Authors: Kalpana Rengarajan, PhD & Rashida Moore DVM DCLAM
The Environmental Health and Safety Office (EHSO) is working on Centers for Disease Control and Prevention (CDC) and National Institute of Health (NIH) driven initiatives including downgrading of biocontainment requirements for SARS CoV-2 work and new guidelines for Dual Use Research of Concern. Also included is a brief description of the EHSO laboratory safety assessment program which is foundational to the research safety program. Please direct questions on these matters to biosafe@emory.edu.
SARS CoV- 2 Research
In May 2020, the Centers for Disease Control and Prevention (CDC) issued Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019. The guidelines indicated that COVID-19 samples should be handled in Biosafety Level 3 (BSL-3) facilities, given the COVID-19 outbreak at the time, the unknown properties of SARS-CoV-2, and the data available at that time. Following CDC’s issuance of its Interim Guidelines, the National Institutes of Health (NIH) Office of Science Policy (OSP) issued companion guidance to align with CDC’s assessment. The NIH Interim Guidance stated that “SARS-CoV-2 best meets the definition of a Risk Group (RG) 3 agent and Institutional Biosafety Committees (IBCs) should consider the agent to be RG3 as a starting point in their risk assessments when reviewing research subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).” Over the course of the last several years, researchers, biosafety professionals, and biosecurity experts have continued to monitor the scientific landscape as it has evolved.
An interagency working group reviewed updated information about the virus, population immunity and the availability of medical countermeasures to culminate in a scientifically rigorous and extensive re-evaluation to determine if the elevated handling criteria should remain in place. Informed by the assessment of that group, the CDC has rescinded their interim elevated BSL-3 guidance, and to align, the NIH has rescinded the interim RG classification. As such, IBCs should consider the agent to be RG2 as a starting point in their risk assessments when reviewing research subject to the NIH Guidelines. Concurrently, NIH is releasing these biosafety considerations for the community.
Based on the above guidance, SARS CoV-2 viral work has been downgraded to be handled at Biosafety Level 2 (BSL-2), after performing risk assessments. Emory’s Institutional Biosafety Committee (IBC) has approved new guidelines on handling of SARS CoV-2 at BSL2/ABSL2 enhanced which will be posted soon on www.ehso.emory.edu.
Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) Policy
January 10, 2025, the National Institutes of Health (NIH) released a notice to provide researchers and research institutions funded by NIH grants and cooperative agreements, Research and Development (R&D) contracts, NIH intramural research projects, and other funding agreements (e.g., Other Transactions) with information pertaining to NIH’s implementation of the US Government policy on oversight of DURC/PEPP Policy. This policy becomes effective May 6, 2025.
For competing grant and cooperative agreement applications, the NIH will request applicable DURC/PEPP materials to be provided as part of Just-in-Time (JIT) materials submitted on or after May 6, 2025. DURC/PEPP materials must be submitted by the Authorized Organizational Representative (AOR). Active grants and cooperative agreements will require applicable DURC/PEPP materials to be provided as part of any non-competing applications, including Research Performance Progress Reports (RPPRs), due on or after May 6, 2025. Non-competing applications that include DURC/PEPP materials must be submitted by an AOR.
At this time the Environmental Health and Safety Office is working through the Institutional Biosafety Committee (IBC)/ Institutional Review Entity (IRE) to provide guidance and assist researchers in following the NIH guidelines.
Research Safety Laboratory Assessments:
Laboratory assessments are foundational to a robust laboratory safety program. The assessment program serves as a tool to provide a safe working environment, identify and correct hazards, and to educate our research community about laboratory safety.
When an EHSO laboratory assessment is to be conducted Principal Investigators and lab contact(s) receive an email directly from their EHSO Research Safety representative (building liaison). The Research Safety representative contacts the lab to schedule the in-person visit.
Before the in-person assessment labs are provided information to prepare for their EHSO Lab Assessment, including instructions to conduct a Laboratory Self-Inspection (LSI). A link to the LSI is provided.
EHSO documents the lab assessments (inspections) in a new electronic platform, EHS Assist. In this platform laboratory staff will be able to directly see and respond to any findings that are identified during the inspection of their laboratory spaces. If findings are identified during the assessment, a report (pdf) will be generated and sent via SciShield. In this communication, instructions are provided for how to log in and respond with photos and descriptions of their corrective action in the new system (EHS Assist).
EHSO Research safety conducts inspections on a quarterly basis by selecting a specific department each quarter. On average, 30-35 inspections are completed per quarter.