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6-Regulation: Malaysia: An ambitious start toward the formulation of a Biosafety Law



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TITLE:  Malaysia: An ambitious start toward the formulation of a Biosafety 
Law
SOURCE: Crop Biotech Net, http://isaaa.org/kc/, sent by checkbiotech/
Syngenta
        http://www.checkbiotech.org/root/index.cfm?fuseaction=
newsletter&topic_id=6&subtopic_id=33&doc_id=2114
DATE:   November 2, 2001

------------------ archive: http://www.gene.ch/genet.html ------------------


Malaysia: An ambitious start toward the formulation of a Biosafety Law
October 2001

A biosafety law is a necessary prerequisite to promote biotechnology 
development and use in a safe and responsible manner. But a law that is too 
ambitious may end up not meeting its goals of encouraging research while 
protecting the environment and human health. Instead it may well do the 
reverse: bona fide researchers and investors may turn to more enabling 
environments while a lack of enforcement may allow the indiscriminate 
release of GMOs into the environment, something no one would want.

Malaysia is taking its first steps toward the formulation of a Biosafety 
Law. The proposed bill needs a lot more work before it can be a piece of 
legislation that protects the environment and human health while 
encouraging biotech development in the country, writes See Yee Ai. 

If you were a policymaker, would you allow the large-scale planting of 
genetically modified (GM) crops? And if you were a consumer, would you eat 
such food?

These were the two questions Science, Technology and Environment Ministry 
deputy secretary-general (policy) Nasaruddin Che Abu posed to participants 
of the public consultation on the Biosafety Bill held in Kuala Lumpur 
recently. 

More than 150 ministry officials, researchers and representatives from 
industry and civil society groups converged to air their views and offer 
suggestions on the proposed Biosafety Bill, promulgated by the ministry. 

The proposed bill is a broad piece of legislation that attempts to regulate 
all activities involving genetically modified organisms (GMOs) and products 
made from them. In practice, this means that the bill will eventually cover 
virtually all biotech research and development and perhaps most food 
imports, production and processing in Malaysia. 

While all stakeholders agree that GMO use and development in the country 
should be regulated, there were differing views as to how much regulating 
is desired, the terms of the regulatory framework and the governmentÕs 
ability to enforce the law effectively. 

While the drafters assert that the bill attempts to balance the views and 
interests of all stakeholders, research institutions and industry players 
feel that the bill is over-cautious and does not take into account the 
complexity of implementing such far-reaching legislation. 

Several ministry officials, representatives from the industry and research 
organisations also voiced concern that such a sweeping law would have a 
negative impact not only on biotechnology development but trade as well. 

Said Datuk Salleh Mohd Nor of TropBio Research Sdn Bhd: "We have to think 
about the impact this bill will have on Malaysia as a developing country - 
not only on our R&D, but also on investments and industry. Our comparative 
advantage is not in IT (information technology), itÕs in our biodiversity. 
But we wonÕt be able to harness it without biotechnology to add value and 
allow Malaysia to survive globalisation."

One of the key dispute over the bill is its broad scope. Unlike the 
Cartagena Protocol on Biosafety (of which Malaysia is a party) - which only 
regulates GMOs released into the environment via planting and field trials 
and excludes GMOs meant for food, feed and processing - the proposed 
Biosafety Bill aims to regulate all GMO uses. 

In addition, "products thereof" which encompasses all products made from 
GMOs including paste, flour and puree (excluded from the Cartagena 
Protocol) are included in the Biosafety Bill. This creates problems, 
especially in the implementation of the proposed law. 

Said Teo Beng Leong of the Federation of Malaysian Manufacturers (FMM): "By 
being all- encompassing, the billÕs strength has become its weakness. 
Certain requirements are applicable for certain activities but become 
impossible for others." 

However, Dr Low Fee Chon, senior fellow at the National Biotechnology 
Directorate who is one of the drafters, justified the inclusion of GMO 
products. "These products are most widely used in food and may have an 
impact on health. We have kept them in the bill as a means to keep an eye 
on them." 

The inclusion of "products thereof" was naturally of concern to food 
manufacturers who complained that food manufacturing was already well-
regulated under the Food Safety Act and its attendant regulations. 

As the control of GM food would already come under new labelling 
regulations currently being drawn up, having to seek approval from another 
authority is seen as an additional burden. 

Labelling had its problems as well. According to the proposed bill, all 
GMOs and their products have to be identified and labelled for 
traceability. This means that anything containing GMOs or their products 
will have to be labelled so that they can be traced to their source. The 
process would entail testing, identification and labelling at every step of 
the product chain from farm to fork, a requirement that can be met only at 
exorbitant cost. 

