Biological safety and its evolution… A little reflection

Biological safety and its evolution… A little reflection

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By By Dr. Juan Antonio Acosta Giraldo

The essential purpose of this article is biological security and its evolution over the last three decades, which coincide with the emergence of the flourishing of modern biotechnology. However, it should be noted that the reoccupation with biological safety was already present in the traditional industrial biotechnology aimed at the production of drugs and water purification, in processes that are older than a century.


Safety, in its mixed sense that combines the quality or condition of insurance with an instrumental nature of a physical, social or legal mechanism that serves to prevent or limit the risks or negative consequences of an accident, is a concept linked to industrial society . That is why we speak of safety in engineering, safety in the automotive industry, safety in bridge construction, safety in mining, safety over fire or safety in electrical installations..

The concept of biological security is a normative concept that incorporates biology as a productive factor and that is projected on several levels: in the first level it must act on the actors that intervene in the generation of knowledge; in the second, it affects the intermediaries who take advantage of this knowledge to produce the consequent goods; the third level concerns the public located in a certain place or area where the research and / or production takes place, while the fourth level has to do with global projection.

However, it is at the end of the 1970s when the concept of biological safety emerges with force, precisely from the risks that the reverie generated by genetic engineering were spreading. Even the most traditional industrial biotechnology realized that, by resorting to the use of genetically modified organisms ( GMOs resulting from genetic engineering), should take extreme care in the management of waste from the processes that involve the use of transgenic organisms due to the possible dangers that they could pose, both from a local point of view for the health of workers and for the population restricted to a specific environment or with a more universal character.

In this context it is worth mentioning a book, published in 1994 under the title Biosafety in Industrial Biotechnology, in which the problems related to the management of bioprocesses were broadly included. It is important to highlight that the concern for the applications of genetic engineering arose from the scientific community itself, led by Paul Berg, father of the recombinant DNA technique and Nobel Prize in Chemistry in 1980 for this finding. Scientists have acted throughout history with a professional ethic, derived from what the North American sociologist Robert K. Merton analyzed in depth (the well-known « ethos Mertonian '). But it is also true that their progressive contact with the political and economic power has been weakening the ethical barriers regarding their responsibility as experts. In any case, at the time of the genesis of genetic engineering there were exceptional moments, with important social movements after the revolution of May 68 in the universities of Columbia and Paris and the influences of the philosopher Herbert Marcuse with his existentialist-Marxist synthesis .

The leading scientists in the biology leading to modern biotechnology placed themselves in positions of the left, with which they considered themselves tributaries of responsibility. For this reason, in 1975 they convened the Asilomar conference, a convention center on the Pacific coast, which was attended by scientists, journalists and some political leaders. In this conference the birth of biological security can be placed as a scientific and political objective, in short, as an objective of scientific policy. As a result of that meeting, a moratorium was proposed, which in a country like the United States, a fervent believer in technology, led to the mobilization of the federal agency for the promotion of biomedical research, the National Institutes of Health (NIH) , which established the guidelines on the requirements that laboratories that were to work with GMOs had to meet, setting three categories or types - P1, P3 and P4 - depending on the danger of the original organism (pathogenicity, dissemination capacity, environmental impact) .

It is necessary to underline that the guidelines established by the NIH to work with genetically modified organisms in confinement conditions have been adopted internationally and the experiences of their application have been successful in the field of safety, since no accidents have been detected. nor problems of leakage or contamination, despite the huge number of experiments carried out in public and private research centers over the last thirty years.


Since its inception, biotechnology has been the subject of important critical movements, particularly in the 1990s and in Central European countries such as Switzerland and Germany.

The analyzes on the perception of biotechnology that results from the communication and dissemination processes configure what I have called the «social space of biotechnology» (for more details on this concept, see the section «Biotechnology in the mirror» in the Web from the Roche Institute,, and represent a valuable indicator of social sensitivity on biological safety.

Since the advent of genetic engineering or gene technology, biotechnology has been the object of important critical movements, especially in the 1990s and in Central European countries such as Switzerland, with the intervention of organizations such as Appell of Basel, mobilized against the "patentability of life", according to its own slogan, or the SAG (Working Group on Gene Technology, based in Zurich), an organization founded in 1990 with the aim of defending ecological principles, animal rights, consumers and Third World countries. From the beginning, this group promoted an intense campaign to stop the release of genetically modified organisms in the external environment, the introduction of transgenic animals - animals modified with recombinant DNA technology and the attribution of patents to parts or components of living beings.

