CTNBio

Resolução Normativa Nº 3, de 16 de agosto de 2007

Normative Resolution No. 03 of August 16th, 2007.

It disposes of monitoring norms of genetically modified
corn in commercial use.


The National Technical Biosafety Commission (CTNBio), in
the use of its legal and regular attributions, observing
the dispositions contained on item III of art. 14 of Law
No. 11.105, of March 24th, 2005, decides:


Art.1. The monitoring norms established on this
Normative Resolution are applicable to the events of
genetically modified corn and its progeny.
Art.2. The scope of the monitoring plan after
commercial liberation will range in consonance with
the use and analysis of CTNBio's risk evaluation, and
also with the opinion on the technical decision.
Art. 3. The monitoring plan will be approved by
CTNBio, considering the answer presented by the
titular of the process to be elaborated based on
scientific methodologies attained to risks hypotheses
raised on the evaluation for technical decision.
Sole Paragraph. The commercial release requests
petitioners will be responsible for implementing the
monitoring plan, which may be executed through hiring
services from institutions capable of executing them
independently, observing the disposition on this
Normative Resolution.
Art. 4. The commercial release request petitioner may
make the following arrangements and make them
available to technology users, to technicians, to
rural extension professionals and consultants:
I – create a Consumer Assistance Service (SAC),
though accessible and appropriate means of
communication;
II – copy informative material regarding the
event approved by CTNBio; and
III – promote technical meetings, aiming at
providing information about the technology
applied on the monitoring plan improvement, to
help the technology users, technicians, rural
extension professionals, and consultants identify
and notify occurrences regarding the object of
monitoring.
Art. 5. The petitioner should keep record of technical
meetings executed, of the collected information, and
of the actions taken, making such data available to
the competent inspection organs and to CTNBIo that
will broadcast them through SIB an on the web page.
Sole Paragraph. All registrations of activities
executed will be kept by the petitioner for, at least,
5 (five) years, after the end of the monitoring
period.
Art. 6. The petitioner will submit the monitoring plan
at moment of delivery of the commercial release
request, and will have 30 (thirty) days to adequate
its monitoring plan proposal for CTNBio's appreciation
and approval, after the publication of favorable
technical decision for the commercial use.
Sole Paragraph. The petitioner that has already
received favorable technical decision for its product
commercial release, or that has entered in a protocol
request with this objective, will have 30 (thirty)
days after this Normative Instruction publication,
extended at CTNBio's discretion, to present the
proposal of the monitoring plan.
Art. 7. During the whole period of monitoring
execution all procedures will be inspected by the
registration and inspection organs and entities.
Sole Paragraph. The organs and entities referred to on
the caput of this article will inform CTNBio about
their procedures, and, at their discretion, they may
invite CTNBio's members to compose the inspection
teams.
Art. 8. Under justification, CTNBio may alter the
monitoring plan at any time.
Art.9. The present Normative Resolution is in force
from its publication date.


Walter Colli
CTNBio President


 


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