Using the tools of biotechnology to aid in restoring species attacked by disease will test the application of current regulatory policy where flowering and propagation of the tree is desired. A genetically modified American chestnut provides a “test case” across all three regulatory agencies, APHIS, EPA and FDA, and offers the application of biotechnology for societal benefit.
Explore if there are effective but less onerous regulatory options for approving the use of advanced biotechnologies, including genetically modified forest trees, developed for societal benefit and where intellectual property rights are publicly held, in order to accelerate the development and consideration of alternative means of combating forest health threats.
To meet this objective FHI’s Regulatory group recommends exploring possible approaches for using GM forest trees to address forest health issues. These approaches would focus on safety and efficacy and be predicated on the core operating values of the FHI including that the public owns the key intellectual property used in the biotechnology solution. The development of a strategy to explore possible alternatives will be pursued in collaboration with regulatory agencies, various constituencies, the FHI Steering Committee, and other interested government agencies and NGOs.
The underlying concepts are:
Safety: Genes that are similar in function, have been well studied and have a strong basis to assume they will cause limited perturbations, could be allowed to be tested in GM trees in natural environments. This is because the tree’s efficacy and ecological effects can only be confidently observed in the field.
Consequences: Effective responses to forest health challenges require action on a time scale capable of avoiding the worst outcomes. Current regulatory timelines dictate that potential biotechnology-based solutions likely cannot be evaluated before the forest health threat has caused significant tree mortality.
Efficacy: Adaptive research methods are well established in tree breeding, and can be used to study efficacy and environmental impacts during field research and hold the potential to understand the implications of introducing GM tree varieties into the environment to address forest health challenges.