BIOSAFETY GUIDELINE &

REGULATION (I)
DR. HARYATI ANUAR
Haryati@ucsiuniversity.edu.my
 Objectives

1. Discuss the biosafety guidelines and regulation.

2. Discuss the environmental benefits of biosafety
3. Explain biosafety protocol
4. Explain the mechanism of implementation of biosafety guidelines
 INTRODUCTION
Definition of biosafety regulation
• the need to protect human and animal health and
environment from the possible adverse effects of the
products of modern biotechnology.
• Biosafety defines the containment conditions under which
infectious agents can be safely manipulated.
• safety with respect to the effects of biological research on
humans and the environment.
 INTRODUCTION
• Essential components of the biosafety guidelines contain some
or all the following, depending on the facility:
• bio-risk assessment and identification; specific biosafety
measures, which cover the code of practice, physical plant
such as laboratory design and facilities, equipment
acquisition and maintenance, medical equipment.
 Important of regulations for biosafety

• Its main objective is to keep a check on harmful biological

agents, toxins, chemicals, and radiation.
• With the advent of genetic engineering, biosafety measures
have gained importance to ensure public and environmental
safety.
• The people should be made aware of the rules, regulations, and
monitoring bodies.
 Need of biosafety regulations

• According to the Food and Agriculture Organization of the

United Nations (FAO),
• biosafety allows us to analyze and manage risks regarding
food safety improving synergies among sectors, improving
food safety and streamlining trade.
 Biosafety practices

• Biosafety is defined as,

• “The discipline addressing the safe handling and
containment of infectious microorganisms and hazardous
biological materials”.
• Primary barriers include biological safety cabinets, fume hoods
and other engineering devices used by laboratory technicians
while working with a biological hazard.
Guideline in Malaysia
 What is LMO?
• “Living modified organism” (LMO) is defined in the Biosafety Act to
mean any living organism that possesses a novel combination of
genetic material obtained through the use of modern biotechnology
• In order to understand the definition of LMO it is important that two
further terms are understood – “living organisms” and “modern
biotechnology”:
• “Living organisms” is defined in the Biosafety Act to mean any
biological entity capable of transferring or replicating genetic
material, including sterile organisms, viruses and viroids.
 National regulatory scheme for LMOs

• The Biosafety Act 2007 describes the framework for the Malaysian
system of regulation for LMOs and product of such organisms and is
complemented by corresponding regulations and guidelines.
• The Act follows the normal structure of laws in Malaysia.
• The Act sets out the main features and delegates the way in which
the provisions are to be implemented to delegated legislation, in this
case, by regulations.
 Activities involving LMOs
• There are five categories of activities involving LMOs that are
regulated by the Act.
• These are:
• i. Release;
• ii. Contained use;
• iii. Importation for release;
• iv. Importation for contained use; and
• v. Exportation.
 Types of approvals involving LMOs
The Act prohibits the five activities earlier identified involving LMOs
unless these have been either:
• approved by the National Biosafety Board; or
• notified to the National Biosafety Board. Following is a brief summary
of these two types of “approvals” under the Act.
 Pharmaceutical products of LMO
• There are 2 key elements to be fulfilled under this category for the
exemption to apply.
i. It must be a pharmaceutical product of LMOs; and
ii. It must be: a. addressed by relevant international treaties; or b.
addressed by relevant international organisations, or c. regulated under
any other written laws relating to pharmaceuticals.

Pharmaceutical: drug or medicine that is prepared or dispensed in

pharmacies and used in medical treatment
 Approval for release and import of LMOs
• activities involving the intentional introduction of LMOs and products
of LMOs into the environment.
• Such an introduction is referred to in the Act as a “release activity”.
There is a list of such activities in the Second Schedule of the Act.
• They are:
i. research and development purposes in all field experiments;
ii. supply or offer to supply for sale or placing on the market;
iii. offer as gift, prize or free item; iv. disposal; v. remediation purposes;
vi. any other activity which does not amount to contained use.
 Cont..
• Thus any activity, other than in contained use or for the purpose of
contained use, is categorized as “release activity”.
• Any such activity is considered as releasing the LMO into the
environment.
• A person must apply for a certificate of approval before undertaking
any activity in relation to an LMO or product of an LMO.
 Environmental Benefits
• Environmental health programs are often cost-effective,
reduce health care costs, and improve productivity,
reducing the significant economic burden of disease in addition
to improving the length and quality of people's lives.
 Benefit on environmental conversations
• There is a number of advantages of environmental
conservation like:
• It offers fresh air and clean water.
• It maintains the outside temperature.
• It preserves nature, biodiversity, and ecosystem.
• It gives growth to more plant species for better medicine.
• It builds a healthy planet and a healthy life.
 Best Way to Conserve
Environment
• A good way would be to start
with conserving water, driving
less and walking more, consuming
less energy, buying recycled
products, eating locally grown
vegetables, joining environmental
groups to combat air pollution,
creating less waste, planting more
trees, and many more.
•THANK YOU