Risk assessment and risk management of LMOs with stacked genes or traits (part I)

I introduce the concept of risk assessment of LM plants with stacked genes and traits under open field (Type 1 in Domestic Law in Japan).

We consider the effect of LM plants on biodiversity in two generations.

1) The first generation
The traits (genes) of first generation LM plants did not affect on competitiveness, productivity of harmful substances, and crossability, such as herbicide-tolerance, Bt.

As a rule, parental LM plants must be accepted for cultivation under open field.
We judge whether traits of stacked LM plants have any interaction or not.

A) NO
We only judge whether each trait express as well as parental LM plants.
B) YES
We request the ad hoc data based on assumable quantitative and/or qualitative effect of LM plants on biodiversity, and newly evaluate the effect.

In the first generation, multi-stacked LM plants are also evaluated as well as two-way stacked LM plants. In this case, we judge not only multi-stacked LM plants but also intermediate stacked LM plants, including falling out the traits from multi-stacked plants. And when no interaction exists among all assumed combination of traits, we judge the effect on biodiversity as well as A).

The traits, such as male sterile, should be carefully taken into account on falling out from the LM plants, since negative impact to biodiversity will be apprehensive when such traits act alone in plants.

2) The second generation
The traits (genes) of first generation LM plants may affect on competitiveness, productivity of harmful substances, and crossability, such as environmental stress tolerance and quantitative and qualitative growth modification.

In this case, the LM plats is probably judged as it affect on the biodiversity in the Domestic Law in Japan. Therefore we have to carefully evaluate “case by case” more than the first generation. And the restriction of cultivation area and/or monitoring will be imposed.

There are two concepts to judge environmental stress tolerance. We evaluate the effect on biodiversity based on the concept A).

A) Biodiversity under domestic condition: The trials at open field in Japan are needed.
B) Biodiversity under environmental stressed condition: The trials at the condition which reproduce the environmental stress is needed.

Regards