Risk assessment and risk management of transgenic pharmaplants

Traits (transgenic genes) in pharmaplants inevitably modify the metabolism. Then the following points may be raised as ad hoc assessment items.

a) Productivity of harmful substances full life cycle and each part of plants, including seeds and fruits.
b) Adverse effects on the predators such as mammals (except for human), birds, earthworm, and the other small animals
c) Productivity of unexpected harmful substances in natural plants cross-compatible with LMO, after transgenic genes were transferred to the plants

Gene expression was regulated in limited part of plants or full body by each promoter. And the traits, crop and environment are different among events and countries. Therefore case by case approach is needed to consider the above points.

In addition, we should bear in mind about adverse effects of volatile metabolites on natural plants, since some metabolites may have high vapor pressure, such as aromatherapy.

As far as I understand, we will discuss on adverse effects on biodiversity of pharmaplants here. Therefore, occupational exposure and oral toxicity for human should not be discussed, or at least separately discussed. On the other hand, oral/Inhalation toxicity for natural living organisms should be carefully discussed, since some metabolites derived from introduced gene may cause unexpected toxicity to natural living organisms.