1. BIOSAFETY ACT 2007 & BIOSAFETY REGULATIONS (APPROVAL & NOTIFICATION) 2010
DEPARTMENT OF BIOSAFETY
MINISTRY OF NATURAL RESOURCES & ENVIRONMENT
BIOSAFETY TRAINING WORKSHOP
17 august 2016
Universiti teknologi malaysia

2. OUTLINE Introduction to Biosafety in Malaysia 1 Biosafety Act 2007 23
Regulatory mechanisms under the Act
COMPULSORY

3. BIOSAFETY BIOSAFETY BIOSAFETY IN THE CONTEXT OF THE BIOSAFETY ACT 2007
Prevention of large-scale loss of biological integrity, focusing both on ecology and human health.[1] These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety is used to protect us from harmful incidents.
BIOSAFETY IN THE CONTEXT OF THE BIOSAFETY ACT 2007
Biosafety is used to describe efforts to reduce and eliminate the potential risks resulting from modern biotechnology and its products. The concept of biosafety encompasses a range of measures, policies and procedures for minimizing potential risks that modern biotechnology may pose to human, plant and animal health, the environment and biological diversity.
COMPULSORY
Talking Points:
Biosafety in general refers to the protection of individuals or the environment.
Biosafety in the context of the Biosafety Act specifically refers to protection from potential risks resulting from modern biotechnology and its products.

4. WHY BIOSAFETY
WHY? to reduce and eliminate the potential risks resulting from (modern) biotechnology and its products so that it is safe for human, plant and animal health, and the environment
Important to ensure sustainable development
COMPULSORY
Talking Points:
Biosafety is important to protect human, plan and animal health as well as the environment.
It is an important component to ensure sustainable growth – to get the benefits of modern biotechnology but at the same time ensuring that the protection goals are maintained.

5. WHAT ARE THE CONCERNS? IMPACT TO ENVIRONMENT IMPACT TO HUMAN HEALTH
Potential to infect/ colonise animals and plants
Infect invertebrates/ vertebrate or domestic animals with economic importance
High survival and disseminate in environment
Etc.
IMPACT TO HUMAN HEALTH
Allergenicity
Toxicity
Pathogenicity
Possible alteration of route of infection
Possible survival outside of host
Antibiotic resistance
Etc.
OPTIONAL
Talking points:
Despite the vast benefits offered by modern biotechnology, there are still concerns to be addressed.
Some examples of impact to the environment are….
Impact to human health includes….
As long as these potential risks are addressed, then LMOs and its products can be used.

6. EVOLUTION OF BIOSAFETY
1996 Administrative GMAC formed (MOSTE) 1998 Strategy XI -National Policy on Biological Diversity 2000 Signed the Cartagena Protocol on Biosafety 2003 Ratified – Protocol in force 2005 Policy Thrust 7 National Policy on Biotechnology 2006/07 Biosafety Bill in Parliament 2007 Biosafety Act passed in Parliament 2008 Biosafety Core Team formed (April) 2009 Biosafety Act enforced (1 December) 2010 NBB formed (March)/GMAC appointment (May) 2010 Department of Biosafety formed (May) 2010 Biosafety Regulations enforced (1 Nov) 2010 Nagoya-Kuala Lumpur Supplementary Protocol on Liability & Redress adopted (Oct)
OPTIONAL
Biosafety started with an informal regulatory system under GMAC formed under the previous Ministry of Science, Technology and Environment (MOSTE).
It is also mentioned as an important component in Strategy 11 of the National Policy Biological Diversity (1998)
On 9 September 2003, Malaysia ratified the Cartagena Protocol on Biosafety
In 2005, Malaysia developed its National Biotechnology Policy to ensure development of science in the field of biotechnology.
The Biosafety Act was passed in Parliament in July 2007.
An administrative set up was formed as the Biosafety Core Team to implement the Biosafety Act.
The transition period for the implementation of the Biosafety Act ended in December 2009 and it was fully enforced.
The National Biosafety Board was formed in March GMAC was formed under the Biosafety Act in May 2010.
In 2010, the Biosafety Core Team was changed to become a Department.
On 1 Nov 2010, the Biosafety Regulations (Approval and Notification) was enforced.
On 2010, the Nagoya-Kuala Lumpur Supplementary Protocol was made available for signing by Parties.