The attitudes of scientists (experts)

Although less frequently, surveys have also been conducted with scientists specializing in genetic engineering, especially in the troubled period of the early 1990s. A model study is carried out by Isaac Rabino of the Center for Biological and Biological Sciences. of Health (State University of New York), which set out to explore the attitudes and concerns of Western European scientists and which was published in Biotech Forum Europe (10/92, pages 636-640).

The majority of those surveyed recognized that public attention to the subject had hindered the development of the field in general terms, although in the field of their personal scientific-technical activity they believed that this attention had reported more positive than negative effects. The most positive responses came from France and the United Kingdom, while the most negative came from Germany and Switzerland.

Genetic engineers, or molecular biologists using such technology, were open-minded to cooperation and collaboration with the public and also accepted that environmentalists should be involved in formulating regulations for recombinant DNA research. However, they claimed ultimate responsibility for regulations in their capacity as experts in the field; they should be consulted in the political management of the issue both at national and international level. They admitted, on the other hand, that they had to assume an important role in the education of the public, the media and governments. They requested clarification of the directives of the European Community, designation of the time for a unitary Europe.

Spanish scientists, who had been underrepresented in Rabino's study (1.3% of a sample of 376), were the subject of a specific demographic study in 1995 by José Luis Luján and Luis Moreno at the former Institute of Advanced Social Studies (IESA) of the CSIC. The results confirmed those obtained at the European level: Spanish scientists spoke out in favor of regulation, emphatically rejected eugenics and believed that there were minimal risks to the environment and health as a result of the application of biotechnological techniques and of genetic engineering. The opinions of experts, biotechnology researchers from the public system and biotechnologists from the industry, were contrasted with those of a group of professionals related to biotechnology, but not cultivators of it, such as that of hospital physicians, and with another further afield, that of science journalists. They were the least seduced by the potentialities of genetic technologies, although their resignation was nuanced, since they valued that the risk of these practices was low, in contrast to common citizenship, which associates these techniques with risk, although, as I have already pointed out previously, based on beliefs and values.

It was in West Germany where the greatest resistance occurred. Although no popular concern was detected in that country at the historic time the Asilomar conference was held in the United States, resistance grew dramatically in the 1980s with opposition from left-wing groups and the Party of the Green.

Germany's opposition was also manifested in institutions such as the Hamburg Institute for Social Research, funded by a cigarette brand, the Bonn Confederation for Nature and Environment Protection and the Berlin Genetic Network. At the center of the activism were some individuals with doctorates in Biological Sciences, associated or forming part of the eco-institutes, in addition to political leaders in the environmental area of ​​some Länder o Federal states.

Denmark and the United Kingdom also faced opposition to gene technology from environmental groups; the speeches did not stop listing contradictions when arguing their rejection of genetically modified agricultural products, referring to their uselessness in a community Europe where there was overproduction of food.

Political activity in opposition to biotechnology began to change and become multinational with the assumption of the critical movement by Greenpeace and Friends of the Earth, two transnational pro-environmental organizations, and with the entry of the issue on the agenda of the European Parliament by middle of the green MEPs.

In the 1990s, only the southern European countries, France, Italy and Spain, lacked organizations opposed to some applications of biotechnology. But with the transformation of an almost marginal movement with scarce resources into one led by large pro-environmental organizations, the situation would change in those countries, which began to have an opposition to biotechnology with the central motive of invoking biosecurity and non-patentability, transnational in nature, if we except France, where the figure of a leader, the farmer José Bové, emerged as the leader of the anti-biotechnology movement.

In this context, it is not surprising that the European Commission decided to launch consultations to find out the perceptions and attitudes of citizens on these issues, which are also crucial for making political decisions, since, in the meantime, the United States has moved quickly along the path of biotechnology on which the scientific community, the business world and capital were betting, and also without great resistance from society in general.

