Environmental Risk Assessment

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Environmental Risk Assessment

• Prasartporn Smitamana
• Plant Biotechnology Research Centre
• The Royal Project Foundation/
• Chiang Mai University

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Why ?
We dont want to see the actions like these.
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What is Risk?
Risk Uncertain consequences, particularly
exposure to unfavorable consequences.
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Biological Risks - the combination of the
likelihood that the adverse consequence of a
biohazardous activity will occur and the
magnitude of such a consequence
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Could we eliminate risk?
NO!!
Thats why we need to Manage risk.
Before we could manage risk, we should know how
risk could be assessed..
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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
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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
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Key Words for Risk Assessment

• Hazard Identification
• Dose-Response
• Exposure Assessment
• Aggregate Risk Assessment (risk to whole
  population)

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Components of Risk Assessment 1. Risk
identification what possible danger is expected
if the GM 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?
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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?
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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?
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• Most biosafety legislation and regulation call
  for
• Case-by-caseand step-by-step evaluation of
  GMOs (EU Directive 2001/18/EC, Cartagena
  Protocol, etc.).
• Environmental risk or impact assessments that
  include effects on nontarget organisms.
• EU directive calls to evaluate
• immediate and delayed effects
• direct effects caused through direct exposure and
  impact by novel transgene product
• indirect effect caused via a chain of events
• However, no methodologies how to do this best are
  specified (till now)!

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Major criterion
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
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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
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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
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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.
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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.
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Why are effects on non target organisms
important?

• Change in biodiversity structure of nontarget
  organisms in agro-ecosystems can result in
  change in function and services provided by these
  nontarget organisms.

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Implications for GM Plants
- Current transgenic insecticidal Bt-plants
express highly bioactive toxins in high
concentrations in all plants part (some
including pollen) throughout the entire season.
- GM product expression coupled to plant
physiology and metabolism, with concentrations
varying depending on tissue, plant age, location
and season. Conclusion GM plants and their
novel transgene products resemble plants
rather than chemicals! Nontarget effect
testing should account for that
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Standard non-target organisms tested according
pesticide paradigm
Water fleas (Daphnia magna) acute, 48 hrs
static renewal with pollen Springtail (Folsomia
candida) chronic, 28 days, yeast test
material Earthworm (Eisenia foetida) 14 days,
soil test material Honey bee (Apis mellifera)
acute, 45 minutes, undigested pollen
water Predatory/parasitoids insects Hippodamia
convergens - adults tested, bitrophic Nasonia
vitripennis adults tested pupal parasitoid of
house flies, minor ecological relevance,
bitrophic Chrysoperla carnea larvae, bitrophic,
coated meal-moth eggs, ca. 1 week Testmaterial
used - Lyophilized leaf protein as dietary test
material - Microbially produced, activated
Bt-toxin Test duration Test endpoints
toxicological parameters - short time, acute
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Differences between pesticides and
GM insecticidal plants

• Pesticides
• - Release controlled by applicator timing, point
  location, etc.
• - Degradation begins immediately after
  application
• Mode of action typically acute, immediate also
  for nontargets
• GM Bt-Plants
• - Release continuous and in all plant parts
• Tissue-specific production coupled to plant
  physiology
• Mode of action not immediate (takes 2 days or
  longer
• before target dies)
• - Sublethal, chronic effects more important for
  nontargets.
• Induces very different dynamics/types of
  non-target effects

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Field tests of GMOs

• 2004 170 million acres of GM crops planted
• More than 25,000 field trials conducted on more
  than 60 genetically engineered plants in 45
  countries
• Soybean, corn, cotton, canola, squash, papaya
• Herbicide/pest resistant
• Pesticide use reduced by 2.7 million pounds in 25
  million fewer sprays in B.T. cotton
• 19 million fewer sprays of herbicides
• Improved yield/ farmers health/ lower cost
• Greenpeace, especially in Europe opposed

http//www.pbs.org/wgbh/harvest/exist/images/farm5
.jpg
Greenpeace uproots GM crops in a Norfolk
fieldnews.bbc.co.uk/.../ tech/newsid_762000/76225
4.stm
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GM crops Concerns

• European opposition fueled by the Mad Cow disease
  in 1990s 100,000 infected cattle, 90 Europeans
  killed (infected carcass used in feed)
• 1998 Monarch Butterfly story non-target
  insects withdrawn
• 2000 StarLink (0.43 of all U.S. corn) not
  approved for human use found in Taco shell
• 1998 Scotland controversial study on mice fed
  with transgenic potatoes (encoding lectin) had
  suppressed immune response
• 2003 Prodigene fiasco Food crop contamination
  with Pharm crop
• Creation of Super-weeds
• Development of pest resistance (refuge strategy)
• In Europe, Japan, GM food must be labeled

http//www.kidzone.ws/animals/monarch3.jpg
http//www.foe.co.uk/campaigns/real_food/images/gm
.jpg
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GMO-Guidelines Project

• Project is funded by the Swiss Agency for
  Development and Corporation (SDC) and aims to
• develop comprehensive, transparent scientific
  guidelines for pre-release biosafety testing of
  transgenic plants, which could serve as an
  international standard.
• 2.   facilitate the development of the scientific
  capacity in developing and developed countries to
  implement the guidelines
• 3.   test the application of the guidelines in
  real policy contexts to assist in the evaluation
  of particular transgenic crops.
• 4.   publish the guidelines and revise them in
  response to new developments thereby providing
  for their up-to-date, long-time use.     

