Abstract
I. INTRODUCTION
T
On July 2008, the European Food Safety Authority declared itself against the commercialization of products made from cloned animals, in spite of the fact that no study has found any difference between the meat and milk of a cloned animal and those of a naturally conceived animal.1 In order to support its decision, the Authority said the experiments made around the world are inadequate to guarantee that these products do not pose any risk to health. On the other hand, the corresponding American agency has approved the commercialization of these products, showing that there is no regulatory consensus on the subject. Thus, the lawmaker must take into account these doubts and possible risks, as they are central elements of the issue.
We are, therefore, facing multiple doubts, and we should approach them cautiously so as to prevent avoidable risks. In my opinion, it is precisely this cautious approach that will greatly influence the system of civil liabilities.2 The lack of scientific certainty and the constant breakthroughs in the field of biotechnology make it necessary to apply this precautionary approach. This principle requires national and international authorities to take precautionary measures in case of lack of scientific data and certainty on possible damage.3 That is the reason several countries have supported the idea that you cannot wait for the possible irreparable damage to occur to take the necessary measures.4 This principle has spread widely and is nowadays included in most national and international laws.5 In this regard, the European Union holds the opinion that the precautionary principle should be applied to biotechnology-related laws; consequently, biotechnology products should be authorized only if they are deemed safe for the environment and the health of humans, animals, and plants after a comprehensive risk assessment has been carried out. Risk-management measures should be based on this precautionary principle if scientific evidence is insufficient, inconclusive, or uncertain, or if the possible risks are considered unacceptable.6
These are some of the reasons the commercialization, transport, and manipulation of biotechnology products, as well as biotechnology-related laws, raise controversies, especially among environmentalists and lobbyists in the biotechnology sphere. We must also take into consideration the different interests of genetically modified organism-producing countries compared with those that do not manufacture such organisms. Probably, this conflict has contributed to the failure to meet the urgent need for a common international system of liabilities in this field.7 This need was included in Section 27 of the Cartagena Protocol on Biosafety, which urged the parties to set international rules and procedures regarding liabilities and compensations arising from this type of damage. Said section states that:
The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms, analysing and taking due account of the ongoing processes in international law on these matters, and shall endeavour to complete this process within four years.
This system should have been adopted in the meeting held in May 2008 in Bonn, but the parties involved did not reach an agreement and postponed the decision until the meeting held in the Japanese city of Nagoya. The parties to the Convention on Biological Diversity (CBD) adopted the Nagoya Protocol in 2010 to provide greater legal certainty regarding the CBD's access and benefit-sharing principles. The Commission's proposal calls for the European Council and Parliament to adopt a regulation that would become effective throughout the European Union.8 A central purpose of the regulation would be “to secure access of EU researchers and companies to quality samples of genetic resources based on reliable access decisions at low transaction costs.”9
The study we carried out revolves mainly around the most convenient system of liabilities for damages arising from biotechnology. It will involve, on the one hand, analyzing the current laws on liability for damages arising from biotechnology and, on the other hand, deciding on an unambiguous position with regard to the need for an international liabilities system. The latter will focus on providing an answer to the knottiest problem: whether the most adequate system should be subjective, whereby only those who cause damage by an illegal means will be held responsible, or objective, in which the person who causes damage, regardless of its lawfulness, will be held responsible for the mere fact of having caused the damage. I anticipate that our position is closer to this last option, although we will include several important nuances in relation to the activities of the public administration in this field.
II. CONCEPT OF BIOTECHNOLOGY AND NEED FOR THE INTERVENTION OF THE LAW
Section 2 of the CBD defines biotechnology as “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.”10 This modern technique makes it possible, among other things, to introduce certain characteristics to plants to make them resistant to pests or insects and to add new features to a food—for example, more proteins in corn. It also has medical uses; the first one to be commercialized was human insulin for treating diabetes, whose future perspectives are promising. With regard to its importance in the agricultural world, the latest data leave no place for doubts: world-wide planting of genetically modified organisms in 2007 was more than 100 million hectares.11
It seems evident that the importance and the possibilities of biotechnology for improving our life quality are very high and should, therefore, be seized; however, this does not mean that this technique is free of risks. In this respect, the U.N. Food and Agricultural Organization acknowledges, as we have just pointed out, that biotechnology may contribute to increasing production and agricultural productivity, but, at the same time, it warns against some potential risks posed by some uses of biotechnology.12 It will, therefore, be necessary to counterbalance constant biotechnological progress with the implementation of measures aimed at guaranteeing the safety of people and the environment against the possible risks of this technology. Thus, the law cannot fail to give a legal valuation and intervene in the conflict between the undeniable advantages of this new field and its inherent risks. In said intervention, we include the system of liabilities to be established, so as to compensate for the possible risks of biotechnology; this is the main topic discussed in this article. The biggest problem to be faced in the regulation of biotechnology will be the lack of scientific certainty in several regards. It is not known whether these activities may be harmful or not, and for this reason, said risk should be the essential element around which the system of liabilities should revolve.