7. CARTAGENA PROTOCOL ON BIOSAFETY AND BIOSAFETY ACT- COMPLIMENTARY LEGAL INSTRUMENTS
Country A
Transboundary movement - CPB
Domestic Law Biosafety Act
Malaysia
OPTIONAL
Talking points:
The Cartagena Protocol on Biosafety (CPB) regulates movement of LMOs from one country to another country
Locally, the Biosafety Act regulates modern biotechnology activities.
Country B
Transboundary movement - CPB

8. BIOSAFETY ACT 2007
Complement the implementation of the National Policy on Biotechnology and also the National Policy on Biological Diversity.
National law that is applicable to all states in Malaysia (including Sabah and Sarawak).
Not intended to disrupt R&D.
Implementing agency is the Department of Biosafety under the Ministry of Natural Resources and Environment
Based in Putrajaya
COMPULSORY
Talking points:
The Act complements and balances the National Policy on Biodiversity and the National Policy on Biotechnology
It is a national law and it is applicable in all States of Malaysia
The implementing agency is the Department of Biosafety that is situated in Putrajaya

9. MALAYSIA’S PROTECTION GOAL
OBJECTIVE OF THE ACT
To establish the National Biosafety Board (NBB); to regulate the release, importation, exportation and contained use of living modified organisms (LMO) & the release of products of such organisms, with the objectives of protecting human, plant and animal health, the environment and biological diversity
COMPULSORY

10. National Biosafety Board (NBB) Members
Secretary General of NRE
(Chairman)
Ministry of Agriculture & Agro-based Industries
DG JBK
(Secretary)
National
Biosafety Board (NBB)
Members
Ministry of Health
Ministry of Science, Technology & Innovation
Ministry of Plantation Industries & Commodities
Ministry of International Trade & Industry
COMPULSORY
The NBB comprises of representatives from 6 relevant ministries
In addition, there are 4 persons who are appointed as experts who have experience and knowledge about biosafety
The Chairperson is the Secretary General of the Ministry of Natural Resources and Environment (NRE)
The DG of the Department of Biosafety acts as the Secretary for the NBB
The Department functions as the operating arm of the NBB
Ministry of Domestic Trade, Co-operatives & Consumerism
4 experts in biosafety
ADMINISTRATIVE SUPPORT FROM DEPARTMENT OF BIOSAFETY

11. DECIDES ON ALL APPLICATIONS – APPROVALS & NOTIFICATIONS
PROMOTE BIOSAFETY R &D, DEVELOPMENT, EDUCATIONAL & TRAINING ACTIVITIES
MONITORS MODERN BIOTECHNOLOGY ACTIVITIES
FUNCTIONS OF NBB
ENFORCES THE LAW
ASSESSES RISK POSED BY LMOS / PRODUCTS
OPTIONAL
Talking points:
The main function of the NBB is to decide on all applications
However there are other functions also of the NBB in fulfilling it’s responsibilities for biosafety in Malaysia
ESTABLISH MECHANISMS TO FACILITATE THE COLLECTION, STORAGE & DISSEMINATION OF DATA RELATING TO LMOs /PRODUCTS/ BIOSAFETY
PERFORM/ PROVIDE FOR OBLIGATIONS FROM BIOSAFETY RELATED AGREEMENTS, CONVENTIONS OR TREATIES 11

12. GENETIC MODIFICATION ADVISORY COMMITTEE (GMAC)
Formed in May 2010
Provides scientific assessment of applications for approval & notifications and gives recommendations to the NBB
Provides scientific, technical and other relevant advice to the NBB or the Minister
Responsible to NBB and also any general directions given by the Minister
EXPERTISE
EXPERTISE
PLANT BREEDING
GENETIC ENGINEERING
VIROLOGY
GENETICS
AGRONOMY
ENV. MICROBIOLOGY
ANIMAL BREEDING
OPTIONAL
Talking points:
Formed in May Comprises of a composite of expertise, such as plant breeding, genetic engineering, animal breeding etc.
Provides scientific and technical assessments and makes recommendations for the NBB decision
Also assists in development of biosafety related policies and any other relevant issues
MOLECULAR BIOLOGY
CROP PHYSIOLOGY
PLANT BIOLOGY
BOTANY
OTHERS, ETC.

13. SCOPE OF THE ACT LIMITED TO MODERN BIOTECHNOLOGY CONTAINED USE
IMPORT FOR CONTAINED USE
*rDNA
*Direct injection
*Cell fusion beyond taxonomic family
*Etc.
LMOs
EXPORT
PRODUCTS OF LMOs
IMPORT FOR RELEASE
RELEASE
COMPULSORY
Talking Points:
Scope of the Biosafety Act is limited to modern biotechnology.
All institutes and persons involved in modern biotechnology will be regulated under this law – private and public entities.
It regulates LMOs as well as products of LMOs.
All stages of R&D is regulated under this law.
All types of organisms which are LMOs are regulated under this law – i.e. Mosquitoes, plants, microbes, fish etc.
All types of activites are regulated under this same law – contained use, import for contained use, export, import for release and release.
ALL INSTITUTES & PERSONS INVOLVED
ALL STAGES OF R&D AND RELEASE
ALL TYPES OF ORGANISM
ALL ACTIVITIES 13

