1. INSTITUTIONAL BIOSAFETY COMMITTEES (IBC) under Biosafety Act 2007
DEPARTMENT OF BIOSAFETY
MINISTRY OF NATURAL RESOURCES & ENVIRONMENT
BIOSAFETY TRAINING WORKSHOP
17 august 2016
Universiti teknologi malaysia

2. OUTLINE Introduction to IBCs Responsibilities of IBC1
Introduction to IBCs 2
Responsibilities of IBC 3
Responsibilities of IBC Chair 4
Responsibilities of BSO 5
Scope of IBC Review 6
Compliance Oversight and Corrective Action
COMPULSORY

3. INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
Under Section 5(1) of Regulations
All organisations involved in research and development that deals with modern biotechnology shall establish an IBC
IBC is a formal expert committee of an organisation undertaking modern biotechnology research and development which involves use of any LMO/rDNA materials –
IBCs are registered with the National Biosafety Board (NBB)
Its function is to monitor & ensure compliance to the Biosafety Act at the institutional level and safe handling of modern biotechnology activities
COMPULSORY
Talking points:
Every organization that is involved in modern biotechnology research and development is required to set up an IBC.
This is a formal expert committee set up by the organization appointment by the management.
This committee is recognized and registered with the National Biosafety Board.

4. IBC RESPONSIBILITIES COMPULSORY Talking points:
1. Provide guidance for safe use of modern biotechnology
2. Monitor activities relating to modern biotechnology
3. Establish/ Monitor implementation of policies/ procedures
4. Determine BSL for facilities
COMPULSORY
Talking points:
Under the regulations, the IBC is has 4 main responsibilities, which are:
Providing guidance for safe use of modern biotechnology
Monitoring activities relating to modern biotechnology
Establishing and monitoring the implementation of policies and procedures for the purpose of handling LMOs
Determining the classes of Biosafety Levels for contained use activity for the purpose of modern biotechnology research and development undertaken within a facility where the IBC is established
Activities related to monitoring activities and establishing and implementation of policies and procedures often overlap.

5. IBC RESPONSIBILITIES
1. Provide guidance for safe use of Modern Biotechnology
Guidance – biosafety policies/issues, safety of lab
Assist in development of procedures
Notify PI of results of IBC’s review, approval or rejection of application
Advise PI on exempted activities
Establish an institutional system to ensure compliance to requirements of the Biosafety Act
2. Monitoring activities relating to Modern Biotechnology
Assess and monitor facilities, procedures, practices, training and expertise of personnel
Ensure information/documents provided in application form are complete
Recommend approval for activities that conform to Biosafety Act and Regulation 2010 & periodically review these projects
COMPULSORY
Talking points:
IBC provides guidance on the institutional biosafety policies, any other issues related to biosafety and lab and lab safety
IBC will also assist in developing proper SOPs for activities related to handling LMOs.
IBC will advise on whether the activity conducted by the PI is exempted under the Biosafety Act.
In addition, the IBC will also establish a working institutional system to ensure compliance.
Monitoring activities
IBC is required to assess and monitor facilities, procedures developed and provide continuous training as needed to the personnel
Review and assess and ensure that information and documents provided in the application form is complete and accurate.
Make a recommendation of approval for activities. Include any additional risk management strategies proposed.

6. IBC RESPONSIBILITIES
2. Monitoring activities relating to Modern Biotechnology (Cont’d)
Assess field experiments – RA, RM & ERP -sufficient
Adopt and implement ERP – accidental spills, personnel contamination, resulting from LMO research
Review and report to Head/NBB of non-compliance and significant research related accidents/illnesses,
Recommend action to be taken for non-compliance
3. Determine Biosafety Levels (BSL)
Set or modify containment level (BSL) for activity
COMPULSORY
Talking points:
Monitoring activities
IBC is required to assess field experiments – Risk assessment, risk management and emergency response plan and even visit the site in the process of assessment.
Adopt and implement the relevant Emergency Response Plan to address any accidental spill, personnel contamination from the LMO related activity.
Review and report to the Head/NBB any non compliance and significant research related accidents/illnesses
IBC will work together with the management by recommending actions to be taken for any non-compliance. IBC protects the institute from any non compliance to the Biosafety Act
Determine biosafety level
As the notification forms are submitted the IBC is to inspect and check the facility that is being used, to ensure that it fulfills the specification of the BSL required to conduct the said activity.
Classification of the facility is determined by the IBC, based on the Biosafety Guidelines for Contained Use Activities.

