Biosafety Council GUIDELINES TO COMPILE THE PUBLIC DOSSIER (NOVEMBER 2001) INFORMATION FOR THE NOTIFIER (VALID FOR 2002) G ENERAL INTRODUCTION

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1 Biosafety Council Service of Biosafety and Biotechnology Dr W. Moens SECRETARIAT GUIDELINES TO COMPILE THE PUBLIC DOSSIER (NOVEMBER 2001) INFORMATION FOR THE NOTIFIER (VALID FOR 2002) G ENERAL INTRODUCTION The Royal Decree of 18 December 1998 (regulating the deliberate introduction into the environment and the marketing of GMOs or products that contain GMOs) dictates in article 8 1 that each application for the deliberate release for experimental purposes also needs to contain a proposal for information to the public. This public dossier should serve to inform citizens about the activities of companies and research institutes in the biotechnology field. Apart from the purpose of reaching a public as broad as possible, such public dossier should also have an educational function. The aim of this public information is to enable citizens to gather knowledge, to weigh up the risks and benefits, to form a proper opinion about these products, etc. To stimulate this learning process it is required by the notifier to use a comprehensible language which is accessible to everyone, to explain scientific terminology and concepts, and avoid advertising messages and affirmative statements which are not scientifically founded (e.g. 'no scientific harm') as these are generally received by the public with suspicion and scepticism. In addition to general and more technical information on the assessment of the risks involved, the public dossier should also be complemented with information concerning the socio-economical aspects of the release since the public also raises questions on the impact on society of biotechnology. The SBB will make these public dossiers available to the public by publishing them on the Belgian Biosafety Server ( ) in three languages (dutch, french and english), under the chapter "Environmental releases in Belgium". For this reason the SBB requires the submission in electronic format (MS Word document) of the public dossier in the three languages mentioned (by to ydevos@sbb.ihe.be and/or suzy.renckens@sbb.ihe.be ). In order to aid the notifier with the preparation of the public dossier of field trials with transgenic crops, the Service of Biosafety and Biotechnology (SBB), the secretariat of the Biosafety Council, has prepared these guidelines.

2 C ONTACT Contact persons: Yann Devos and Dr. ir. Suzy Renckens Secretariat of the Biosafety Council Section of Biosafety and Biotechnology (SBB) Scientific Institute of Public Health (IPH) Juliette Wytsmanstraat Brussels tel: 02/ , fax: 02/ and web: T HE GUIDELINES The section below contains the guidelines to be followed when preparing a public dossier. 2

3 LOGO of the COMPANY or RESEARCH INSTITUTE Information for the public. COMPANY or RESEARCH INSTITUTE XXX Title of the experiment. European notification number B/BE/XX/YY (Short introduction about the reglementary framework and application procedure. XXX and YYY to be completed by the SBB.) The release of genetically modified organisms (GMOs) in the environment is strictly regulated at the European level by Directive 90/220/EEC (recently replaced by Directive 2001/18/EC of 12 March 2001) and at the national level in Belgium by the Royal Decree of 18 December 1998 "regulating the deliberate environmental introduction and/or marketing of GMOs or products that contain GMOs". To ensure the safe use of GMOs, both of the statutes above stipulate that the release of GMOs for experimental aims is prohibited without prior permission from the authorised minister. This decision is based on a thorough evaluation of the biosafety of the planned release (risk-assessment), which is to be conducted by the Biosafety Council. To acquire the necessary permission from the competent Minister, the company or research centre XXX must submit an application file to the General Inspectorate of Raw Materials and Processed Products of the competent authority. In accordance with the advice of the Biosafety Council, the authorised minister has granted permission to company or research centre XXX to conduct experiments with transgenic XXX during the year or years XXX, as stipulated in the application B/BE/XX/YY (Valid for classical procedures) The release will take place at one or more experimental locations in Flanders / Wallonia / Brussels in the municipality of XXX and will follow the normal growth period of crop XXX which is from month XXX to month YYY. (Valid for simplified procedures) In the year XXX the release is planned at one or more experimental locations in Flanders / Wallonia / Brussels in the municipality of XXX and will follow the normal growth period of crop XXX which is from month XXX to month YYY. 3

