Areas for regulation

Regulations governing GMOs can potentially act at a number of key stages:

a) Research and development (R&D)

Development of GM individuals or a GM variety can be a long process. It begins in the laboratory, where the GMOs are produced and where presence of the transgene is confirmed etc., and proceeds to field testing of the organisms produced to ensure they have the desired characteristics. Regulations here may cover the conditions under which laboratory experiments take place; exchange of GM material between laboratories and conditions for testing GMOs in greenhouses, other contained facilities or in the field.


b) Seeking approval for commercialization

After the R&D stage, there may be interest in bringing the GM product to the market. Regulations here may cover assessment of the potential human health and environmental risks, to be carried out prior to eventual approval.

c) Commercial release

If approval is granted, the next stage is the commercial release of the GMOs. Regulations here may cover aspects such as how and where GMOs may be released (e.g. minimum distance of GM crops from organic agriculture or non-GM fields; need for GM-free refuges) and, if used for food, the kind of labelling needed, if any; whether post-commercialisation monitoring of the impacts of GMOs is necessary or what kinds of sanctions should be imposed following eventual violation of the regulations.

d) Imports of GM material or food

Applications may be made to import GMOs or their genetic material (semen, seeds etc.) for release in the environment. Similar GM varieties may or may not already be approved in the importing country. Regulations here may cover the kind of information required for approval e.g. whether information on potential environmental impacts from the exporting country is sufficient or whether new tests are required in the importing country.

Applications may also be made to import "GM food", food from GMOs (e.g. GM fish) or food that contains ingredients from GMOs (e.g. chocolate containing GM soybean). Regulations may cover the kind of information required for approval e.g. whether new food safety data is needed or whether data from the exporting country may be used.

Phillips, in a 2003 IFPRI publication, points out that the GM crops currently commercialised are extensively traded internationally and that the countries growing them are also major exporters of these crops. For example, in 2000, a total of 168 countries imported maize, with 85% of the trade coming from the main countries growing GM maize. Although many developing countries may not be actively involved in developing their own GM products, they may nevertheless wish to introduce regulations to cover the import of GM material or food.

For more information on regulatory frame work see
"Regulating GMOs in developing and transition countries", Background document to Conference 9: 28 April - 1 June, 2003, Food and Agriculture Organization.
http://www.fao.org/biotech/C9doc.htm#top