|Frequently Asked Questions |
What is biosafety?
The increasing use of genetically modified organisms (GMOs) in the agri-food sector has raised, together with great expectations, a number of concerns for its impact on health, the environment and socio-economic systems.
In this context, the term “Biosafety” is used to describe policy, regulatory and management frameworks to control potential risks associated with the use of new biotechnology (Fao, 2011. Biosafety Resource Book. Module E: legal aspects. Pg. 1 ).
As regards the software, the term "biosafety" applies to those factors characterizing a given country, aimed at controlling the adventitious mixture of GM and non-GM products. Furthermore, the term “modern biotechnology” includes only plant organisms obtained through recombinant DNA techniques (genetically modified organisms–GMOs) used for commercial purposes (Food, Feed, Cultivation).
What is the Software “Biosafety Scanner” used for?
The Biosafety Scanner software provides a range of useful information for the planning and management of GMO control activity in crop production, with particular reference to international commerce.
Data processing gives a concise picture of whether or not, in the country of interest, conditions exist which can favour GMO contamination of crop production or the import of products not conforming to European standards with regard to traceability and labelling requirements.
It will be possible, however, to evaluate the following by means of the information displayed and on the basis of the user’s needs:
1. how to source supplies and whether or not to request certification (should worked or semi-worked raw material need to be imported);
2. which batches should be controlled and which transformation event should be looked for in the analysis (should surveillance and monitoring programs have to be planned). In the latter case the Software also displays useful information for border document control.
Who can use the Software?
The Software was developed for all interested parties in the agri-food industry and for those institutes responsible for the supervision and control of GMOs.
In particular, it is aimed at all companies importing raw materials of plant origin which are intended for processing and at those institutes in charge of planning the supervision and control activities of GMOs. It can also be used for research or investigation.
Why do I use the Software?
The traceability and labelling of products consisting of, containing or produced from GMOs is one of the key measures in managing the risks to health, the environment and socio-economic systems.
At the international level, the Cartagena Protocol on Biosafety, implemented by Regulation (EC) No. 1946/2003/CE, assigns to the Parties to the Convention the duty to adopt measures to prevent risks and develop particular protocols and procedure for the transport, management and safe use of GMOs.
At the European level, Regulation (EC) No.1829/2003 on genetically modified food and feed and amending Directive 2001/18/EC on the deliberate release of GMOs, requires that the labelling of such products, in addition to responding to the demands of the majority of consumers, facilitates informed choice as regards methods of manufacture or production. To this end, the Regulation (EC) No.1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from GMOs, introduces a threshold of contamination for food and feed no higher than 0.9%, above which all products consisting, containing or produced from GMOs must be labelled.
The Regulation (EC) No. 619/2011 also fixes a threshold limit of 0.1% for feed as containing genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired.
At present, however, a threshold for GM contamination in seeds has still to be established.
Although EU and international regulations recognize a key role to traceability and labelling in the management of risks arising from the use of GMOs, the complexity of international trade, the asynchronous authorisations and regulatory differences between countries have limited the achieving of these requirements. Markets are therefore vulnerable to the entry of unauthorized GMOs or to products not properly labelled with regard to GM content.
In this context, the software "Biosafety Scanner" is a useful tool to support the activities concerning the management and control of GMOs in crop production.
How reliable is the software?
All data used for the processing of the software is derived from institutional websites of GMO responsible national authorities and, failing that, from the scientific bibliography of the sector or produced by non- governmental bodies. Considering the amount of data available on websites and, in order to make the information displayed more reliable, a series of cross checks have been carried out between the different information relating to the specific data, to choose the most suitable, for example, for the identification of GMO trade names. In other cases, however it was necessary to homogenise the data, for example, to identify the different transformation events or the names of the inserts of the gene constructs.
How often is the Software updated?
All data shown in the software is updated in real time by monitoring the sources used in the preparation of the database, with the exception of GMO cultivated areas which are updated annually.
How is the EI calculated?
The EI represents a short evaluation of GMO production and management in relation to a particular country and is calculated considering a particular crop.
The index seeks to inform the user of whether or not conditions exist in a particular country which could favour GMO contamination of plant production or cause the importation of products which do not conform to European regulations.
The choice of the parameters to calculate the index was made considering a number of variables which can favour/prevent the unintended presence of GMOs in the crop production of a given country (for further explanations please refer to point 3 of the Biosafety Scanner user’s guide).
An algorithm calculates the index (high/medium/low) on the basis of the quantitative/qualitative responses provided by the database: a high index provides more assurance about the absence of GM material in imported crop production, or vice-versa. The estimated index is calculated on the basis of the traceability and labelling requirements set by European standards. Considering the different variables which can determine the potential presence of GMOs in crop production, the index cannot be given a predictive value in a strict sense.