The document discusses biosafety regulation in Malaysia. It outlines several key laws and regulations related to biosafety, including the Biosafety Act of 2007, Biosafety Regulations of 2010, and various international agreements that Malaysia has ratified. The Biosafety Act established the National Biosafety Board to regulate activities involving living modified organisms, including import, export, contained use, and release. The act aims to protect human, plant, and animal health as well as the environment. Researchers must obtain approval or submit notifications to the board for various activities related to modern biotechnology and genetically modified organisms.

1. BIORISK ACT & REGULATION IN
MALAYSIA
Assoc. Prof. Dr. Venugopal Balakrishnan
INSTITUTE FOR RESEARCH IN MOLECULAR MEDICINE, UNIVERSITI SAINS MALAYSIA

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ACT
• A bill which has passed through the various
legislative steps required for it and which has
become law. Related Terms: Statutes,
Legislation, Law, Regulation, Enactment, Bill.
Synonymous with the term enactment or
statute.

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LAWS INVOLVED IN BIORISK
• BWTC DRAFT BILL, 2015
• Biosafety Act (Act No.678, 2007)
• Strategic Trade Act 2010 (Act 708,2010)
• Malaysian Quarantine and Inspection Services (MAQIS),Act 2011
• Prevention and Control of Infectious Diseases Act (Act No. 342, 1988),
Regulations 2006
• Plant Quarantine Act (Act No.167,1976)
• Occupational Health and Safety Act (Act No. 514, 1994)
• Destruction of Disease-Bearing Insects Act (Act No.154,1975)
• Postal Services Act 2012 (Act No.741,2012)
• Emergency (Public Order and Prevention of Crime)Ordinance,1969
• Emergency (Essential Powers) Act (Act No. 216,1979)
• Public Order (Preservation) Act (Act No.296, 1958)

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LAWS INVOLVED IN BIORISK
• Aviation Offences Act (Act No.307,1984)
• Animals Act (Act No.647, 1953) Revision of Laws (Rectification of Animals Act
2013)
• Animal Walfare Act 2015
• Environmental Quality Act (Act No.127,1974)
• Environmental Quality (Prescribed Premises) (Scheduled Wastes
Treatment and Disposal Facilities) Regulations 1989 (P.U.(A) 294/2005) (as
amended)
• Waters Act (Act No. 418, 1920)
• Food Act (Act No.261, 1983)
• Fisheries Act 1985 (Revision 2012)
• Human Tissues Act 1974
• Wildlife Conservation Act 2010
• Protection of New Plant Varieties Act 2004

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Regulation
• Regulations are issued by various federal government
departments and agencies to carry out the intent of
legislation enacted by Congress. Administrative
agencies, often called "the bureaucracy," perform a
number of different government functions, including
rule making. The rules issued by these agencies are
called regulations and are designed to guide the
activity of those regulated by the agency and also the
activity of the agency's employees. Regulations also
function to ensure uniform application of the law.

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Regulations
International
• United Nation Security Council Resolution 1540
• International Health Regulations (2005) IHR
Core Capacity Monitoring Framework:
Questionnaire for Monitoring Progress in the
Implementation of IHR Core Capacities in
Capacities in States Parties 2011 Questionnaire
• IATA Dangerous Goods Regulations
• United Nations COETDG Model Regulations

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Regulations
Malaysia
• Biosafety Regulations 2010
• Prevention and Control of Infectious Diseases Regulation 2006
• OSH (Employers Safety and Health General Policy Statements) (Exception)
Regulations 1995
• OSH (Control of Industrial Major Accident Hazards) Regulations 1996-CIMAH
• OSH (Safety and Health Committee) Regulations 1996-SHC
• OSH (Classification, Packaging and Labelling of Hazardous Chemicals) Regulations
1997-CPL
• OSH (Safety and Health Officer) Regulations 1997-SHO
• OSH (Use and Standards of Exposure of Chemicals Hazardous to Health) Regulations
2000-USECHH
• Occupational Safety and Health (Notification of Accident, Dangerous Occurrence,
Occupational Poisoning and Occupational Disease) Regulations 2004 (P.U.(A)
128/2004

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POLICY
• A policy is a set of ideas or plans that is used
as a basis for making decisions, especially in
politics, economics, or business.
• An official organization's policy on a particular
issue or towards a country is their attitude
and actions regarding that issue or country.

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POLICY
International
• Convention on Biodiversity
• Cartagena Protocol on Biosafety
• 1925 Geneva Protocol
• Biological Toxin and weapon Convention
• WHO Laboratory Biosafety Manual, 3rd Edition, 2003
• WHO Laboratory Biosecurity Guidance, 2006
• Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, 2009
• The Laboratory Biosafety Guidelines, 3rd Edition, 2004, Health Canada.
• Canadian Biosafety Standards and Guideline, 1st Edition, 2013
Malaysia
• Malaysia Laboratory Biosafety and Biosecurity Policy and Guideline 2015
• National Biodiversity Policy
• National Biotechnology Policy

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Standard
• Standard document is defined as “a
document approved by a recognized body
that provides, for common and repeated use,
rules, guidelines, or characteristics for
products or related processes and production
methods, with which compliance is not
mandatory.

