18/04/01

Principio de Precaución: La pureza absoluta no existe, ni la seguridad absoluta tampoco

 El Ministro italiano de Agricultura, Pecoraro Scanio, después del culebrón del secuestro de semillas de soja y maíz, ha reconocido en diversas declaraciones que no es posible la tolerancia cero en cuanto al contenido adventicio de OGM. La tolerancia cero es reconocida como imposible por muchos informes científicos, entre otras cosas porque los métodos de análisis son extremadamente sensibles y porque una vez que hay determinados genes (OGM o no) dentro del “pool” de genes de la especie, tarde o temprano acaban llegando a todas partes, aunque sea en trazas.

 http://www.politicheagricole.it/mipa/rassegna%20stampa/img/00000057.tif

 La pureza genética absoluta no es posible, pero por las mismas no es posible tampoco la seguridad absoluta que algunos parece que pretenden lograr con el llamado Principio de Precaución, que parece que solamente se aplica a los OGM. Si hay o va a haber un umbral del 0,3%, del 0,5% o el porcentaje que sea para considerar un producto libre de OGM, también tiene que haber un umbral, aunque sea menos mensurable para la precaución.

 Los riesgos asociados a la biotecnología existen, pero también los asociados a la mejora genética distinta de la biotecnología, al riego con aguas residuales, a la quema de los MER, a coger el automóvil, y en general, a todas y cada una de las actividades y aspectos de la vida. La cuestión es saber con precisión razonable cual es el riesgo y si éste es asumible.

 El llamado Principio de Precaución es una trampa dialéctica y en demasiadas ocasiones se usa un arma para basar una postura política en la defensa de una seguridad imposible, aprovechando la preocupación sobre la seguridad alimentaria y el medio ambiente.

 Científicamente se puede demostrar en muchos casos que algo produce una cosa, (una alergia, un efecto determinado..), pero es extremadamente difícil en la mayor parte de los casos imposible demostrar con seguridad absoluta que algo no produce un efecto determinado. Por poner un ejemplo: existen dudas sobre si el maíz OGM Starlink produce alergias a determinadas personas, que parece ser que aún no se han encontrado. Aún suponiendo que se pudiera hacer comer tacos de maíz Starlink a todos y cada uno de los habitantes de EEUU, todavía se podría decir que hay que probar con todos los del mundo, e incluso podría caber la duda de las generaciones venideras. Lo mismo ocurre cuando se invoca el desconocimiento de los efectos de los OGM en el medio ambiente “a largo plazo” ¿Cuánto es el largo plazo? ¿Años? ¿Meses? Siglos?. El Principio de Precacución llevado al extremo es la coartada es ideal para dar largas sine die al tema de los OGM alegando su falta de seguridad, a pesar de que las pruebas y controles no tengan parangón con las de los productos no OGM.

 En la revista Nature Biotecnology del mes de abrli, Cregory Conko y Henry H. Miller, escriben un artículo titulado “Precaución sin principio” donde se describe como no esta claro que en que consiste exactamente el Principio de Precaución, la incompleta evidencia científica de su significado y su invocación para justificar acciones políticas.

 http://www.nature.com/cgi-taf/DynaPage.taf?file=/nbt/journal/v19/n4/full/nbt0401_302.html

 


 

PRECAUTION WITHOUT PRINCIPLE
April, 2001
 
Henry I. Miller and Gregory Conko write that government regulators now have a more subtle, updated version of the assertion, "Hi, I'm from the government, I'm here to help": a wolf in sheep¹s clothing called the "precautionary principle."

The authors say it has already laid waste to several industries and boasts a body count in the tens of thousands. It is now being used to cripple public sector and academic researchers as well as the biotechnology industry. Although a widely accepted definition of the "principle" does not exist, its thrust is that regulatory measures should prevent or restrict actions that raise even conjectural threats of harm to human health or the environment, although there may be incomplete scientific evidence as to their potential significance. Several European countries have used the precautionary principle to justify paralyzing restrictions on agricultural and food biotechnology, and the European Commission (EC) has invoked it to justify a moratorium on the approval of new recombinant DNAmodified products 1 .

