Today, Senator Richard Burr (R-NC), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a new report with recommendations for strengthening the safety and security of biomedical research laboratories as we continue to build on the lessons learned from the COVID-19 pandemic and historical biosafety lapses.
“The COVID-19 pandemic, recent Ebola outbreaks, and advances in synthetic biology capabilities all demonstrate the ever-evolving landscape of biological threats and the urgent need to prepare for them, and have renewed Congressional and public interest in regulations regarding high-containment laboratories,” the report states. “Carefully conducted research is necessary to understand and combat these types of threats… Conducting research without effectively understanding and addressing the risks, however, can pose a threat to public health and safety. Gaps in policies and protocols and the lack of a strategic and measured approach to laboratory practices can lead to devastating results.”
The report concludes, “It is imperative for national health security that we address compliance challenges within [the Federal Select Agent Program], improve the culture of responsibility, including among federal laboratories, and take steps to resolve outstanding biosafety and biosecurity challenges.”
The policy brief, titled “Strengthening the Safety and Security of Laboratories,” is the fifth in a series released by the Ranking Member on the federal government’s continued pandemic response. The first installment, titled “Modernizing CDC: Ensuring a Strategic Approach and Improving Accountability,” was released in May 2021. The second paper, titled “Reforming and Strengthening ASPR: Ensuring Specialized Capabilities, Sufficient Capacity, and Specific Authorities to Meet the 21st Century Public Health Security Threats,” was released in June 2021. The third paper, titled “Preparing for Future Health Threats: Improving and Sustaining Foundational Public Health Capabilities in Response to COVID-19,” was released in July 2021, and the fourth paper titled “Strengthening FDA’s Regulatory Readiness: Implementing Lessons Learned from the COVID-19 Pandemic,” was released in September 2021.
The policy brief, “Strengthening the Safety and Security of Laboratories,” examines the gaps in the biosafety and biosecurity framework and recommends steps to ensure our nation has the capabilities to continue to be the leader in biomedical research and innovation for years to come.
Specifically, the report includes the following recommendations.
· Eliminate gaps in the biosafety and biosecurity frameworks: Modernize the Federal Select Agent Program to address current gaps and evolve with scientific progress, while appropriately balancing support for innovation and the research enterprise and taking steps to mitigate risks.
· Ensure appropriate risk categorization of research: Ensure the definition for research involving enhanced potential pandemic pathogens fully captures the entirety of relevant research and provide ongoing training to ensure such research is appropriately considered under the P3CO framework. Designate an entity that has strategic insight into policies related to such research across departments to consider any such applications.
· Improve the oversight of high-containment laboratories: Establish a federal strategy for the management of government-owned, high-containment laboratories to ensure appropriate oversight.
· End the culture of complacency: Improve training for both program officers and researchers so they can understand, account for, and appropriately manage and mitigate biosafety and biosecurity risks.
To read the full policy brief, click here.