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(1) This Procedure is effective from 25 July 2024. (2) This Procedure sets out how the University ensures the safe use of regulated biological materials (RBMs) for research or teaching activities, in accordance with legislative requirements. (3) This Procedure applies to Deakin staff, students and associates who use RBMs for research and teaching activities, regardless of where the work is carried out, and to non-Deakin personnel who are either listed on a Deakin Biological Work Safety Assessment, Laboratory Biosafety Committee (LBC) Application or have a legitimate need to access Deakin-controlled biological containment facilities. (4) This Procedure is pursuant to the Research Conduct Policy. (5) The University is committed to meeting its responsibilities under the relevant legislation with respect to the safe handling, containment, and security of RBMs by: (6) Deakin will maintain a Biosafety Committee called the Laboratory Biosafety Committee (LBC) responsible for ensuring, on behalf of the University, that all activities relating to the use of RBMs are conducted in accordance with relevant legislation and Australian Standards. (7) The LBC will conduct business in accordance with the LBC terms of reference. (8) The Specialist, Biosafety and Biosecurity is authorised to report on biosafety and biosecurity matters and ensures that notifiable events and dealings are reported to regulators within legislated timeframes. (9) The Specialist, Biosafety and Biosecurity fulfils the requirements of a Biological Safety Officer as defined in AS/NZS2243.3:2022 and is responsible for Approved Arrangements under the Biosecurity Act 2015 (Cth). (10) The Specialist, Biosafety and Biosecurity is authorised to intervene (and if necessary, suspend work) on matters or activities that have the potential to adversely affect the health and safety of people or the environment and to ensure that work with RBMs proceeds in compliance with applicable legislation and LBC decisions. (11) The Deputy Vice-Chancellor Research and Innovation will submit an annual report to the Office of the Gene Technology Regulator to demonstrate that Deakin is meeting its obligations and responsibilities under Gene technology legislation and the Guidelines for Accreditation of Organisations. (12) Heads of Academic Units (or equivalent) are responsible for ensuring that biosafety and biosecurity requirements regulated by the LBC are implemented within their Academic Units and to monitor implementation of this Procedure. (13) Each Academic Unit that conducts work with RBMs should appoint a local area Biosafety Officer who is authorised to advise and report on biosafety and biosecurity matters. This person may be the Laboratory Manager or equivalent. (14) The Laboratory Manager (or equivalent role with overall responsibility for operation of the biological containment laboratory or facility), in conjunction with the local area Biosafety Officer is the co-ordinator of acquisition, registration, usage and disposal of RBMs and ensures records are kept in relation to these activities. (15) The Laboratory Manager is responsible for: (16) Staff and students who use RBMs for research or teaching, are responsible for being aware of and complying with relevant legislation, regulations, codes of practice, Australian Standards, LBC approved biosafety and biosecurity guidelines or procedural documents to achieve the highest standards of practice. (17) Researchers are responsible for obtaining all relevant internal or external approvals (including permits or licences) prior to commencement of work with RBMs (including GMO dealings), and ensure they meet the conditions of any approvals. (18) Researchers who are not directly involved in conducting research using RBMs but intend to be authors on a publication that requires LBC approval, must be satisfied that approval has been obtained and the research was conducted according to the applicable legislation and Deakin-specific requirements. (19) All staff, students and non-Deakin personnel listed on a Deakin LBC application, Biological Work Safety Assessment or who have a need to access a biological containment facility unsupervised, must first be approved as an Authorised Person by undertaking education and training, and competency assessment, in accordance with Deakin’s Biosafety Training requirements (See Deakin Biosafety and Biosecurity induction and training). (20) Personnel conducting Biosecurity Activities including the use of biosecurity-controlled materials or considered to be a ‘relevant associate’ of a biosecurity containment facility must complete a ‘Biosecurity Fit and Proper Person Test’ before being determined to be an Authorised Person approved to conduct Biosecurity Activities. (21) Personnel who intend to use RBMs for research or teaching purposes must complete a Work Safety Assessment: Biological Hazards form to identify and manage potential risks posed to the health and safety of people and the environment as well as the identification of any relevant approvals required prior to performing the proposed work (See Research and work safety assessments page) (22) The Work Safety Assessment: Biological Hazards form must be reviewed and approved by the local Biosafety Officer and Area Manager (this can be the