The Biosafety Committee for the use of Genetically Modified Microorganisms

The Biosafety Committee is advisory to the Office of the Secretary, Rectorate, and operates within the Health and Safety Committee, at The University of Malta.

1. Purpose

The Biosafety Committee (BSC) is established to oversee and ensure the safe handling, containment, and management of research work involving Genetically Modified Microorganisms (GMMs) within The University of Malta.

The committee's primary goal is to protect human health, the environment, and comply with all relevant regulations and guidelines.

2. Scope

The Biosafety Committee shall oversee activities relating to the contained use of Genetically Modified Microorganisms, and compliance with local legislation, including but not limited to:

• Risk assessment and risk management of GMM research projects.
• Review and approval of GMM research proposals, including evaluation of containment Class level and measures.
• Development of policies and procedures related to the safe handling, storage, transportation, and disposal of GMMs.
• Monitoring and auditing of GMM research facilities to ensure compliance with biosafety regulations.
• Ensuring that the correct permit for each lab is in place according to the declared containment level as per Risk Assessment.
• Incident response and investigation related to GMM accidents or breaches.
• Liaison with regulatory agencies and compliance with applicable laws and guidelines.

3. Membership

The Biosafety Committee shall consist of members representing diverse expertise relevant to GMM research and biosafety and appointed by Secretary Rectorate at The University of Malta.

The Biosafety Committee conflict of interest policy precludes discussion by the committee member when it pertains to their own research projects or affiliated projects other than for clarifications when these arise. The committee member(s) involved in the project must abstain from the meeting during such discussions.

The chairperson, co-chairperson and committee members shall be appointed on an annual basis. Members whose terms are completed are eligible for re-appointment.

The Committee shall have an administrative support. All Committee members including the chairperson and co-chairperson are to be appointed by the chairperson of the Health and Safety Committee or delegate.

The chairperson may also appoint consultants to the Committee, as required (non-voting). The collective areas of expertise of members must cover the safe use of genetically modified microorganisms, and they should have a broad knowledge of  the research applications of such organisms. The chairperson may also invite ad hoc consultants as deemed necessary based on applications.

 Membership may include but is not limited to the following University personnel:

• Chairperson (Voting)
• Co-Chairperson (Voting)
• Biosafety Officer (Voting)
• Personnel managing and/or carrying out research in GMM laboratories (Voting)
• Personnel responsible for provision of technical support (Voting)
• Health and Safety Officer(s) (if different from the Biosafety Officer) (Voting)
• Administrative support

4. Responsibilities

The Biosafety Committee shall have the following responsibilities:

• Evaluate, review and approve risk assessments for proposed GMM research projects to confirm appropriate containment measures. The technical evaluation of the Risk Assessment will be performed by the members with expertise relevant to GMM research whilst the rest of the committee will have a supporting role to ensure compliance with the administrative and safety requirements.
• Develop and maintain standard operating procedures (SOPs) for safe handling, containment, and disposal of GMMs.
• Provide guidance to researchers and laboratory personnel on biosafety practices and procedures.
• Investigate and report incidents involving GMMs, including accidents, spills, or breaches of containment to the University Health and Safety Committee.
• Maintain records of all approved GMM research projects and incidents.
• Serve as a liaison between the institution and regulatory agencies regarding GMM research activities.

5. Meetings and decision making

The Biosafety Committee shall meet regularly, at least twice a year or whenever needed for matters of urgent nature to review research proposals, discuss safety issues, and make decisions regarding biosafety matters.

A quorum will be at one-third (1/3) of the members of the Biosafety Committee with dissenting votes noted in the minutes.

Decisions of the committee shall be made by consensus whenever possible. In cases where consensus cannot be reached, decisions may be made by a majority vote of the members present, with the chairperson having the deciding vote in the event of a tie.

Applicants for a biosafety registration or protocol may appeal a decision of the Biosafety Committee if the applicant believes there has been a procedural error.

The appeal must be filed in writing to the chairperson of the Biosafety Committee outlining the perceived process error within 15 working days of receipt of notification of decision from the Biosafety Committee. The chairperson of the Biosafety Committee will respond to the applicant in writing with a decision within 15 working days of receipt of the appeal.

If the applicant is not satisfied with the decision of the chairperson of the Biosafety Committee, the applicant will indicate this in writing to the Secretary, Rectorate office on behalf of the Health & Safety Committee within 15 working days of receiving the chairperson's decision.  This latter will consider the submission and respond to the applicant with a decision within 15 working days, which decision shall be final.

Decisions of the Biosafety Committee relating to operational, regulatory, environmental and health and safety considerations of the application or protocol may not be appealed and are final, subject to any recommendations or directives from ERA or other regulatory agency.

6. Reporting

The Biosafety Committee shall report its activities, decisions, and recommendations to the institution’s Health and Safety Committee once a year.

7. Review and Revision

These Terms of Reference shall be reviewed annually by the Biosafety Committee and revised as necessary to ensure their effectiveness and relevance to the institution's biosafety program.

8. Confidentiality

Members of the Biosafety Committee shall maintain confidentiality regarding sensitive information discussed during meetings, including research proposals, incidents, and personnel matters.

9. Amendment

These Terms of Reference may be amended by a majority vote of the Biosafety Committee members present at any regular meeting.

10. Effective Date

These Terms of Reference shall take effect upon approval by [Health & Safety Committee and shall remain in force until amended or revoked.