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Science.com

April 24, 2004



Issues of bio-safety guidelines and BT crops



By Ijaz Ahmad Rao


Bio-safety guidelines are the rules to regulate the safe development of Biotechnology products and their safe application for human and animal health, plants and environment.

Biotechnology existed long before such a terminology was actually coined in; on one hand it offers significant opportunities to enhance agricultural productivity and food security through disease-resistant varieties of plants and animals through the introduction of foreign genes while on the other it has raised a number of regulatory issues related to risk/benefit associated with genetically-modified organisms (GMOs), genetic diversity, the environment, human and animal health. Today the word “biotechnology” has become a household word around the globe; therefore there is a critical need for a regulatory framework in Pakistan to ensure safe use of new technology and importation of biotechnology products.

In Pakistan, research activities in biotechnology have recently picked up, with the agricultural sector being most active while efforts are being directed towards capacity building in biotechnology-related issues and the formulation of frameworks for a biotechnology policy.

In January 2001, a draft of Bio Safety Guidelines was prepared by our prominent scientists, since then it has undergone several reviews and reexamined by a number of national and international experts, beside the Ministry of Environment constituted a National Bio-safety Expert Committee (NBEC) for updating the bio-safety laws, handling of living modified organisms (LMOs) and recommending measures for management, safe transfer and movements of LMOS. But unfortunately, the guidelines are still awaiting a positive response from the Ministry of Environment.

The enactment of biosafety guidelines will essentially setup legal requirements for import, export, transport, and handling of genetic engineering seeds, crops and foods, besides setting conditions for the researchers, in the field of health, agriculture, environment, etc.

The proposed bio-safety guidelines have a three-tier safety mechanism such as Institutional Bio-safety Committee (IBC), Ministerial Bio-safety Committee (MBC), and National Bio-safety Committee (NBC) that controls and monitors the whole process from the lab-testing, field-testing to commercialization and the project can be stopped at any time, at any tier, if found hazardous to human beings or environment.

Although in July 2002, the Ministry of Science and Technology stated Biotechnology as one of its priority areas and declared that it would take all necessary steps for the speedy promotion of biotechnology at the federal, provincial and local levels and efforts would also be made to use it for a variety of commercial and industrial purposes. It also indicated that a biotechnology policy would be prepared within few months. Dr. Ata-ur-Rahman an ardent supporter of biotechnology has been on record saying on electronic and print media that biotechnology on his list is one of the two frontier technologies, and it will be pursued aggressively unlike Pakistan’s meek pursuit in some of the other areas in the field of S&T. He also mentioned on one occasion during a live telecast on PTV that he personally took up the matter of biosafety guidelines with the then minister of environment to move quickly on this issue.

You don’t have to be a rocket scientist to understand that the absence of biosafety guidelines are the biggest stumbling block for biotechnology to flourish or for any meaningful investment in the field of biotechnology in the country.

Today, the role of biotechnology consists of more than thirty areas of human and animal health, agriculture — environment, renewable energy, waste water treatment, bioremediation and bio-processing, mineral extraction, and drugs as well as in disease diagnostics. It is worth knowing that a number of imported biotech products are already in our markets; which are helping millions of people very effectively at low costs like human insulin, vaccine of Hepatitis B so on; but in the absence of bio safety regulations we cannot explore this emerging technology to develop our own economy.

Pakistan is an agriculture-based country and agriculture remains the dominant sector of the economy. Pakistan is the fourth largest producer of cotton after China, the USA and India. Life of millions of people mostly from rural areas is dependent on this crop while 65 per cent of our annual export income comes from its exports.

Last season the world’s fourth largest producer of cotton suffered huge losses due to significant pest attack of Bollworms known as “Sundies”. Although presence and pressure of pests, especially bollworms, is not a new phenomenon to the cotton crop around the world but it would have been prevented in Pakistan also if our farmers were allowed to grow Bt Cotton as have been adopted by millions of cotton growers in USA, Australia, China, India so on to control different types of sundies like “Lashkari Sundi” and “American Sundi” since 1996.

Pakistan’s lethargy to put in place its national biosafety guidelines has encouraged unscrupulous traders to exploit the existing demand for Bt Cotton, there have been reports of illegal cultivation of Bt Cotton in Sindh and Punjab. This could seriously undermine the technology and disturb farmers’ confidence, since these seeds are exotic and have not undergone any kind of regulatory trials. Their crossing with non-GM local varieties and multiplication could make them ineffective and disease prone.

Similarly, indigenously developed Bt Cotton, Bt Rice and Bt Tomato etc at NIBGE (Faisalabad) and CEMB (Lahore) could not be stated fit for cultivation in the absence of biosafety guidelines, since the evaluation of these Bt crop varieties cannot be ascertained unless these are released and tested in the field.

Among other environmental and health benefits there will a saving of billions to the national exchequer due to less dependence on pesticides.

Though, Pakistan has ratified and / or signatory to many international agreements like TRIPS, Intellectual Property Rights (IPR), the Cartagena Protocol of Bio-safety and so on, to show its growing worldwide interest in the GMOs trade under WTO rules and regulations but the process for the approval of proposed Bio safety regulations from last four years lingered by the Ministry of Environment reflects lack of commitment to current responsibilities towards national issue.

In both developed and developing countries, the safe application of biotechnology to problems of agricultural productivity requires an appropriate bio-safety system that encompasses both policy and regulations; so many countries are aligning their biotechnology policies either with those of the United States or the European Union. Although there isn’t a single documented case of an illness caused by foods developed with biotechnology since they first came on the market in the mid-1990s. While a report by European countries validating the safety of biotech crops, summarized more than 15 years of research by 400 research teams funded by European governments, concluded that “the use of more precise technology and the greater regulatory scrutiny (over biotech foods) probably make them even safer than conventional plants and foods”. But still many countries seeking to use the new technology to address limitations in food and fiber production are being pressured from within as well as by outside forces to formulate biosafety systems. In November 2002 European Union (EU) countries approved enhanced labeling requirements for biotechnology food and feed; according to new requirements all biotechnology food products to be labeled irrespective of whether the biotechnology component is present in the final product, effectively extending labeling requirements to highly refined products like corn and soybean oil produced from biotechnology crop varieties and food ingredients made from biotechnology products, even though the products may have no detectable traces of the biotechnology component.

Now the European Union has asked Pakistan to start labeling its products, especially agricultural ones, regardless whether it is GMO-free or not. But Pakistan is lagging far behind in the acquisition and management of biotechnology and its products and much of the problem lies in the lack of appropriate regulatory system as a result there is no laboratory in Pakistan that can identify and properly label which food products are genetically modified, So in such circumstances Pakistan may lose agricultural export amounting to $250 million per year to EU countries

In short, undoubtedly, there is strong desire and support at the Government and other stakeholders’ level for early adoption of biotechnology. It is also fathomable that designing a workable and transparent framework for bio-safety regulations have not been an easy task — the main challenge being creating an appropriate balance between potential benefits and risks; that’s why countries are making and modifying its Bio-safety regulations according to their national interest.

One truly believes that the ministry of environment will do a great service to technology-starved Pakistan by giving approval to bio-safety guidelines at the earliest. Follow up actions such as developing capacity building and strengthening international collaboration on bio-safety protocol will boost public confidence in biotechnology, otherwise we will not only continue to suffer in economic growth and technological advancement but the research, investment, and knowledge achieved so far will go wasted.

The writer contributes on issues of biotechnology and IT



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