4 Responsible to be contacted in order to obtain additional information concerning the experiments: This implies the co-ordinates of the company or the research institute as well as the co-ordinates of the responsible to be contacted. It is desirable to appoint a responsible within the company or the research institute who can answer to questions of citizens. This person should be able to inform the public about the activities of the company or the research institute and this way constitute the link between the company or the research institute and the press, organisations, citizens and other actors. 0. TABLE OF CONTENTS: Please produce a table of contents that within the same document links to the different parts of the text. By clicking on a title of the table of contents, one has to arrive at the corresponding part of the text in the document. 1. DESCRIPTION OF THE GENETICALLY MODIFIED PLANTS: Not everyone is familiar with the scientific jargon. It would therefore be useful to the public if it would be explained what transgenic plants are and how they differ from conventionally bred crops. This means that a number of basic concepts should be explained (see topic 14 "Glossary"). Further, the plant species that is (are) being used and its (their) new traits should be mentioned. This includes: the common and scientific name of the employed plant species and/or varieties the nature of the new trait or traits (e.g. male sterility, restoration of fertility, herbicide tolerance, insect tolerance, stress resistance, etc.) a comprehensible explanation about the function of the new traits a comprehensible explanation about the mode of action of the new traits The purpose of supplying this information is to teach the public that every transgenic crop is a specific case, depending on the used species or variety, the trait introduced and the environment it is released into. 2. PURPOSE OF THE EXPERIMENT: This part comprises a description of the aim(s) of the experiment. What is the purpose of the experiment? Does one intend to increase candidate elite lines in open field (or cages)? Or is the aim to evaluate fungal tolerance or insect tolerance of certain lines in open field? Or are the experiments carried out to investigate the biological action of a specific herbicide and to determine the yield? Does it concern an evaluation of the agricultural performance of the transgenic crop and the collection of agricultural and qualitative data? Or does the experiment aim at producing transgenic seeds? Or is the purpose only a demonstration experiment? Also here, notions that are not familiar to the public need to be explained. It seems interesting to us to explain why such experiments need to be carried out in the open field, and to relate this to the previous and future steps in the research process (see next topic). 4

5 3. OVERVIEW OF PREVIOUS AND FUTURE ACTIVITIES: The citizen needs to understand that the creation of a new variety is a long process, and that a long history precedes the planned field introduction. In this part the previous activities (history) can be discussed, such as experiments carried out in contained conditions (laboratoria, growth rooms, greenhouses, etc.). In addition, also future plans, objectives (e.g. the marketing of genetically modified crops) and the future steps in the research process can be discussed that would be considered when the used strategy has proven to work (outline of a vision for the future). 4. ADVANTAGES FOR THE ENVIRONMENT, THE FARMER OR THE CONSUMER: The public also needs to understand why such experiments with transgenic plants are performed. It should be made clear that the public can profit indirectly from it, because these crops are mainly developped to supply an added value to farmers and the environment (crops where the risk of crop failure by insect or pathogen damage can be reduced, or crops that are more resistant to adverse climatological conditions or certain types of soil polution). It is advisable to mention and explain what the potential advantages and the possible improvements can be in comparison to conventional agricultural practices. Please, provide well founded arguments by referring to the available scientific literature (articles, reports, websites, etc.; see topic 13 "References"). 5. BIOLOGY AND LIFE CYCLE OF THE PLANT: To make the rest of the story understandable for everyone it is necessary to supply basic information on the life cycle and the biology of the employed plant(s) or crop(s) G ENERAL BIOLOGY OF THE PLANT : This comprises a short description of the biology of the plant. A general description of the employed species as crop, its origin, ecology, occurrence (e.g. in which biotope it is found), morphology, development, etc. Is it a bulbous or tuberous plant, an annual or perennial, etc R EPRODUCTIVE BIOLOGY OF THE PLANT : More information is also needed about the reproductive biology of the plant. Does the plant reproduce vegetatively or generatively, and how does this reproduction work? Which are the different steps and processes necessary to result in a successful reproduction of the parental plants? Generative reproduction pollen and pollination At least the following questions should be answered. How does pollination in field conditions occur? Are the plants self pollinators or wind pollinators and/or insect pollinators? By which transport 5