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Ecological approach to nontarget species
selection

• Case-specific species selection, i.e. depending
  on GM crop and its cropping context.
• Following several steps
• Establish functional categories (pollinator,
  biocontrol)
• Classify the nontarget species known to exist in
  the relevant ecosystems
• Rank and select testing species based on
  ecological principles
• Exposure Analysis
• Hazard analysis
• Science-based Risk Assessment for Nontarget
  Effects of Transgenic Crops, BioScience 54, 2004
  637-649

Determine ecological endpoint (parameter) and
testing protocol

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• Exposure analysis
• Nontarget species could be affected by
• GM products in the GM plant, plant
• secretions, herbivores, herbivore
• secretions or other species containing
• the transgene product
• Metabolites of the GM products
• INTERACTIONS of the GM products with
• metabolites and other plant/herbivore
• compounds

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• IMPROVEMENTS
• Case-specific (not universal)
• ecological endpoints
• (instead of toxicological)
• informs the design of
• realistic testing protocols
• (realistic exposure routes)
• center of assessment
• hazard hypotheses to
• be confirmed or refuted
• (1 or several experiments)

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• Report contains
• Key findings Recommendations should include
  following criterion
• Gene Flow
• Biodiversity
• Health
• Sociocultural Matters

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Key findings Transgenes have entered some
landraces in Mexico. ..., there is no doubt that
transgenes will spread in Mexican maize, and that
they are present now. Probable primary source of
transgenes Unlabelled imported maize grown in
the US imported to Mexico for food/feed. Some of
these are grown- typical practice in Mexico and
transgene spread through gene flow follows
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• Some Conclusions
• Removing transgenes after introgression into
  landraces is likely to be difficult and often
  impossible.
• Whether they will persist permanently after
  introgression and spread is not known.
• There is no evidence to suggest that patterns of
  inheritance of transgenes in Mexican maize or
  teosintes differ from their behavior in other
  organisms.... However, specific studies on
  whether negative or positive or neutral effects
  occur are lacking to date.

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Some conclusion (cont.) Because of its
cultural, spiritual status in Mexico, campesinos
in Mexico consider the presence of any transgene
in maize as an unacceptable risk ... and is
considered a contamination.. Risk assessment
of transgenic maize in Mexico is inextricably
linked to the central role of maize. So far
there is no evidence that introgression of
todays GM maize traits poses a significant harm
to health or the environment in Canada, Mexico
and the US. However, this has not been studied in
the context of Mexican ecosystems.
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ENVIRONMENT AS INTERNATIONAL CONCERN

• Environmental issues are often universal
• Environmental problems are often transboundary,
  e.g. pollution (Trail-Smelter Arbitration),
  conservation of migratory animals (Tuna-Dolphin
  case)
• Environmental problems are often global, e.g.
  protection of the ozone layer

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ENVIRONMENT AS REGIONAL CONCERN

• In addition to IL specific rules only binding
  on states in a geographic region
• Most significant in Western Europe EU
• Largely based on treaties
• Only binding on consenting states
• Rationale
• Regional environmental concerns
• Transboundary concerns
• Expansion of capacity

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Environmental protection Policies

• Promote sustainable use of Thailand natural
  resources
• Support Asian countries in implementing
  commitments under international and regional
  conventions
• Enhance human and institutional capacities
• Promote integration of environmental
  considerations into poverty alleviation
  strategies
• Foster regional and sub-regional co-operation
• Network of regional centers of excellence in
  environmental science
• Improve framework for regional environmental
  governance
• Mobilize international financial resources

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Steps in Risk Assessment 1. setting the
scene for the risk assessment 2. The
actual risk assessment
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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
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The actual risk assessment 1. Identification of
potential adverse effects that may arise from
modification of the genotypic and/or phenotypic
characteristics of GMO and its introduction to a
potential receiving environment, taking into
account risks to human health
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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
GMO.
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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
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5. Estimate the overall potential environmental
impact, including a consideration of potential
impacts that may be beneficial to human health
or the environment.
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Risk Assessment Procedures for GMO to be used for
Field Trial
Core Questions Part 1A. Genetically Modified
Organisms A. Objectives of the proposed
activity- What is the intended eventual use
of the organism to be released?
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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?
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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?
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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?
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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?
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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
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Information for the Risk Analysis

1. Parent (Wild type) Organism
2. Genetic Constituents
3. Phenotype of Organism
4. Attributes of the Environment

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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
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B. Biological Environment Vegetation - Weed
species - Forest tree species - other crops
Entomological Communities Insect
pest Predator/ beneficial insects -
Avian species reptiles -
Profile of microorganisms
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C. Social Environment - local population near
the site - cultural profile - ecological
support system - economic activities - health
facilities - security of the site
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CONCLUSION

• Many environmental challenges
• Lack of political will and commitment on
  environmental issues
• Implementation, compliance and enforcement
• Education and awareness
• Regional co-operation

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Even if you're on the right track, you'll get
run over if you just sit there.

• Will Rogers

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Thank you.