Introduction to Malaysian Biosafety Act 2007

And

Institution Biosafety Committee UTM

STRUKTUR JKKP INDUK UTM Chairman

DPC (P&I)

Administration Representative - Department / Unit

- College - Faculty

- UTM International Campus

Employee Representative

PERTISAS (Persatuan Pegawai Tadbir Dan Ikhtisas UTM)

PERKABA (Persatuan Kakitangan Bukan Akademik UTM)

PKA UTM (Persatuan Kakitangan Akademik UTM)

KKA UTM (Kesatuan Kakitangan Am UTM)

OSHE Unit

Institutional Biosafety Committee UTM

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UTM komited memastikan aktiviti-aktiviti program biokeselamatan di laksanakan

dalam persekitaran yang selamat dan sihat untuk seluruh warga UTM, pihak lain

yang berurusan dengan UTM dan persekitarannya. Perlaksanaan dan

keberkesanan polisi ini berlandaskan kepada:

Kepimpinan oleh pihak eksekutif dengan kerjasama dan penglibatan secara aktif daripada seluruh kakitangan UTM;

Kefahaman dan kepatuhan terhadap keperluan statutori serta piawaian negara dan antarabangsa;

Menyediakan pelan tindakan dan memastikan ianya di laksanakan dengan cekap dan berkesan;

Memupuk budaya kerja yang selamat melalui pendidikan dan latihan yang berterusan;

Menyemak dan memperbaiki polisi dan objektif dari masa ke semasa mengikut perubahan perundangan dan organisasi.

Scope of IBC Review

1. LMO/rDNA activity Notifications/Applications to NBB

2. Modifications to Approved Projects

3. Project Extension and Notice of Termination

4. Exemptions

5. Incidents and Personnel Exposure

6. Biosafety Manuals

7. Laboratory Inspections

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IBC Review

1. Notifications/Applications: NBB

• PI submit relevant NBB form & IBC Assessment Form incl. ERP

• IBC approval : valid 2 yrs or longer.

• First review: 12 months after initial approval date

• Subsequent review: after 1 year or earlier

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PI

IBC

IBC Decision

NBB

Approval for Field Experiment

NBB Decision

Notification

Acknowledgement

No

No

Yes

Yes

PI Commerce Work PI Commerce Work

Certificate of Approval

NBB Form & IBC Assessment Form

Application Review Flowchart

What is reviewed?

• Agent characteristics (e.g. virulence, pathogenicity, environmental stability)

• Types of manipulations planned

• Insert sources (e.g. species)

• Nature of DNA sequences (e.g. structural gene, oncogene)

• Hosts and vectors to be used

• Product of the transgene? (protein?)

• Qualification of personnel

• BSL level and RA, RM (approval) and ERP (both)

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IBC Review

2. Modifications to Approved Projects

• LMO/rDNA materials, laboratory location or any change that increase/change Risk Group (RG) or Biosafety Level (BSL)

• implement modification after approval of IBC & NBB

3. Project Extension & Notice of Termination

• Submit Form at least one month before IBC meeting

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IBC Review 4. Exemptions

• Carried out under standard microbiological lab practice.

5. Incidents and Personnel Exposure

• Incident Reporting Form

• Occupational Disease/ Exposure Investigation Form

• IBC minutes on discussions & actions

• NBB may request for detailed report if necessary

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IBC Review 6. Biosafety Manuals

• Biosafety protocols & manuals - available in every labs

• IBC review document during inspection

7. Laboratory Inspections

• IBC conduct routine inspections

• PI notified for corrective actions – if any problems

• NBB may send representative to joint the routine inspection

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Reporting on Incidents

1. Internal Reporting

• PI report incidents to IBC via BSO < 24 hrs

• PI report occupational exposure to IBC/Head/OHSC < 24 hrs

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– unintended release, spill, research related illnesses, exposure to individuals or environment, non-compliance etc

Reporting

2. External Reporting

• PI submit Incident Reporting Form to NBB < 48 hrs (reviewed by BSO)

• PI submit Occupational Disease/ Exposure Investigation Form to NBB < 24 hrs

3. Other External Reporting

• NBB may recommend that IBC inform incident to external agencies: eg MOH, DOA, State etc

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Training IBC Members

• Training on biosafety and related regulations & IBC policies

• Refresher training on changes in guidelines

Laboratory Personnel

• Mandatory general biosafety training (NBB may help)

• BSL3 and BSL4: PI must have specific training (NBB)

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Principal Investigator (PI)

• Obtain approval from IBC/NBB to conduct MB activity

– export, import, contained use and field

experiments

• Conduct initial RA (IBC will finalize)

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(1) Leading & conducting modern biotech R&D