III. LIABILITY FOR DAMAGES ARISING FROM BIOTECHNOLOGY
Everybody knows that no damage should ever be caused to third parties and that if it occurs, those responsible should provide compensation for it.13 It was Roman law, through the Roman Lex Aquilia, that first introduced the possibility of substituting redress for punishment with regard to damages. Unfortunately, the causation of damages is inevitable, and the law must act in two ways: punishing (a task pertaining to penal and administrative law) and providing compensation for damages (channeled through civil law).14 The latter deals with torts, which can be defined as a series of acts that, although not described in criminal law, entail civil liabilities15 for their perpetrator, who is thereby bound to provide compensation for the damage caused.16
Prior to my critical analysis of the prevailing system of liabilities for damages arising from biotechnology, I provide a brief description of criminal and administrative liabilities, which, although not here studied in detail, should not be dissociated from one another.
A. Criminal Liability
In connection with biotechnology-related criminal liability, penal law, in order to cope with the existence of risks in biotechnology activities, usually sets a protective barrier, identifying abstract and concrete crimes of endangerment, as a basis for the criminal protection of the legal rights17 it intends to defend, in this case human health18 and the environment.19 In this regard, some authors have condemned the inadequacies of the traditional reactive criminal law and demanded a new preventive criminal law, the latter being a vital instrument of protection in certain technologic sectors.20
It is criminal law that can provide a solution to limit these dangerous situations and serve as a preventive measure against possible future damages.21 There is obviously a significant difference between crimes of endangerment and injuries. In the latter, the key element is the destruction or damage of the object of the action, whereas in the former, the element is the dangerous and perilous situation. It can therefore be inferred that the basis of these crimes of endangerment lies in the prevention of damage.
Doctrine usually divides dangers in two categories: concrete and abstract. Crimes of abstract endangerment are those that require only the performance of the action described as perilous without endangering the legal right. The importance of crimes of abstract endangerment makes this approach one of the most effective ways to deal with typification in the biotechnology field, as the acknowledgement of the protected legal rights and the possible injury caused by the action on the object under protection justifies the implementation of this technique.
Crimes of concrete endangerment specifically require the creation of a situation of real danger and the possibility of a concrete injury as a result of the action.
The problem here is that we do not know the consequences of a significant number of biotechnology activities, or whether the possibility of endangering the protected legal right is real. I am specifically referring to the uncertainty regarding the risks of said activity; we can infer or imagine what these risks may be, but it will be difficult to know if they actually lead to a dangerous situation, as we will be sure about the dangers of a certain activity only in a few cases. To be able to apply these crimes of endangerment, the necessary element will be the certainty of probable damage to a legal right.
Therefore, the response of risk-related criminal law is insufficient, although valid, to defend the different legal rights to be protected. It will be necessary to resort to other branches of the legal system and to other crimes, such as damage to the environment.22
I believe that the Spanish lawmakers have made enormous mistakes by defining most biotechnology-related crimes, highly complex themselves, which entail damage to the principle of legal security. Moreover, there is an increasing number of blank criminal laws that redirect us to administrative law in order to punish certain behavior. The 1995 Criminal Code has focused only on crimes related to human gene manipulation, leaving aside, either intentionally or unintentionally, the legal regulation of possible crimes committed with new biotechnologies. It is also necessary to consider the large number of crimes of abstract endangerment that can be found in the 1995 Criminal Code. Their introduction has created controversy. Nevertheless, I believe that biotechnology-related crimes should be considered mainly as crimes of abstract endangerment, thus setting a new standard in criminal law intervention. In some cases, crimes of concrete endangerment may be needed, but to a lesser extent.
B. Administrative Liability
In this section, we cannot forget to mention administrative liability, which will play an important role, especially in the agricultural field, that derives from non-compliance with the existing regulations and that may lead to an administrative punishment, regardless of the occurrence of damages, and a civil punishment when damage has been done. Before analyzing this issue in depth, I want to point out that, as we will see below, the existence of an administrative authorization and compliance with its rules do not automatically absolve the perpetrator of criminal or civil liability.
