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

OUTLINE Introduction to Biosafety in Malaysia 1 Biosafety Act 2007 2 3 Regulatory mechanisms under the Act COMPULSORY

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.

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.

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.

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 2010. 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.

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

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

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

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

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

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 2010. 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.

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

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

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

(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

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…]

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.

TWO REGULATORY PROCESSES 1 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

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.

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.

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.

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

:Department of Biosafety Malaysia Acknowledgement –Google Images THANK YOU www.biosafety.nre.gov.my Email: biosafety@nre.gov.my : @DOBmy :Department of Biosafety Malaysia