What’s New: 2019

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 Summary [PDF – 802 KB].

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 report [PDF – 802 KB].

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.

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) 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 Store
  • On your Apple device through the App Store: App Store
  • On your Windows device through the Microsoft Store: Microsoft Store

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 the Checklist App.

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. The infographics cover 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