A significant case related to this matter makes reference to the liability of food companies to guarantee the safety of commercialized food and foodstuffs.23 It is nevertheless interesting that the Agricultural Modernization Act, dealing with agricultural businesses and emphasizing that they need to assume the risks mentions only the civil, social, and tax liabilities that may derive from the management of the exploitation, inexplicably omitting the criminal and administrative liabilities. Therefore, this concept should not be understood as specific and restricted.24
We must also highlight that the Regulation (EC) 178/2002 of the European Parliament and of the Council (28 January 2002), which sets down the general principles and requirements of agricultural legislation, creates the European Food Safety Authority, and establishes procedures related to food safety, whereby member states shall be responsible for overseeing compliance with food legislation as well as stipulating measures and punishments applicable to breaches of food laws and foodstuff-related legislation, pointing out that said measures and punishments need to be effective, adequate, and dissuasive.25 In our legislation, these measures are included in the Royal Decree 1945/1983 (22 June), which governs offenses and punishments related to consumer affairs and agricultural production. This Royal Decree 1945/1983 lists all administrative offences and classifies them into groups following a practical criterion: health, consumer protection, agri-food quality, and food inspection. It is obvious that administrative liability arising from the commission of an offense is completely independent of civil or criminal liability enforceable on the perpetrator, regardless of the fact that he cannot be punished twice for the same act.26
This legislation is inspired by the same principles that exist at the community and international levels: preventative or precautionary principles that imply the adoption of measures adequate to prevent potential adverse effects on human health and the environment deriving from these activities. The law that governs the punishments system divides offences into mild, serious, and very serious, which may entail fines, permanent or temporary closure of facilities, crop seizure, disqualification from carrying out activities included in the law, or the broadcast of the punishments imposed by appropriate media. Although the law points out that failure to comply with any of its provisions will lead to the corresponding administrative punishments we have just highlighted, it is important to emphasize that the perpetrators of an administrative, biotechnology offense must return things to their previous state and pay compensation for any damages in an amount set by the Administration, establishing criteria for difficult cases. It is therefore evident that civil liability is one of the elements used by the lawmaker to protect rights and property.
Finally, we should point out that it is important that the Royal Decree provides for the possibility of imposing accessory punishments, thus enabling the Administration to confiscate goods that may pose a risk to the consumer. In case of severe offenses, it is possible to close an agriculture company or establishment for a maximum of 5 years. Furthermore, in cases of very severe offenses, it is possible to bar a company from being hired by the Administration for as long as 5 years.
C. Civil Liability
As we have already said, the consequence of causing damage is that the perpetrator has to pay compensation for it. Therefore, a liability arises for the perpetrator, whereas a credit right arises for the victim, who is entitled to demand that the former act appropriately to provide compensation for the damage.27
The obligation to provide compensation for any damage can be fulfilled in two ways: either by in natura compensation, which is the substitution or fixing of the thing affected so that it can return to the state prior to the damage; or by means of equivalent compensation, which involves paying a corresponding amount of money.28
But before determining the scope of this liability, we must study the general criteria of civil liability in the field of biotechnology. Here, the main problem we face is identifying whether we are dealing with a case of subjective or objective liability. If there is no need to prove the offense, only the damage caused and the causal link, we talk about objective liability. If, on the other hand, apart from proving the damage and the causal link, it also is necessary to determine the fault of the perpetrator of the damage, we are speaking about subjective liability.
Most widely accepted doctrine calls for objective liability in matters of civil liability arising from damages caused by biotechnology.29 This is supported by the fact that the perpetrator of the damage assumes the risk of causing the damaging result when he starts his activity. Therefore, the risk the perpetrator of the damage assumes arises from his actions per se, as his subsequent behavior, whatever it may be, has no influence on his liability. This is what we have been calling “civil liability without negligence.” In the field of biotechnology, civil liability should be regarded as objective liability, whereby he who produces a risk must assume the obligation to provide compensation for the damages arising from said risk.30 In this regard, the Supreme Court declared on 9 July 1994 that precedents “agree on the idea that whoever produces a risk, even if the initial activity was legal, must bear the burden of the consequences derived from the dangerous activity he benefits from «cuius est commodum, eius est periculum».”31
On the other hand, in connection with damages arising from biotechnology, not even the existence of an administrative authorization pursuant to the legal system exempts the perpetrator of the damage from his civil liability. This is the case, for example, for a company that genetically modifies a certain food and in the process produces environmental damage, even though it abided by every safety regulation. Said subject assumes, from the very beginning of the process, the consequences of the possible risks and becomes potentially guilty of the damages caused, regardless of whether he acted with the required diligence. This has been included in section 9.1 of Spanish Law 26/2007 on Environmental Liability (23 October) “…Compliance with the requirements, precautions and conditions established by legal and statutory regulations or set in the administrative authorizations necessary for carrying out an economic or professional activity, especially in integrated environmental authorizations, shall not exonerate those included in Annex III from the responsibility….” This seems to be the path to be followed by international regulations, especially the Cartagena Protocol.
