ICTSD Outputs and Activities on Biotechnology, Trade and Sustainble Development

Biotechnology: Addressing Key Trade and Sustainability Issues

A.1 What is biotechnology?

Biotechnology is any technology that uses biological systems or living organisms to make or modify products or processes for a specific use. Biotechnology in this broad sense has been in use for thousands of years, starting with the domestication and selection of plants and animals as early as 10,000 BC (see Table 1). More recently, however, the term has become associated with a scientific process that involves the manipulation of the DNA (deoxyribonucleic acid) of an organism. This so-called ‘modern’ biotechnology includes a variety of different scientific techniques, such as genomics, bioinformatics, cloning, embryo transfer and other technologies, which are widely used in the medical, industrial and agricultural sectors.

Biotechnology also includes the deliberate alteration of the genetic make-up of plants or animals by adding, altering or deleting one or more of the thousands of genes that control the characteristics of the plant or animal. This process, which is known as ‘genetic modification’ or ‘genetic engineering’, takes a useful gene from one plant or animal and inserts it into the genome of another plant or animal. The final altered plant or animal is known as ‘transgenic’ or genetically modified or engineered, and is often described as a ‘genetically modified organism’ (GMO) or ‘living modified organism’ (LMO).

A.2 Terminology

Different countries and organisations use different terminologies when referring to biotechnology processes and products (see Box 1). Some do not commonly distinguish between ‘modern’ and ‘traditional’ (or ‘conventional’) biotechnologies, assuming that one is simply a continuation of the other. Others prefer to distinguish between the different types of biotechnology, arguing that products of ‘modern’ biotechnology pose new and distinct challenges regarding potential risks, regulatory needs, ethics and consumer acceptance. Agricultural biotechnology that involves adding, altering or deleting genes, in particular, is defined and regulated separately by most countries and organisations, while medical biotechnology products are commonly included under the broader regulatory framework for pharmaceutical products.

Terminology also varies with regard to the products of biotechnology. The United States Food and Drug Administration (USFDA), for instance, uses the term ‘bioengineered foods’ rather than the more frequently used terms ‘genetically modified foods’ and ‘genetically modified organisms’, arguing that the use of these terms can be misleading because almost all foods have undergone some form of genetic modification (USGAO, 2002). The European Union (EU), on the other hand, refers specifically to GMOs in its regulations, defining them as organisms whose genetic characteristics have been modified artificially. Civil society activists have at times employed more ominous terms in their anti-GMO campaigns, such as ‘frankenfoods’, ‘genetic pollution’ or ‘genetic monsters’, highlighting deep emotional and ethical concerns surrounding the technology.

BOX 1: Primary terms for biotechnology used by different organisations/countries

The Convention on Biological Diversity (CBD) defines biotechnology as “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.”

The Cartagena Protocol on Biosafety defines modern biotechnology as “the application of in vitro nucleic acid techniques, including rDNA and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family.” However, only living modified organisms (LMOs) are covered by the Protocol. LMOs are defined as “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.”

The UN Food and Agriculture Organization (FAO) adopts the definition of biotechnology in the Convention on Biological Diversity, but also provides a narrower interpretation “which considers only the new DNA techniques, molecular biology and reproductive technological applications […] covering a range of different technologies such as gene manipulation and gene transfer, DNA typing and cloning of plants and animals.”

The Organization for Economic Co-operation and Development (OECD) defines biotechnology as “the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services.” In addition, the OECD has a list-based definition that includes applications in DNA/RNA, proteins and other molecules; cell and tissue culture and engineering; process biotechnology techniques; gene and RNA vectors; bioinformatics; and nanobiotechnology.

The Codex Alimentarius Commission, a global food standards body, uses the Cartagena Protocol’s definition of modern biotechnology in its Principles for Risk Assessment of Foods derived from modern biotechnology. Two standards have been adopted that refer to recombinant-DNA plants and micro-organisms (bacteria, yeasts or filamentous fungi) in which the genetic material has been changed through in vitro nucleic acid techniques, including rDNA and direct injection of nucleic acid into cells or organelles.

The World Trade Organization (WTO) dispute panel, which was initiated by the US with Canada and Argentina, uses the term ‘biotech products’. In its original request for the establishment of a panel, the US defined the term as a short form of ‘products of agricultural biotechnology’.

The United States Food and Drug Administration (USFDA) regulates ‘bioengineered foods’, which are defined in the Premarket Notice Concerning Bioengineered Foods (January 2001) as foods derived from a plant that is developed using the introduction into an organism of genetic material that has been manipulated in vitro.

The European Union (EU) recognises the broad definition of biotechnology, but regulations such as Directive 2001/18/EC and Regulation (EC) 1829/2003 are specifically aimed at GMOs, defined as “organisms, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.”

Canada defines biotechnology as the manipulation of living organisms to produce goods and services, and divides it into health, environmental, agricultural and industrial biotechnology. In the field of agricultural biotechnology, the Canadian government has adopted the Cartagena Protocol’s definition of LMOs.