Use of the precautionary principle is sometimes represented as "erring on the side of safety." But the authors believe the way it is typically applied to research and development and to commercial products can actually increase risk.

Potential risks should be taken into consideration before proceeding with any new activity or product, whether it is the choice of site for a power station or the introduction of a new drug into the pharmacy. But advocates of the precautionary principle focus primarily on the possibility that technologies could pose unique, extreme, or unmanageable risks. What is missing from the precautionary calculus is an acknowledgment that even when technologies introduce new risks, most confer net benefits; that is, their use reduces many other, far more serious hazards. Examples include blood transfusions, magnetic resonance imaging (MRI) scans, and automobile air bags, all of which offer immense benefits and only minimal risk. The real danger of the precautionary principle is that it distracts consumers and policy-makers from known, significant threats to human health and often diverts limited public health resources from those genuine and far greater risks.

The authors go on to say that dozens of scientific bodies, including the UK¹s Royal Society, the US National Academy of Sciences, the World Health Organization, and the American Medical Association have analyzed the oversight that is appropriate for gene-spliced organisms and arrived at remarkably congruent conclusions: The newer molecular techniques for genetic improvement are an extension, or refinement, of earlier, far less precise ones; adding genes to plants or microorganisms does not make them less safe either to the environment or to eat; the risks associated with recombinant DNA-modified organisms are the same in kind as those associated with conventionally modified organisms; and regulation should be based upon the risk-related characteristics of individual products, regardless of the techniques used in their development.

Notwithstanding the EC¹s promises that the precautionary principle would not be abused, regulators treat recombinant DNA-modified plants and microorganisms in a discriminatory and inconsistent fashion, and without proportionality to risk. Both the fact and degree of regulation turn on the use of certain production methods techniques have been used individual products.

For example, recombinant herbicide-tolerant crop plants, such as soybeans and canola, are subject to lengthy, hugely expensive mandatory testing and pre-market evaluation, whereas plants with virtually identical properties but developed with older, less precise genetic techniques are exempt from such requirements. In the United States, Department of Agriculture requirements for paperwork and field trial design make field trials with gene-spliced organisms 1020 times more expensive than the same experiments with virtually identical organisms that have been modified with conventional genetic techniques 5 .

The authors say that the real-world impacts of this wholly disproportionate approach are instructive. If a student doing a school biology project takes a packet of "conventional," but genetically improved, tomato or pea seeds to be irradiated at the local hospital and plants them in his backyard in order to investigate interesting mutants, he need not seek approval from any local, national, or international authority. However, if the seeds have been modified by the addition of one or a few genes by recombinant DNA techniques, this would-be researcher (or equivalent highly skilled agricultural scientists) faces a mountain of bureaucratic paperwork and expense.

Not only does this discrimination flaunt the scientific consensus about the essential continuity between the traditional and molecular genetic improvement of plants, but it also ignores the fact that recombinant DNA technology is more precise and predictable and the modifications far better characterized than with other techniques. Logical application of the precautionary principle to situations of scientific uncertainty would dictate that greater precaution apply to the cruder, less precise, less predictable "conventional" forms of genetic modification. Instead, by torturing the precautionary principle, regulators have chosen to set the burden of proof far higher for recombinant DNA technology than for conventional plant breeding. And, as the EC¹s moratorium on new product approvals demonstrates, even when that extraordinary burden of proof is met through unprecedented amounts of testing and evaluation, regulators frequently declare themselves unsatisfied.

Remarkably, although the EC characterized its communication on the precautionary principle as an attempt to impart greater consistency and clarity, it specifically declined to define the principle, adding naively that "it would be wrong to conclude that the absence of a definition has to lead to legal uncertainty." Although reliance on regulatory agencies and courts to define and elaborate statutory policy is not unusual, this reluctance to define what purports to be a fundamental principle makes confusion and mischief inevitable, leaving innovators' legal rights and regulators' legal obligations subject to the wholly subjective and sometimes nefarious judgment of governments or even individual regulators. As it is being applied, the precautionary principle provides neither evidentiary standards for "safety" nor procedural criteria for obtaining regulatory approval, no matter how much evidence has been accumulated. In effect, regulators are given carte blanche to decide what is "unsafe" and what is "safe enough," with no means to ensure that their decisions actually reduce overall risk or that they make any sense at all. Contrary to the claims of its supporters, the precautionary principle tends to make governments less accountable, not more so, because its lack of definition allows regulators to justify any decision.

