Biotechnology Regulations

The need for biotechnology regulations was recognized in the 1980’s and since then several countries have discussions over the norms controlling biotechnology products. But it was only in the year 2000 that the trading countries considered setting up well defined norms to control the genetically modified foods. In the United States, the GM foods are considered similar to the traditional ones while in Europe, GM foods require to be specifically labelled as a part of the biotechnology regulations. This labelling has been implemented as mandatory for the customers have the right to know what they are buying. There are still arguments going on about the European rule of GM food markings as biotechnology regulations.

The first specific citation to biotechnology regulations was by the Organization of Economic Cooperation and  Development, which stated that the risk that might be caused by biotechnologically modified products would be same as that of conventional ones and has to be treated the same. This rule was then adopted by US and Canada, but Europe stood apart. In Europe there were strict biotechnology regulations which came into being in 1990. The biotechnology regulations were constantly revised beginning with mandatory labelling of genetically modified organisms in 1997, later extended to any product that had a novel DNA. It is not only the genetically modified foods but also animal feeds that require labelling in Europe. Products derived from genetically modified organisms also require labelling in EU. According to the new rule of biotechnology regulations in Europe, it basically requires to create an account of every other product which has been derived from genetically modified organisms.

United States does not have any strict rules governing biotechnology regulations and according to 1986 law, the biotechnologically produced products will be treated similar to its traditional counterpart. This law was set up after several researches that proved that the biotechnological processes produced no specific risks when compared to conventional processes. The biotechnology regulations were similar to that of other produces and was checked based on their composition and use. In United States, there is no single biotechnology regulations organization and all products that were produced through genetic modification would be ruled by common laws under the Food and Drug Administration, Agriculture Department and the EPA. The biotechnology regulations were similar to those of other conventional products and there are many laws governing the food, feed, drugs, pesticides, and other toxic substances and biotechnology regulations are based on these common laws.

The controversy began when the common rules could not classify a genetically engineered product under a certain category like a plant that could produce its own pesticide. This, then made way for new biotechnology regulations for ‘plant-incorporated protectants’ where several laws governing plants and pesticides were combined to produce newer laws as biotechnology regulations. Based on these limits of the common laws, the EPA, USDA and the FDA in the United States came up with several specific biotechnology regulations to ensure the quality, efficiency and safety from the potential threats of biotechnology products.

It was in the late 1970s that Canadian Biotechnology Strategy began its initial formation when the need for biotechnology regulations and advancements was recognized. The CBS works to promote and provide support over biotechnology regulations to the several federal regulatory commissions. The CBS is divided into seven ministries of biotechnology sector, namely industry, agriculture, health, environment, fisheries, natural resources and international trade. The Canadian Biotechnology Advisory Committee carries over the responsibilities of public awareness, ethical, social and biotechnology regulations issues. The EACSR (External Advisory Committee on Smart Regulations) lends the helping hand to the Canadian government and recommends biotechnology regulations after analysing the complexities of biotechnology.

In India, the government looked unto biotechnology regulations, after the issue over Bt brinjal. With the advancement of the biotechnology sector in India, there arose the need for biotechnology regulations to control the agricultural biotechnology sector and the recombinant pharmaceutical industry. It was in 2007 that the National Biotechnology Development Strategy was approved to oversee the safety concerns and biotechnology regulations of genetically modified products and processes. The Food Safety, Drugs and Cosmetics safety are controlled by the respective departments to ensure the safety of the customers and the environment.

Japan and Korea also has genetically modified products labelling as a mandatory biotechnology regulations effort, but the requirements are not as strict as Europe and excludes highly processed foods, animal feed and certain oils. Mandatory labelling is also implemented in Australia and New Zealand in biotechnology regulations of foods and other eatables that contain more than 1 percentage of bio engineered material in it.