6 agents is the pollen dispersed? Are the pollen concentration and the viability of the pollen reduced a lot in function of the distance towards the source? What happens after successful pollination? Does the behaviour of transgenic plants differ from that of conventional plants? seed and fruit The next step in the story are the seed and fruit. What are seed and fruit, and what's their function? How do they originate? What amount of seed and fruit does the plant produce? How are these dispesed (active or passive transport)? Is this process being facilitated by special structures (e.g. hairs, fluff, membraneous wings)? Under which conditions is the seed able to germinate? What are the chances for survival? Can the seed survive in the soil for a long time under optimal conditions? Also here, it is necessary to indicate whether transgenic plants behave in a similar way Vegetative reproduction Depending on the type of crop, the plant parts that are able to develop into a clone of the parental plant (roots, tubers, bulbs, shoots or other parts of the plant) will need to be discussed. The function of the concerned plant part should be clarified. 6. POSSIBLE EFFECTS ON OR RISKS FOR THE ENVIRONMENT: Here, the possible effects on or risks for the environment of the introduction in the open field of transgenic crops need to be discussed. The different risks should be touched on (e.g. vertical and horizontal gene flow, volunteers, interaction with target and non-target organisms). The difference should be explained between the 'hazard' and the 'exposure' that together determine the 'risk' (risk = hazard x exposure). Please provide a well founded argumentation by referring to relevant scientific literature (see topic 13 "References"). It could be mentioned that conventional agriculture also has disadvantages (make a comparison with conventionally cultivated crops). If insufficient data are available about the possible effects on or risks for the environment, it should be explained what will be undertaken to obtain more information in the future, when the used strategy has proven to be successful O UTCROSSING AND DISPERSAL IN NATURAL ECOSYSTEMS : Dispersal of transgenic pollen A short introduction that explains that for certain crops the possibility exists that transgenic pollen is spread outside the trial field, wild relatives are pollinated and consequently undeliberate dispersal of transgenic crops in the environment occurs. survival and dispersal of pollen When such data are available, citizens should be informed about the chance of dispersal of pollen. Thee notifier will have to indicate whether wild relatives are present in the vicinity of the trial field, how far pollen is dispersed, to which extent the amount of pollen decreases in function of distance 6

7 (leptocurtic distribution) and how the viability of the pollen decreases in function of time and distance. intra- and interspecific hybridisation Can pollination with the same crop grown in the vicinity of the trial field occur and/or can pollination with wild (close) relatives occur? Are these crops or wild relatives which can cross-hybridise present in the vicinity of the trial field? Do they flower at the same moment? Are they compatible (reproductive barriers)? If so, what are the chances for successful hybridisation? Dispersal of transgenic seed Also here it is advised to indicate how transgenic seed can end up in the environment. Will a quantity of seed remain at the trial field after sowing and/or after harvesting? Can the seed get outside of the trial field? In addition to this spatial dispersal, also a disperal in time is expected (dormant seeds that survive in the soil for years). Will produced seed be viable and remain viable? Will the seed be able to sustain embryonic development? How far can they be dispersed outside the trial field? How does the numbers decrease with distance (distribution)? Selective advantage Please indicate whether the new traits possibly influence positively the behaviour of the transgenic plant in the presence of the necessary selection pressure. Will the transgenic plant be better adapted and exhibit a selective advantage as compared to the wild relatives? Does this disturb a certain equilibrium? Will the transgenic plants perform better than their wild relatives? Are they less sensitive to certain environmental stress and does this enable them to survive or reproduce better? Does the seed produced have a higher chance of survival? Do they exhibit a more invasive behaviour which causes them to multiply more rapidly? What effect does an altered abundance and distribution of transgenic plants have on the natural ecosystem? An important question is also whether such selected crops are still competitive with respect to weeds. Are transgenic seedlings that escaped able to survive outside the trial field? Volunteers What are volunteers? What causes volunteers to occur after harvesting the crop? What impact can volunteers have if they are not managed? 6.2. I NTERACTIONS WITH TARGET ORGANISMS : It is worth to mention in which way target organisms can limit yield and cause crop failure by damaging the plants, and that therefore their control is necessary. It is necessary to know whether adverse effects are expected and therefor to indicate what are these effects (e.g. the development in the target organism of resistance to pesticides). In addition it could be discussed whether similar expected adverse effects also occur with conventional agricultural practices, whether the advantages balance these ecological disadvantages. Furthermore, it can be considered whether the occurrence of such negative effects can be managed and contained (e.g. to delay the development of resistance by taking specific measures). 7

