Environmental Risk Assessment Prasartporn Smitamana Plant Biotechnology Research Centre The Royal Project Foundation/ Chiang Mai University

Environmental Risk Environmental Risk AssessmentAssessment

Prasartporn SmitamanaPrasartporn Smitamana

Plant Biotechnology Research CentrePlant Biotechnology Research Centre

The Royal Project Foundation/The Royal Project Foundation/

Chiang Mai University Chiang Mai University

Why ?Why ?We don’t want to see the actions We don’t want to see the actions like these……………….like these……………….

What is Risk?What is Risk?

Risk – Uncertain consequences, Risk – Uncertain consequences, particularly exposure to particularly exposure to unfavorable consequences.unfavorable consequences.

Biological RisksBiological Risks - ‘the combination - ‘the combination

of the likelihood that the adverse of the likelihood that the adverse

consequence of a biohazardous consequence of a biohazardous

activity will occur and the magnitude activity will occur and the magnitude

of such a consequence’of such a consequence’

Could we eliminate risk?Could we eliminate risk?

That’s why we need to That’s why we need to ManageManage risk…. risk….

Before we could manage risk, we should Before we could manage risk, we should know how risk could be assessedknow how risk could be assessed....

Risk AssessmentRisk Assessment - the process of - the process of

identifying hazards to human health identifying hazards to human health

and the environment that may be and the environment that may be

caused by any planned release activity, caused by any planned release activity,

including the process of assigning including the process of assigning

magnitudes and probabilities of the magnitudes and probabilities of the

adverse effectsadverse effects

Objective of Risk Assessment Objective of Risk Assessment (Cartagena Protocol on Biosafety)(Cartagena Protocol on Biosafety)

‘‘to identify and evaluate the potential to identify and evaluate the potential

adverse effects of LMOs on the adverse effects of LMOs on the

conservation and sustainable use of conservation and sustainable use of

biological diversity in the likely potential biological diversity in the likely potential

receiving environment, taking also into receiving environment, taking also into

account risks to human account risks to human health…’health…’

Key Words for Risk Assessment:Key Words for Risk Assessment:

Hazard IdentificationHazard Identification Dose-ResponseDose-Response Exposure AssessmentExposure Assessment Aggregate Risk Assessment (risk to Aggregate Risk Assessment (risk to

whole population)whole population)

Components of Risk Assessment: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?

2. 2. Risk evaluationRisk evaluation – what is the – what is the

probability that such danger will probability that such danger will

occur? How much damage can be occur? How much damage can be

expected from such occurrence? expected from such occurrence?

How does it compare with How does it compare with

alternatives?alternatives?

3. 3. Risk mitigationRisk mitigation – what – what

measures can be adopted to measures can be adopted to

reduce the probability that the reduce the probability that the

danger will occur or to minimize danger will occur or to minimize

the damage if danger occurs?the damage if danger occurs?

Most biosafety legislation and regulation call for: Most biosafety legislation and regulation call for:

““Case-by-caseandCase-by-caseand”” ““step-by-stepstep-by-step”” evaluation of GMOs (EU evaluation of GMOs (EU Directive 2001/18/EC, Cartagena Protocol, etc.). Directive 2001/18/EC, Cartagena Protocol, etc.).

•Environmental risk or impact assessments that include Environmental risk or impact assessments that include effects on effects on nontarget organismsnontarget organisms. .

•EU directive calls to evaluate:EU directive calls to evaluate:

•immediate and delayed effectsimmediate and delayed effects

•direct effects caused through direct exposure and direct effects caused through direct exposure and impact by novel transgene productimpact by novel transgene product

•indirect effect caused via a chain of eventsindirect effect caused via a chain of events

However, no methodologies how to do this best are specified However, no methodologies how to do this best are specified ((‘till now)‘till now)!!

‘‘The risk assessment should be carried out case The risk assessment should be carried out case by case and on the basis of transformation by case and on the basis of transformation event’event’

‘‘The risk assessment done on the particular The risk assessment done on the particular GMO will determine the required biosafety GMO will determine the required biosafety level’level’

Major criterion :Major criterion :

Biosafety level 1Biosafety 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


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


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.


involving agents that pose a high

individual risk of life-threatening

disease. Requires personnel training,

strict working practices, qualified

supervision, and strict physical

containment.