7. IBC CHAIR RESPONSIBILITIES
(1) Provides executive leadership, and
(2) Maintains ultimate responsibility for safe conduct of activities
Head of organization as IBC chair is required to:
Be aware of all requirements for Biosafety Act compliance
Provide leadership and support at management level
Determine that facilities are appropriate and safe for the research proposed
As necessary, appoint ad-hoc sub comm. for exemption activities
As necessary, appoint Rapid Response Team (RRT) to review hazardous incidents within 24 hrs of occurrence and immediately engage relevant parties
OPTIONAL
Talking Points:
The IBC Chair provides the ultimate executive leadership for the IBC set up and maintains responsibility for safe conduct of activities at the institute
IBC chair is required to:
Have awareness of all requirements for Biosafety Act compliance
Provide leadership and support at management level
Determine that facilities are appropriate and safe for the research proposed
Appoint ad-hoc sub comm. for Exemption activities to ensure a proper review to determine exempted activities
Appoint Rapid Response Team (RRT) to review hazardous incidents within 24 hrs of occurrence and immediately engage relevant parties – to work together with existing safety committees in the institute.

8. IBC CHAIR RESPONSIBILITIES
Ensure laboratory personnel receive appropriate training prior to the initiation of research projects,
Support the work/decisions of IBC in its charge to protect the organization and staff, reduce liability for the organization, and be good stewards of public trust in the products of biotechnology
Provide written notification of IBC decisions to PI
Ensure activity does not start before getting acknowledgement letter from DG of Biosafety
OPTIONAL
Talking Points:
Ensure laboratory personnel receive appropriate training prior to the initiation of research projects – provide necessary resources to enable training required
Support the work/decisions of IBC in its charge to protect the organization and staff, reduce liability for the organization, and be good stewards of public trust in the products of biotechnology, and
Provide written notification of IBC decisions to PI – decisions, request for additional information or additional conditions imposed should all be in written documentations
Ensure activity does not start before getting acknowledgement letter from DG of Biosafety – do not allow for any activity to start before getting acknowledgement from the DG of Biosafety

9. Biological Safety Officer (BSO) Responsibilities
Appointed by Head of organization
Member of IBC (voting member) and must be affiliated with the organization
Recommended to be permanent
Contact person for NBB & other regulatory agencies
OPTIONAL
Talking Points:
Appointed by Head of organization
Member of IBC (voting member) and must be affiliated with the organization (not contract staff or any personnel seconded to the organization)
Recommended to permanently hold this position, no rotation to retain institutional memory
Becomes the main contact person for NBB & other regulatory agencies

10. BSO Responsibilities (CONT’D)
Assists in assuring compliance to BA
Submits all applications (notification/ approval) and annual report of IBC on behalf of organization
Periodically inspects laboratories
Reports significant problems/non compliance/ research-related accidents or illnesses to IBC
Provides guidance in development of ERP-handling LMO/investigating incident
Makes recommendations to IBC on the BSL for activities
Works with Rapid Response Team (RRT) to provide technical advice on research safety and laboratory security procedures to PI, laboratory personnel and IBC
OPTIONAL
Talking Points:
Assists in assuring compliance to the Biosafety Act
Submitting all applications (notification/ approval) and annual report of IBC on behalf of organization
Periodically inspect laboratories that are involved in modern biotechnology work
Report significant problems/non compliance/ research-related accidents or illnesses to IBC
Provide guidance in development of ERP-handling LMO/investigating incident
Make recommendations to IBC on the BSL for activities and ensure that the facilities chosen for the said activity is suitable
Work with Rapid Response Team (RRT) to provide technical advice on research safety and laboratory security procedures to PI, laboratory personnel and IBC.

11. SCOPE OF IBC REVIEW LMO activity - Notifications/Approval
Modifications to Approved Projects
Project Extension Review of Approved Projects & Notice of Termination
Exemptions
Incidents and Personnel Exposure
Biosafety Manuals
Laboratory Inspections
COMPULSORY
Talking points:
As part of the responsibility of IBC to monitor modern biotechnology activities, there are 6 areas that IBC reviews which are:
LMO activities – through review of Notifications/Approval forms
Modifications to Approved Projects
Project Extension Review of Approved Projects & Notice of Termination
Exemptions
Incidents and Personnel Exposure
Biosafety Manuals
Laboratory Inspections