However, we could go even further by saying that even if said authorization exists, it cannot mean, in my opinion, the abdication of the Administration's liability, as we could doubt its diligence and efficiency, as it fails to set sufficient regulations in order to prevent or avoid damages; or about its capacity to review the procedure once started.32 Most legislation (here I refer specifically to the European and the Spanish) have exempted the Administration from liability for these cases, which does not seem to be correct, as in most cases, it can be understood that damage can derive from the deficient operation of public service, as it does not take the necessary measures to prevent the danger. The Administration, as we have pointed out several times, should have a leading role in inspecting, reviewing, and revoking authorizations. Although doctrine is doubtful about this, it is the reason I support the idea that whenever the Administration has authorized the activity that produces the damage, it should be held civilly responsible for the damages produced, even if said authorization has been granted pursuant to the law and only if the Administration's activity has been negligent.33 It would be even more difficult to determine in which cases the Administration did not act with the required or necessary levels of diligence. This is supported by two arguments:
1. The Administration could predict the damage beforehand, but did not pass the correct regulations. It should have prevented the damage with appropriate regulations.
2. The Administration's lack of diligence in controlling, inspecting, and revoking the authorizations of activities deemed dangerous.
Therefore, we can say that the precautionary principle would be decisive for the argument that the system of liabilities we support affects the Administration in certain cases, which could therefore incur civil liabilities, as it is responsible for setting down the rules for commercialization and manufacture. Here, we refer to those cases in which the Administration does not establish the necessary rules or regulations which, based on the precautionary principle, prevent the causation of damage by manufacturers. Although we accept that opinion as valid and true, we also believe that this principle leads to the need to apply more diligence in genetically modified organism-related issues for manufacturers and that it has great importance for the determination of civil liabilities for damages arising from biotechnology.
This measure I hereby support may seem unattainable or difficult to agree with when it comes to states to legislate on this topic. However, it would be convenient that, at least in cases where the Administration has authorized the damage-causing biotechnology activity, the manufacturer should be held responsible and that, unless it is impossible for the manufacturer to answer, the Administration should subsidiarily take responsibility for the damage caused.34
The European Union has recently passed a regulation on liability for environmental damage (Directive 2004/35/EC on Environmental Liability). Section 1 of said Directive says its aim is to set an environmental liability framework for preventing and repairing environmental damage. The system includes damages produced by biotechnology. To summarize, we can say that for damages caused by professional activities deemed dangerous,35 the objective liability system established by the Directive will be applicable.36 This system has also been included by Spanish lawmakers in the recent Law 26/2007 (23 October) on Environmental Liability, in agreement with the guidelines set by the Directive, establishing the liability system as an objective system.37
Another challenge will be those cases in which damage has been caused, but its perpetrator is unknown. In today's world, where anonymous damage is increasingly common, the law has decided to favor the victim instead of punishing the culprit, disregarding, as we have already said, the subjective criterion on genetically modified organism-related issues.38 In this regard, Carlucci's comments become interesting, as he says civil liability is not a means to punish the culprit, but rather to translate the damage to a third party provided there is a reason for said change.39
Many new types of liabilities have arisen, such as the so-called manufacturer's liability, which appeared, in the first place, as an evolution of liability for discrete things, although it becomes autonomous when it combines with the objective criterion based on risk–benefit.40 Ghersi reminds us that providing compensation for damage is a consequence of the incorporation of a potentially hazardous element and a benefit obtained with its use, which correlatively imposes the liability to accept the responsibility of compensating for the damage caused.41
Because of the objective nature of this liability, those people who suffer damage arising from biotechnology activities will face a difficult problem: determining the causality of the damage. In this regard, it will be necessary to locate and identify the perpetrator of the damage. In the case of transgenic agriculture, it would be difficult to identify the farmer or company that caused the damage because of its homogeneous nature. Think of the following example: if hazardous effects are discovered for a type of transgenic soy, it would be difficult to locate the producer of said soy and to place the guilt on somebody, and it would be impossible to prove the causal link, although new labeling regulations aim to mitigate the problem.
Duarte Machado believes that the civil liability of companies, laboratories, and educational institutions should be attached only as an attribution factor of the risk involved in genetic engineering, explained in the Conditions Equivalence Theory. Consequently, said liability arises with the mere existence of the activities of the company—not with the causation of damage—and the direct link between said activity and the damage.42
It can be concluded that a specific regulation for biotechnology activities is essential. After evaluating the risks and characteristics of biotechnology, I deem it necessary that the liabilities system derived from the damages it produces be governed by specific laws—in contrast to today's situation, in which we find said system included in other areas, with few, or no, references to damage caused specifically by biotechnology products.
