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By Lorna Haynes
Although any discussion about the use of genetic engineering focuses on biosafety aspects, the subject is little known, not only in society but also among practitioners of the technology and public officials working in related areas.
What does Biosafety mean?
Although any discussion about the use of genetic engineering focuses on biosafety aspects, the subject is little known, not only in society but also among practitioners of the technology and public officials working in related areas. Therefore, some reflections on what "biosafety" means and its implications for regulating the use of genetically modified organisms (GMOs or "transgenic") and the creation of a national biosafety framework are appropriate. The Cartagena Protocol is an international agreement, in force since September 11, 2003, ratified by Venezuela, which establishes a minimum floor for the regulation of activities with GMOs. It should be noted that this Protocol exists because it is globally recognized that GMOs introduce new risks to health and the environment and that they should be treated differently from other organisms and their products.
The meaning of the word biosecurity is understood by its components: "bio" from bios (Greek) which means "life," and "security" which refers to the quality of being safe, free from harm, risk or danger. Therefore, biosecurity is the quality that life is free from harm, risk or danger. However, there are other meanings associated with the word "Biosafety" that are derived from associations in the sub-consciousness with the other meanings of the words "safe" and "security" defined in the dictionary (Sopena 1981) such as the quality of being : (i) true, undoubted, reliable; (ii) unaware of suspicion; (iii) firm, steady, solid. Even when "biosecurity" is defined as the quality of life being free from harm, risk or danger, it inevitably carries these nuances associated with the use of the word in its other meanings and contexts that add to "biosecurity" a sense that it is Try something trustworthy, true, unsuspected, solid. Thus, the word transmits to the listener a sense of tranquility and the public may be left with a sense of false "security" when it is claimed to have taken biosecurity into account in the decisions that concern them. It can be seen as a kind of trap since the risky essence of the phenomena in question is hidden in the same word.
Risk prevention is the essence of biosecurity and therefore requires that the possible dangerous consequences of an action be evaluated and a legal framework that restricts or prohibits said action be created.
What does Estimation or Risk Assessment mean?
Risk is serious and uncertain damage. In the study or risk analysis, an attempt is made to identify all the damages and dangers that could occur, be they for health, for the environment and for cultural or socio-economic impacts. Risk estimation refers to its quantification and attempts to approximate the magnitude of the consequence and the probability that it will occur. For risk analysis and estimation, it uses scientific information, data and evidence and the results of experiments based on the current state of knowledge. It is not an exact science because it is about predicting very little known phenomena. The risk assessment stage is not based on science: it means forming an evaluative judgment about something, such as good or bad, acceptable-unacceptable, fair or unfair etc. and it must be based on universal ethical values that take into account the rights of current and future generations. Legislation must establish the ethical principles and criteria that govern the making of these decisions.
How is Biosecurity implemented?
Biosecurity is put into practice through legislation regulating the creation of, and activities with, GMOs, and, jointly, the capacity and infrastructure to implement it. To illustrate what this involves, we summarize the most important principles and norms in force in European legislation (European Parliament 2001, 2003) that govern one of these activities, namely, the release into the environment of transgenic plants and their placing on the market. and use in food for humans and animals. The European Union also has other complementary and binding regulations on other products, activities and organizations, in addition to criminal laws, so that, with this example, only a part, but a significant part, of what we have will be appreciated. to be incorporated into a national biosecurity framework.
Principles and Considerations on Biosafety in the European Union (EU)
The Precautionary Principle: if there is evidence of serious risks to health or the environment, do not wait for scientific evidence to adopt measures to prohibit the action and prevent the risk.
1. The Prevention Principle: the goal is to prevent risks.
2. Respect for ethical principles. (For example, you might ask if: Is it ethical to create herbicide-resistant crops that involve the use of higher amounts of poisons that pollute the environment and harm health?)
3. Transparency: requires consultation and public participation in establishing the legal framework and in its implementation and public access to information.
4. Strict liability: the impacts of GMOs are often irreversible and may affect other farmers and neighboring countries and consumers of the products. Therefore, it is necessary to establish strict liability for damages from current and future impacts, direct and indirect, both inside and outside the country.
5. Step-by-step principle: an activity is not authorized without having complied with previous steps of safety tests that, based on the protection of health and the environment, justify it. It means that the containment of GMOs is reduced and the release scale is increased gradually, step by step, as long as the results show that continuing to the next step of trials with a lower degree of containment does not present risks to health or the environment. .
6. Studies must be case by case: it is recognized that each GMO is unique and the risks must be evaluated in each case, for each GMO and take into account the long-term cumulative effects. You cannot generalize data from one case to another.
