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.(ref1997)

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 government’s 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), it’s in our biodiversity. But we won’t 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 bill’s 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 MICCI’s 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 didn’t 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 Malaysia’s 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 Nasaruddin’s 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 shouldn’t 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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