As there is legislation on the intentional release into the environment of genetically modified organisms, which legislation lays down requirements, authorizations, and necessary proceedings, it is becoming increasingly necessary to establish a particular system for handling damages caused by these products. The question we need to answer is whether agricultural biotechnology is different in essence—different per se in its technology—from other agricultural breeding technologies.43
Although there are different positions on this issue, only two are important: on the one hand, there are those who understand that genetic engineering is simply a branch of the traditional agricultural system, just another technique, and therefore do not support specific regulations for it44; and, on the other hand, there are those who believe biotechnology is a totally different and new activity that requires special legislation and strict control that could provide warranties and safety regarding the scope of this technique and its byproducts.45
In conclusion, unlike criminal cases, the typification prior to the illegal act is not a necessary factor for civil unlawfulness, which is to say that there is no list of torts, as it refers to every act contrary to the law. And damaging the right of a third party, or violating a situation protected under the law, is definitely contrary to the law.46
The example Guerra Danieri gives about the Brazilian legislation on transgenic organisms is interesting, because it takes this situation to the extreme. In that country, cultivating genetically modified organisms is an unlawful act, and therefore, there is no possibility of running any risk.† Consequently, it would not be necessary to wait for the finding of damage to determine the unlawfulness of the behavior. In this case, from a legal point of view, the topic of liability is simpler, as we deal with a prohibited activity, and the legal solutions to the problems caused would be the same as for other types of liability.47
Thus, we can state that the liability for risks, or objective non-absolute liability, will be essential for drafting legislation on liabilities arising from damage produced by biotechnology. As a consequence, it will be possible to protect more users and consumers, who should always be prioritized against those who, aiming at a (legal) benefit for themselves, perform activities that may involve risks, regardless of the non-existence of fault or negligence, and in spite of the required diligent measures taken.
IV. THE POLEMIC CASE OF LIABILITY WHEN CONVENTIONAL AND GENETICALLY MODIFIED CROPS COEXIST
The coexistence of conventional and genetically modified crops is a usual practice nowadays. This coexistence makes reference to the ability of farmers to choose from conventional, “green,” and genetically modified crops, provided they abide by the legal regulations on purity and labeling. Said coexistence may involve the risk that genetically modified crops could contaminate conventional and “green” crops. This contamination could be caused in several ways, such as by mixing different harvests or moving pollen from one crop to another.48 The possibility of this crossing between crops is one of the most controversial points in the debate between supporters and detractors of transgenic crops.49 According to a study carried out by the Joint Research Centre of the European Commission and submitted to the European Food Safety Authority, it is necessary to put more measures into practice to reach the objective of reducing the accidental presence of transgenic organisms among other types of seeds to less than 0.1%. The report, based on the production of seeds of corn, sugar beet, and cotton in the EU, states that it is possible to maintain the current threshold of 0.9% of accidental presence of genetically modified organisms in non-transgenic products and to prevent their labeling as GM free, provided seeds do not exceed 0.5% of transgenic rests. It is also necessary to implement complementary measures, such as arranging plots according to the direction of the wind, building hedges in traditional and transgenic crop plots, using varieties of genetically modified organisms whose flowering periods are different from those of traditional crops, or leaving wider spaces between crops.
The international community as a whole, and the European Union in particular, have addressed this issue only superficially, from the economic point of view, without regulating a system of liabilities, giving as an excuse the principle of subsidiarity50 and leaving the issue for member states to regulate. Section 7 of the Recommendation of the Committee (23 July 2003) on guidelines for drafting strategies and better national practices in order to guarantee the coexistence of genetically modified and conventional and “green” crops says that “the European Committee believes that member states should draft and implement coexistence measures.”
As Jiménez Liébana says, environmental and sanitary aspects are regulated by Directive 2001/18/EC51 on intentional release to the environment, which establishes a procedure for granting authorizations only after an assessment of the risks for health and the environment, with an eye to determining whether adverse effects exist, as well as the appropriate protective measures if environmental or health risks exist. For this reason, the argument used by the Committee has been that those aspects related to accidental contamination and coexistence, which have not been regulated by any community law, concern only the economic aspects and the freedom of choice of the farmer as regards the type of crop, as none can be excluded from the European Union.52
Therefore, the revelation by the United Kingdom that it has been discovered that the seeds of traditional crops contain up to 10% genetically modified material demonstrates the risks of coexistence. The British say said contamination was caused by varieties of genetically modified crops cultivated 800 m away from traditional crops. This is an argument that, according to the question asked by Baroness Sarah Ludford of the Committee, increases the need for the EU to be as cautious as possible regarding the use of genetically modified seeds and the potential contamination of traditional crops by genetically modified ones.53 This written question was answered by Police Officer Byrne, saying that the Committee did not have reliable information about the cause of the presence of genetically modified material in said seeds. He also said that the Committee is willing to set down criteria of purity in connection with the presence of genetically modified seeds, including regulations on the minimum distances between fields of seeds and land with potential sources of involuntary pollination by genetically modified plants—distances that can differ depending on the risk of pollination.
