for you, and that they help to provide additional insight into these processes – for both the regulated community as well as anyone else who is interested in learning more about compliance with the select agent regulations.  Please feel free to share them with others in your organization who may be interested as well.

If you have any questions, 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 policy statement regarding the entity annual internal inspection required by section 9(a)(6) of the select agent regulations. The revised policy clarifies that the annual inspection must include the biosafety, security, incident response and training sections of the regulations.

The revised policy replaces the previous FSAP policy statement on the subject (issued August 9, 2018).  All elements of the revised policy take effect immediately.

The policy is available online at https://www.selectagents.gov/regulations/policy/annualinspection.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 finalized updates to its guidance document for Responsible Officials (ROs), the Responsible Official Resource Manual. This document includes helpful information for ROs on fundamental responsibilities of the role, authority, delegating, compliance, reporting, records, and internal inspections. The new guidance is available at https://www.selectagents.gov/compliance/guidance/ro/index.htm.

A draft version of this guidance document was previously shared with the regulated community for review and input prior to being finalized. Based on comments from the regulated community, the final document includes a security risk assessment section and a table that outlines the notification process utilizing the select agent program forms.

In addition, changes from the previous published version of the document include removal of the section titled “Three Year Cycle of RO Tasks” and adds references to FSAP’s recently issued policy and guidance on entity annual internal inspections.

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) recently announced the deployment of a major system update to the electronic Federal Select Agent Program (eFSAP) information system. Entities are encouraged to sign up for our upcoming webinars covering the new APHIS/CDC Form 1 amendment types and the eFSAP inspection module. To register for these webinars, please visit the Training Registration 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 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 revised Frequently Asked Question (FAQ) on its website in order to address the applicability of the exclusion provisions found in section 3d(4) and section 4d(4) (a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure) to a clinical or diagnostic laboratory identifying a select agent in a specimen presented for diagnosis or verification or proficiency testing as outlined in sections 5 and 6 of the select agent regulations.

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

If a laboratory receives a diagnostic sample and extracts nucleic acids for polymerase chain reaction (PCR), do the inactivation requirements found in section 3d(4) and section 4d(4) apply to the extracted nucleic acids?

The inactivation requirements found in section 3d(4) and section 4d(4) do not apply if the purpose of the diagnostic work is not for future use of a known select agent, and the nucleic acids extracted do not meet the definition of regulated nucleic acids:

1. Nucleic acids that can produce infectious forms of any of the select agent viruses or
2. Recombinant and/or synthetic nucleic acids that encode for the toxic form(s) of any of the select toxins if the nucleic acids: (i) Can be expressed in vivo or in vitro, or (ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro.

However, if the diagnostic work identifies a select agent, then the original clinical or diagnostic sample would be considered a select agent and must be transferred or destroyed on-site (by a recognized sterilization or inactivation process) within seven calendar days after delivery of patient care by health care professionals has concluded, or put into long term storage inventory (if registered with FSAP).
It is strongly recommended, but not required, that a clinical or diagnostic laboratory validates their inactivation procedures in-house to reduce the risk of failure of an inactivation procedure. The failure of a clinical or diagnostic laboratory to destroy a select agent or toxin using an inactivation procedure could result in civil and/or criminal penalties.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of a major system update to the electronic Federal Select Agent Program (eFSAP) information system.  With this release, APHIS/CDC Form 1 now joins APHIS/CDC Forms 2-4 in providing registered entities the ability to complete all sections of the form 100% electronically in eFSAP.  We have also made enhancements to the eFSAP inspection module based on feedback from FSAP and entity users during the late 2018 pilot period.

Beginning January 31, 2019, authorized SAMS account holders at all registered entities will notice the following updates:

Additional APHIS/CDC Form 1 Amendment Types

Responsible Officials (ROs) and Alternate Responsible Officials (AROs) have the ability to perform the following Form 1 amendments directly in eFSAP:

• Section 3: Add, Remove, or Reactive select agents and toxins
• Section 4: Request Change of Responsible Official
• Section 6: Add, Remove, or Modify Buildings
• Section 6: Add, Remove, or Modify Laboratory Rooms and Suites
• Section 7: Add, Remove, or Modify work objectives

In preparation for these new amendment types, in November 2018 FSAP staff began migrating entities’ Form 1 Sections 7a and 7c data to a new format.  Entities were asked to verify that the data was migrated correctly by the end of December 2018.  FSAP would like to thank the majority of entities who completed this verification and encourage those few entities that have not yet verified their data to do so as soon as possible. To make use of the new electronic amendment types listed above, verification of the new Form 1 section 7a and 7c is required.