14. Scope limited to modern biotechnology
Natural regeneration
Cell fusion
Transfection
Modern biotechnology
Cultivation methods
Transformation
Conjugation/agroinfection
Tissue culture
OPTIONAL
IAASTD – International Assessment of Agricultural Science and Technology for Development
GMOs in vitro manipulated DNA and RNA
Natural breeding
Reproduced illustration from IAASTD

15. LMO (INTerpretation in biosafety act)
Any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology
OPTIONAL
The term LMO and genetically modified organism (GMO) can be used interchangeable in the context of the Biosafety Act.
The term LMO is used in the language of the Act to maintain consistency with the language used in the Cartagena Protocol on Biosafety

16. (INTerpretation in biosafety act)
PRODUCTS
(INTerpretation in biosafety act)
Derived from LMOs or part of LMOs
Contains detectable recombinant DNA; or
Profile, characteristic or properties of the product is or are no longer equivalent to its conventional counterpart irrespective of the presence of the recombinant DNA
OPTIONAL

17. CONTAINED USE
Any operation including R&D, production or manufacturing operation involving LMOs, or storage of LMOs, undertaken within a facility, installation or other physical structure such as it prevents contact and impact of the LMOs on the external environment
OPTIONAL
[Covers laboratories, Animal Unit, Growth Room, Glasshouse and Bioreactor Facility…]

18. RELEASE (INTerpretation
in biosafety act)
Includes:
R&D purposes in all field experiments
Supply or offer to supply for sale or placing on the market
Disposal
Etc.
OPTIONAL
Talking points:
1. Intentional introduction of LMO or its products to the environment through field trial, or placing in the market and so on.
2. As long as it is not in contained use, it is considered a release.

19. TWO REGULATORY PROCESSES1 2
NOTIFICATION – PART IV OF ACT
APPROVAL - PART III OF ACT
DEVELOPING LMO- FROM BENCH TO MARKET
R&D
Contained use
Import for contained use
R&D
Field Trial
Commercialization
Direct introduction of LMO to the environment
Placing in the market
Commercial planting
TYPE OF ACTIVITIES
COMPULSORY
Talking points:
1. There are 2 regulatory processes under the Biosafety Act.
2. All contained use activities and export of LMO falls under notification process
3. All release activities of LMO falls under approval process, this includes field trial as there is contact with the environment.
4. Even if the LMO is not locally developed, but imported for the purpose of release, it is an approval process.
DIRECT COMMERCIAL USE – NO R&D
Export LMO
Contained use for industrial production
Import LMO/product for placing in the market or release 19

20. COMPULSORY Talking Points:
All contained use activities are regulated via the Notification Process.
Applications must go through the IBC for R&D work.
No fees required.
Once submitted to the JBK, an initial assessment is done by the JBK.
After it is cleared, the DG of Biosafety will issue an acknowledgement.
After receiving the acknowledgement the PI can start the activity.
The assessment will continue and the NBB will decide in 90 days.
8. Assessment of NBB may result in-
No order
Order Cessation
Impose Terms
Order Rectification
Other Orders
9. If it is not approved, an appeal may be made to the Minister.
10. Notification decision can be reviewed.
11. Any non compliance may result in a penalty.

21. COMPULSORY
Talking Points:
All release activities are regulated via the Approval Process.
Applications must go through the IBC for field trials.
The application will also be reviewed by any relevant Government agencies.
A public consultation is mandatory for the approval process.
NBB will decide in 180 days.
Decisions may vary – Approved; Approved with Terms and Conditions; Rejected
Activity can start only after getting the Certificate of Approval
8. An approved person shall not undertake any release activity or any importation of LMO other than for which the certificate has been issued
9. If it is not approved, an appeal may be made to the Minister.

22. SUMMARY OF REGULATORY PROCESSES
NOTIFICATION
APPROVAL
PURPOSE
Contained Use
Release
TIME
90 days
180 days
CONSULT PUBLIC No
Yes
FEES
None
START ACTIVITY
Sufficient with JBK acknowledgement
Need certificate of approval
APPEAL OR REVIEW
COMPULSORY
The differences between the 2 regulatory mechanisms are summarized in this table.

23. PENALTY Non compliance to get approval from NBB for release and contained use activities involving LMO/products
Where such person is an individual :
a fine not exceeding RM250,000 or to imprisonment for a term not exceeding 5 years or to both;
continuing offence, further fine no exceeding RM10,000 for each day
Where such person is a body corporate :
a fine not exceeding RM500,000;
continuing offence, further fine no exceeding RM20,000 for each day
COMPULSORY
Talking points:
It is mandatory to get an approval from the NBB to conduct modern biotechnology activities and handle LMO and it’s products.
Any non compliance can result in a penalty under the law. 23

24. :Department of Biosafety Malaysia
Acknowledgement –Google Images
THANK YOU
:Department of Biosafety Malaysia