Courses on biosafety

ICGEB Biosafety Workshops

For information ask to:

"Risk Assessment: role of Science in GMO-making". Trieste 30 Giugno - 4 luglio 2014



Presentation and documents:

Day 1 
Welcome and introduction. Decio Ripandelli, ICGEB (ITA)

Environmental Risk Assessment. Alan Gray, Centre for Ecology & Hydrology (CEH)

Applying Risk Assessment Methodology. Wendy Craig, ICGEB (ITA)

Food and Feed Risk Assessment. Mike Wach, CERA (USA)

Socio-economic Considerations. Monica Racovita, ICGEB (ITA)

Biosafety risk assessment for GMOs: the problem formulation approach. Mark Tepfer, INRA (FRA)

Day 2

Application of the problem formulation approch, model case study. Mark Tepfer, INRA (FRA)

SuperCam catalog of harms.

Challenging Pathways to Harm. Wendy Craig, ICGEB (ITA)


Day 3

Hypothetical drought-tolerant biofortified white maize4 for release in Kenya Line HspArmar1. Monica Racovita, ICGEB (ITA)

Social Economic Risk Assessment. All resource Team

Case study: Hipothetical drought-tolerant biofortfied white maize for release in Kenya line HspAmar1


Day 4

Social economic risk assessment. Team

Food and Feed safety. Case study

Risk Communication. CERA (USA)

Risks 1.

Risks 2.

Risks 3.


Day 5

 Data Deficiency Letter. Committee of Biosafety and Risk Assessment

 Risk Management Post release Environmental Monitoring (PREM). Alan Gray (CEH)

Risk Communication. CERA (USA)

Socio-economic Letter. Committee of Biosafety and Risk Assessment


Case Study

ipothetical drought-tolerant biofortfied white maize for release in Kenya line HspAmar1

Maize Biology Document


UNIDO E-Biosafety 


On line courses relating to the risk assessment, the management and comunication of risk.


For information ask to:

E-learning master "Biosafety in Plant Biotechnology" , VI edition. Ancona, 23-27 june 2013


Presentation and documents:

Principles for the establishment of the Safety and Nutritional Status of Conventional and Novel Food. Harry A. Kuiper - Former Chair EFSA GMO Panel

GM food & feed safety from a policy perspective, new developments. G.A. Kleter, E.J Kok, H.A.Kuiper

NTO Risk assessment of BT maize Jeremy Sweet, Cambridge UK (Environment Working Group, EFSA GMO Panel)

Herbicide tollerant Rice: LL & IMI. Jeremy sweet, Cambridge UK

FURARN. Ine Perty

RNAi and the rootstock-Variety system. Silvia Sabbadini, Ph.D. Department of Agriculture, Food and Environmental Sciences, Marche Polytechnic University
















A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

Agrobacteria: bacterial plant pathogen able to infect plants through horizontal gene transfer. The bacteria of this class are able to introduce plasmids (DNA molecules), such as for example the Ri plasmid of Agrobacterium rhizogenes and the Ti plasmid of Agrobacterium tumefaciens, which respectively are the direct cause of a pathology that involves the uncontrolled growth of thin and filamentous roots and of a pathology known as crown gall disease in dicots. The introduced Agrobacterium DNA integrates into the genome of the infected plants resulting in a stable transformation that can be transmitted to the offspring.

Allele: each of the alternative forms which may occur in a gene. The most frequent allele in a population is defined wild type and differs by one or more mutations from the other alleles. The presence of alternative alleles is called polymorphism. Each eukaryotic genome contains an allele of maternal and one of paternal origin of each gene. An organism with two copies of the same allele is called homozygous, an organism with two different alleles of the gene is called heterozygous.

Antibiotic resistance: resistance of microorganisms (bacteria, yeasts and fungi) to the bacteriostatic or bactericidal effect of one or more classes of antibiotics. This effect may be mediated by different classes of enzymes (e.g. lactamase, phosphatase, acetyl-transferase, etc.), encoded by genes usually present on plasmids or on mobile genetic elements (transposons).

Antibiotics: natural compounds obtained from microorganisms able to inhibit the growth or to kill other microorganisms.

Bacterium: unicellular prokaryotic organisms whose genetic heritage is mainly contained in a single circular molecule of DNA and is not contained in the nucleus but directly in the cytoplasm.

Base pair: Unit of measurement of the length of the double strand nucleic acids.

Biodiversity or biological diversity: "The variability among living organisms of all kinds, including, among others, the land, the sea and those of other aquatic ecosystems and the ecological complexes of which they are part. This includes diversity within species, between species and diversity of ecosystems "(article 2, Convention on Biological Diversity).

