Taipei, Taiwan
May 15, 2008
USDA/FAS GAIN report TW8025
http://www.fas.usda.gov/gainfiles/200805/146294586.pdf
Highlights
Taiwan has implemented
registration for stacked traits, effective immediately, in
accordance with a May 6 notice issued by the Department of
Health (DOH). Taiwan believes that this is supplementary to
existing GM registration requirements on single events. While it
does not intend to make a notification to the WTO, DOH is open
to suggestions from interested parties. DOH did not specify a
deadline for completion of commercial stacked event
registration. As a result, no impact on US corn and soybean
trade is anticipated.
Summary
Taiwan has implemented
registration for stacked traits, effective immediately, in
accordance with a May 6 notice issued by the Department of
Health (DOH). Taiwan believes that this is supplementary to
existing GM registration requirements on single events, and does
not intend to make a notification to the WTO. DOH also did not
specify a deadline for completion of commercial stacked event
registration. As a result, no impact on US corn and soybean
trade is anticipated due to Taiwan’s implementation of stacked
event registration.
According to the following Guideline for Food Assessment of
Foods Derived from Genetically Modified Plants with Stacked
Traits, commercial stacked events belong to Category I and II
are allowed to submit a simplified dossier for DOH’s approval
registration review, however, Category III stacked events will
be treated as brand new events that require submission of a
comprehensive dossier for full review. According to DOH’s
investigation, there are some twenty commercial stacked corn
events on the Taiwan market, one of which falls into Category
II, and the rest are Category I. There are no soybean stacked
events commercialized.
DOH is open to suggestions from interested parties to improve
Taiwan’s stacked event registration process. The following
English version of the Guideline is not yet published on the DOH
website.
Guideline for food safety
assessment of foods derived from genetically modified plants
with stacked traits
I. Food safety
assessment of foods derived from genetically modified plants
with stacked traits
This Guideline applies only to foods produced using
genetically modified plants with stacked traits obtained
through conventional breeding between genetically modified
plants that are already approved.
II. Classification of genetically modified plants with
stacked traits:
A) Category I: plants with two or more traits that are
unrelated.
B) Category II: plants with two or more traits that are
related but with different modes of action.
C) Category III: plants with two or more traits that
function in the same biosynthetic pathway (i.e., have
increased potential for interaction).
III. Food safety assessment of foods derived from
genetically modified plants with stacked traits belonging to
category I and II
The following bridging studies would need to be carried out
to confirm that the stacked product is derived from the
combination by traditional breeding of the single
genetically modified events. The bridging studies would
consist of molecular characterization: a fingerprint-type
Southern blot analysis, in comparison to the parental lines;
information on the expression of new proteins: analysis of
gene expression in the stacked product to confirm that gene
expression in relevant tissue(s) is comparable to that in
the single genetically modified events; and compositional
analysis and agronomic variables: the compositional and
agronomic analysis for the stacked product would be
undertaken over a single growing season (4 sites), and
relevant comparisons would be made either with the
single-event genetically modified plants or with the non-
genetically modified control of comparable genetic
background.
Protein safety evaluation and animal feeding studies of
foods derived from genetically modified plants with stacked
traits belonging to category I and II would need to be
conducted when necessary.
If no changes to protein mode of action can be expected in
the stacked product, no additional safety evaluation of the
proteins and animal feeding studies would be required. If an
interaction between the introduced proteins affecting their
mode of action is expected, the need for additional studies
should be evaluated on a case-by-case basis.
IV. Foods derived from genetically modified plants with
stacked traits belonging to category III are considered as
new genetically modified foods, requiring a complete food
safety assessment carried out in accordance with DOH
guidelines.
V. Review process
Recognizing the rapid pace of development in the field of
biotechnology, the approach to food safety assessment of
foods derived from modern biotechnology should be reviewed
when necessary to ensure that emerging scientific
information is incorporated into the risk analysis. When new
scientific information relevant to a risk assessment becomes
available the assessment should be reviewed to incorporate
that information and, if necessary, risk management measures
adapted accordingly.
Original document:
http://www.fas.usda.gov/gainfiles/200805/146294586.pdf
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