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

BioSafety
Volume 1, Paper 6 (BY95006), May 24th 1995 
Online Journal, URL - http://bioline.bdt.org.br/by

Regulation in biotechnology - recent developments and future prospects

Geraldine M. Schofield Unilever Research, Colworth Laboratory, Sharnbrook, Bedford, MK44 1LQ, UK

Email: Geraldine.Schofield@urcgb.sprint.com

Code Number: BY95006:
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SUMMARY

In general, regulatory mechanisms are put in place as a response to concerns over safety, which can be both real and conjectural. This paper outlines recent developments in the regulation of modern biotechnology in the areas of agriculture and food.

Even before the first product of modern biotechnology had been developed, let alone reached the market place, a plethora of regulations were already being put forward to regulate the technology and its product. The use of gene technology draws in debate ranging from embryo research to comparisons with nuclear power, and to animal welfare. It is a powerful technology which can offer much in the way of economic gains, major health benefits and opportunities in agricultural output. However, it is not an easy science to explain or understand, it may seem too powerful and all embracing and is the stuff of science fiction.

From voluble pressure groups through interested parties to the general public concerns have been expressed about risks from this technology. The issues cannot be avoided; they have to be taken seriously, serious people deserve serious answers. Issues such as the effect of biotechnology on the structure of agriculture, the citizens right-to-know, socio-economic impacts, bioethics and the extent of public participation are all areas which need to be openly discussed. But, the regulatory process is not the forum in which those debates should take place. Regulation must be based on sound science and be commensurate with actual risks, and, with a fast developing technology it must be flexible enough to be able to keep pace with developments. This is obviously a difficult balancing act and to be effective needs input from all sides including industry and academia.

What we saw with the initial development of gene technology was an excellent example of self-regulatory regimes and Government guidelines. What emerged in the late 80's in Europe was a prescriptive set of EC Directives produced without reference to previous experience and with little, if any, consultation of practitioners. This led to a major overhaul of the Directives in a very short time frame. Much time and resource which has been spent on recovery from on unworkable situation could have been saved if more consultation had taken place at the beginning.

In the interests of a single market the EU chose to produce 'Byzantine' (Anon, 1994) rules which were practically superseded prior to implementation by Member States and, in some case have still not been implemented 4 years after their due date as is the case with Greece and Directive 90/220/EEC).

Due to industrial pressure and the recent EC Commission White Paper on Growth, Competitiveness and Employment, which extolled modern biotechnology as an area offering the greatest potential for innovation and growth, the Commission undertook a review of the Community biotechnology regulatory framework. The Commission has now acknowledged that the biotechnological regulatory framework is a factor impacting on industrial competitiveness, which confirms the need for balanced and proportionate regulatory requirements commensurate with the identified risks. As a response to this pressure the Commission has recommended the following two- track approach for the future development of the biotechnological framework:

     the exploitation of existing possibilities for revising
     measures/procedures/degree of oversight/requirements, through
     use of  the 'light' procedure of adaptation to technical progress 
     and the bringing forward of amendments to existing legislation 
     in order to incorporate changes which cannot be achieved by 
     technical adaptation while leaving the basic structure of the 
     framework intact.

Considering Directives in detail:

Directive 90/219/EEC: The Contained Use of Genetically Modified Organisms

Two of the major problems have been:

a)  the exact boundaries between small and large scale work and

b)  an arbitrary containment classification based on intended purpose 
of the process, namely research or production, rather than by 
assessment of risk. 

Fig. 1 Current Structure of the Regulations

 
     streamline and ease the administrative notification/
     consent requirements,

     ensure that the classification of the genetically modified
     microorganisms and of the activities in which they are 
     used are appropriate to the risks involved,

     ensure the conditions of use are appropriate to the risks 
     involved,

     extend the flexibility of the Directive so it can be more 
     easily adapted to technical progress by regulatory committee 
     procedures,

     replace the existing requirements by record-keeping, or 
     notification for information purposes, for certain low risk 
     activities,

     replace the explicit consent requirements by implicit consent 
     for certain activities,

     reduce time periods involved in implicit/explicit consent 
     procedures,

     adapt the present risk classification system for genetically 
     modified microorganisms, in the light of experience,

     remove the differentiation between activities in research
     laboratories and production plants.

