BioSafety Journal Pontificia Universidad Católica de Valparaíso ISSN: 1366 0233 Vol. 1, Num. 1, 1995

BioSafety:
Volume 1, Paper 4 (BY95004), May 22nd 1995 
Online Journal, URL - http://bioline.bdt.org.br/by

Biotechnology decision making: public information and participation in the context of European Directives 90/219/EEC and 90/220/EEC

Report on a Seminar held in the Netherlands

Ir. Piet Schenkelaars

MEBO Environmental Consultancy, P.O. Box 38, 2250 AA
Voorschoten, The Netherlands                           
E-mail 100302.1402@compuserve.com
Tel: +31.71.611298                                             
Fax: +31.71.617791 

Code Number: BY95004
Size of Files:
   Text:  19K
          No associated graphics files

INTRODUCTION

On 23 April 1990, the European Community adopted Council Directives designed to anticipate and control risks from new applications of biotechnology. These were Council Directives 90/219/EEC (1) on the contained use of genetically modified micro-organisms and Council Directive 90/220/EEC (2) on the deliberate release of genetically modified organisms to the environment. These Directives have the dual purpose of ensuring an equal level of protection of people's health and environment from possible risks while helping to achieve a single European market for biotechnology products. Appropriate legislation is also important in developing an atmosphere of acceptance and public confidence in biotechnology.

In this context, public information and public participation in decision-making procedures on notifications and authorizations for the use of genetically modified organisms (GMOs) may well be crucial to create such an atmosphere. In the European Union public information and participation is at the discretion of the national competent authorities. According to Article 13 of Directive 90/219/EEC, (1) "Member States have the possibility to make wider consultations concerning any aspects of a contained use, provided that confidentiality is respected. Article 7 of Directive 90/220/EEC (2) stipulates that "where a Member State considers it appropriate, it may provide that groups or the public shall be consulted on any aspect of the proposed deliberate release, provided that confidentiality is respected".

On assignment from the Netherlands' Ministry of the Environment, MEBO Environmental Consultancy prepared an inventory of the (legal) possibilities for public information and participation within the framework of national regulations on safety in biotechnology in European countries, including the views of several non-governmental organisations (NGOs) on these possibilities. The inventory provided the background information for the "Seminar on Public Information and Participation", which was held on July 6th, 1994 in the Netherlands. The purpose of the seminar was to obtain an overview of the different mechanisms and practices of public information and participation in European countries. In addition, it also aimed at gaining insight in how these mechanisms and practices are perceived by the NGOs.

In summary, the general findings were that there are considerable differences in legal provisions and policy-making between European countries. Moreover, the country reports and seminar revealed marked differences in the way these national legal provisions and policies are perceived by NGOs throughout Europe.

CONTAINED USE

As regards public access to information on the contained use of GMOs, the majority of European countries have established legal provisions in their regulations, with Italy, Portugal and Switzerland being the exceptions. However, the nature of these provisions differ widely from country to country. The contents range from having information available upon request to announcing the submission of notifications through newspapers and placing them on a public register. Moreover, except in Belgium, Ireland, Portugal, Switzerland and the United Kingdom, most European countries have established legal provisions for public participation in the notification procedures. In some of the countries it is possible to submit comments to the Competent Authority (CA) and in other countries one may legally challenge, appeal or object a decision by the CA. In addition, the national biosafety advisory committees on contained use to the CAs of Germany and Norway have representation from NGOs.

In general, NGOs have hardly made any use of existing possibilities. Furthermore, several NGOs from France and the UK specifically said that they had not investigated the workings of these notification procedures, as they like to focus their attention on deliberate releases of GMOs to the environment. Like the Danish NGOs, they also indicated that they had never been consulted by the CA of their country.

In Sweden, access to information is no problem, though the CA only seeks comments from specific NGOs. Therefore, it has been proposed to regulate from which organisations comments should be sought. Furthermore, since the Nordic NGOs obtain the information they want, they are, in general, satisfied with the possibilities for public access to information.

The Dutch NGOs had the same view, although they thought that active participation in the procedures by the public was difficult, due to the highly technical terms used in the notifications.

In Ireland, where the CA determines which notifications will be made public through announcements in newspapers, the NGOs held the opinion that it should be mandatory to announce and publish all notifications.

Finally, in Germany, NGOs were annoyed about the latest revision of the German Law on Genetic Engineering in December 1993, as the possibilities for public participation in the notification procedures through public hearings had been drastically reduced.