same person). (23) All work involving RBMs or material likely to contain these (including Risk Group 2 Biological Agents) must be submitted for review and further approval by the Specialist, Biosafety and Biosecurity. (24) Advice from the LBC must be sought prior to the acquisition or handling (receipt, use or storage) of security sensitive, high risk biological agents or RBMs reasonably likely to contain these. (25) Work with RBMs must not commence prior to the receipt of written approval. (26) Personnel who intend to bring or transport biological materials into Australia, must seek advice from the Specialist, Biosafety and Biosecurity regarding the import conditions and whether a Biosecurity Import Permit is required, prior to importing the goods into Australia. (27) Staff and students must obtain approval from the LBC or an alternative appropriately constituted IBC before undertaking a dealing involving GMOs or the use of gene technology, by submitting the relevant application form (see Biosafety and biosecurity forms, guidelines and legislation). (28) Staff and students must first determine the type or class of dealing as Exempt, Notifiable Low Risk or Licenced Dealings (which include Dealings Not involving Intentional Release – DNIR or Dealings involving Intentional Release – DIR). (29) The LBC will confirm the classification of the ‘Dealing’ and determine if the risks associated with the project have been identified and managed. Work must not commence on a project prior to receiving written approval by Deakin’s LBC. (30) All Deakin project applications to work with GMOs must identify a Principal Investigator who is a paid member of staff at the University and has the ultimate responsibility for the safe and compliant use of the RBMs described in the project and for monitoring procedures. (31) The role of a Principal Investigator does not relieve the individual responsibility of each listed investigator who works with RBMs approved in the project application. (32) Staff and students who are listed on a project approved by an LBC at another institution within Australia, must submit a Notification of involvement in external project involving dealings with GMOs form and provide a copy of the IBC application approved by the other institution for noting by the LBC. (33) Requests for amendments to an approved LBC project must be submitted via ResearchPoint and approved prior to being implemented. (34) Principal Investigators must submit a Progress Report using the relevant form on request by the Deakin LBC. The LBC will review the report and decide whether the project may be continued, suspended, modified or discontinued. (35) Principal Investigators must submit a Final Report using the relevant form to the Deakin LBC: (36) Investigators must maintain records of RBMs used according to the Research Data Management Procedure and report any inventory changes to the local area Laboratory Manager (or equivalent). (37) The Laboratory Manager (or equivalent) maintains an inventory of RBMs for their area of responsibility and provides and reports to Deakin Biosafety annually or on request. (38) Research Ethics and Integrity maintains a central register of RBMs in use by University staff and students to manage compliance and provide relevant advice. (39) Projects conducted in countries other than Australia must comply with applicable international standards, guidelines as well as any country specific legislation. (40) Staff and students should discuss a proposal to use RBMs in another country with the Specialist, Biosafety and Biosecurity, to assist with compliance with international standards, guidelines and codes of practice. (41) External institutions may request to use Deakin’s Laboratory and Biosafety Committee for the review of their projects that use GMOs. Requests from an external institution to use Deakin’s LBC will only be considered if: (42) Where approval is granted to use Deakin’s LBC, a formal agreement between the external institution and Deakin must be developed in consultation with Deakin’s LBC and include (but not limited to) terms addressing matters described in the Guidelines for Accreditation of Organisations. (43) Incidents concerning the non-compliant use of RBMs will be managed in accordance with the process for allegations of non-compliance to LBC Approvals or Biosafety and Biosecurity Regulatory requirements (See Research Code Breach and Serious Research Code Breach website). (44) For the purpose of this Procedure:Biosafety and Biosecurity Procedure
Section 1 - Preamble
Section 2 - Purpose
Section 3 - Scope
Section 4 - Policy
Section 5 - Procedure
Laboratory Biosafety Committee
Specialist, Biosafety and Biosecurity
Related roles and responsibilities
Researcher Responsibility
Biosafety and Biosecurity Education and Training
Biosecurity Fit and Proper Person Test
Biological Work Safety Assessments
Importation of Biological Material
GMO project applications
External projects using RBMs at another institution within Australia
Amendments to an approved LBC project
GMO Project Reporting
Biological Materials Reporting
External projects using RBMs at another institution in a country other than Australia
External Institutions that use Deakin’s Laboratory and Biosafety Committee
Reporting of non-compliances concerning the use of RBMs
Section 6 - Definitions