Attachment

DRAFT, PRE-DECISIONAL 3. Does RML have collaborations with Wuhan Institute of Virology? No, RML scientists do not and have never collaborated directly with WIV scientists. Commented [NIH6]: NIAID - please see comment above. 4, Why does RML use bats for research on risky pathogens? NIH 2023-11-27 12:38:00 RML has a long history of studying emerging infectious diseases. RML has been using Commented [SS([7R6]: To OLPA: NIAID can bats in research for at least 50 years. Some of the work using bats at RML sve condi the sateen Ween ext : : : : F affiliations of individual scientists prior to, or included studies on rabies and MERS-CoV. Coronaviruses (CoV) are a large family of seer reotiraieiaste aie are AEN viruses. They are primarily respiratory viruses and are responsible for many common Sear athies coraauiaents GE NIH lave ranided colds. They have also been the cause of three very-seriousrecent serious and deadly and grants directly to WIV in the past. seeent-outbreaks or pandemics: the 2003 SARS-1 pandemic (SARS-CoV-1), the 2013 Selgrade, Sara (NIH/NIAID) [E] MERS outbreak (MERS-CoV), and the 2019 COVID-19 pandemic (SARS-CoV-2). CoV 2023-11-29 08:12:00 often use bats as a reservoir. The emergence of SARS-CoV-1 and MERS-CoV, spurred great interest in improving the NIH's understanding of the diversity CoVs. Since CoV are considered to be among the likely pathogens to cause future pandemics, it is imperative to study bat CoV for their potential to cause current and future pandemics. Because of the interest in CoV, RML scientists decided to study WIV-1 to see if it grew well in the bats and if the bats shed the virus. In other words, the research was to determine if WIV-1 had potential to spread to people-and-be-e-potential pandemic patheges. RML scientists collaborated with UNC scientists to obtain the WIV-1 virus. constructed in the UNC lab. from them . The experiments were done at RML's BSL-4 facility. It is important to note that- WIV-1 is not a human pathogen and is not a progenitor of SARS-CoV-2. Fhe Further, the RML study demonstrated that WIV-1 did not grow well in bats and that the bats did not shed the virus. quite different from what turned out to be the case for SARS-CoV-2 - The work was done in 2016 and published in 2018 in PNASViruses. 5. What safety measures are in place to protect this research? RML constructed a BSL-4 facility andbegen-using-itin 2008 and began using it in 20098. BSL-4 facilities are the safest and most strictly regulated infectious disease facilities for high consequence pathogens. They have the highest levels of scrutiny on research, safety, security, and personnel reliability. These facilities meet the requirements outlined in national guidelines and regulations. such as the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6" edition. the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. and the Select Agent regulations. These facilities are inspected annually by extemal agencies. such as the Federal Select Agent Program (FSAP) and the Association for Assessment and Acereditation of Laboratory Animal Care (AAALAC). to ensure compliance with federal regulations and industry standards. Additionally. all research involving recombinant DNA and those studies conducted at high and maximum containment (BSL-3 and BSL-4)