IV. PROVIDING FOR SAFETY: MECHANISMS AT NATIONAL AND REGIONAL LEVEL
33. To implement adequate risk assessment and risk management, countries would need
to establish or designate or strengthen national and/or regional authorities/ national
institutional mechanisms for oversight and/or control of the use of organisms with
novel traits. The authority or mechanism should have, or have access to, relevant
scientific and technical knowledge and experience.
34. Effective oversight mechanisms require that: a risk assessment has been done;
or the organism has been exempted from oversight on the basis of experience and knowledge;
relevant users supply to the authority/national institutional mechanism all required
relevant information or appropriate references; users record the outcome of relevant
activities and inform the authority/national institutional mechanism of the outcome
when required. In particular, they should provide relevant information if there is
an unexpected or adverse effect on human health or environmental impact during, or
as a result of, the notified use.
35. To fulfil their responsibilities efficiently and effectively, authorities/national
institutional mechanisms need adequate capacities which should help to avoid any
delay in making decisions.
36. For organisms with novel traits requiring evaluation, an authority/national institutional
mechanism should determine who is responsible for preparing and reviewing risk assessments
and proposed risk management. It might consider local review to be appropriate; it
might conduct the review itself; it may establish a multidisciplinary body, consisting
of scientific experts; or it may choose to use a combination of particular expertise
from inside and outside the country or region.
37. Mechanisms for oversight and/or control can include prior notification to the
authority/national institutional mechanism of contained use facilities and certain
contained uses and releases of organisms with novel traits, and the marketing of
products containing or consisting of organisms with novel traits. If prior notification
of activities under oversight is required, such notification may or may not require
a positive decision from the authority/national institutional mechanism before the
notified use can proceed.
38. As set out in Agenda 21 and relevant provisions of the Convention on Biological
Diversity, authorities/national institutional mechanisms are responsible for encouraging
public participation by allowing access to information on which decisions are based,
whilst respecting confidential commercial information. This should allow for local
knowledge and circumstances to be taken into account in risk assessments. Users are
encouraged to enter into dialogue with their staff/ personnel as well as with the
general public and workers about their activities. Examples of mechanisms for informing
the public are provided in Annex 7.
39. The responsibility for establishing and/or implementing appropriate mechanisms
providing for safety lies with countries and/or regions.