1. A
Party that makes a
final decision regarding
domestic use,
including placing on the
market, of a
living modified organism that may be
subject to
transboundary movement for direct use as
food or
feed, or for
processing shall, within fifteen
days of making that
decision, inform the
Parties through the
Biosafety Clearing-House. This
information shall contain, at a
minimum, the
information specified in Annex II. The
Party shall provide a
copy of the
information, in
writing, to the
national focal point of each
Party that informs the
Secretariat in
advance that it does not have
access to the
Biosafety Clearing-House. This
provision shall not apply to
decisions regarding
field trials.
2. The
Party making a
decision under paragraph 1 above, shall ensure that there is a
legal requirement for the accuracy of
information provided by the
applicant.
3. Any
Party may
request additional
information from the
authority identified in paragraph (b) of Annex II.
4. A
Party may take a
decision on the
import of
living modified organisms intended for direct use as
food or
feed, or for
processing, under its
domestic regulatory framework that is consistent with the
objective of this
Protocol.
5. Each
Party shall make available to the
Biosafety Clearing-House copies of any
national laws,
regulations and
guidelines applicable to the
import of
living modified organisms intended for direct use as
food or
feed, or for
processing, if available.
6. A
developing country Party or a
Party with an
economy in
transition may, in the
absence of the
domestic regulatory framework referred to in paragraph 4 above, and in
exercise of its
domestic jurisdiction,
declare through the
Biosafety Clearing-House that its
decision prior to the first
import of a
living modified organism intended for direct use as
food or
feed, or for
processing, on which
information has been provided under paragraph 1 above, will be taken according to the following:
(a) A
risk assessment undertaken in
accordance with Annex III; and
(b) A
decision made within a predictable
timeframe, not exceeding two hundred and seventy
days.
7. Failure by a
Party to
communicate its
decision according to paragraph 6 above, shall not imply its
consent or refusal to the
import of a
living modified organism intended for direct use as
food or
feed, or for
processing, unless otherwise specified by the
Party.