African Crop Science Journal African Crop Science Society ISSN: 1021-9730 EISSN: 2072-6589 Vol. 3, Num. 2, 1995, pp. 181-184

Issues, concerns, and strategies in addressing biosafety

YILMA KEBEDE

Pioneer Hi-Bred Intl. Inc. 7300 N.W. 62nd Avenue P.O. Box 1004 Johnston, IA 950131-1004, USA

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ABSTRACT

Biotechnology guidelines and policies are essential to creating public and political confidence, encourage future investment and reduce fears and scepticism. We need to be aware of technologies that could be detrimental and encourage those that are potentially useful. Thus, the over-regulation of the science need not carry the day but be tempered with caution. Most new technologies have gone through phases of caution and remain under regulation, and most technological advancements are not inherently bad but unanticipated misuse or side effects could bring many into disrepute. Fear of the unknown has forced us to evaluate advances in technology for any unintended side effects. Gatherings, such as this conference on sorghum biosafety, are important in creating awareness, sorting out issues, and arriving at some consensus. Countries in the developing world are in the proccess of developing safety regulations, thus the opportunity is ripe for coordination and harmonization of regulations. The International Service for the Acquisition of Agri-Biotech Applications (ISAAA) is in a unique position to implement this process through capacity building and information exchange. There is interest in biotechnology companies in this regard and Pioneer Overseas Corporation has been contributing to the ISAAA initiative.

Key Words: Biotechnology guidelines, ISAAA. sorghum

RESUME

Les lignes directrices et les politiques de biotechnologie sont essentielles pour creer une confiance publique et politique, encourager des investissements futurs et reduire la peur et le scepticisme. Il est bon de connaitre les technologies qui peuvent s'averer nuisibles et celles qui sont potentiellement utiles afin de les utiliser avec prudence. La plupart de technologies ont depasse la phase d'utilisation avec prudence; elles sont sous controlees et les plus avancees ne sont pas necessairement mauvaises saul en cas de mauvaise utilisation occasionnant des effets secondaires indesirables. Les reunions telles que cette conference sur la biosecurite du sorgho sont des occasions de sensibilisation pour discuter du probleme et arriver a un consensus. Comme les pays en voie de developpement sont dans le processus de mise en place de reglements de biosecurite, le moment est donc propice pour coordonner et harmoniser les reglements. Le service International d'Aquisition des Applications de l'Agrobiotechnologie (ISAAA) est tres bien place pour realiser ce processus par le developpement de sa capacite et l'echange d'information. A cet egard, compagnies de biotechnologies et les corporations pionieres etrangeres ont commence a contribuer l'initiative de l'ISAAA.

Mots Cles: Lignes directrices de biotechnologie, ISAAA, sorgho

INTRODUCTION

The improvement in crop performance involves a host of factors (physical, biological, social, economic). Plant breeding has played a key role in delivering improved cultivars to farmers, the agroindustry and consumers. Biotechnology is proving to be a promising tool for effective plant selection and understanding of mechanisms for plant improvement. A number of possibilities are being pursued among which the following hold promise: tolerance to low rate usage herbicides, resistance to problem pests (toxicity), resistance to viral infection, added value (starch, oil content, amino acids), and enhancing breeding methods (choice of parents, marker assisted selection).

There is a growing interest in establishing programmes to integrate biotechnology with traditional plant breeding. The concern is not whether or when the technology will work but with other non-biological issues which affect the future of genetically engineered plants. Such issues include: biosafety- regulatory approval for field testing, risks involved, and timeline for commercialization; proprietary protection-risks and rewards, return on investment; public knowledge-proper awareness; and finance research support (Gosser and Fraley, 1989).

The growing interest and awareness in biotechnology is best exemplified by the increased use of the prefix bio- with many words (.e.g. biodiversity, biopesticides, biofertilizers, even biodiplomacy, bio-piracy, bio-bucks and bio-policy). Our concern here lies in biosafety where regulations concerning testing and transfer have become a prerequisite. Some of the issues, risks and strategies to address the condition will be discussed. In order to get an overall picture of biosafety we will need to consider the major players against a background of the issues. risks and strategies. The major players are: (1) technology generators (seed industry, National Agriculture Research Systems (NARS) and International Agriculture Research Centres (IARCs), (2) technology users (NARS, farmers), and (3) regulatory bodies (national, regional and international).

ISSUES

Recent advances in biotechnology have created new opportunities for efficient crop improvement and added value to new varieties/hybrids. The process has necessitated caution to avoid any unforeseen problems. However, perceived problems should not unjustly prejudice a technique that holds promise.

As much as technology generators (especially the seed industry) are aware of the situation, the need for timely commercialization of a new technology to keep market share and return on investment ~s also an important issue. However, the need to convert laboratory and small scale trials to wide area commercial tests where resources are expensive also requires establishment of a framework of agreed scientific principles of safety and trial conduct.