DELIBERATE RELEASE

Except in Italy and Portugal, European countries have established provisions for public information as regards applications involving the deliberate release of GMOs to the environment. This varies from having information publicly available through public registers to announcing applications in the proximity of the sites of release through posters at the town hall as in France, or through announcements in national newspapers and governmental publications as in Austria, Belgium, Denmark, the Netherlands and the United Kingdom.

As regards public participation in the application procedures, all European countries, except Belgium, Ireland, Italy, Portugal and Switzerland have established provisions. The possibilities vary from submitting comments to legally challenging, appealing against or objecting to decisions made by the CA. In addition, the national biosafety advisory committees to the CAs of Germany, France, Norway and the United Kingdom have NGO representation.

In general, NGOs often make more use of the possibilities to become informed about and/or to participate in the procedures on applications for the deliberate release of GMOs to the environment than to the opportunities to be involved in notifications on contained use of GMOs. A general, very important point for discussion was the differences in public access to information between European countries, especially in the case of market-applications. Only in some countries is it mandatory to make information publically available. NGOs from countries, where this is not mandatory, complained about these differences. However, they indicated that they were able to obtain the information through networking with NGOs from countries where information is made public. Nonetheless, the NGOs proposed to harmonize these provisions throughout Europe. In addition, nearly all NGOs indicated that they had not much confidence in current approaches to risk assessment and risk management of the release of GMOs to the environment, especially with a view on the potential long- term ecological effects.

Finally, most NGOs wished socio-economic consequences and ethical aspects, especially in the case of market applications, to be included in the decision-making procedures.

In Germany, NGOs exercised considerable critique on the revision of the German Law on Genetic Engineering in December 1993. In most cases, the possibility to hold a public hearing has been abolished. According to the German CA, this revision was welcomed by applicants since applications could be processed more quickly. As a consequence, the German NGOs have withdrawn their representation from their national biosafety advisory committee.

NGOs from Ireland and Italy explicitly urged the CAs from their countries to make information publicly accessible and to establish mechanisms for participation in the application procedure.

Moreover, several NGOs from Denmark, the Netherlands and the United Kingdom expressed the opinion that the CAs should react to comments or objections submitted. At the moment, they felt as if their comments were not seriously taken into account by the CAs.

The Norwegian NGOs were in general satisfied with the regulations in their country. Nonetheless, they showed some scepticism since it was as yet not clear in how far the CA will take their comments or objections into consideration. In the main, Swedish NGOs were also satisfied. Although, in general, they hold minority positions they felt that, on occasion, their comments were taken into account and had had real impact on the decision-making by the CA.

Some of the NGOs from France, Switzerland and the United Kingdom held the position that deliberate releases of GMOs to the environment should not be permitted at all, as the behaviour of GMOs in the environment and their ecological risks cannot adequately be predicted. Moreover, they viewed these applications of genetic engineering as not compatible with strategies for sustainable agriculture.

Tentative follow-up activities

At the seminar, the participants, representatives of the CAs as well as of NGOs, shared the view that the meeting should only be considered as a first step. The following issues for discussions between NGOs, CAs and industry were suggested:

1) A more in depth debate on risk assessment, including:

       the scope of risk assessment; how far should secondary  
       and indirect effects be considered in risk assessment,  
       for instance in the debate on the environmental release 
       of herbicide resistant plants? 
       
       strategic approaches to risk assessment and 
       how to take scientific uncertainties into account?; 

2) A debate on procedural issues, such as:
 
       proposals to amend Directives 90/219/EEC and 90/220/EEC 
       and deregulation; 

       the kind of information that should be made publicly    
       available:
 
       the kind of information that should be kept             
       confidential, and
  
       the establishment of public registers; and 

3) A debate on broader issues, like: 

       socio-economic and ethical aspects; the role of         
       biotechnology in sustainable development.

Other remarks

At the final session of the seminar, Dr. Mayer from Greenpeace-UK presented the following ranking of countries as regards their attitude to public involvement (see table 1). The ranking was to be regarded as a subjective assessment of whether the countries appear to welcome and make easy public involvement. The scale moves from the frankly hostile at the bottom, through grudging acceptance, to those countries at the top which take real steps to seek public opinion. Countries considered to be grudgingly accepting were those where the public could obtain information but where this was not encouraged or made easy. Ccountries considered to be hostile showed they had little intention of making information available.

Table 1.

RANKING OF COUNTRIES ACCORDING TO THEIR ATTITUDE TO PUBLIC INVOLVEMENT IN DECISION MAKING OVER THE USE OF GMOS. (Derived by Dr. S. Mayer, Greenpeace-UK using information in the MEBO survey.) ______________________________________________________________

Country             Attitude to public participation

SWEDEN                             RECEPTIVE
AUSTRIA                               ..
DENMARK                               ..
NORWAY                                ..
THE NETHERLANDS                       ..
GERMANY                       INCREASING AMBIVALENCE
SPAIN                         GRUDGING ACCEPTANCE
UNITED KINGDOM                        ..
BELGIUM                               ..
FRANCE                                ..
(IRELAND)                          HOSTILE         
SWITZERLAND                           ..
PORTUGAL                              ..
ITALY                                 ..