Why are effects on non target Why are effects on non target

organisms important?organisms important? Change in biodiversity structure of nontarget Change in biodiversity structure of nontarget

organisms in agro-ecosystems can result in organisms in agro-ecosystems can result in change in function and services provided by these change in function and services provided by these nontarget organisms.nontarget organisms.

Implications for GM PlantsImplications 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

Standard non-target organisms tested according Standard non-target organisms tested according ‚pesticide paradigm‘‚pesticide paradigm‘

Water fleas (Daphnia magna) – acute, 48 hrs static renewal with pollenSpringtail (Folsomia candida) – chronic, 28 days, yeast + test materialEarthworm (Eisenia foetida) – 14 days, soil + test materialHoney bee (Apis mellifera) – acute, 45 minutes, undigested pollen + water

Predatory/parasitoids insectsHippodamia convergens - adults tested, bitrophicNasonia vitripennis – adults tested; pupal parasitoid of house flies,

minor ecological relevance, bitrophicChrysoperla 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

Differences between pesticides and Differences between pesticides and GM insecticidal plantsGM 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

Field tests of GMOsField tests of GMOs 2004: 170 million acres of GM crops planted2004: 170 million acres of GM crops planted More than 25,000 field trials conducted on More than 25,000 field trials conducted on

more than 60 genetically engineered plants in more than 60 genetically engineered plants in 45 countries45 countries

Soybean, corn, cotton, canola, squash, papayaSoybean, corn, cotton, canola, squash, papaya Herbicide/pest resistantHerbicide/pest resistant Pesticide use reduced by 2.7 million pounds in Pesticide use reduced by 2.7 million pounds in

25 million fewer sprays in B.T. cotton25 million fewer sprays in B.T. cotton 19 million fewer sprays of herbicides19 million fewer sprays of herbicides Improved yield/ farmers’ health/ lower costImproved yield/ farmers’ health/ lower cost Greenpeace, especially in Europe opposedGreenpeace, especially in Europe opposed

Greenpeace uproots GM crops in a Norfolk fieldnews.bbc.co.uk/.../ tech/newsid_762000/762254.stm

http://www.pbs.org/wgbh/harvest/exist/images/farm5.jpg

GM crops: ConcernsGM crops: Concerns European opposition fueled by the Mad Cow European opposition fueled by the Mad Cow

disease in 1990s – 100,000 infected cattle, 90 disease in 1990s – 100,000 infected cattle, 90 Europeans killed (infected carcass used in Europeans killed (infected carcass used in feed)feed)

1998: Monarch Butterfly story – non-target 1998: Monarch Butterfly story – non-target insects – withdrawninsects – withdrawn

2000: StarLink (0.43% of all U.S. corn) – not 2000: StarLink (0.43% of all U.S. corn) – not approved for human use – found in Taco shellapproved for human use – found in Taco shell

1998: Scotland – controversial study on mice 1998: Scotland – controversial study on mice fed with transgenic potatoes (encoding lectin) fed with transgenic potatoes (encoding lectin) had suppressed immune responsehad suppressed immune response

2003: Prodigene fiasco – Food crop 2003: Prodigene fiasco – Food crop contamination with Pharm cropcontamination with Pharm crop

Creation of Super-weedsCreation of Super-weeds Development of pest resistance (refuge Development of pest resistance (refuge

strategy)strategy) In Europe, Japan, GM food must be labeledIn 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

GMO-Guidelines ProjectGMO-Guidelines Project

Project is funded by the Swiss Agency for Development and Corporation (SDC) and aims to:

1. 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.

Ecological approach to nontarget species Ecological approach to nontarget species selection*selection*

Case-specific species selection, i.e. depending on GM crop and it‘s cropping context.