8 6.3. I NTERACTIONS WITH NON - TARGET ORGANISMS : Special attention should be given to the range of action of the newly produced protein and the effects the protein has on the soil microflora and fauna (e.g. mycorrhizal fungi). This is thought to be important because by leaf accumulation (e.g. in the case of transgenic fruit trees), fruit accumulation (e.g. apples) and root secretion, a substantial concentration of the protein can potentially build up in the soil. The amount, the bioavailability, the degradability and the persistence of the protein in the soil play an important role in the determination of these effects. In the same way a possible exposure to the protein and the effect of the protein on pollinators and other organisms (e.g. birds) should be discussed. Exposure via transgenic pollen or transgenic fruit might also be discussed. In the presence of antibiotic resistance genes in the transgenic plants, also the risks related to horizontal gene transfer of this kind of genes to pathogenic microorganisms should be discussed. If information about the interaction with non-target organisms is not available, the notifier should indicate what will be done in the future to fill those gaps and how this will be investigated and analysed in the future I MPACT OF LARGE - SCALE AND LONG - TERM USE : If data on the impact on the environment and public health of large-scale and long-term use of the described transgenic plants are available, these should be discussed here. Potential scenarios can be presented. 7. CONTAINMENT, CONTROL AND MONITORING MEASURES: Citizens need to be informed about the existence of trial protocols and protocols, which provide instructions for the organisation (from sowing to harvest), the follow-up and the harvest of the parcels where transgenic crops are grown as well as for the waste management on these parcels. If no protocol exists for a specific crop, the containment, control and monitoring measures that are taken should be explained. The public should also be informed about the existence of containment measures taken in order to try to keep the transgenic plants in the trial field. The public should also recognise the use of such measures and understand why these are required C ONTROL OF POLLEN DISPERSAL : It should be clear that the dispersal of transgenic pollen in the environment needs to be prevented as much as possible. Therefore the containment measures taken to control this problem should be mentioned. The notifier needs to indicate what are the isolation distances to other fields of the same crop or of wild relatives in order to guarantee pure seed production or to reduce unwantend crosspollination. Other measures taken to contain pollen dispersal should be mentioned. E.g. the removal of the flower buds (removal of the flowering stage), the wrapping of flowering flowers with 8