With so much of our food being processed and sold by small and medium 
industries and small-time traders, it would be difficult, if not 
impossible, to enforce this part of the law uniformly. What would be the 
likely result is that larger manufacturers would be compelled to comply, 
while leeway will be given to small traders; which begs the question of 
fairness. 

There is also much debate over the definitions used in the bill. While to 
the lay audience the difference lies in semantics, Dr Hassan Mat Daud, of 
the Malaysian Agricultural Research and Development Institute (Mardi), said 
that the definition would determine what the bill regulates. 

"LMOs are living modified organisms, which include only those organisms 
which are still alive and can propagate themselves. GMOs include all, even 
those like crushed corn seed, which are not capable of propagation," he 
explains. 

But of greatest concern to the Malaysian International Chamber of Commerce 
and Industry (MICCI) were the sections they considered "draconian." 

Perhaps for the first time in Malaysian law, the Biosafety Bill proposes 
financial security for anyone who had gained approval to release GMOs or 
their products. 

In theory, according to this bill, the National Biosafety Board can require 
anyone who has obtained approval to import, process or conduct experiments 
on GMOs and their products to get insurance or other forms of financial 
security before they are allowed to proceed. 

"This bill assumes that all GMOs and their products are hazardous," says an 
exasperated local scientist. "What type of message are they giving to our 
scientists? Leave Malaysia and do research elsewhere?" 

The bill also allows for broad liability and redress for harm to the 
environment and biological diversity as well as "harm or damage caused 
directly or indirectly by the GMOs and/or products thereof to the economy, 
social or cultural practices, livelihoods, indigenous knowledge systems, or 
indigenous technologies." 

Both MICCI and FMM feel that there should be caveats to this section. 

"We believe that if a company has been negligent or broken the law 
intentionally it should be punished. But no company will undertake any 
activity for which it cannot quantify the financial risks (as is prescribed 
under this section)," said MICCIÕs Clive Pegg. 

Said Teo: "There should be protection in the case when a company has 
undertaken due diligence to do all that is possible in the light of current 
scientific evidence. Otherwise, if someone 30 years from now discovers 
something which we didnÕt know about before, the company may lose 
everything in a liability suit." 

The ministry has decided to put both these financial sections on hold 
pending Cartagena Protocol deliberations on the issue, though Third World 
Network consultant Prof Gurdial Singh Nijar urges the government to retain 
them. 

In addition, the penalties proposed for this bill exceeds that of other 
laws covering environmental protection and human health. The maximum fine 
imposed on anyone who contravenes this law is RM2mil and the maximum jail 
term is 10 years. (By comparison, the maximum fine for forest encroachment 
and illegal logging under the Forestry Act is RM500,000 and that for open 
burning under the Environmental Quality Act is RM100,000.) 

Together with the financial security and the proposed liability clause, a 
stiff penalty that is inconsistent with other comparative laws may lead 
investors to perceive these biotech-specific penalties as a disincentive to 
investment. 

Another issue drafters have to consider is MalaysiaÕs capacity to enforce 
the law. Enforcement, not lax laws, has been the setback with other 
regulations. 

The broad scope of this bill almost ensures that the National Biosafety 
Board will be inundated with paperwork and applications from research 
organisations, importers, manufacturers and exporters. 

Dr Low says the ministry is cognisant of the problem with enforcement and 
proposes to enforce the law via existing mechanisms. "There are also plans 
for training to educate our people on biosafety. We are also in the process 
of rapid capacity building for risk assessment and risk communications." 

A biosafety law is a necessary prerequisite to promote biotechnology 
development and use in a safe and responsible manner. But a law that is too 
ambitious may end up not meeting its goals of encouraging research while 
protecting the environment and human health. Instead it may well do the 
reverse: bona fide researchers and investors may turn to more enabling 
environments while a lack of enforcement may allow the indiscriminate 
release of GMOs into the environment, something no one would want. 

This brings us back to the beginning. What should the answer to 
NasaruddinÕs two questions be? 

The biosafety law should create an environment where both questions are 
answered with a conditional "yes" - yes, provided all the safety 
requirements have been met. It shouldnÕt end up saying "no." 


See Yee Ai is the executive director of the Malaysian Biotechnology 
Information Centre
http://www.bic.org.my, a not-for-profit organisation dedicated to providing 
science-based information on biotechnology. She can be reached at 
yeeai@bic.org.my



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