Bio-safety guidelines are the rules regulating the safe development of biotechnological products and their application for human and animal health, plants and environment.
Biotechnology on one hand 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, environment, human and animal health.
The word, 'biotechnology' has become a household word around the globe; and there is a critical need for a regulatory framework in Pakistan to ensure safe use of the 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 the issues and the formulation for its framework.
In January 2001, a draft of 'bio-safety guidelines' was prepared by experts in the field and since then it has undergone several reviews and reexaminations by a number of experts.
Besides, the ministry of environment formed a 'national bio- safety expert committee' (NBEC) for updating 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.
The enactment of guidelines will essentially set up legal requirements for import, export, transport, and handling of genetic engineering seeds, crops and foods, besides setting conditions for researchers.
The proposed 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 lab-testing, field-testing to commercialization.
Although in July 2002, the ministry of science and technology said that it would take necessary steps for the speedy promotion of biotechnology at the federal, provincial and local levels and use it for a variety of commercial and industrial purposes. It also indicated that a policy would be prepared within few months.
The role of biotechnology today has spread over more than 30 areas of human and animal health including, agriculture - environment, renewable energy, waste water treatment, bioremediation and bio-processing, mineral extraction, and drugs as well as in disease diagnostics. A number of imported products are already in our markets which help millions very effectively.
In Pakistan, life of millions, mostly from rural areas is dependent on cotton crop while 65 per cent of our annual export income comes from its exports.
Last season, Pakistan suffered huge losses due to significant pest attack of bollworms known as "sundies". Although the presence of pests, especially bollworms, is not a new phenomenon but it would have been prevented if our farmers were allowed to grow Bt cotton as have been adopted by millions of growers in the USA, Australia, China, and India.
The delay in this regard has encouraged unscrupulous elements to exploit the existing demand for Bt cotton and there have been reports of illegal cultivation of Bt cotton in Sindh and Punjab. This could seriously undermine the technology and disturb farmers' confidence. Their crossing with non-GM local varieties and multiplication could make them ineffective and disease prone.
Similarly, indigenously developed Bt cotton, Bt rice , Bt tomato etc at NIBGE (Faisalabad) and CEMB (Lahore) could not be stated fit for cultivation in the absence of the guidelines.
Among other environmental and health benefits there will be a saving of billions to the national exchequer due to less dependence on pesticides. Though, Pakistan has ratified and/or is a signatory to many international agreements like TRIPS, intellectual property rights (IPR), the Cartagena Protocol of Bio-safety and so on, the delay by the ministry of environment reflects a lack of commitment to the current responsibilities towards national issue.
While a report by European countries validating the safety of biotech crops summarized more than 15 years of research concluded that "the use of more precise technology and the greater regulatory scrutiny (over biotech foods) probably make even safer than conventional plants and foods", still many countries seeking to use the new technology are being pressured from within as well as by outside forces to formulate biosafety systems.
In November 2002, the European Union (EU) approved enhanced labelling requirements for biotechnology food and feed; according to new requirements, all biotechnology food products to be labelled irrespective of whether the biotechnology component is present in the final product, effectively extending labelling 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 EU has asked Pakistan to start labelling 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 the EU countries.