    World production, 1993 (1000 tonnes)

                      Oils        Meals
   
    Soya bean        17,282       76,265
    Palm             13,775          -
    Rape seed         9,182       14,597
    Sunflower seed    7,539        9,212

Imports of Soy beans into Europe are over 13 million tonnes.

It is vital that trade issues and harmonisation of information is addressed now. This can be done via OECD or other international organisations but it is crucial that reciprocal agreements are not tied up in bureaucratic procedures which would eventually undermine the validity of the regulatory processes as they are overtaken by events.

(Fig 3.)Regulatory Gates

There is a proposal to amend the Council Directive (82/471/EEC) concerning the authorization and circulation of certain feed materials but no Regulation on Novel Foods in the EU exists. The last proposed text of such a regulation was rejected under qualified majority voting rules in June 1994. A new version of the text produced by the French Presidency is currently under discussion. The main sticking point of the last text was labelling and is likely to be the main issue this time round. Previously, there was a blocking minority of Member States voting against compulsory labelling of ingredients or products of gene technology. It is probable that the split in opinion among the Member States will remain unless a compromise can be reached. European industry once again can quote the U.S. where products such as genetically modified tomatoes and virus resistant squash are being commercialised with no label requirements and, it seems, little outcry from the general public. Perhaps the U.S. system of self publicity by Companies, of open consultation and freedom of access to information has served them better than our more closed system of consultative committees and hesitation to extol the virtues of potential new products.

This labelling issue is however still occupying much valuable time as products come closer to market. Scientifically it is difficult to justify the labelling of a food or ingredient, which is similar to that already consumed, and is safe, purely on the basis that it may contain copy genes. Each person every day consumes DNA from all the food we eat and from the microorganisms with which it, and us, are associated. There are many DNA sequences in common among plant and animal life and distinguishing minuscule fragments of incorporated DNA would, in a processed food, be difficult and probably meaningless. However we are dealing here with a technology which sparks interest and concern, and lends itself to the call to a right-to-know by consumer and environmental groups. One way of informing the public is by labelling but this is not the only way of informing the general public, and it is not necessarily an efficient and effective way of providing the information required. If genetic modification techniques are to achieve a place in food production they will only do so with joint efforts. There is still a lot to learn and industry welcomes the chance to contribute to this learning process and offer practical solutions whenever it can. Governments, academia and industry must maintain a dynamic network of information exchange. We must work together on the initiatives of sensible research and extensive open communication as long as that communication process does not grind to a halt the progress of a valuable technology.

There can be no doubt that the Food Industry welcomes regulation based on practicable scientifically sound data. Innovation in the food industry is as important for continuing growth as it is in other sectors of industry and the quality and standards of food safety are being developed alongside the changes in food technology. Product safety is in industry's interest and companies take safety very seriously. But if consumers perceive that food produced by, or containing products of, modern biotechnological processes is not safe, then it will not be used and regulation can help this process of acceptance. Minimisation of risks requires accurate identification of hazards and only then can they be eliminated or reduced. Regulation must help rather than hinder this process.

(Fig 4) Processing of genetically modified oilseed rape

If we do not have a regulatory process commensurate with the risks and relevant to specific products then this technology could fail to deliver its promise.

REFERENCES

Anon 1995. BioBusiness, Biotech prospects look up Down Under, February 1995

Anon 1994. House of Lords Select Committee on Science and Technology. Regulation of the United Kingdom Biotechnology Industry and Global Competitiveness, July 1996, HMSO, London.

Anon 1993 Copies of the Chinese regulations are available from OECD's Science and Technology Directorate or the China Development Centre for Biotechnology, Beijing.

Miller, H. 1994. U.S. must rationalize biotech. regulation Bio Technology 12, May 1994.

Screen 1995. Screen Newsletter, January 1995.

Published by Bioline Publications and Science and Technology Letters

Copyright held by the author.

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

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