The only contribution made by the Committee through its Statement to the European Parliament, the Council, the Economic and Social Committee, and the Regional Committee, “Sciences of Life and Biotechnology: a Strategy for Europe,” has been the statement that it will support the development of methodologies to control the potential long-term environmental impact of genetically modified crops and methodologies to control the effects of genetically modified food and foodstuffs. The Statement proposes that the European Food Safety Authority reinforce and improve the quality of early detection methods of new risks.
After this statement, the Committee made a recommendation on the topic of coexistence, thereby confirming the aforementioned, by saying in section 5 that “the topic of coexistence addressed in this Recommendation concerns possible economic losses and consequences of mixing genetically modified crops and traditional crops, and the most appropriate management measures to take in order to reduce the mixing to the minimum.”
It is evident that the suggestion of the Committee is that member states should draft and implement convenient measures for coexistence, and that the Committee should help only by advising said member states on the process of issuing guidelines.54 The only interesting point made by the Committee is that the measures to be taken should allow all types of crops and guarantee that purity and labeling regulations for crops that are not genetically modified are less strict than those for genetically modified foodstuffs and seeds. We believe Jiménez Liébana is right in saying that if said presence exceeds the thresholds for genetically modified organisms, it can cause conventional, or even “green,” crops to be labeled as genetically modified and thereby lead to economic losses—not only because of the lower price of the product, but also because of the costs incurred by farmers to implement the necessary measures to prevent said contamination.55
Although there is no regulation in this regard, it seems reasonable that the costs should be born by the farmer using genetically modified crops instead of by the farmer of conventional crops. We must remember that in Spain, the new law on Environmental Liability excludes liability in this issue for cases where damage is not caused to the environment as a whole, but rather to someone's private property. It is therefore essential to draft regulations to fill this gap, which may be highly detrimental to some farmers. Logically, there will be no legal thresholds for the presence of non-genetically modified organisms in modified crops.
In 2005, the Committee decided to create a forum for exchanging and coordinating information on scientific studies and improved practices in the field of the coexistence of genetically modified and conventional and “green” crops. In this way, member states could know the practices developed within the different national strategies.56
In Spain, there is no specific legislation on the topic yet, although a Royal Decree bill for regulations on the coexistence of genetically modified and conventional and “green” crops57 has been discussed, which bill aimed at establishing coexistence rules, whose breach would fall under the offences and punishments system set down in Law 9/2003 and which would abide by Regulation (EC) 1830/2003 with regard to labeling and traceability. The regulations included in this Royal Decree are based on general principles laid down in the Guidelines of the European Committee on coexistence and, in particular, on transparency in the exchange of information, cooperation of all those involved in the production process, and equitable balance between the interests of farmers of every type of crop.
This first draft was withdrawn and replaced by another because of the pressure exerted by some agricultural, consumer, and environmental organizations, which believed the draft would not blame those responsible for genetic contamination and that therefore, the future of sustainable agriculture would be at risk, leading to the irreversible presence of transgenic organisms in agriculture.
The first controversial issue was connected to the concept of coexistence: whereas the draft defined it as the farmer's freedom of choice between conventional and “green” crops on the one hand and genetically modified crops on the other—always abiding by the legal liabilities applicable to the production system chosen—those organizations wanted it to be defined as the absence of contamination by transgenic organisms in conventional and “green” productions.58
Here, we see again that no regulation governs liabilities connected to this issue. That is why we consider it urgent to establish regulations on this issue, as well as a system of specific liabilities for damages caused by biotechnology products.
Footnotes
1
For further information on the recommendations of the European Food Safety Authority on this issue, please go to www.efsa.europa.eu or 
2
I want to highlight here that this is my personal opinion, as this idea has not been permanently stated in contemporary doctrine, and opposing opinions can be found.
3
For further information on the Precautionary Principle, refer to my work: “La necesidad de intervención jurídica en la biotecnología: El principio de precaución.” In Aspectos Legales de la agricultura transgénica. Ma José Cazorla González, Ramón Herrera Campos, publishers. University of Almería.
4
See Zaccai, Y., Missa Zaccai, E., Missa, J.N. Le principe de precaution: Signification et consequences, Editions de l'univerité de Bruxelles, 2000, p 111.
5
Nowadays, the precautionary principle inspires policies of the European Union related to the health of consumers and the protection of the environment. The Protocol on Biosafety, signed in Montréal on January 2000, also included the Precautionary Principle as an objective, thereby admitting the possibility that a country, even if it belongs to the World Trade Organization, may refuse to import genetically modified organisms merely by alleging doubts about the safety of a product for health and the environment. Likewise, the Convention on Climate Change included said Principle in its section 3.3: “the parties shall take precautionary measures to predict, prevent and reduce to the minimum level the causes of climate change and mitigate its adverse effects.”
