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The Ministry of Environment and Natural Resources has established the
National Bio-safety Framework for Sri Lanka (NBFSL) to regulate and control
the importation of Genetically Modified Organisms (GMO) and food (GMF), as
well as genetically modified feed and processed products into Sri Lanka,
September 2005 by Q. Perera.

Prof Athula Perera, University of Peradniya, National Project Coordinator,
and National Bio-safety Framework Development Project has taken part in the
preparation of these regulations and other deliberations.

GMO and GMF are being produced by the use of the modern recombinant DNA
technology (genetic engineering/gene technology), where genes are
identified, separated from one organism and transferred to the genetic
system of another organism which is often from different species. This gene
will produce a new protein in the organism which it never had earlier in its
natural state. Such organisms are referred to as Genetically Modified
Organisms (GMO) and any food obtained from such organisms are known as
Genetically Modified Food (GMF).

Many GM organisms are being produced today. These genes produce proteins
that are toxic to certain insect pests. For example transgenic soybeans
carrying foreign genes that provide tolerance to herbicides, transgenic
virus resistant papaya, blue colored roses and rice producing high levels of
vitamin A are some of the other transgenic plants.

Transgenic animals include fish with higher growth rate and animals such as
cattle and sheep producing various products including human milk proteins in
their milk. GM microbes include those that produce many types of
pharmaceuticals/drugs including human insulin, and a large number of
different enzymes used in industries such as textiles, cosmetics,
confectionary etc.

There is world-wide agreement that GMO/GMF, despite their many uses, can
pose threats to human health as well as to the environment. The new proteins
can be toxic and allergenic to humans; the new genes in plants can transfer
to other closely related crops through natural breeding systems; the toxic
proteins can affect other non-target organisms like the myriad of
butterflies, the various birds? life such as crows, mynahs, parrots, etc. No
long-term research has been done to ascertain these harmful after effects.

Entry of these into Sri Lanka can have adverse effects on the farmers, in
addition to ethical and moral issues including the patenting of genes.
Therefore, it is said that there remains considerable uncertainty about
potential risks associated with this technology. The possible costs of
mitigating or reversing any harm that may occur as a result of the use of
modern biotechnology may prove to be immense, and far-reaching, especially
to the government which is ultimately responsible for assuring the health
status and food security of the people.

Safety measures are intended to be developed to minimize risks to human
health and the environment. In doing so, it should be ensured that the
knowledge, practices and benefits of the country's traditional biotechnology
techniques are safeguarded. Safety measures taken should be based on the
principle that if there is any perceived threat of serious or irreversible
damage, lack of scientific certainty shall not be used as a reason for
postponing measures to prevent environmental degradation and health impacts.
This shifts the burden of proof, requiring that modern biotechnology
applications used in Sri Lanka are first proved to be harmless, instead of
waiting to take action once they have been proven harmful.

At present, there are no laws to control the entry of these GMO/GMFs into
the country and therefore, many such products may be already in the market
right now. They maybe present in some cereal and soybean products, some
types of sweets etc. depending on the source of the material used to produce
them. They can be detected by a simple laboratory test. Already a training
programme had been conducted at the Biotechnology Centre of the University
of Peradeniya to show how GMO/GMF can be detected.

Due to the risks that may arise by the use of GMO/GMF, more than 100
countries, including Sri Lanka have decided to establish safety measures
with respect to the importation of GMO/GMF. One obligation that has to met
with regard to the Cartagena Protocol Sri Lanka established the National
Bio-safety Framework (NBF) by carrying out a project funded by the United
Nations Environment Programme (UNEP) and the Global Environment Facility
(GEF).

The NBF of Sri Lanka includes, National Bio-safety Policy, Regulatory
mechanism, Administrative structure, Risk assessment & management procedures
and Public participation. v The project began by establishing a national
database on Biotechnology & Bio-safety by conducting an island-wide survey
with expert information of institutes, technology, techniques, equipment,
legal instruments, health aspects (e.g. drugs), industries, media,
import/export and libraries. This database shows the present situation in
Sri Lanka with regard to Biotechnology & Bio-safety. It can be used to
identify experts to be included in risk assessment and management
committees.

Training programmes were carried out for risk assessment & management,
laboratory safety procedures and for GMO/GMF detection methods. A regional
workshop was carried out in Colombo to share the experiences of the regional
countries including India, Bangladesh, Nepal and Bhutan and to identify
areas for regional cooperation.

In order to move forward in the area of bio-safety a national policy was
established. The main policy objective is to implement bio-safety measures
in order to regulate and manage the importation of GMO/GMF based on the
precautionary principle and the advanced informed agreement (AIA) deals with
the necessity for regulations, public awareness & participation, risk
assessment, as well as regulating industrial use.

Sri Lanka, at present, does not have any laws to deal directly with GMO/GMF,
but it is apparent that some provisions in the existing laws could be
effectively used to control, check or even ban the introduction of certain
GMOs based on the precautionary principle.

The NBF recommends that a new law be enacted to regulate and monitor all
applications and uses (including applications and uses on human beings), all
development, research, productions and manufacture for commercial, research
and other purposes, contained use, deliberate release, all marketing and
other commercial applications, all imports and exports and all methods of
disposal in relation to applications of modern biotechnologies, including
all GMOs and products. There will be transparency and public participation
in decision-making, with no scope for confidential information. Labelling
will be mandatory.

Prof Athula Perera, University of Peradniya, National Project Coordinator,
and National Bio-safety Framework Development Project has taken part in the
preparation of these regulations and other deliberations.

The new law will make it possible to bring in regulations to the Plant
Protection Act, Food Act, Consumer Affairs Authority Act, Control of
Pesticides Act and Fisheries and Aquatic Resources Act in order to regulate,
control and when necessary prevent the entry of GMOs relevant to their
respective sectors and they can also act as concurrent bodies in the
approval of GMOs and products.

Until a new law is passed, the Consumer Affairs Authority Act can be used to
provide for compulsory labelling of all GMOs and products; the Food Act can
be used to approve all food items containing GMOs and GM start-up cultures
in food processing; the Fauna and Flora protection Ordinance and the Animal
Diseases Act can be used to control, regulate and even prohibit the entry of
all GM animals and animal products; the Animal Feed Act can regulate,
control and even prevent any animal feed containing GM material and to
prevent GM feed being subsequently used for human consumption.

A GM plant should first get approval under the provisions of the new law
before it is given the rights under a future Plant Breeders Rights Act
(being drafted at present). The Intellectual Property Act can deny patents
to any inventions that can be detrimental to the public. The new law need
not confine itself to GMOs and products but can also be used to address
damage caused by any introduced species such as alien invasive species.

Once the an application for a permit can be sent by the NFP to several
competent authorities, if necessary, for concurrent approval.
Pharmaceuticals /drugs produced by GM microbes need not go through this
procedure as they are in the most pure form and are covered by other
international regulatory mechanisms and organizations (WHO).

The National Bio-safety Framework is now complete for implementation.

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