Document text
Principal Investigator: Kevin Michael Tuohey
Organization: BOSTON UNIVERSITY MEDICAL CAMPUS
Fiscal Year: 2024
Award: $1,953,496
Funding agency: National Institute of Allergy and Infectious Diseases
Core 3: Environmental Health and Biosafety Regulations and Requirements
Abstract
The Environmental Health and Biosafety Regulations and Requirements (EHBRR) Core includes three
components: Environmental Health and Safety, Emergency Management, and Occupational Medicine. The
Core is integrated with campus-wide services under the direction of the Office of Research Compliance (ORC).
The role of the EHBRR Core at the NEIDL is to provide for and ensure the health, safety and preparedness of
all personnel who work at and support the NEIDL's BSL4 facility, and in this manner all who work within the
building. These responsibilities are carried out in a coordinated and collaborative manner starting with the initial
application for NEIDL employment or assignment, and continuing throughout the duration of work in the
NEIDL. The EHBRR Core includes the Chief Safety Officer, Responsible Official, Occupational Health Officer,
and the BSL-4 Biosafety Officer. EHBRR, as part of the BU Office of Research Compliance utilities the
expertise of the University Chemical Hygiene Officer, Chemical Safety Officer, Environmental Manager,
Radiation Safety Officer, Chief Medical Physicist and others. EHBRR oversees the NEIDL Personnel Suitability
and Reliability Program (PSRP) addressing initial and annual clearances and chairs the Personnel Suitability
Review Team. Once individuals are cleared for entry into the NEIDL, EHBRR provides or coordinates initial
and ongoing competency-based training including NEIDL orientation, lab safety, CPR, select agents, insider
threat, agent/lab/equipment specific information and response to emergencies. EHBRR manages emergency
response planning, exercises, after-action reports and correction action plans. The BSL-4 Biosafety Officer
chairs the BSL-4 NEIDL Training Advisory Committee tasked with ensuring that those entering BSL-4 labs are
prepared to do so. EHBRR coordinates, manages and documents inventory audits with the Laboratory
Manager and the Principal Investigator and conducts follow up investigations and reporting if necessary. The
core is responsible for all aspects of safety within the BSL-4 laboratories including the testing and verification
of biocontainment systems in coordination with the Facilities Core, the decontamination of equipment and
space and the management of certifications. EHBRR does so using contracted services when unable to do so
directly. EHBRR manages compliance with the Centers for Disease Control and Surveillance (CDC) Select
Agent Program and the Boston Public Health Commission (BPHC) BSL-4 Laboratory Regulations. These
responsibilities include registration/permitting activities, maintenance of records and oversight of administrative
actions required to maintain compliance. EHBRR coordinates closely with Principal Investigators on proposed
work plans prior to submission to the Institutional Biosafety Committee (IBC).
Terms: <Active Follow-up><Address><Advisory Committees><Area><BSL-4 facility><BSL4 facility><Boston><Budgets><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Certification><Chemicals><Collaborations><Competence><Contract Services><Core Facility><Decontamination><Development><Disease Surveillance><Emergencies><Emergency Situation><Emergency response><Emerging Communicable Diseases><Emerging Infectious Diseases><Employment><Ensure><Environmental Health><Environmental Health Science><Equipment><Equipment and supply inventories><Exercise><Health><Human Resources><Hygiene><Individual><Industrial Medicine><Infectious Diseases / Laboratory><Infectious Diseases Research><Institution><Inventory><Investigation><Laboratories><Leadership><Maintenance><Manpower><Medical><Medical Surveillance><Monitor><Occupational Health><Occupational Medicine><Occupational or Industrial Medicine><Preparedness><Principal Investigator><Process><Professional Organizations><Public Health><Radiation><Readiness><Records><Regulation><Regulatory Affairs><Reporting><Research><Research Resources><Resources><Role><Safety><Services><System><Task Forces><Testing><Training><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><Universities><Work><active followup><advisory team><biosafety level 4 facility><chemical safety><developmental><exercise program><fitness program><follow up><follow-up><followed up><followup><hazard><institutional biosafety committee><operation><operations><personnel><professional association><professional membership><professional society><programs><response><social role>