In spite of the assurance of the European Union and other advocates of precautionary regulation to the contrary, regulators of biotechnology applied to agriculture and food production seldom consider the potential risk-reducing benefits of new technologies. For example, the use of recombinant DNA-modified plants with enhanced pest or disease resistance has reduced farmers¹ use of chemical pesticides, reducing runoff into waterways, and the exposure of workers who manufacture, transport, and apply these chemicals. It has also permitted farmers to more widely adopt environment-friendly, no-till farming practices. And recently developed rice varieties enhanced with pro-vitamin A and iron could drastically improve the health of hundreds of millions of the malnourished in developing countries. These are the kinds of tangible environmental and health benefits that have been given little or no weight in precautionary risk calculations.

But benefits aside, the authors say that the safety of this new technology is not really in doubt. Both theoretical and empirical evidence shows the extraordinary predictability and safety of gene-spliced organisms.

Recombinant DNA-modified plants are now grown worldwide on more than 100 million acres annually, and more than 60% of processed foods in the United States contain ingredients derived from recombinant organisms. There has not been a single mishap resulting in injury to a single person.

For anti-biotechnology activists, the deeper issue is not really safety at all. Often, the controversies over the testing and use of gene-spliced organisms stem from a social vision that is not just strongly anti-technology, but one that poses serious challenges to academic, individual, and corporate freedom.

The authors go on to say it is precisely the anti-technology nature of the precautionary principle that makes it the darling of many non-governmental organizations. Greenpeace, one of the principal advocates of the precautionary principle, wrote in its 1999 Internal Revenue Service filings that the organization¹s goal is not the prudent, safe use of recombinant DNA-derived foods or even their labeling; rather, they demand nothing less than these products' "complete elimination [from] the food supply and the environment." 6 Many of these groups do not merely proselytize for illogical and stultifying regulation or outright bans on product testing and commercialization; they advocate and carry out vandalism of field trials.

Carolyn Raffensperger, executive director of the Science and Environmental Health Network, a consortium of radical groups, asserts that the precautionary principle "is in the hands of the people," as illustrated, according to her, by violent demonstrations against economic globalization, such as those in Seattle at the 1999 meeting of the World Trade Organization 7 . "This is [about] how they want to live their lives," says Raffensperger.

In the authors' view, it¹s really about how a small, vocal, violent group of radicals wants to dictate to the rest of us how we should live our lives. In other words, the issue here is freedom and its infringement by ideologues who disapprove, on principle, of a certain technology. But bullies should not be permitted to use untruths, conspiracy, and violence to oppose legitimate research into technologies that can improve our safety and well-being. We should no longer allow extremists to dictate the terms of the debate.

References
1.Hodgson, J. Nature Biotechnol. 18, 918919 (2000).
2.Anderson, C. Nature 354, 255 (1991).
3.Durodié, W. Poisonous Propaganda: Global Echoes of an Anti-Vinyl Agenda (Washington DC: Competitive Enterprise Institute, 2000).
4.European Commission. Communication From the Commission on the Precautionary Principle (Brussels: February 2, COM 1, 2000).
5.Huttner, S.L., Miller, H.I. & Lemaux, P.G. US Agricultural Biotechnology: Status and Prospects. Technological Forecasting and Social Change 50, 2539 (1995).
6.Greenpeace. 1999 Federal Income Tax Filing with the U.S. Internal Revenue Service: IRS Form 990, Part III, Statement of Program Service
Accomplishments, ``Genetic Engineering.``
7.Appell, D. Sci. Am. 284, 1819 (2001).

 

 

 


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