Who is responsible for biosafety?

The Institutional Biosafety Committee (IBC) is comprised of the following representatives:

• The Syracuse University Biosafety Officer
• The Health Services Medical Director
• Faculty and staff representatives from laboratories and departments conducting research involving infectious material and/or recombinant DNA
• Two non-affiliated members
• The Director of the Office Research Integrity and Protection Services (non-voting)
• The Director of the Environmental Health and Safety Services (non-voting)
• Ad hoc consultants, as necessary, to review research outside the expertise of current members

(i) Responsibilities: Link

The IBC is responsible for:

1. Reviewing applications and authorizing research involving recombinant DNA (rDNA) to determine whether the facilities, procedures, and practices meet applicable and related requirements;
2. Ensuring that all personnel who work with biological agents or who may receive a workplace exposure to biological agents have sufficient training and/or experience to enable them to perform their duties safely and in accordance with CDC/NIH guidelines and the conditions set forth by this Program;
3. Ensuring that all possession and use of human pathogens, select agents and toxins at Syracuse University is in compliance with applicable regulations, in accordance with CDC/NIH guidelines, and meets the conditions set forth by this Program;
4. Reviewing activities and developing policies associated with biological agents that pose a potential hazard to personnel or the environment.

(ii) Duties: Link

The IBC shall:

1. Review rDNA research conducted at or sponsored by Syracuse University for compliance with the NIH Guidelines.
2. Report any significant problems with or violations of the NIH Guidelines and any significant research related accidents or illnesses to the appropriate institutional official and NIH/OBA within 30 days of incident.
3. File the appropriate reports with the NIH, CDC, APHIS, and FBI in a timely manner.
4. Be familiar with CDC/NIH guidelines and related regulations regarding the possession and use of Select Agents/Toxins and rDNA, the terms of the Biological Safety Program, and any information submitted in support of requests for the use of Select Agents on campus.
5. Review the training and experience of all individuals who will use Select Agents and Biosafety Level 2 or higher material, and determine that their qualifications are sufficient to enable them to perform their duties safely and in accordance with applicable regulations, guidelines, and the conditions set forth by this Program.
6. Establish a program to ensure that all individuals (employees, students, visitors) whose activities may expose them to Select Agents/Toxins and Infectious Material are properly instructed in the inherent hazards, use, and access restrictions of those agents.
7. Review for approval, all protocols involving Select Agents, human pathogens and listed toxin research.
8. Review and approve the biosafety aspects of all research involving select agents and biological material that require work to be conducted at Biosafety Level 2 or higher.
9. Develop and implement policies as necessary to ensure that biological research and material use, storage, handling, etc. is conducted according to all applicable guidelines.
10. Periodically assess compliance of staff who maintain biological agents with the requirements of this Program.
11. Assess suspected or alleged violations of protocols, external regulations or University policies that involve biological safety activities.
12. Recommend and require remedial action to correct any violations of requirements identified in the Biological Safety Program.
13. Recommend, as necessary, and in consultation with medical personnel or public health professionals, a program of medical surveillance and enforcement. This shall include the collection of specimens from personnel engaged in a project, when applicable.
14. Review the entire Biological Safety Program at least annually to determine that activities are being conducted safely and in accordance with CDC/NIH guidelines and the conditions of this Program. The review shall include an examination of records, relevant reports from the Biosafety Officer, results of related inspections, written safety procedures and the adequacy of the University’s management control system over use, access and security of Select Agents.
15. Maintain written records of all IBC meetings, actions, decisions and recommendations.

(iii) Meetings: Link

1. The IBC shall meet as often as necessary to conduct its business, but not less than once in each calendar year.
2. A quorum shall consist of at least one ­half of the voting IBC’s membership, which must include the Biosafety Officer or designee.
3. All issues requiring IBC action will be approved or disapproved based on the majority opinion of all voting members of the IBC. Application for the use of Select Agents or Toxins shall be approved or disapproved based on the majority opinion of the technical members of the IBC only.

The Biosafety Officer is responsible for the following:

1. Biological laboratory inspections;
2. Reviewing research proposals;
3. Developing and implementing a University wide Biological Safety Program;
4. Providing general biosafety training
5. Coordinating IBC meetings;
6. Evaluating control measures as necessary;
7. Coordinating emergency response for biohazard spills;
8. Investigating associated laboratory accidents and incidents;
9. Conducting periodic program reviews as authorized by the IBC;
10. Maintaining an inventory of select agents, and biohazardous agents requiring Biosafety Level 2 facilities that are stored or used at the University;
11. Maintaining a database of facilities authorized to possess or use select agents or toxins;
12. Maintaining copies of select agent transfer forms (EA­101).

The Biosafety Officer has the authority to stop any experiment based on a hazard assessment of the experiment and associated procedures.

1.3 Deans, Directors and Department Heads Link

Deans, Directors and Department Heads responsibilities include: Ensuring departmental (including all entities within the department) compliance with all policies and procedures as outlined in this Program and as adopted by the IBC.

1.4 The Principal Investigator Link

The Principal Investigator (PI) of the laboratory is responsible for:

1. Ensuring compliance with all program requirements in all affected facilities, laboratories, etc. where biological agents of concern are used, handled, or stored;
2. Developing written Standard Operating Procedures that address the specific safety issues used in the laboratory to protect employees;
3. Arranging for immediate emergency response, if necessary, for biohazard spills, injuries and overexposures;
4. Instructing and training staff in the practices and techniques required to ensure safety, compliance, use of protocols, and accident procedures,
5.  Maintaining written documentation for all training activities;
6. Supervising the safety performance of the authorized staff to ensure that the required safety practices and techniques are employed;
7. Informing the staff of the reasons and provisions for any precautionary medical practices advised or requested, (i.e. vaccination, serum collection, medical examinations)
8. Investigating and reporting in writing (when applicable) to the Office of Biotechnology Activities (OBA), the Biosafety Officer, and the IBC any significant problems or incidents pertaining to the operation and implementation of containment practices and procedures;
9. Correcting conditions that may result in the release of biohazardous agents;
10. Ensuring the integrity of the physical containment (e.g. biological safety cabinets) and the biological containment (e.g. purity, genotypic and phenotypic characteristics);
11. Notify the IBC in writing of all rDNA research and experiments involving human pathogens;
12. Provide the IBC with a list of all biological organisms in your possession;
13. Obtaining and maintaining adequate facilities and equipment to facilitate the safe use, handling, and storage of biological agents;
14. Assuring the security of select agent use, handling and storage in your possession.

1.5 Laboratory Personnel Link

Laboratory personnel are required to:

1. Attend training prior to use, handling, or other activities with the potential for exposure to select agents or toxins;
2. Know the provisions of this Program and of the laboratory specific Standard Operating Procedures;
3. Report accidents, possible overexposures or unsafe conditions to their supervisor;
4. Use personal protective equipment and engineering controls when recommended and provided;
5. Conduct all related activities in accordance with the Biological Safety Program, applicable regulations, and guidelines.