The international regulation of biotechnology. The case of rDNA techniques (1973-1982)
Resumen
The 1970s rapidly became a focus for public interest and excitement. All areas of biology were influenced by the revolution in technical developments and in particular by the rDNA technique. This technology has been used, and still is used, to create recombinant DNA from a variety of viral, animal and bacterial sources. There is serious concern that some of these artificial recombinant DNA molecules could prove biologically hazardous. This article is about the adventure of the regulation of the use of rDNA technique, research and work. In focusing on public policy and regulation, and in particular on the European public and science policies, the intention is to study how societies learn to digest new knowledge and to manage its consequences. Taking into account that this learning process is a multidimensional one and that the debates about biotechnology were from the start international, we will show that the process of regulating a new technology is very complex. We will also reveal how ethical and moral intentions can be confronted, in the debates and negotiating processes, with other interests, such as personal, sectorial, community, national, international, economic, legal and political interests.
Key words: Biotechnology, biotechnology regulation, biotechnology decision, rDNA techniques, Asilomar, biohazard, science policy, genetic engineering.
Texto completo:
PDFReferencias
F. Séruselat, “Vers une approche des définitions du concept de l’éthique”, La lettre éthique, Vol. 5, 1990.
Title of the first chapter of the work by Sharon McAuliffe and KathleenMcAuliffe, Life for Sale, ed. Coward, McLann and Georghegan, New York, 1981.
Deoxyribonucleic acid: a molecule having the structure of a double helix andrepresenting the chemical basis of heredity. Present in chromosomes and in mitochondria and chloroplasts.
S.N. Cohen, A.C.Y. Chang, H.W. Boyer and R.B. Helling, “Construction ofbiologically functional bacterial plasmids in vitro”, Proc. Natl. Acad. Sci., USA, Vol. 70, 1973, pgs. 3240-3244.
M.F. Singer and D. Soll, “DNA hybrid molecules”, Science, Vol. 181, 1973, pg.1114.
Paul Berg, et al., “Potential Biohazards of Recombinant DNA Molecules”,Science, Vol. 185, 1974, pg. 303.
Janet H. Weinberg, “Decision at Asilomar”, Science News, 22 March 1975, pg. 196.
Michaël Rogers, “The Pandora’s Box Congress”, Rolling Stone, 19 June 1975, pg. 77.
HMSO, Report of the Working Party on the Practice of Genetic Manipulation, Williams Working Party, Comnd. 6600, Her Majesty’s Stationery Office, London, 1974.
HMSO, Report of the Working Party on the Practice of Genetic Manipulation (Williams Working Party) Comnd. 6600, Her Majesty’s Stationery Office, London, 1976.
The main Directorate-Generals concerned by biotechnology that we may citein this article are: DGIII: internal market and industrial affairs, IV: competition, V: employment, social affairs and education, VI: agriculture and rural development, XI: environment, nuclear safety and civil protection, XII: science, research and development, XIII: telecommunications, the information industry and innovation (in 1989, education and consumer protection became separate services, split off from DGV and XI respectively).
Member European sectorial federations of the EBCG in 1991: Association ofMicrobial Food Enzyme Producers (AMFEP), Conseil Européen des Fédérations de l’Industrie Chimique (CEFIC), Confédération des Industries AgroAlimentaires, Comité Européen des Obteneurs des Variétés Végétales (COMASSO), European Federation of Pharmaceutical Industries’ Association (EFPIA), Fédération Européenné de la Santé Animale (FEDESA), Green Industry Biotechnology Platform (GIBIP), International Group of National Associations of Agrochemical Manufacturers (GIFAP). Member national bio-Industrial associations of the EBCG since April 1989: Associazione Nazionale per Io Svillup delle Biotechnologie (Italy) (ASSOBIOTEC), Bioindustry Association (United Kingdom) (BIA), Bioresearch Ireland (Ireland) (BRI), Foreningen af Bioteknologiske Industrier i Danmark (Denmark) (FBID), Groupe Belge de la Coordination de la Bio-industrie (Belgium) (GBCB), Nederlandse Industriële en Agrarische Biotechnologie Associatie (Netherlands) (NIABA), Organisation Nationale Interprofessionelle des BioIndustries (France) (ORGANIBIO).
Interesting to note that the European Council of Chemical Industry Federations (CEFIC) gave the EBCG a chairman and a secretary and defrayed the costs of the secretariat.
European Commission, Proposal ... Official Journal of the European Communities, 301, pgs. 5-7.
“If any action by the Community appears necessary to achieve, in thefunctioning of the Common Market, one of the aims of the Community in cases where this Treaty has not provided for the requisite powers of action, the Council, acting by means of a unnanimous vote on a proposal of the Commission and after the Assembly has been consulted, shall enact the appropriate provisions.”
European Commission, Draft Council Recommendation concerning the registration of recombinant DNA work, Com (80), Vol. 467, 8 July 1980.
European Commission, Draft Council Recommendation, concerning theRegistration of recombinant DNA work, COM (80), Vol. 467, 8 July 1980.
This committee brought together the representatives of the national rDNAcommittees.
North Atlantic Assembly, Genetic Manipulation (Recombinant DNA Research, Application and Regulation), 1981.
Council of Europe, “Thirty-Third Ordinary Session of the Parliamentary Assembly, Recommendation 934 (1982) on genetic engineering”. Text adopted by the Assembly on 26 January 1982 (22nd sitting).
This remains a problem for all attempts at “risk assessment” and underlinesthe basic limits inherent in this approach: to evaluate the risks implied by new technologies, reference is possible only to the risks implied by an existing technique similar, even if only remotely, to the new technique.
J. Becker, “Recombination DNA Research: EEC dispute”, Nature, 24/31 December 1981.
Council Recommendation (472 EEC). Concerning the registration of workinvolving recombinant DNA, 1982.
World Council of Churches, Biotechnology: its challenges to the church andto the world, Report by WCC Subunit on Church and Society, WCC Geneva, 1989.
Members of the SAGB in 1991: Ferruzzi, Hoechst, Hoffmann-La Roche, ICIplc, Monsanto Europe SA, Rhône-Poulenc, Sandoz Pharma Ltd., Unilever plc.
Enlaces refback
- No hay ningún enlace refback.
Revista semestral editada por el Centro de Estudios Filosóficos, Políticos
y Sociales Vicente Lombardo Toledano de la Secretaría de Educación Pública,
la Universidad Autónoma Metropolitana-Iztapalapa y Edicions UIB de la Universitat de les Illes Balears.
Lombardo Toledano 51, Col. Ex-Hda. Guadalupe Chimalistac,
Del. Alvaro Obregón, C.P. 01050, México, D.F.
Tels. (5255) 5661-4679 y 5661-4987
Fax: (5255) 5661-1787