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STANDARDS
International
• ISO 35001:2019 -Laboratory Biorisk Management
• ISO 15189:2007-Medical Laboratories
• ISO 15190:2003 – Medical Laboratories – Requirements for
safety
• ASNI/ASSE Z9.14-2014 - Verification Methodologies For
Ventilation Systems For Biosafety Level 3
Malaysia
• Malaysian Standard MS 1042-3:2015 (Safety in
Laboratories-Code of Practice-Part 3: Biosafety and
biocontainment in microbiology laboratories (First revision)

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Guidelines
• A guideline is a statement by which to determine
a course of action. A guideline aims to streamline
particular processes according to a set routine or
sound practice. By definition, following a
guideline is never mandatory. Guidelines are not
binding and are not enforced.
• Guidelines may be issued by and used by any
organization (governmental or private) to make
the actions of its employees or divisions more
predictable, and presumably of higher quality.

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GUIDELINES
International
• Laboratory Biosecurity Guidance, World Health Organization, September 2006
• Laboratory Biosafety Manual, Third Edition, World Health Organization, Geneva 2004, ISBN 92
4154650
• Guidance on Regulations for the Transport of Infectious Substances 2007-2008, World Health
Organization, Applicable as from 1 January 2007
• Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition, U.S. Department of
Health and Human Services, Public health Service Centres for Disease Control and Prevention,
National Instituted of Health, HHS Publication No. (CDC) 21-1112, Revised December 2009
• The Laboratory Biosafety Guidelines-Health Canada
• NIH Guidelines for Research Involving Recombinant DNA Molecules
• Biosafety risk assessment methodologies-Sandia Report
• Tuberculosis Laboratory Biosafety Manual, World Health Organization 2012
Malaysia
• Guidelines on the Handling and Management of Clinical Wastes in Malaysia, Department of
Environment, Ministry of Natural Resources & Environment, Third Edition August 2010
• Malaysia Laboratory Biosafety and Biosecurity Policy and Guideline, 2015

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Outline
1
• Introduction to Biosafety in Malaysia
2
• What Researchers need to know about
being compliant to the Biosafety Act 2007
3
• Summary

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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
15

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WHAT ARE THE CONCERNS?
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IMPACT TO
ENVIRONMENT
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.

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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
EVOLUTION OF BIOSAFETY

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BIOSAFETY IN MALAYSIA
Strike a balance - creating an enabling
environment to gain the maximum benefit
from modern biotechnology but at the same
time minimizing risks to the environment and
health
National Biotechnology
Policy 2005
National Biodiversity
Policy 1998
Biosafety Act 2007

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BIOSAFETY ACT 2007
• Complement the implementation
of the National Policy on
Biotechnology (2005) and also the
National Policy on Biological
Diversity (1998).
• Fulfill Malaysia’s obligation under
the Cartegena Protocol on
Biosafety (CPB) to have a
domestic regulatory framework.
• Boost the confidence of investors
in modern biotechnology
• Give a clear direction on
regulatory framework on modern
biotechnology.
• Not intended to disrupt R&D

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OBJECTIVE OF THE ACT
To establish the National Biosafety
Board; 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
MALAYSIA’S PROTECTION GOAL
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*The term LMO is used interchangeably with GMO

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National
Biosafety
Board
Members
Secretary General of NRE
(Chairman)
4 experts in biosafety
(4 appointed)
ADMINISTRATIVE SUPPORT FROM DEPARTMENT OF BIOSAFETY
DG JBK
(Secretary)
Ministry of Health
Malaysia
Ministry of
Plantation
Industries and
Commodities
Ministry of
Domestic Trade,
Co-operatives &
Consumerism
Ministry of
International
Trade &
Industry

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 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
GENETIC MODIFICATION
ADVISORY COMMITTEE (GMAC)
EXPERTISE
EXPERTISE
PLANT BREEDING
GENETIC ENGINEERING
VIROLOGY
GENETICS
AGRONOMY
ENV. MICROBIOLOGY
ANIMAL BREEDING
MOLECULAR BIOLOGY
CROP PHYSIOLOGY
PLANT BIOLOGY
BOTANY
OTHERS, ETC.

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SCOPE OF THE ACT
LIMITED TO
MODERN
BIOTECHNOLOGY
RELEASE
IMPORT FOR
RELEASE
EXPORT
CONTAINED USE
ALL INSTITUTES
& PERSONS
INVOLVED
ALL STAGES
OF R&D
AND
RELEASE
ALL TYPES OF
ORGANISM
ALL
ACTIVITIES
IMPORT FOR
CONTAINED USE
LMOs
PRODUCTS OF
LMOs
*rDNA
*Direct
injection
*Cell fusion
beyond
taxonomic
family
*Etc.

