Press Release

#SubOversight Reviews Oversight Concerns of Federal Select Agent Program


WASHINGTON, DC – The Subcommittee on Oversight and Investigations, today held a hearing examining continued concerns over the Federal Select Agent Program’s oversight of dangerous pathogens. The program is jointly managed by the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA).

#SubOversight members received an update from Dr. Mary Denigan-Macauley, Acting Director, Health Care, Government Accountability Office (GAO), about a new report from the agency out earlier this week which raised several concerns about the program’s oversight.

Dr. Denigan-Macauley discussed the report, saying, “The Select Agent Program does not fully meet key elements of effective oversight. In particular, the program has oversight shortcomings related to each of our five key elements: independence, performing reviews, technical expertise, transparency, and enforcement.” Dr. Denigan-Macauley also stressed that the program does not currently have a joint strategic plan and workforce plan, but noted that it did take some steps to develop a strategic plan over the summer.

Energy and Commerce Committee Chairman Greg Walden (R-OR) highlighted the committee’s long history of oversight over the program, saying, “In recent years, this subcommittee held hearings on several safety lapses at federal labs that potentially exposed federal personnel and other individuals to hazardous biological agents. While the executive branch has taken several steps to improve lab safety since these lapses were detected, the GAO’s report on the Federal Select Agent Program oversight of dangerous pathogens shows that there are fundamental problems that have not been addressed by reactive, short-term responses.”

Dr. Freeda E. Isaac, Director, Agriculture Select Agent Services, Animal and Plant Health Inspection Service (APHIS), spoke to how USDA is responding to GAO’s recommendations, saying, “We agree that the independence of the select agent program is important, and think that minimizing any potential conflicts of interest with USDA laboratories is essential. In practice, I regularly meet with the APHIS Administrator’s office to provide updates on the select agent program major activities, enforcement actions, and overall administration of the program. We are developing a document that will formally outline this relationship.”

Additionally, Dr. Samuel S. Edwin, Director, Division of Select Agents and Toxins (DSAT), Centers for Disease Control and Prevention (CDC), stated, “I would like to acknowledge the important contribution that the GAO’s continued engagement and recommendations for FSAP have made in our work to improve the program. DSAT accepts and will implement all of GAO’s recommendations in its current report.”

#SubOversight Vice Chairman Morgan Griffith (R-VA) spoke to some of GAO’s concerns, saying, “This program at its inception was created in a fragmented state – a marriage of two subcabinet agencies in different cabinet departments. The program was created with a security emphasis of guards, guns, gates in response to terrorist attacks. Fifteen years later, does this regulatory model for bioresearch laboratories make the most sense with more concern about biosafety and the growing public health threat of emerging infectious diseases?”

For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE.


Press Release