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

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. The NCBP Procedures for GMOs under Contained use experiment(PBG,1991)

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 - i nvolves 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 activity- What 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

Component/Description A. Physical Environment - Area - Soil type/topography - Climatic type - Meteorological data; rainfall pattern,wind direction, velocity, temperature, relative humidity NCBP Field Evaluation on the Indicative conditions of the Proposed Test Site

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

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