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6-Regulation: Sri Lanka establishes National Biosafety Framework



------------------------------- GENET-news -------------------------------

TITLE:  To ensure safety, genetically modified organisms and food will be
        regulated
SOURCE: Asian Tribune, by Q. Perera
        http://www.asiantribune.com/show_news.php?id=15668

DATE:   20 Sep 2005

------------------ archive:  http://www.genet-info.org/ ------------------


To ensure safety, genetically modified organisms and food will be regulated

Colombo, 20 September (Asiantribune.com): 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.

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 have 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.

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. Labeling 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 labeling 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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