Transcript No Slide Title

RISK ASSESSMENT OF
GMOs UNDER CONTAINED
AND FIELD USE
EXPERIMENTS
Veronica O. Sinohin; Senior Science Research Specialist
Ecosystems Research and Development Bureau (ERDB)
DENR Alternate representative, National Committee on
Biosafety of the Philippines (NCBP)
Risks - the combination of the
likelihood that the adverse
consequence of a biohazardous
activity will occur and the
magnitude of such a consequence
Risk Assessment - the process of
identifying hazards to human
health and the environment that
may be caused by any planned
release activity, including the
process of assigning magnitudes
and probabilities of the adverse
effects
Objective of Risk Assessment
(Cartagena Protocol on Biosafety)
to identify and evaluate the
potential adverse effects of LMOs
on the conservation and
sustainable use of biological
diversity in the likely potential
receiving environment, taking
also into account risks to human
health
Components of Risk Assessment:
1. Risk identification – what
possible danger is expected if the
GM plant is handled, eaten as food
or feed or planted as a crop beyond
that ordinarily obtained with its
traditional counterpart with a
history of safe use?
2. Risk evaluation – what is the
probability that such danger will
occur? How much damage can be
expected from such occurrence?
How does it compare with
alternatives?
3. Risk mitigation – what
measures can be adopted to
reduce the probability that the
danger will occur or to minimize
the damage if danger occurs?
Steps in Risk Assessment:
1. “setting the scene” for the risk
assessment
2. The actual risk assessment
As a first step in the RA, it is useful to “set
the scene” of the assessment by listing on
a cover note:
- the applicant
- the recipient organism, including
whether the recipient plant can cross
fertilize with wild flora and/or with
cultivated crops
- the type of application (e.g. contained
use, field trials under controlled
conditions or a commercial release)
- the inserted or modified genes or
sequences
The actual risk assessment:
1. Identification of potential adverse
effects that may arise from
modification of the genotypic and/or
phenotypic characteristics of LMO and
its introduction to a potential
receiving environment, taking into
account risks to human health
2. An evaluation of the likelihood of these
adverse effects being realized, taking
into account the level and kind of
exposure of the likely potential
receiving environment to the LMO
3. Evaluate the consequences should
the identified effects be realized
(the risk)
4. Consider appropriate risk
management strategies
5. Estimate the overall potential
environmental impact, including a
consideration of potential impacts that
may be beneficial to human health or
the environment
5. Estimate the overall potential
environmental impact, including a
consideration of potential impacts that
may be beneficial to human health or
the environment
The NCBP Procedures for GMOs under
Contained use experiment(PBG,1991)
•Upon receipt of proposal, the NCBP will form
a working group, members of which may be
drawn from the NCBP itself, who will assess
the proposal based on the Procedures for
Evaluation (Section II, No. 3, PBG, 1991).
•Assessment of Risk will be based on the
characteristics of the biological product and on
the process by which it was obtained.
Questions from the Procedure of
Evaluation:
• Characteristics of research
organisms(plants ; microorganisms)
•Degree of genetic manipulation
•Location of experiment
•For experiments involving rDNA plant
- Characteristics of donor DNA
- Construction method of rDNA
•For experiments involving rDNA
microorganisms
-characteristics of the recipient
organisms
- pathogenicity, active compounds
- characteristics of donor DNA
- characteristics of rDNA organisms
- epidemiological factors
- laboratory environment
The risk assessment should be
carried out case by case and on the
basis of transformation event
The risk assessment done on the
particular GMO will determine the
required biosafety level
Containment
Containment describes the safe
method for maintaining control
over the distribution of GMOs in
the laboratory and in the
environment
Biological containment - involves the use of
specific combination of vector and host to
reduce the probability of transfer of a
vector to an unintended host and to limit
subsequent survival of the host-vector
combination in the environment.
Physical containment - involves physical
constraints on the movement of GMOs of
uncertain risk or potential hazard. It
involves well qualified and competent
personnel who follow safe, standard
procedures, and a working environment
designed to prevent unintended spread of
GMOs in the environment
Biosafety level 1 – is suitable for work
with strains of viable organisms that are
known not to cause disease in humans,
animals, and plants. Appropriate for
undergraduate and secondary laboratory
work
Biosafety level 2 – is suitable for work
involving GMOs with moderate potential
hazards to humans and environment.
Personnel are trained to handle the GMO and
access to the laboratory and containment
facilities are limited
Biosafety level 3 – is suitable for work with
indigenous or exotic agents that may cause
serious or potential lethal disease as a result
of exposure. Requires personnel training,
strict working practices, qualified supervision,
and strict physical containment.
Biosafety level 4 – is suitable for work
involving agents that pose a high individual
risk of life-threatening disease. Requires
personnel training, strict working practices,
qualified supervision, and strict physical
containment.
Risk Assessment Procedures for GMO to
be used for Field Trial(NCBP Series No. 3;
1998)
Core Questions:
Part 1A. Genetically Modified Organisms
A. Objectives of the proposed activityWhat is the intended eventual use of
the organism to be released?
Core Questions:
Part 1A. Genetically Modified Organisms
B. What species is/are to be released? Is the wild type organism found at the
site of release? Is it capable of causing
human, animal or plant disease?
C. Describe the site chosen for the
planned release?- How close is the site
to existing populated areas, centers of
agricultural activity, protected areas, or
habitat of endangered species?
Core Questions:
Part 1A. Genetically Modified Organisms
D. Habitat and Ecology: What is the
natural habitat of the wild type
organism?; Is the wild type
organism or its closest taxonomic
relative present at or near the site of
release?
Core Questions:
Part 1A. Genetically Modified Organisms
E. GMO Genetics: What genetic
manipulations have been made?;
Give the characteristics of the GMO
and specify how it differs from its
wild type counterpart?; How many
copies of the manipulated gene/DNA
sequence are present? How is the
level of expression regulated?
Core Questions:
Part 1A. Genetically Modified Organisms
F. Data on stability, survival and transfer
under contained conditions: Was this
organism studied under containment?
What containment level was used in the
study of this organism? What are the
dispersal mechanisms used by the GMO or
its wild life type counterpart in air, water
and soil?
Core Questions:
Part 1A. Genetically Modified Organisms
G. Experimental Procedures: Describe in
detail the overall experimental design for
the release, including methodology,
layout of site for release, schedule of
release and duration of entire activity
Information for the Risk Analysis
A. Parent (Wild type) Organism
B. Genetic Constituents
C. Phenotype of Organism
D. Attributes of the Environment
NCBP Field Evaluation on the Indicative
conditions of the Proposed Test Site
Component/Description
A. Physical Environment
- Area
- Soil type/topography
- Climatic type
- Meteorological data; rainfall
pattern,wind direction, velocity,
temperature, relative humidity
Distance to:
- Bodies of water
- Populated areas
- Center of agricultural
activity
- Protected areas/habitat of
endangered spp.
* Does it fall under Environmental Critical
Area per DENR AO 96-37?
B. Biological Environment
Vegetation
- Weed species
- Forest tree species
- other crops
Entomological Communities
Insect pest; Predator/ beneficial
insects
- Avian species; reptiles;
- Profile of microorganisms
C. Social Environment
- local population near the site
- cultural profile
- ecological support system
- economic activities
- health facilities
- security of the site
THANK
YOU!!!
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