What’s New: 2018

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.

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.

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/2018-20694.

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.

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 Summary.

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 here).

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.

• 2/02/18 – Change in Leadership at the Agriculture Select Agent Services (AgSAS)

The Federal Select Agent Program would like to announce a change in leadership at the Agriculture Select Agent Services (AgSAS). On Monday, February 5, 2018, Dr. Freeda Isaac will leave AgSAS to become the Executive Director of National Import Export Services, under Animal and Plant Health Inspection Service’s (APHIS) Veterinary Services.

Also effective on February 5, Dr. Keith Wiggins will become AgSAS’ Acting National Director. Before this assignment, Dr. Wiggins served as the Associate National Director of AgSAS. Dr. Wiggins began his APHIS career in 2005. Throughout the last 13 years has served in leadership roles from enforcing regulations for the import of animal products and by-products to mitigate the introduction of foreign animal diseases, to ensuring that agricultural viruses, bacteria, and toxins are safeguarded to prevent agro-bioterrorism and public health threats. Prior to joining APHIS, Dr. Wiggins practiced veterinary medicine in North Carolina, was a Regional Veterinarian for Hill’s Pet Nutrition, and taught college courses at Livingstone College, the College of Southern Maryland, and Prince George’s Community College. Dr. Wiggins holds a Doctorate in Veterinary Medicine from Tuskegee University. He served as a Missile Launch Officer in the United States Air Force, and is currently serving as a Chief Public Health Officer in the New Jersey Air National Guard.