9 pollenproof mesh or the installation of isolation cages, or taking care that no compatible crops are being grown in the vicinity of the trial field etc C ONTROL OF THE DISPERSAL OF TRANSGENIC SEEDS : Usually, one takes care that seeds of the field are harvested. However, it is possible that a small portion of the seed remains in the field. The containment of this kind of seed dispersal by harvesting the crop before maturity of the seed can be a way of managing. Also the dispersal of transgenic seed outside of the trial field and the mixing of transgenic and non-transgenic seed is not desired. This implicates that the required and the taken control measures should be discussed (conditioning of the seed, emptying of the sowing machine and management of the seed residues). So, how is the dispersal of transgenic seeds controlled and contained? 7.3. C ONTROL OF VOLUNTEERS ( FOLLOW - UP, MONITORING, POST - HARVEST TREATMENTS ): It should be indicated that after finishing the trial the field will be followed for 1, 2 or several years, depending on the crop, and checked regularly for volunteers. Explain what these measures are and why they should be taken? In this, the follow-up measures (monitoring) described in the trial protocols and protocols for transgenic sugar beet, Brassicaceae and chicory can serve as a base. Example for volunteers: The seed that is deposited in the soil during harvesting will most often remain in the field a couple of weeks after harvest to germinate. It will not be ploughed and the germinated seedlings will be destroyed by an appropriate treatment. How is dealt with small quantities of seeds that are deposited on the soil during harvest? Are they ploughed? Are they allowed to germinate? How are the seedlings destroyed? Is the location checked regularly after finishing the trial? Also the vegetative material that can result in the development of a new clone of the parental plant needs to be controlled. Also here the notifier must mention the proposed measures. E.g. the placing in plastic containers of bulbs that can be removed from the soil again after harvest, or to leave tubers in the soil to check the resulting volunteers. 8. DESTRUCTION OF TRANSGENIC MATERIAL: It should be mentioned that both the harvested transgenic material that is not intended to be used in further product development or experiments and the transgenic material not being harvested will be destroyed. The transgenic seeds that are not going to be used for further product development or experiments will be destroyed. It should be stated clearly that the use of this material for food and/or feed is prohibited! What happens with the harvested material? Which type of material is not harvested? What kind of trials is not harvested? How will the material be destroyed? 9

10 9. EMERGENCY SITUATIONS: Here one should explain how unexpected events will be identified at an early stage and how these will be managed. It should be mentioned as well that in exceptional cases the plants can be destroyed (e.g. by treatment with an appropriate herbicide). 10. INSPECTION: (to be copied literally by the notifier) In Belgium, the 'General Inspectorate of Raw Materials and Processed Products' is in charge of surveillance over field trials with transgenic plants. In order to plant its controls the notifier is obliged to inform the competent authority about the date of sowing and the date of harvesting in advance. On the field, inspectors make sure the sow and harvest treatments are carried out according to the ministerial permission and the different protocols. In addition, the inspectors take samples of the plant material that are analysed in official laboratories. 11. ACTIVITY REPORT: (to be copied literally by the notifier) At the end of the growing season an activity report prepared by the notifier needs to be delivered to the competent authority, i.e. the General Inspectorate of Raw Materials and Processed Products, before 31/12/2002. This activity report comprises at least the following data: a copy of the logbook, the site and period of release, the precise nature of the actually released transformants, the actual surface of the trial plot, the aim(s) of the trial, the frequency and nature of the observations on the trial plot, the measures that were taken to prevent unwanted release of transgenic material outside the trial plot de method used for the destruction of the harvest and the efficacy of this, the results obtained during the trial, an overview of the surveillance of the trial plot. 12. SOCIO-ECONOMICAL ASPECTS: The advice of concerned parties learned that in general public dossiers lack socio-economical aspects. This part of the information should be aimed at those aspects that have an influence on division of labour, employment at large in broad sense, influence on processing of products, price/quality, etc. The involved parties presented a number of unanswered questions and gaps: Which is the added value of the technology in comparison with other possible technologies in this field (conventional and alternative)? What is the added value in comparison with existing products? 10

11 What is the economic and social necessity of the development? What is the general social importance of that biotechnological application? Is there a need for this new product? Are there possible effects on employment? What are the expectations on financial level? How do you see the further development of this product? What are the further steps in this research project? Which social actors benefit of the technological potential in the research? How does the company or research institute commit itself to inform the public about the progress of the research? Which commitment does the company make to assess the possible worries and questions concerning this research of the people directly involved and of the public in general. 13. REFERENCES: Research pointed out that the use of affirmative, not scientifically underpinned statements and advertising messages have a negative effect on the public. These are received by the public with suspicion and scepticism. Therefore provide a scientific base for your statements and findings by referring to relevant scientific literature or websites etc. 14. GLOSSARY: Since not all citizens are as familiar with the issues discussed, it is recommended to explain particular concepts. *** 11