Evaluation of Living Modified

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Evaluation of Living Modified
Organisms as Potential Plant Pests



Terri Dunahay, Ph.D.


Team Leader


International Policy

Biotechnology Regulatory Services

Animal and Plant Health Inspection Service


Terri.G.Dunahay@usda.gov

International Plant Health Risk Analysis Workshop

October 26, 2005


Niagara Falls

Overview


What is an “living modified organism”
(LMO)?



Evaluation of LMOs as potential plant
pests


Why?


ISPM
-
11



Risk assessment of LMOs in the United
States


comparison to ISPM
-
11

What is an LMO?


“Living modified organism"

means any
living

organism
that possesses a novel combination of genetic material
obtained through the use of modern biotechnology;


“Modern biotechnology”

includes:


Recombinant DNA and direct injection of nucleic acid into cells
or organelles, or


Fusion of cells beyond the taxonomic family




“Genetically engineered organisms”, “genetically modified
organisms”, “GMOs”, “transgenic organisms” “biotech crops”


Global Adoption of Genetically
Engineered Crops (2004)




(million hectares)

USA


47.6

Argentina

16.2

Canada


5.4

Brazil



5.0

China



3.7

Paraguay


1.2


India



0.5

South Africa


0.5

Uruguay


0.3

Australia


0.2

Romania


0.1

Mexico



0.1

Spain



0.1

Philippines


0.1


Soybeans


herbicide tolerant


Corn


insect resistant (Bt)


herbicide tolerant


Cotton


insect resistant (Bt)


herbicide tolerant


Canola


herbicide tolerant


(ISAAA, 2004)

ISPM
-
11


Revised 2004: “Pest risk analysis of quarantine
pests including analysis of environmental risks
and living modified organisms”



Provides guidance on evaluating LMOs as potential
plant pests



There has been little discussion about practical
implementation of this guidance and relationship of
LMO risk assessment to the conventional PRA
process


Why evaluate LMOs as potential plant pests?


LMOs are generally common plants that have
been modified using modern biotechnology
techniques to add or alter a trait affecting
agronomic properties or product quality



Risk assessment process asks whether this
change could intentionally or unintentionally
cause the engineered organism to be harmful to
plants in agriculture or the environment, as
compared to the non
-
engineered organism.

Use of ISPM
-
11 for assessment of LMOs



Initiation Stage of ISPM
-
11


identification of pests and
pathways of quarantine concern



Most LMOs are not pests


Often familiar organism with one or more new traits


Does this trait change the probability that the
organism could cause harm to plants?



Conventional crops


first step is to request Pest List



For LMOs, first determine if the LMO is a potential pest


Go to Annex 3


provides guidance for determining
the potential for a LMO to be a pest

Annex 3
-

What characteristics of LMOs
might contribute to increased plant pest risk?


Donor or recipient organism is a plant pest


Nucleic acid vector is derived from a plant pest


Introduced trait increases likelihood for organisms to
become weedy or invasive, for example, by changing
the reproductive or survival potential


Gene transfer to weedy relatives


Effects on non
-
target organisms


Changes in agronomic practices


Production of toxins or anti
-
nutrients


Possible conclusions of pest assessment of
LMOs as per Annex 3

YES

-

the LMO
is

found to be a potential pest



LMO would be subject to Stages 2 and 3 of
the PRA as a potential quarantine pest


NO

-

LMO
is not

found to be a pest



LMO is not subject to further assessment
under ISPM
-
11



organism would be subject to same
phytosanitary requirements as conventional
counterpart

How does risk
assessment

of LMOs in the United
States relate to PRA
under ISPM
-
11?

Regulation of LMOs by USDA/APHIS



“Regulated Articles”


If the organism has been produced or
modified using genetic engineering


If there is a possibility that the organism
could be a
plant pest

(cause harm to
plants)



Authorizations are required for importation,
interstate movement, or field testing of
regulated articles

Pest risk assessment to allow unconfined
environmental release (“commercialization”)



Developers can apply for “non
-
regulated
status” for a genetically engineered organism if
they want to import or grow it without oversight
by Biotechnology Regulatory Services



Must provide data to demonstrate the
organism will not present a greater plant
pest risk than the conventional plant


Systematic reviews of new genetically
engineered organisms



Molecular characterization of each new
gene and protein produced




What is likelihood this new gene or trait
will increase the potential of the organism
to pose a pest risk?




What are the characteristics of the whole
organism that could make this organism
more of a pest than the non
-
engineered
organism?

Data requirements to determine “non
-
regulated status”


Data must include comparison to
conventional crop regarding:


Potential weediness


Effect of gene transfer to compatible
relatives


Production of new products or enzymes, or
changes in plant metabolism


Harm to non
-
target organisms


Possible change in cultivation practices

Non
-
regulated status of genetically
engineered organisms



“Non
-
regulated status” is granted if risk assessment
results in conclusion that the organism poses no greater
risk as a plant pest than its conventional counterpart



Comparison to ISPM
-
11
-

To date, all LMOs subjected to
this review by APHIS have been determined
not

to pose
a pest risk, (OR product withdrawn from review)


No situation where a LMO was determined to be a potential
pest and the developer wanted to release or import that
product for commercialization.


No need to go past “Stage 1


initiation”

Regulation of LMOs in APHIS


Plant Protection and
Quarantine (PPQ)


Does the
conventional
variety of that
organism pose a
pest risk (directly,
or as a vector for
pests?)


Biotechnology
Regulatory Services
(BRS)


Does the genetic
modification alter
pest potential of
the organism?


Conclusions



Increasing international development and adoption
of LMOs will result in more requests for decisions
regarding importation and use of these products



PRA framework under the IPPC is an appropriate
mechanism for assessing potential plant pest risks
of LMOs



There is a need for increased awareness and
discussion by NPPOs about LMO risk assessment
and the relationship of LMO risk assessment to PRA
as performed for “conventional” pests


For More Information:



www.aphis.usda.gov/brs
(APHIS

biotechnology regulation)



www.aphis.usda.gov/ppq/pra

(APHIS PRAs)



www.usbiotechreg.nbii.gov

(USG unified site on biotechnology)