6
Comunicación sobre la Ciencia de la Vida y la Biotecnología, una estrategia para Europa. COM (2002) 27, 23 January 2002.
7
I have supported the need to establish a framework for international liability on biotechnology since I started my investigation in this field, as shown in La Responsabilidad Derivada de los Daños producidos por la Biotecnología, Ed. Reus, Madrid 2007.
9
The proposal contains a draft regulation with the following features: Genetic Resources. The regulation applies to “genetic resources,” defined as material of plant, animal, microbial, or other origin containing functional units of heredity and having “actual or potential value.” The regulation does not apply to genetic resources for which access and benefit sharing is governed by a specialized instrument to which the EU is a party. The explanatory notes specifically identify the International Treaty on Plant Genetic Resources for Food and Agriculture as such a specialized regime that will be unaffected by implementation of the Nagoya Protocol. Obligations of Users of Genetic Resources. The regulation imposes on users of genetic resources an obligation to “exercise diligence” to determine that genetic resources and traditional knowledge associated with them were accessed in accordance with applicable access and benefit-sharing laws. To this end, users would be required to “seek, keep, and transfer to subsequent users” information about the following:
1. the date and place the genetic resources and associated traditional knowledge were acquired; 2. a description of the items acquired, using unique identifiers where they are available; 3. the source from which the items were obtained; 4. whether the items are subject to rights and obligations regarding access and benefit sharing; and 5. any decision made regarding the access, as well as the mutually agreed terms of access. Users would be required to maintain such information for a period of 20 years following the end of the period of use. They would also be mandated to declare at identified points that they complied with their due diligence obligation.
10
See Section 2 of the “Convenio sobre la diversidad biológica,” Rio de Janeiro, June 1992.
11
The report of the International Service for the Acquisition of Agri-biotech Applications says that transgenic crops have grown by 13% in the last 10 years, thus increasing the total planted hectares to 102 million.
12
This is acknowledged by the FAO in a declaration published in March 2000 in Japan on the occasion of the meeting of the “Action Group of the Committee on the Codex Alimentarius to Establish Rules and Guidelines regarding Food Derived from Biotechnology.”
13
Reglero Campos says that one of the three most important principles in law is the obligation not to cause damage to third parties (“Iuris preacepta sunthaec: honeste vivere, alterum non laedere, suum cuique tribuere.” Reglero Campos, L.F. (Coordinator) Lecciones de responsabilidad civil. Ed. Aranzadi, S.A., Navarra 2002, p 33.
14
It is evident that if there is no damage, no civil liability arises; however, administrative and criminal liabilities may be present.
15
Apart from the general works on civil law, it is advisable to refer to Ángel Yagüez, R. Lecciones de responsabilidad civil, ed. Universidad de Deusto Bilbao, 1978; Borrell Maciá, A. Responsabilidades derivadas de la culpa extracontractual, Barcelona, 1942; Quintano Ripollés, “Antijuridicidad civil y penal en el evento jurídico del daño,” in RDP, 1949, p 863 ff; Santos Briz, J. Derecho de daños, Madrid, 1963; Soto Nieto “La llamada compensación de culpas,” RDP, 1968, pp 409–427. Bercovitz Rodríguez-Cano, R.: “Principios de Derecho Europeo sobre responsabilidad civil” in Aranzadi civil, n° 2, 2005.
16
Ossorio Serrano, J.M. Curso de Derecho Civil II-2°. Moreno Quesada et al. Ed. Tirant lo blanch, Valencia, 2006, p 476 ff.
17
We know that personal rights that may be damaged or endangered by biotechnology have already been acknowledged in most legal systems. Thus, biotechnology may violate the right to life, to personal integrity, and to the environment, which are already protected by criminal law.
18
Another element to be taken into consideration is public health, which, as a community value, has started to concern the State for the last few years. The European Council itself highlighted in its Recommendation number R15 the role of criminal law in protecting life and health, which introduces collective safety as another essential element to be safeguarded. But we should not stop there; we must go deeper into public health, one of the pillars of the European Union legislation.
