Europe Releases Guidelines for Growing Pharmaceutical-Producing GM Plants

The European Food Safety Authority (EFSA) has published the first European guidelines for growing genetically modified plants producing pharmaceuticals or industrial enzymes. Under the guidelines, applicants need to specify the differences between the GM plant and its non-transgenic counterpart and how these differences affect the plant's function and growth. EFSA says that the comparative analysis is important, particularly "with regard to accidental intake by humans, livestock and wildlife animals, the exposure of farmers and workers handling the GM plants, and the exposure of passers-by and of people living in the vicinity."

The guidelines also state that applicants need to detail the measures they will take to prevent the escape of GM plant materials into the environment. With regards to plants that produce stable bio-active substances, for instance, the applicants should devise ways to prevent or reduce herbivory and leakage through drainage or sewage. Applicants should also provide data that will allow the assessment of confinement measures under all environmental conditions, including worst-case scenarios.

EFSA will only take into account the "risks" of growing the GM plant. The European Medicines Agency (EMEA) will be in charge of assessing the safety of plant-produced substances.

According to an article published by nature, the guidelines "compare favorably" with rules set out by the U.S. Food and Drug Administration (FDA) and Department of Agriculture (USDA).

Download the guidelines at http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902783659.htm Subscribers to Nature can read http://www.nature.com/news/2009/090807/full/news.2009.630.html for more information.