Following several steps:

(1) Establish functional categories (pollinator, biocontrol)

(2) Classify the nontarget species known to exist in the relevant ecosystems

(3) Rank and select testing species based on ecological principles

(4) Exposure Analysis

(5) Hazard analysis

*Science-based Risk Assessment for Nontarget Effects of Transgenic Crops, BioScience 54, 2004: 637-649

Determine ecological endpoint (parameter) and testing protocol }

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

In teractioneffect

Direc

t effect

In teractioneffect

1 trophic level: Transgenic plants t

Novel transgene productExisting compounds

Unprocessed novel and/orexisting plant com pounds:

Existing herbivore compounds

Processed novel and/orexisting plant com pounds:


2 trophic level: Herbivoresn d

3 trophic level: Natural enem iesr d

IMPROVEMENTS:- Case-specific (not universal)

- ecological endpoints (instead of toxicological)

- informs the design ofrealistic testing protocols (realistic exposure routes)

- center of assessment: hazard hypotheses tobe confirmed or refuted (1 or several experiments)

In teractioneffect

Direc

t effect

In teractioneffect

1 trophic level: Transgenic plants t

Novel transgene productExisting compounds

Unprocessed novel and/orexisting plant com pounds:


Processed novel and/orexisting plant com pounds:


2 trophic level: Herbivoresn d

3 trophic level: Natural enem iesr d

Report contains:

Key findings & Recommendations should include following criterion:

•Gene Flow

•Biodiversity

•Health

•Sociocultural Matters

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

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.

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 today’s 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.”

ENVIRONMENT AS ENVIRONMENT AS INTERNATIONAL CONCERNINTERNATIONAL CONCERN Environmental issues are often universalEnvironmental issues are often universal Environmental problems are often Environmental problems are often

transboundary, e.g. pollution (transboundary, e.g. pollution (Trail-Smelter Trail-Smelter Arbitration)Arbitration), conservation of migratory , conservation of migratory animals (animals (Tuna-Dolphin case)Tuna-Dolphin case)

EnvironmentalEnvironmental problems are often global, e.g. problems are often global, e.g. protection of the ozone layerprotection of the ozone layer

ENVIRONMENT AS ENVIRONMENT AS REGIONAL CONCERNREGIONAL CONCERN

In addition to IL – specific rules only binding on In addition to IL – specific rules only binding on states in a geographic regionstates in a geographic region

Most significant in Western Europe – EUMost significant in Western Europe – EU Largely based on treatiesLargely based on treaties

Only binding on consenting statesOnly binding on consenting states Rationale:Rationale:

Regional environmental concernsRegional environmental concerns Transboundary concernsTransboundary concerns Expansion of capacityExpansion of capacity

Environmental protection PoliciesEnvironmental protection Policies Promote sustainable use of Thailand natural resourcesPromote sustainable use of Thailand natural resources Support Asian countries in implementing commitments under Support Asian countries in implementing commitments under

international and regional conventionsinternational and regional conventions Enhance human and institutional capacitiesEnhance human and institutional capacities Promote integration of environmental considerations into Promote integration of environmental considerations into

poverty alleviation strategiespoverty alleviation strategies Foster regional and sub-regional co-operation Foster regional and sub-regional co-operation Network of regional centers of excellence in environmental Network of regional centers of excellence in environmental

sciencescience Improve framework for regional environmental governanceImprove framework for regional environmental governance Mobilize international financial resourcesMobilize international financial resources

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: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

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.

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.

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?

Core Questions:


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:


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:


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:


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:


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

Component/Description

A. Physical Environment

- Area

- Soil type/topography

- Climatic type

- Meteorological data; rainfall pattern,wind direction, velocity, temperature, relative humidity

Field Evaluation on the Indicative conditions of the Proposed Test Site

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

CONCLUSIONCONCLUSION

Many environmental challengesMany environmental challenges Lack of political will and commitment on Lack of political will and commitment on

environmental issuesenvironmental issues Implementation, compliance and enforcement Implementation, compliance and enforcement Education and awarenessEducation and awareness Regional co-operationRegional co-operation

““Even if you're on the right Even if you're on the right track, you'll get run over if track, you'll get run over if

you just sit there.”you just sit there.”

Will RogersWill Rogers

Thank youThank you..

Documents

Environmental Risk Assessment Prasartporn Smitamana Plant Biotechnology Research Centre The Royal Project Foundation/ Chiang Mai University