12. IBC REVIEW 1 - LMO activity – Notifications & ApprovalPI
Relevant NBB Form (A/B/E/)
IBC RA Matrix, SOPs, supporting documents
IBC
Req. Add. Info
Inspection report of premises
IBC Decision No
Yes
IBC approved NBB Form (A/B/E)
IBC Assessment Form (Annex2)
Inspection report (if any)
JBK
Notification
Approval for Field Experiment
COMPULSORY
Talking points:
This is a flow chart of the process of getting clearance from the National Biosafety Board to conduct modern biotechnology or field trials
An internal review by the IBC must be done before the PI can submit the application to the Department of Biosafety
PI to submit relevant NBB form, Risk Matrix, SOPs, supporting document for IBC review in the manner as determined by the internal institutional procedure
IBC should record outcome of review for proposed activity using the IBC assessment form (IBC/AP/13/Annex 2) and complete the IBC Assessment part in the Form
IBC may request additional information from the PI to ensure documentation is complete prior to approval from IBC and submission to JBK
IBC may conduct inspection of premises (if necessary) during the assessment and this report should be submitted together with the IBC assessment report
Estimated time period for the IBC to complete the review the notification/application of approval is XX days (it depends on each institute’s internal procedure).
NBB
Decision
Yes
Acknowledgement
NBB
Decision No
PI Commence Work
Yes
Certificate of Approval
PI Commerce Work & include any additional T&C from NBB
PI Commence Work

13. IBC REVIEW 1 - LMO activity – Notifications & Approval (cont’d)
3 IMPORTANT checkPOINTS TO ensure the notification/approval forms are complete PI
CHECK POINT 1 – BEFORE SUBMISSION OF APPLICATION BY PI
IBC
CHECKPOINT 2 – IBC REVIEW
IBC Decision
COMPULSORY
Talking points:
During the process of application of approval or notification, there are 3 important stages that a thorough review is required.
Checkpoint 1 is by the PI. The PI should diligently look through the guidance in filling up the form, answer all the questions in the form, seek any clarifications in filling up the form, refer to the Sample completed form and develop any related document for the submission.
Checkpoint 2 is the review by the IBC. Here the IBC is to check on the information provided by the PI, and request for additional information for any items lacking. If the IBC is not satisfied with the information provided, the IBC should continue to provide guidance to the PI to complete the information in the form prior to the IBC approval.
Checkpoint 3 is the final compilation of the odcumentations for submission. This can be carried out by the PI with the guidance of the BSO.
CHECKPOINT 3 – FINAL CHECK BY PI AND BSO
JBK

14. IBC REVIEW 1 - LMO activity – Notifications & Approval (cont’d)
CHECKPOINT 1 – BEFORE SUBMISSION OF APPLICATIONS BY PI PI
Ensure correct form and number of copies are submitted
2. Ensure all the correct supporting documents are included
3. IBC to record application of submission, case number, documentation of assessment in IBC minutes
4. Provide requested information by IBC promptly
COMPUSORY
Talking points:
It is the responsibility of the PI to consult the BSO and use the available guidance in filling up the relevant form.
Ensure that the correct version of the form is being used. Older versions of the forms that are submitted will be rejected by the Department of Biosafety.
Upon submission, IBC will record the application of submission for IBC for review, provide an institutional case number, and begin documentation of assessment via the IBC minutes.
Make sure that all the correct supporting documents are provided. This includes any literature to support the facts given, SOPs (that is finalized, not draft!), plasmid maps, and any other items required.
IBC

15. IBC REVIEW 1 - LMO activity – Notifications & Approval (cont’d)
CHECKPOINT 2 – IBC REVIEW
IBC
Agent characteristics
Project Objective, methodology, types of manipulations planned
3. Qualification of personnel
Categories of people authorized to handle project – Students? Technicians? Researchers?
Experience & expertise
Training and instruction
Health
Others
COMPULSORY
Talking points:
What is reviewed by the IBC?
1. Agent characteristics (e.g. virulence, pathogenicity, environmental stability) (if working with microbes)
2. Project objective(s), methodology, types of manipulations planned, Sources of the inserted DNA sequences (e.g. species), Nature of inserted DNA sequences, hosts and vectors to be used
3. Qualification of personnel – IBC will pay attention on whether the PI and the personnel involved are able to handle the activity safely.
IBC Decision