In Dr Mayer's view, however, none of the countries has fulfilled the NGOs' expectations. Sweden was the only country to get a glowing reference, from the Swedish Society for Nature Conservation, but the organisation expressed worries about what would happen when the EU model of decision-making reaches their country.

FINAL SESSION

At the final session, dr. Del Bino from the EU Commission, DG XI, elucidated recent policy commitments towards open dialogue, access to information and transparency undertaken by the Commission in 1992 and 1993. As regards access to environmental information at a Community- wide level the Council of Ministers adopted on 7 June 1990 Directive 90/313/EEC on the Freedom of Access to information on the Environment. This Directive places an obligation on all public authorities at national, regional or local level to ensure freedom of, access to, and dissemination of information relating to the environment. This includes any available information in written, visual, oral or data base form, on the state of the environment and on activities or measures adversely affecting or likely to affect the environment as well as information on administrative and other measures taken. Under this Directive any person has a right of access to all information other than that protected under commercial and industrial confidentiality, without having to prove an interest. The authorities are obliged to respond within 2 months, and reasons must be given for a refusal to provide the information requested. To the opinion of Dr. Del Bino, this is quite a far-reaching piece of legislation in terms of access to information. However, there are no general Community provisions concerning public consultation or participation, as this could be considered an issue to be dealt with by Member States under the principle of subsidiarity. More specifically for biotechnology, the specific provisions on access to information of Directives 90/219/EEC and 90/220/EEC on the use and release of GMOs had to be seen as complementary to those of Directive 90/313/EEC. Dr. Del Bino indicated that the EU Commission has an open and positive attitude to public information and consultation.

Nonetheless, at least at the national level, one of the most frequent criticisms put forward by the NGOs was that even if public opinion is sought or given, there is no feedback on how these views have been taken into consideration. This was specifically raised as a problem in Denmark, the Netherlands, and the United Kingdom, where the public has opportunities to obtain information and to submit comments on applications. Unless there is feedback, claims of proper consultation and involvement will continue to ring rather hollow.

The controls which are exerted over what are legitimate areas for risk assessment poses another difficulty. Exclusion of the public through the construction of a purely technical agenda for the risk assessment was seen by most NGOs as missing the point. In their view, more fundamental questions have to be asked, such as:

      why is the risk being taken and in whose interest is     
      society being asked to take this risk? 
     
      what other ways are there of providing the claimed       
      benefits that would not involve genetic transfer? 

      are the claimed benefits actually real for those who     
      will bear the risks? 

Therefore, it was suggested that CAs and their advisory committees must enter into dialogue with the public about what constitutes harm, and how to deal with scientific uncertainty and ignorance. In addition, it was proposed not to commit to only one high risk technology, but to develop a diversity of approaches, including ecological agriculture.

According to Dr. Mayer, what constitutes harm to nature is decided by advisory committees, whose members make judgements from their own world-view with little or no opportunity for democratic review. This was illustrated by considering the UK's Guidelines on Fast Track procedures for Certain Releases of GMOs, in which the UK's advisory biosafety committee had effectively decided upon a definition of harm which had never been subjected to external scrutiny. To her opinion, genetic pollution was being tacitly sanctioned, since the committee had decided that the transfer of some specified genes does not constitute (significant) harm. A different world-view, which considers any genetic pollution constitutes harm by introducing DNA which could not have been transferred by natural mechanisms, would have come to a different conclusion from a review of the same scientific data.

In the plenary discussion after Dr Mayer's contribution, one of the members of the UK advisory committee commented that information about the proposals for 'fast track' procedures had been sent out, but no response at all was received. This was perceived as very frustrating by the people involved in administration.

At the end of the seminar, the question of how to bridge the gap between differences in world-view was raised. One of the participants phrased the issue as follows: "One world-view is that science has answers and the other is that it may not. What are the consequences? The problem we all will go away with is: Are we correct to cling to either one of these world-views? Can we ever constructively discuss these things? Or does it come down to a straight fight and who wins public hearts and minds?"

Obviously, this last option would be of no use to any of the parties involved in the public debate on current developments in biotechnology.

Published by Bioline Publications and Science and Technology Letters

Copyright held by the author.

Editorial Office: biosafe@biostrat.demon.co.uk