It is true that the United States was not spared a confrontation on the issue, mainly in the field of food. To cite a relevant case, the president of the Foundation on Economic Trends (Washington), Jeremy Rifkin, published in January 1993 an article in collaboration with Ted Howard, director of the Foundation Campaign for a Healthy Eating (Pure Food Campaign) under the shocking title of "Consumers reject frankenstein food» ( Consumers reject "frankenfoods").

It is relevant to note that the article was published in the magazine Chemistry and Industry (Chemistry and Industry). Rifkin has led the anti-biotechnology movement (especially in the agri-food sector) for a decade and in the first years of it managed to generate quite a significant reaction, to the extent that some few but relevant surveys carried out in the United States registered results. quite significant rejection of the biotechnological application in agri-food, especially in relation to gene transfer (70% of the respondents considered the introduction of animal genes into plants unacceptable and almost 90% considered the incorporation of human genes into plants unacceptable). farm animals and fish, while about 85% admitted that it was "very important" to label all foods resulting from genetic engineering).

Evolution in the United States has not followed these paths despite the pessimism that all these reactions and positions generated in proponents of biotechnology such as Henry Miller, molecular biologist and official at the FDA, who has blamed scientists for having triggered the alarms and summoned to monsters. Although there is still a debate between biotech agriculture and organic farming, it is centered and delimited by economic interests, and even Rifkin himself has modulated his attitude towards biotechnology.

But let's go back to Europe, where the situation is different. From 1978 to practically the present, with a maximum three-year periodicity, Eurobarometers have monitored European citizens in the six countries from the beginning of the EC, until they were extended to twenty-four in the most recent consultation.

The results are neither black nor white. There are gradients in the scale, which goes from rejection to acceptance at all levels: biological, applications, and countries. The acceptance of contradiction due to the personal risks that the condemnation of heredity may entail), or gene therapy, which also carries risks, demonstrable with data and which are much greater and evident than in the case of genetically modified foods. In the case of Europe, there is great heterogeneity, with countries highly receptive to biotechnology applications, such as Spain, Finland and Portugal, and very negative countries, such as Austria and Luxembourg, which have recently been joined by Greece. (A new paradox is offered by this country, which has gone from a very favorable position to a very negative one). There is a majority of European countries with intermediate positions, although with nuances depending on the applications.

Among the most rejected, in addition to modified or transgenic foods, are xenotransplantation and cloning of animals.

The diagnosis of social perception of biotechnology in Europe is closely related to the concept of biological security and is characterized by being inspired by values, beliefs and interests, although the most evident global characteristic is ambiguity. In any case, the discourse of the opposition, essentially environmentalist, towards transgenic foods has been peppered with metaphors related to monstrosity, as is the case of a critical number of The Ecologist referring to "the devil's seeds" or the aforementioned allusion to the frankenstein food.

In recent times there have been new applications in health, such as stem cells or stem cells of embryonic origin, which, together with the identification of possible risks associated with their use, raises new doubts and promotes debates in the sector application that had so far generated less controversy. In any case, the concerns for these biotechnological applications in health rest more on ethical considerations than on a strict concern for the problem of safety, although this problem is underlying the concern for these applications.

For a more complete analysis of the issues related to public perception in biotechnology, see "Problems in the analysis of public perception of biotechnology: Europe and its contradictions", by Emilio Muñoz, in Social perception of science (Rubia, Fuentes and Casado eds., UNED Ediciones, 2004).


The various legislative regulations on biological safety are a direct reflection of cultural peculiarities and the interests associated with them.

Concerns for the biological security of scientific, social and political spaces converge in the legislative sphere. With the agreement in principle, as has been shown, of scientists and experts, administrators and managers have launched to legislate profusely on issues related to biotechnological applications.

Regulatory processes have taken place at different political levels, from the supranational to the regional level, although the most relevant have been the supranational ones (United Nations, UNESCO, Parliament and the European Commission), while the national ones have covered a great variety of topics, although the main focus has been projected on issues related to knowledge transfer and intellectual property, as well as on issues related to safety: food, pharmacological, environmental, fundamental rights.

In general, it can be said that regulations of a more general nature are a reflection of cultural peculiarities and the interests associated with them. In this sense, it should be noted that the laws and regulations established by the European Union have mainly affected agriculture, food and intellectual property (in the case of biotechnology patents, which have led to an extensive and complicated debate over a decade). The OECD, for its part, has located its regulatory concerns in the health field and has placed particular emphasis on issues related to genetic diagnosis.