16. IBC REVIEW 1 - LMO activity – Notifications & Approval (cont’d)
CHECKPOINT 2 – IBC REVIEW (CONT’D)
4. Confirm validity and completeness of information provided by PI
5. Endorse time period proposed by PI to complete the activity
6. If it is inter-agency collaborative research, ensure that the partner IBC has endorsed use of their facilities
COMPULSORY
Talking points:
What is reviewed by the IBC?
4. Confirm validity and completeness of information provided by PI – check all supporting documents, SOP and matrix
5. Endorse time period proposed by PI to complete the activity, ensure that the activity cannot start until they receive acknowledgement from DG of JBK
6. If it is inter-agency collaborative research, ensure that the partner IBC has endorsed use of their facilities
IBC Decision

17. IBC REVIEW 1 - LMO activity – Notifications & Approval (cont’d)
CHECKPOINT 2 – IBC REVIEW (CONT’D)
IBC
7. Ensure that RA, RM and ERP of activity is sufficient
8. Ensure that facility is suitable for activity
MATCH
RA OF LMO ACTIVITY
Agent characteristics (e.g. virulence, pathogenicity, environmental stability), Project Objective, Methodology, Types of manipulations planned, Sources of the inserted DNA sequences (e.g. species), Nature of inserted DNA seq, hosts and vectors to be used, Qualification of personnel
PREMISES
Containment conditions to be implemented including RM and ERP as specified, SOPs, premise features and work practices
COMPULSORY
Talking points:
What is reviewed by the IBC?
7. Ensure that RA, RM and ERP of activity is sufficient. Make any additional recommendations to PI to be imposed to address any biosafety concerns. Ensure that the form is revised and the recommendation has already been incorporated.
8. Containment conditions to be implemented as according to the RA, RM and ERP as specified. Conduct an inspection to the premises to be used.
IBC Decision

18. IBC REVIEW 1 - LMO activity – Notifications & Approval (cont’d)
CHECKPOINT 3 – FINAL CHECK BY PI AND BSO BEFORE SUBMISSION TO JBK
IBC Decision
Provide IBC Assessment Report - IBC/AP/10/Annex2
Ensure form is in final version & complete
IBC Chair and Head to provide statutory declaration in Form and insert official stamp
Provide any premises inspection reports if necessary
4. Monitor progress of submission and any required response from JBK/GMAC/NBB to the PI
COMPULSORY
Talking points:
Provide IBC Assessment Report – IBC/AP/10/Annex2
Ensure form is final version and complete – all the recommended changes should be included, date of commencement of activity is logical, all documents included and CD contains final version soft copy of all documents submitted
IBC Chair and HOD to provide statutory declaration in Form and official stamp (in hardcopy as well a softcopy)
Provide any premises inspection reports if any
5. Monitor progress of submission and any required response from JBK/GMAC/NBB to the PI. Ensure PI responds promptly to any request for additional information
JBK/NBB

19. IBC REVIEW 1 - LMO activity – Notifications & Approval (cont’d)
CHECKPOINT 3 – FINAL CHECK BY PI AND BSO BEFORE SUBMISSION TO JBK (CONT’D)
USE THE CHECKLIST 1
1 original Form A/B/E 2
6 identical copies of the form 3
Supporting documents 4
CD with Form and supporting documents 5
IBC Assessment Report 6
Proof of payment
COMPULSORY
Talking points:
A checklist is provided in all the forms. Please use the checklist to ensure that nothing is forgotten.
Provide one original form
All 6 copies should be identical with the original. Ensure all info provided can be clearly read/seen
Any additional information must also be provided (soft copy as well as hard copy)
One CD containing the identical Form submitted as well as any supporting documents must be submitted. One CD for one application only.
An IBC Assessment Form must be included. Any inspection reports of the proposed field trial site should also be included (if any). Provide 1 original and 6 copies
Proof of payment for the application (applicable for field trial only)
8. PI and BSO are to take note of Acknowledgement letter and ref number issued by JBK. This will be JBK’s response for acceptance of the application or notification form.
After submission, JBK will provide Acknowledgement letter and issue reference number

20. Important note on sops submitted
OPTIONAL
Talking points:
The PI and the IBC is to ensure that activity specific SOPs in a proper SOP format should be provided.
SOPs are required to be provided for risk management of the activity for example disposal, transportation etc.
The SOPs should be in the final version and not a draft (needs clearance from the institute.) It is assumed that by approval through the institute, the SOPs have been evaluated and validated to assure that individuals can understand and physically accomplish the procedure and that all individuals are accomplishing the intended outcome of the SOP.
JBK can provide a template upon request, or the institute can use their own format for SOPs.
If using your own format, ensure that the SOP includes (a) the background/conditions for the SOP (b) the context and purpose for which the SOP is used (c) any other related SOPs that are needed to fulfill this SOP (d) specific procedure or actions to be taken (e) any documentations involved in conducting this SOP

