Response to Biohazard / Recombinant DNA Incidents
To ensure timely and appropriate follow-up and to comply with federal reporting requirements, Principal Investigators shall report exposures and releases involving biohazards and recombinant DNA materials as well as violations of the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) to the University Biological Safety Officer (BSO).
This policy defines immediate follow-up and reporting requirements for biohazard and recombinant DNA incidents. Detailed procedures on response to spills and exposures can also be found on the EHS Website.
A. Personnel Exposures
Needlesticks or other percutaneous injuries from a contaminated sharp item; splashes to mucous membranes (eyes, nose, mouth) or bites/scratches from animals that have been exposed to biohazards or any recombinant DNA material, whether or not the exposure leads to illness.
Immediate Response :
To the SKIN: Immediately remove contaminated clothing and wash the contaminated area with soap and water for 15 minutes.
To the EYES: Flush the eye with water for at least 15 minutes at an eyewash or faucet. Remove contact lenses while flushing the eyes.
If transport assistance is needed or injury requires emergency treatment, contact the Department of Public Safety (DPS) at 911 from a University phone or 609 258 3333 from a cell phone.
Weekday, daytime hours: Seek treatment at University Health Services. Ask a co-worker to call ahead (609 258 5035).
After hours, evenings, and weekends: For exposures to biosafety level 2 agents, including recombinant DNA material, contact DPS and request transport to the Emergency Department at the University Medical Center of Princeton. For exposures to biosafety level 1 materials, follow up with UHS on the next business day.
Report exposures and/or suspected illnesses associated with biohazards and any recombinant DNA within 8 hours to the BSO.
The BSO investigates the report and notifies the IBC Chair.
a. For events that do not involve recombinant DNA material, the BSO conducts an investigation and prepares a report for the Principal Investigator.
b. If the IBC Chair and BSO determine that the incident involves (non-exempt) recombinant DNA, an incident summary will be sent to the NIH Office of Biotechnology Activities within 24 hours. The Dean for Research will also receive a copy of the incident summary.
c. The BSO will prepare a detailed incident report for review by the IBC Chair, with a copy to the Research Integrity and Assurance IBC Administrator.
d. After review by the IBC Chair, the report will be sent by the BSO to NIH OBA within 30 days of notification of the incident.
B. Spills and/or release to the environment of recombinant DNA or biosafety level 2 material
Significant spill or release of biosafety level 2 or any recombinant DNA materials outside of containment equipment; theft, loss or release of biosafety level 2 or any recombinant DNA materials to the environment, including escape of a transgenic animal.
See attachment 1 for guidance on response to spills.
Notify the BSO within 24 hours via email or phone if not already contacted for assistance with spill-clean up.
a. If the event involved (non exempt) recombinant DNA, the BSO will prepare a report for review by the IBC Chair and RIA IBC administrator. The report will be sent to the NIH OBA within 30 days of initial notification to the BSO.
b. For events that do not involve recombinant DNA, the BSO will compile a report for the Principal Investigator.
C. Use of Recombinant DNA without Approval from the IBC
Research with recombinant DNA as described in Sections III-A, B, C and D of the NIH Guidelines must be approved by the IBC prior to initiation. Failure to obtain IBC approval prior to initiation of this type of research must be reported to the BSO within 24 hours.
BSO will prepare a detailed report for review by the IBC Chair and RIA IBC administrator. The report will be sent to the NIH OBA within 30 days.
(After hours, the BSO can be contacted through the Department of Public Safety.)