Points to consider in seeking biosafety approval for research, testing, and environmental release of experimental genetically modified biocontrol products during research and development
Seasoned regulatory experts from around the world have come up with a
protocol that developers of genetically modified(GM) biocontrol products
will find useful in understanding the required safety data and
information when generating a regulatory dossier to be used for the
evaluation and decision making. Regulators will also likely benefit from
the tool as it will help support their systematic and rigorous
evaluation towards the product.
GM biocontrol products are novel in nature and involve the release of GM
organisms into the environment, sometimes intentional, to prevent the
transmission of vector-borne parasitic and viral diseases and the spread
of invasive plant and animal species. These interventions are often not
completely covered by existing biosafety regulations and this poses new
challenges and opportunities for regulatory overview and
decision-making. Thus, a group of experts have come up with the tool for
technology developers to organize and plan their information gathering
on a case-by-case basis when developing a regulatory dossier in order to
gain approval to conduct laboratory research, confined field testing,
and controlled release of the GM control products into the environment.
The recommendations resulting from the new protocol may also be
informative for other types of genetic biocontrol products.
The new tool takes into account that information on the receiving
environment and intended use of the GM biocontrol product will be
significantly different in each situation. Hence, the plans for risk
assessment and risk management are expected to also be different for
each situation as it will be dependent on the potential spread of the
product. It also considers that containment may encompass physical
confinement in indoor and outdoor facilities, and environmental release
may be conducted in phases starting with isolated small-scale testing
that will work into a larger scale testing in different conditions with
a separate biosafety approval to be obtained for each of the different
phases of release.