(2) Accountable to IBC

PI Responsibilities

Prior to conducting activity

• Familiarize all requirement of guidelines/regulations for safe handling of LMO/rDNA materials

• Develop SOPs for laboratory activities:

- describe all potential biohazards

- Precaution to be taken

• Establish policies: limit access to those know potential hazards

• Obtain approval for ERP: to handle accidental spills and personnel contamination

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PI Responsibilities

Prior to conducting activity (Cont’d)

• Ensure Lab personnel :

– know why precautionary safe practices implemented

– received appropriate immunisations (if needed)

• Train laboratory personnel:

– aseptic techniques for handling LMO/rDNA: understand the potential risks

– practices and techniques: to ensure safety and dealing with accidents

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PI Responsibilities

After approval by IBC/NBB

• Do not modify: research project / change of BSL and/or RG or premise.

• Immediately report: significant implementation problems related to laws, regulations and guideline

• Complete required training as specified

• Notify the IBC promptly: accidents /human illness / unintended release etc

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PI Responsibilities

While conducting activity

• Limit access to facility while handling LMO/rDNA

• Provide PPE: specific to LMO/rDNA materials

• Ensure all staff applies safety practices

• Follow safety protocols outlined in the ERP (placed in lab)

• Ensure integrity of the biological and physical containment/biosafety level

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Laboratory Personnel

Responsibilities include:

• Follow general safety practices & good lab. techniques

• Work within BSL and use PPE

• Follow and comply with all biosafety regulations and guidelines (provided by PI & BSO)

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Researchers, Technician, Technologist, Student, Post-doctorate etc. –

Laboratory Personnel

Responsibilities include (cont’d):

• Immediately notify the PI or BSO: health condition (i.e. pregnancy, allergenicity)

• Report problems, mistakes, spills, etc. to the PI (or BSO) ASAP

• Report non-compliance of biosafety guidelines: PI, BSO or IBC

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Principal Investigator

IBC

YES/NO

FLOW CHART OF BIOSAFETY RELATED FORMS FOR APPROVAL OF PROJECTS RELATED TO LMOs BEFORE SUBMISSION TO RAs

NBB

Notification/Approval

RAs

• RA - Research Alliance

•IBC - Institutional Biosafety Committee

•NBB - National Biosafety Board

FORMS FORM E N DESCRIPTION NBB/A/ER/10/ FORM A

X X APPROVAL FOR RELEASE ACTIVITIES OF LIVING MODIFIED ORGANISM (LMO) (RESEARCH AND DEVELOPMENT PURPOSES IN ALL FIELD EXPERIMENTS) OR IMPORTATION OF LMO THAT IS HIGHER PLANT

NBB/A/ER/10/ FORM B

X X APPROVAL FOR RELEASE ACTIVITIES OF LIVING MODIIFED ORGANISM (LMO) (SCRESEARCH AND DEVELOPMENT PURPOSES IN ALL FIELD EXPERIMENTS) OR IMPORTATION OF LMO OTHER THAN HIGHER PLANTS

NBB/A/ER/10/ FORM C

X X APPROVAL FOR RELEASE ACTIVITIES (SECOND SCHEDULE 2-6) OR IMPORTATION OF LIVING MODIFIED ORGANISM (LMO) THAT IS A HIGHER PLANT AND PRODUCT OF SUCH ORGANISM

NBB/A/ER/10/ FORM D

X X APPROVAL FOR RELEASE ACTIVITIES (SECOND SCHEDULE 2-6) OF LIVING MODIFIED ORGANISM (LMO) OTHER THAN A HIGHER PLANT AND PRODUCT OF SUCH ORGANISM

NBB/N/CU/10/ FORM E

X X NOTIFICATION FOR CONTAINED USE AND IMPORT FOR CONTAINED USE ACTIVITIES INVOLVING LIVING MODIFIED ORGANISM (LMO) FOR BIOSAFETY LEVELS 1, 2, 3 AND 4

NBB/N/Ex/10/ FORM F

X X NOTIFICATION FOR EXPORT OF LIVING MODIFIED ORGANISM (LMO)

IBC/IR/10/ ANNEX3 X X INSTITUTIONAL BIOSAFETY COMMITTEE INCIDENT REPORTING FORM

IBC/OD/10/ ANNEX4 X X INSTITUTIONAL BIOSAFETY COMMITTEE OCCUPATIONA L DISEASE / EXPOSURE INVESTIGATION FORM

IBC/PE-NT/10/ ANNEX5 X X PROJECT EX TENSION & NOTICE OF TERMINATION/COMPLETED

Note: Form E should be submitted during application by ALL PIs doing research on LMOs.

The remaining forms should be filled accordingly as and when the need arises.

Reference

• Malaysian Biosafety Act 2007

• Biosafety regulation 2010

• WHO Biosafety Guideline 2004

Thank You