Biotechnology: Science which uses technological applications on living organisms to develop or to produce products of industrial or scientific interest. An important branch of biotechnology uses the recombinant DNA technology to produce in the laboratory variation in genome of cells or organisms by modification, insertion or deletion of one or more genes in order to obtain an organism with desired characteristics.

Competent national authorities: each Party of Cartagena Protocol shall designate one or more competent national authorities, which shall be responsible for performing the administrative functions required by this Protocol and which shall be authorized to act on its behalf with respect to those functions.

Contained use: means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment (article 3, cartagena Protocol).

Cultivar: variety of cultivated plant, obtained by artificial selection, which presents a set of specific morphological, physiological and agronomic characteristics of particular interest transmittable through propagation by seed or by vegetative parts of the plant.

Decision: binding act for the Member States of the European Union and directly applicable.

Deliberate release: "Any intentional introduction into the environment of a GMO or combination of GMOs for which no specific containment measures are used to limit their contact with the general population and the environment and to ensure a high level of security for them " (Art. 2, Directive 2001/18/EC).

Directive: a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. It can be addressed to a single Member State (individual directive) or to all Member States (general directive). The national legislator must approve one or more acts implementing directive. Directive indicates the deadline by which it must be implemented into national law.

DNA (deoxyribonucleic acid): organic molecule containing the hereditarily transmitted genetic information. The DNA is made up of two chains of deoxyribonucleotides, joined by hydrogen bonds between complementary base pairs (adenine with thymine, cytosine with guanine) and coiled around in opposite directions (antiparallel) each other to form a double helix.

Gene flow: transfer of genetic material from one population to another; which can occur through the normal reproductive mechanism (vertical gene transfer) or it can be occur through other mechanism between sexually incompatible species (horizontal gene transfer).

Gene: it is a fundamental, physical and functional unit, of the inheritance that transmits information from one generation to the next. A gene have a defined and fixes position (locus) in a particular chromosome. From a biochemical point of view, a gene is a polynucleotide sequence of DNA that transcribes an messenger RNA coding for a specific protein. A gene consists of a coding region and a regulative transcription region. Often, with the exception of prokaryotes, genes are structurally discontinuous, i.e. they contain an alternation of coding sequences (exons), which are found in the mature transcript, and non-coding sequences (introns) that are removed from the RNA after the transcription. The exhibition of the characters encoded by the information contained in the genetic material (genotype) represents the phenotype.

Genetic engineering or recombinant DNA technology: is the set of technologies that allow the manipulation of the genome of living organisms in order to obtain individuals with new phenotype.

Genetically modified microorganism (GMMO): a microorganism whose genetic material has been modified with nucleic acid recombination techniques, with techniques of direct introduction of genetic material or with cell fusion or hybridization techniques, however in a different way from the recombination or crossing processes occurring in nature.

Genetically modified organism (GMO): an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination” (article 2, directive 2001/18/EC).

Genome: all nucleic acid sequences that constitute the genetic heritage of a complete organism.

Herbicide: phytosanitary with toxic action on plant species, it’s used for the control of weeds. Some herbicides are selective while others have a broad spectrum action.

Living modified organism: “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology” (article 3, Cartagena Protocol).

Microorganism: any cellular or non-cellular microbiological entity capable of replicating or transferring genetic material, including viruses, viroids, animal cells, and cultured plant cells.

Mutation: any permanent change in the nucleotide sequence of the DNA more or less able to exert an influence on the phenotype. Mutations can be classified by origin as spontaneous mutations (arise in the absence of mutagenic agents) or induced (due to chemical, physical or biological).arketing. The provision of third parties, for a fee or free of charge "(Art. 2, Directive 2001/18/EC).

Notification: about GMOs, it is the submission of the information required by directive 2001/18/EC and by the local regulations to the competent authorities of a Member States, in order to obtain the authorization for the deliberate release of GMOs into the environment.

Notifier: the person submitting the notification.

Placing on the market: “making available to third parties, whether in return for payment or free of charge” (article 2, directive 2001/18/EC).

Recommendation: it is a non-binding act, it allow European institutions to disclose their positions and suggest action without imposing legal obligations on recipients.

Regulation: it is a binding act, it is mandatory in all its elements and directly applicable in the legal systems of the Member States of the European Union.

Species: taxonomic category that includes individuals belonging to one or more populations able to cross each other giving birth to fertile offspring.

Transgene: gene synthesized in laboratory or from another organism that is artificially inserted into a host organism that is sexually incompatible with the donor organism.

Transgenic: organism whose genome has been modified by the introduction of foreign one or more genes or nucleotide sequences with the technique of recombinant DNA, and that can transmit this modification to his descendants.