21. Important note on ibc ASSESSMENT
Form E_IBC Assessment
Important note on ibc ASSESSMENT
Date of IBC assessment
OPTIONAL
Talking points:
There are two specific documents for IBC assessment, one is the IBC assessment in the Form itself and one more is the IBC assessment report (IBC/AP/13/Annex2)
If IBC assessment, it is mandatory to fill the form.
If the institute has it’s own format for IBC assessment report, it is ok. As long as it has the same assessment criteria as the template provided by the Department of Biosafety
The title of project is the same in both forms.
The date of IBC assessment should be the same in both forms.

22. Important note on ibc ASSESSMENT
IBC/AP/13/ANNEX 2
Important note on ibc ASSESSMENT
OPTIONAL (RELATED TO PREVIOUS SLIDE)
Talking points:
The date of IBC assessment should be the same in both forms.
Date of IBC assessment

23. IBC REVIEW 2 - MODIFICATIONS TO APPROVED PROJECTS
PI SHOULD NOT initiate or implement any significant change or modification to IBC approved projects without prior review and approval of the IBC and NBB
Modification refers to changes in LMO materials, procedures, personnel, laboratory location or any change which may increase/change Risk Group of the project or its BSL
COMPULSORY
Talking points:
PI should not initiate or implement any significant change or modification to IBC approved projects without prior review and approval from IBC and NBB
Modification refers to change in changes in LMO materials, procedures, personnel, laboratory location or any change which may increase/change Risk Group of the project or its BSL
If any modification in procedures is required, based on observation or any recommendations from incident investigation, IBC should assess the proposal and then submit the request to the Department of Biosafety for review.

24. IBC REVIEW 3 - PROJECT EXTENSION REVIEW OF APPROVED PROJECTS & NOTICE OF TERMINATION
PI should submit IBC Project Extension Review/ Notice of Termination Form (IBC/PE-NT/10/Annex 5) to extend time period of activity or report that activity has been completed/no longer active
Form should be submitted at least one month prior to the next scheduled IBC meeting
Notice of Termination should include description of when and how the LMO materials were disposed.
COMPUSORY
Talking points:
Near the end of the approved time period to run the activity, it is the responsibility of the PI to report back to the IBC whether the activity will be terminated or an extension of time is needed.
The PI is required to submit the IBC Project Extension Review/Notice of Termination Form (IBC/PE-NT/10/Annex 5) to the IBC for review.
This Form should be submitted at least one month prior to the next scheduled IBC meeting. It is the responsibility of the PI to take note of the IBC meeting schedule and initiate the submission of this form.
BSO should have continuous monitoring of all ongoing activities and remind any PI whose activity is near the end of the approved time period.
If the activity is terminated, a description of when and how the materials were disposed should be stated in the form.
If the materials are being kept for the next phase of the research, there should be clear documentation on how long it is being kept, at what volume, location and inventory and person in charge.
The BSO is responsible to ensure that the IBC Project Extension Review/Notice of Termination Form (IBC/PE-NT/10/Annex 5) is sent to the Department of Biosafety in a timely manner

25. IBC REVIEW 3 - PROJECT EXTENSION REVIEW OF APPROVED PROJECTS & NOTICE OF TERMINATION
If project extension involves the following changes, a New Notification should be submitted:
New PI,
New Risk Group,
BSL,
Type/amount of LMO,
Moving of LMO materials to another laboratory/facility.
COMPULSORY
Talking points:
A New Notification should be submitted If the project extension involves the following change – New PI, New Risk Group, Change of BSL, Type/amount of LMO handled, Moving of LMO materials to another laboratory/facility that was not initially approved as part of the premises for activity

26. IBC REVIEW 4 - EXEMPTIONS
IBCs should be notified of exempted projects using internal procedure
An ad hoc sub committee can review projects to verify the status of exemption
Techniques and contained use activities that are exempted are listed in First Schedule (Regulations 2010)
Exempted activities should be carried out under conditions of standard microbiological lab practice
Personnel should have appropriate training
COMPULSORY
Talking points:
IBCs should be notified of exempted projects using internal procedure
An ad hoc sub committee set up within the IBC can review projects to verify the status of exemption
Techniques and contained use activities that are exempted are listed in First Schedule (Regulations 2010). The Department of Biosafety may be consulted for any queries with regards to this.
Exempted activities should be carried out under conditions of standard microbiological lab practice
Personnel should have appropriate training
BSO will ensure that the IBC monitors these exempted activities and reports back to the Department of Biosafety through the Annual Reports.