In the United States, it is the fields of health and environmental protection that have accumulated legislative initiatives.

In the actions of large multilateral organizations, norms have circulated around fundamental rights, thus connecting with ethical approaches.


The ethical and evaluative dimensions constitute another avenue through which concerns for the biological safety of scientific-technical, social and political spaces flow, and converge, in which natural and artificial barriers of beliefs also play.

Despite this confluence, it is important to note that there are bifurcations in the strategy and way of tackling the problem depending on the sector in which life sciences technologies are applied. In this way, ethical approaches to the implications of modern biotechnology in health have circulated on the basis of signals supported by beliefs and responsibility, focusing the main problems on issues related to reproductive technologies, on the situation of children. embryos, in the need to increase citizen participation (governance) in medical practice and in new advances in biomedicine, with greater or lesser potential for their translational application, in what I have called, in a recent contribution to the Trends Forum Social, "redesign of life." Bioethics, which was introduced in the early 1970s by the oncologist Van Ressenlaer Potter with his article « Bioethics: the

Science of Survival», Published in 1970, and with the book Bioethics: Bridge to the Fu ture in 1971, which has moved in analysis and reflection along the path of principled ethics.

The situation is different in the case of biotechnological applications to agriculture and the food sector, which have also had ethical considerations, although these have been moved for their analysis within the comparisons of costs and benefits in line with Luddite, or consequentialist trends (utilitarians). The document " Ethical Aspects of the Labeling of Foods Derived from Modern Biotechnology», Of May 5, 1995, which included the opinion of the Advisory Group on Ethical Implications of Biotechnology of the European Commission, is quite illustrative in this regard.

It seems clear that policy has played a decisive role in the recognition and in the implementation and development of biosafety


On the issue of biological security, it seems clear that the decisive role that politics has played in its recognition and in its implementation and development must be recognized. It is true that the scientists themselves, exercising a certain self-control, were the first to warn of the potential risks of a technology that emerged with the aura of being all-powerful. This has led other experts, in view of the important general social and political reactions, have criticized the scientific colleagues who made the forward-looking reflection for an excess of alarmism. In any case, biosafety issues related to the emergence of new (modern) biotechnologies can boast of having the fewest number of victims or problems on their backs. Paradoxically, the problems and the victims, although quite rare, have been on the side of those applications that are best accepted by society, as is the case of gene therapy.

However, this satisfactory situation has been disturbed with the arrival, not of a technology, but of a debatable decision of scientific policy. Following the terrorist attacks of September 11, 2001 in the United States, the Bush Administration launched a research program on bioterrorism ( Bioterror Research Program), which has led to a proliferation of work on potentially dangerous organisms. In parallel, these initiatives have led to an increase in the construction of high-security laboratories, levels P3 and P4 according to the NIH guidelines mentioned above. Despite these logical precautionary measures, the accumulation of papers on topics that involve risks has generated an avalanche of errors in security, especially at the University of Texas –but not only–, which has made the question of biological safety ( biosafety) has been placed on the agenda of the United States Congress (the, October 2007). This case highlights, once again, the importance of political decisions on issues of social impact. This reflection leads me to make a section to refer to two areas, although different, of biological safety, since they are areas in which lives are lost in an absolutely overwhelming way, such as the workplace and that of road traffic. over which the indifference –to use a mild term– of the citizenship is impressive.

In any case, the reflection on biological safety related to life sciences and their technological developments has had as one more asset the ability to generate new concerns for safety, such as food safety.

However, political confusion has continued to arise, such as those arising from the essentially European application of the precautionary principle. It is a political principle that has a difficult accommodation or adjustment with respect to science and the scientific method. By increasing concerns, experimentation is not allowed, which constitutes a basic instrument for the generation and contrast of scientific knowledge.

It would seem more logical to apply principles of foresight and prevention that are more in line with scientific rationality and its logic. In this way, a balance could be established between the good and the bad of modern biotechnology. We are afraid of the

Dr. Juan Antonio Acosta Giraldo

Managing Director

DISAM Consulting GROUP

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