Inspection Module version 1.1

In late August 2018, FSAP released the first version of a new, interactive, electronic inspection module in eFSAP.  From September – December, 2018, FSAP employed limited use of the inspection module during an initial pilot phase.  Based on feedback from FSAP inspectors and entities participating in the pilot, additional features and refinements have been implemented.  The following is the full list of features entities will now experience:

• Entities have awareness regarding the inspection team and inspection focus as soon as FSAP staffs the inspection and generates checklists for the inspection.
• Entities have the ability to respond to inspection findings on an individual basis as time and resources permit.
• The inspection resolution page (inspection report) contains toggle filters allowing quick navigation to inspection findings based on their status (open vs. closed) and type (departure, general concern, request for information, etc.)
• Directly through the inspection module, FSAP has the ability to close inspection findings or ask for additional information.
• Entities have the ability to print their inspection findings with or without all correspondence with FSAP regarding the inspection findings.
• eFSAP generates automated entity notifications regarding the following inspection-related events: when inspections are scheduled, as inspection findings are released for entity review, any time there is correspondence to or from FSAP regarding resolution of inspection findings, and upon closeout of each finding.

In addition to the major features listed above, eFSAP users will also notice the following minor enhancements:

• Users will be notified when trying to upload a file with a title containing special characters incompatible with eFSAP (e.g., ~, #, &, ?, +)
• The Help and Support Section at the bottom of every page of eFSAP now contains a direct link to the eFSAP resource center.
• Entities are able to request a change of their lead regulatory agency (HHS vs. USDA) in a manner similar to how they currently request a renewal of their registration

For more information, please review the tutorials with screenshots of the new features attachedpdf icon to this message.  Entities are also encouraged to sign up for our upcoming webinars covering the new APHIS/CDC Form 1 amendment types and the eFSAP inspection module. To register for these webinars, please visit the Training Registration 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.

This information concerns those individuals whose Federal Select Agent Program (FSAP) approval to access select agents and toxins had an expiration date falling within or shortly after the Federal Bureau of Investigation’s Criminal Justice Information Services Division (CJIS) partial government shutdown period.

The furloughed CJIS employees who process security risk assessments have resumed normal operations.  During the 20 day shutdown for these employees, CJIS continued to receive FD-961 Forms and fingerprint cards for security risk assessments.  To address the renewal of FSAP access approvals associated with the backlog in the processing of security risk assessments created by the 20 day shutdown period, FSAP has determined that all personnel with current access approval whose FD-961 has been received by CJIS will remain approved for a period of 60 days (unless that person is identified by CJIS as a “restricted person”) to allow CJIS sufficient time to process these renewal security risk assessments and FSAP to process access approvals.

If you have any questions, please contact sra.cdc@leo.gov.

Due to the absence of either an FY 2019 appropriation or Continuing Resolution for the Department of Agriculture, the Agriculture Select Agent Services is unable to accept any packages mailed to:

Animal and Plant Health Inspection Service
Agriculture Select Agent Services
4700 River Road, Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737

Information can be submitted through fax: 301-734-3652, email: AgSAS@usda.gov, or submission through eFSAP.

Due to the absence of either an FY 2019 appropriation or Continuing Resolution for the Department of Justice that affected the Federal Bureau of Investigation’s Criminal Justice Information Services Division (CJIS), the Federal Select Agent Program (FSAP) has determined that all personnel whose access approval expires during the shutdown will remain approved. After the resolution of the shutdown, FSAP will notify entities of the revised access approval expiration date through eFSAP.

Entities should continue to submit renewal documents to CJIS.  Please email documentation to fd961@leo.gov and sra.cdc@leo.gov. For new applications, please mail document to CJIS at:

Bioterrorism Security Risk Assessment Group E-3
CJIS Division
1000 Custer Hollow Road
Clarksburg, WV 26306-0002

Do not mail or email documents directly to FSAP. CJIS will start processing security risk assessments after the resolution of the shutdown.

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.

If you have any questions, please contact sra.cdc@leo.gov.