27. IBC REVIEW 5 - INCIDENTS & PERSONNEL EXPOSURE
IBC to ensure Accident/Incident are reported
Review information provided through Incident Reporting Form (IBC/IR/10/Annex3) or/and Occupational Disease /Exposure Investigation Form (IBC/OD/10/Annex 4)
Discussions and actions pertaining to incident should be documented in minutes of IBC meeting
Accident/Incident should be reported to JBK through IBC annual report
NBB may request for detailed report if necessary
COMPULSORY
Talking points:
The IBC will ensure that all Accidents and Incidents are reported through an established internal reporting system. Near misses may be included as well for the purpose of developing any preventive steps and to help review existing procedures
A review will be done by the IBC by using the Incident Reporting Form (IBC/IR/10/Annex3) or/and Occupational Disease /Exposure Investigation Form (IBC/OD/10/Annex 4) – which ever is relevant. Relevant stakeholders such as the Occupational Safety and Health committee or other management personnel may be called to participate in the review.
Discussions and actions pertaining to incident should be documented in minutes of IBC meeting
Accident/Incident should also be reported to JBK through IBC annual report
NBB may request for detailed report if necessary

28. IBC REVIEW 6 – BIOSAFETY MANUALS
Collection of biosafety protocols and procedures (safety manuals) must be available in every laboratory
IBC will review these document during inspection
COMPUSORY
Talking points:
A collection of biosafety protocols and procedures must be available in every laboratory
It is the duty of the PI to ensure that proper documents are maintained in the laboratory and all the personnel who are involved in the activity should have access and understand these documents.
All personnel who are using the premises should be aware about the ERP of the LMO related activity being conducted in the facility
IBC is required to review these document during inspection

29. IBC REVIEW 7 – LABORATORY INSPECTIONS
IBC will conduct routine inspections and sometimes as part of assessment of proposed activity
Inspection checklists are provided in JBK website
Problems are reported to PI for remedial procedures. Inspection reports will be maintained on file by IBC
Routine inspection may also be conducted by representatives/officers authorized by NBB
COMPULSORY
Talking points:
IBC is required to conduct routine inspections and sometimes as part of assessment of proposed activity
Some examples of Inspection checklists are provided at the Department of Biosafety website
Problems are reported to PI for remedial procedures. Inspection reports will be maintained on file by IBC
Routine inspections may also be conducted by representatives/officers authorized by NBB

30. Compliance Oversight & Corrective Action
IBC may take the following actions:
Suspension of the use of LMO materials
Cessation of the approval for use of the LMO materials
Confiscation of the LMO materials
Destruction of the LMO materials
Any other action necessary to protect the public and/or the organization, including suspending the relevant research activity
Reporting to the NBB through JBK
COMPULSORY
Talking points:
As the IBC is appointed and authorized by the management, it may be empowered to take suitable actions to address non-compliance.
Types of actions include suspension, cessation, confiscation, destruction, or any other action necessary. These are subject to the approval at the institutional level.
These disciplinary actions should be reported to the Department of Biosafety. Proper documentations on termination of the Notification should be followed even if corrective actions are already in place.

31. Compliance Oversight & Corrective Action (cont’d)
PI has to be take the following actions to prevent any non compliance:
Comply with all legislative requirements when conducting research involving LMO materials
Immediately report any significant problems with respect to the implementation of relevant laws, regulations and guidelines
Notify IBC promptly of any significant research related accidents that have resulted or could result in human illness, in unanticipated plant or animal disease, or in the unintended release of an organism under study from an intended confinement
Complete required training as specified
COMPULSORY
Talking points:
The PI has to be responsible to do the following to prevent any non compliance to the IBC or the Biosafety Act:
Comply with all legislative requirements when conducting research involving LMO materials
Immediately report any significant problems with respect to the implementation of relevant laws, regulations and guidelines
Notify IBC promptly of any significant research related accidents that have resulted or could result in human illness, in unanticipated plant or animal disease, or in the unintended release of organism under study from an intended confinement
Complete required training as specified

32. :Department of Biosafety Malaysia
THANK YOU
:Department of Biosafety Malaysia