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SCOPE LIMITED TO MODERN BIOTECHNOLOGY

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Application of:
(a) In vitro nucleic acid techniques,
including recombinant DNA and direct
injection of the nucleic acid into cells or
organelles; or
(b) Fusion of cells beyond taxonomic
family, that overcome natural
physiological reproductive or
recombination barriers and that are not
techniques used in traditional breeding
and selections
MODERN BIOTECHNOLOGY
25

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Any living organism that possesses a
novel combination of genetic material
obtained through the use of modern
biotechnology
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Genetically modified plant cell
Inserted gene of interest
Agrobacterium Genetically Modified Plant
Plant
Product from Genetically modified Plant
LMO - PLANT
LMOs

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 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
27
PRODUCTS

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[Covers laboratories, Animal Unit, Growth
Room, Glasshouse and Bioreactor
Facility…]
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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
Contained Use

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R&D purposes in all field
experiments
Supply or offer to supply for
sale or placing on the market
Offer as gift, prize or free item
Disposal
Remediation purposes
Any other activity which does
not amount to contained use
RELEASE

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•Export LMO
•Contained use
for industrial
production
•Import LMO/product for
placing in the market or
release
R&D
•Contained
use
•Import for
contained use
R&D
•Field Trial
DEVELOPING LMO- FROM BENCH TO MARKET
Commercialization
• Direct introduction of
LMO to the environment
•Placing in the market
•Commercial planting
NOTIFICATION –
PART IV OF ACT
APPROVAL - PART III OF ACT
DIRECT COMMERCIAL USE – NO R&D
TWO REGULATORY PROCESS

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Non compliance to get approval
from NBB for release and contained
use activities involving
LMO/products
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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
PENALTY

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MODERN BIOTECHNOLOGY RESEARCH
ACTIVITIES* IN MALAYSIA
* Activities that have been notified to the National Biosafety Board
8.5%
8.5%
46%
37%

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33
WHAT INFORMATION IS NEEDED?
Contained Use Field Trial
 Type of activity conducted
 Facility used
 Nature of LMOs being worked on
 Proposed transport of LMOs
outside stated premises and
precautions taken
 Disposal of LMOs
 Decontaminating equipment
 Actions and precautions taken to
minimise risks posed by proposed
activities
 Etc…
 Location
 LMO characteristics
 Size and scale of trial
 Survival capabilities of LMO
 Disposal of LMOs
 Decontaminating equipment
 Actions and precautions taken to
minimise risks posed by proposed
activities
 Etc…
FORM A, FORM B, FORM
C, FORM D, FORM E,
FORM E

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Confidentiality can be claimed for the following:
• that the information is not known generally
among, or readily accessible to, any person
within the circle that normally deals with the
kind of information sought to be made
confidential (unpublished data…)
• that the information has commercial value
because it is secret and
• that reasonable steps have been taken to
keep the information secret
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CONFIDENTIAL BUSINESS
INFORMATION

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CRITERIA FOR
• Any information which is to be treated as CBI should
be clearly marked “CBI” in the relevant parts of the
submitted forms and any other information given.
• The following information shall not be considered
confidential:
– The name and address of the applicant
– A general description of the LMO
– A summary of the risk assessment of the effects on the
conservation and sustainable use of biological diversity,
taking also into account risks to human health; and
– Any methods and plans for emergency response
35

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Role of IBC
• Provide guidance to Principal Investigator (PI) on biosafety
policies and issues in the use of Living Modified Organism
(LMO)/rDNA research, including safety of laboratory
personnel and other members of the organisation.
• Recommend approval for LMO/rDNA research project that are
found to conform to Biosafety Act 2007 and Biosafety
(Approval and Notification) Regulations 2010 and periodically
reviewing these research projects.
• Assess and monitor the facilities, procedures, practices,
training and expertise of personnel involve in LMO/rDNA
research.

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Role of IBC
• Notify the PI of the results of the IBC’s review, approval, or rejection
of their application for approval and notification of all activities
involving the use of LMO/rDNA to the National Biosafety Board
(NBB).
• Assess and set containment levels for LMO/rDNA research and
modify containment levels as necessary.
• Assess field experiments to ensure that the proposed risk
assessment, risk management and emergency response plan are
sufficient.
• Adopt and implement emergency response plan covering accidental
spills and personnel contamination, resulting from LMO/rDNA
research.

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Role of IBC
• Review and report to the Vice Chancellor and to the NBB
any significant problems with non-compliance of the
Biosafety Act 2007 and Biosafety (Approval and
Notification ) Regulations 2010 and any significant
research-related accidents or illnesses.
• Ensure the information provided in the relevant
application form (Approval/Notification) is correct and
complete.
• Perform other functions as prescribed by the Biosafety
Act 2007 and its regulations or guidelines.

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39
1
• Approval must be obtained from the
National Biosafety Board for any modern
biotechnology activities
2
• IBC is responsible to monitor and ensure
compliance at the institutional level
3
• Guidance and more information is available
at www.biosafety.nre.gov.my
WHAT DO YOU NEED TO KNOW
ABOUT THE BIOSAFETY ACT?

40. Thank you
Presented by
Venugopal Balakrishnan | Institute for Research in Molecular Medicine