Users, on the other hand, prefer the latest technologies to improve earnings. At the same time, they need assurance of safety that agriculture and the environment are adequately protected. Regulatory bodies are required to harmonize these concerns and to realize that wide area testing and obtaining data in a timely and cost effective manner without compromising safety is of paramount importance.

RISKS

Delays in testing and approval could jeopardize investment in research and could result in the loss of a competitive edge and customers. Consumers could be deprived of potential benefits from crops with improved agronomic performance and fewer chemical requirements. On the other hand, there could be undesirable effects in the absence of adequate monitoring and guidelines. Regulatory bodies' or guidelines could be restrictive and

bureaucratic which could further be compounded by scarcity of finance and personnel to review and monitor trials. There could also be conflicts of interest in monitoring products which they have helped develop.

STRATEGIES

Foremost for researchers is the need for providing sufficient precaution for containment. Researchers should have an improved understanding of factors that impact biotechnology product transfer to undertake a proper risk assessment. Notification of regulatory authorities of intent and educating the public, opinion leaders and the media would also be essential.

The technology user should be involved in providing feedback and voicing concern. Emphasis on capacity building and further linkages with organizations such as IARCs. International Service for the Acquisition of Agri-biotech Applications (ISAAA). United States Department of Agriculture (USDA) and ABSP would help in understanding products.

The regulatory mechanism should be based on risks. The mechanism, should provide guidelines and adequate oversight with enough flexibility in reviewing research protocol. In essence. the regulatory mechanism should create an enabling environment that will stimulate rather than discourage the transfer of technology.

INDUSTRY PERSPECTIVE

The major portion of research relies on traditional plant breeding with biotechnology (focused on plant transformation ) expected to have a significant role for future products. Among the goals that have been established at Pioneer Hi-Bred International for Research and Product Development (Anon.1994). the following are relevant to this workshop: (1) use new technologies to augment current crop improvement methods and transfer non-traditional traits into commercial products, and (2) vigorously protect intellectual property, comply with regulatory requirements and follow responsible environmental practices.

At present Pioneer Overseas Corporation is working on transforming some of its major crops in its own laboratories or in research partnerships. There is a considerable amount of time and money spent in understanding the whole transformation process. Stable transformation will enable Pioneer Overseas Corporation to put desirable traits directly into plant ceils. This achievement will shorten time for developing new products and give Pioneer Overseas Corporation the ability to offer products with new traits not possible through traditional plant breeding techniques.

BIOSAFETY

In dealing with biosafety, the question is not how we can reduce the potential risk. but what the relative risks of the new technologies are compared with the technologies which they replace (Persley et al., 1993). In addressing the question of safety in its biotechnology development programmes, Pioneer Overseas Corporation

(a) has established an institutional biosafety committee;  
(b) has traditionally supported the development of regulatory  
     oversight of research and development of the products of
     biotechnology;
(c) has endorsed the system implemented by USDA-APHIS. i.e..   
    notification of regulatory authorities of intent to conduct
    tests and provide information on methods of containment:
(d) supports the implementation of systems to fast track
    applications where trials are a repetition of previously
    known trials or those that conform to acceptable containment
    standards and 
(e) does not feel that biotechnology poses an entirely new set
    of safety issues (Townsend, 1994).

FRAMEWORK FOR ANALYSIS

Safety guidelines should recognize economic interests and ecological requirements. Thus, there is a need to develop some framework for identifying the issues involved in dealing with the major aspects of biosafety as it relates to testing and transfer. This in turn will help us assess the different protocols. Some of the guidelines are highlighted below.

Containment. Physical and biological isolation.

Familiarity. Having enough information or experience on the organism, target environment and interactions to judge safety, and also recognizing that some biotechnology derived products will be comparable to traditionally developed products.

Risk/Benefit. Assessment through field trial and recognizing the precision of the development of the technology. Pesticides may not be risk free but have had a net beneficial effect.

Demand. Consider need and priority of the technology; i.e. user/market requirement, for example, herbicide resistance vs Striga resistance.

Institutional Environment. Developers of the technology, users of the technology (level of technology), experiences elsewhere.

Through better definition of these issues, this framework can provide a tool to gauge safety and ensure that future development efforts are not unduly prejudiced.

REFERENCES

Anon. 1994. Annual Report. Pioneer Hi-Bred International Incroporated, Des Moines, IA, USA.

Gosser, C.S. and Fraley, R. 1989. Genetically engineering plants for crop improvement. Science 244:1293-1295.

Persley, G.J., Graddings, L.V. and Juma, C. 1993. Biosafety - The safe application of biotechnology in agriculture and the environment. Research Report No. 5, ISNAR, The Hague.

Townsend, R. 1994. Pioneer Hi-Bred's perspective on field testing of transgenic maize. In: Biosafety for Sustainable Agriculture. Sharing Biotechnology Regulators' Experience of the Western Hemisphere. Krattiger, A.F. and Rosemarin, A. (Eds.), pp. 181-190. ISAAA; Ithaca & SEI: Stockholm.

Copyright 1995 African Crop Science Society