7. Monitoring of unforeseen effects: it is mandatory to establish a plan for monitoring and detecting possible unforeseen, direct and indirect impacts after release in the short and long term and measures must be established to ensure monitoring (through, for example, an official inspection and monitoring system.) Monitoring reports must be submitted to request renewal of an authorization.
8. Inspections: inspections should be organized to supervise compliance with the control and monitoring measures and to oversee unauthorized activities.
9. Independent Investigation: independent investigation must be carried out on the risks of the release into the environment and placing on the market of GMOs and derived foods
10. Right to final consumer information: consumers of products have the right to know if a product is of transgenic origin. (This also applies to what is consumed in restaurants.) Therefore the labeling of GMOs and all their products is required.
11. Labels and Traceability: it is mandatory to identify all GMOs with labels at all stages of product placement on the market to ensure the possibility of tracing and identifying impacts and determining responsibilities for any damage that occurs. All food for human or animal consumption produced using GMOs must be labeled even if they do not contain DNA or proteins of transgenic origin in the final product.
12. Limited time: Authorizations for release to the environment or placing on the market are for a limited time and their possible renewal will take into account new evidence and scientific advances.
13. Contingency Plan: A contingency plan must be established for the control and removal of GMOs in case of emergency and serious risks.
14. Elimination of Antibiotic Resistant Markers: before December 31, 2004, for GMOs destined for the consumer market and before December 31, 2008 for non-market releases.
15. Socio-economic impacts: every three years a report must be produced on the socio-economic impacts for each category of GMOs.
16. Confinement: measures are established to avoid genetic contamination.
The genetic contamination of seeds with transgenes from non-transgenic crops is undermining the supply of non-transgenic seeds and non-transgenic foods, violating the rights to non-transgenic agriculture and food. European legislation specifies that when risks to health or the environment that cannot be "managed," that is, "effectively prevented," are identified, such activity is not authorized. Since it has been seen in practice, that it is impossible to prevent genetic contamination, it is concluded that non-transgenic agriculture cannot co-exist with transgenic agriculture. To protect conventional, ecological and traditional production systems from GM contamination, the creation of GM-free zones has been suggested. The problem of how to achieve the confinement (# 17 above) that allows the co-existence of non-transgenic agriculture with GMOs, is the subject of debate in the EU, but they deprive the rights to non-transgenic agriculture and food and, in cases of contamination, the responsibility falls on the polluter, the one that uses transgenics.
Challenges of Biosafety Implementation
Considering points 7-10 (above) on monitoring, control, risk assessments and independent scientific studies, it is evident that the controls necessary to guarantee biosecurity against the risks of GMOs are complicated, they involve the use of expensive state-of-the-art infrastructure and technology, highly qualified technical personnel and a modern and efficient administrative system is needed. Creating such a biosecurity framework means a huge and unnecessary cost, an onerous burden for countries to protect themselves against the risks of GMOs that, for the most part, are being imposed by transnational commercial interests. It is an unnecessary expense because there is no need for transgenic plants: they do not offer any benefits for food or agriculture, but they do offer many risks, and there are non-risky, truly sustainable ecological alternatives to solve the problems of food production healthy.
For all third world countries, creating a coherent and strong biosecurity framework means diverting resources to solve real acute national problems of hunger, clean water, health and education. It is worth reflecting on the moral justification of allowing corporate interests to impose these technologies, the control and regulation of which require sacrificing basic needs of the population in order to mount an expensive defense apparatus against the risks of GMOs. Given the huge investments required, the lack of knowledge on the subject, and powerful interests promoting GMOs, there is a risk that weak and permissive legislation will be created that leaves the population and the environment exposed to risks. In Venezuela, we deserve legislation as demanding as the most advanced in force and can always be improved. Without implementation, without a complete biosecurity framework, the legislation is a dead letter and when the risks associated with an activity cannot be prevented, the Precautionary Principle forces us to prohibit it.
1. European Parliament: Directive 2001/18 / EEC on the release into the environment of genetically modified organisms of March 12, 2001
2. European Parliament: Regulation 1829/2003 on genetically modified food and feed of September 22, 2003
3. European Parliament: Regulation 1830/2003 on traceability of September 22, 2003
4. Sopena 1981
Member of the University Commission for Environmental Affairs of the Universidad de los Andes,
Founding member CENTINELA, Mérida, Venezuela. RAPAL-VE Coordinator
Based on Work presented at the 2003 National Meeting of REDBIO, Agro-Food Biotechnology Network. Doc 3-5 2003, Caracas