19
For further information on Criminal Law and Biotechnology, please consult the following works: Morillas Cueva, L.: “Delitos relativos a la manipulación genética.” Derecho penal español: parte especial/ (coord.) by Cobo del Rosal, M. 2005; Benítez Ortúzar, I.E., Morillas Cueva, L. and Peris Riera, J. (Coords.): Estudios Jurídico-Penales sobre genética y biomedicina. Tribute to Prof. Dr. D. Ferrando Mantovani. Ed. Dykinson. Madrid, 2005; Bustos Pueche, J.E.: La antijuridicidad, presupuesto de la responsabilidad extracontractual. In La Ley. Year XXV No 6091. Wednesday, 22 September 2004; Bustos Ramírez, J.: Los bienes jurídicos colectivos, Ed. Ariel 1986; Canestrari, S.: Dolo eventual e colpa cosciente. Milan, 1999; Carmona Salgado, C.: Compendio de Derecho Penal Español. Parte especial. Cobo del Rosal (Dir.) Ed. Marcial Pons, Madrid, 2000; Cuadrado Ruiz, M.A.: “¿Protege el Derecho Penal a los consumidores?” in Actualidad Penal, 1999, n° 1; Forti,: Colpa ed evento. Milano, 1989; Gianelli, F.: “Il Dolo nel Diritto Penale,” Rivista Penale, 2001; Gracia Martín, L., Boldova Pasamar, M. A., Alastuey Dobón, M.C.: Tratado de las consecuencias jurídicas del delito, Tirant lo blanch, Valencia, 2006; Luzón Cuesta, J.M.: Compendio de Derecho Penal. Parte Especial. Ed. Dykinson, 2004; Maqueda Abreu, M.L.: “La idea de peligro en el moderno Derecho Penal. Algunas reflexiones a propósito del Proyecto de Código Penal de 1992” in Actualidad Penal, n°. 26, 1994; Mendez Rodríguez, C.: Los delitos de peligro y sus técnicas de tipificación. Centro de Estudios Constitucionales, Madrid, 1993; Morillas Cueva, L.: “Seguridad Alimentario y Derecho Penal: El fraude de Alimentos” Proceedings of the 7th World Congress on Agricultural Law, Pisa-Siena, 2002. Scuola Superiorie Sant'Anna; Sainz-Cantero Caparros, J.E.: Los delitos de incendio. Ed. Comares, 2000; Sessano Goenaga, J.C.: “La protección penal del medio ambiente” in Revista Electrónica de Ciencia Penal y Criminología, 2002 (); Derecho penal español: parte especial/(coord.) by Cobo del Rosal, M. 2005.
20
Mantovani, F.: “Manipulaciones genéticas, bienes jurídicos amenazados, sistemas de control y técnicas de tutela,” in Revista de Derecho y Genoma Humano, 1994, pp 93–120.
21
Compare Herzog, F.: “Limites del Derecho penal para controlar los riesgos sociales,” in Poder Judicial, n° 32, December 1993, p 59 ff.
22
As Jiménez Liébana says, the liability system mirrored in this law is as inadequate as the one included in other special environment-related laws, which merely reproduce the contents of the already-repealed law 15/1994, without going deeper into definitions.
23
See Frota, M.: “Seguridad alimentaria-imperativo de ciudadanía” in E.C. No 66, 2003. p 133 ff.
24
Espín Alba, I. and Vattier Fuenzalida, C.: Derecho agrario. Colección Jurídica General. Director: Rogel Vide, C. Ed. Reus, Madrid, 2005.
25
See Section 17 of the Regulation (EC) 178/2002 of the European Parliament and of the Council (28 January 2002), which sets down the general principles and requirements of agricultural legislation, creates the European Food Safety Authority, and establishes procedures related to food safety.
26
Compare Section 9 of the Royal Decree 1945/1983 concerning liability arising from offenses.
27
Ossorio Serrano, J.M. Curso de Derecho Civil…. p 480 ff.
28
Reglero Campos, L.F. (Coordinator) Lecciones de responsabilidad…. p 93.
29
See Guerra Daneri, E. “Aspectos jurídicos de la responsabilidad en la agricultura Transgénica.” Rivista di Diritto Agrario, aprile-giungo 2000.
30
Martín says that whoever creates a risk must predict it, and if he does not take sufficient precautions, especially the precaution of not generating the risk, must be held liable. Martín, G.: Précaution et évolution du Droit, Le principe de précaution, sous la direction d'Olivier Godart, Ed. de la Maison des Sciences de l'Homme, Paris, 1997.
31
Compare S.T.S 9 July 1994 (RJ 1994/6302 Speaker
32
As Serrano Paredes points out, the question is defining whether the damage would have been produced if the Administration had been efficient in exerting control, such as by taking corrective measures or revoking authorization. It would be equally important to know if the administrative liability could work as an instrument to prevent the Administration from avoiding the tasks pertaining to it. See Serrano Paredes, O.: “En torno a la existencia o no de responsabilidad ambiental por el ejercicio de actividades autorizadas,” in Diario La Ley, n° 6126, November 2004.
33
On the other hand, Cordero Lobato says that the Administration should not be held liable for the damage caused by an activity it authorized, as said possibility would turn the Administration into guarantor of the damages associated with the risks of development, a liability this author understands it has been exonerated from in section 141.1 of the LRJPAC. See Cordero Lobato, E. Derecho de daños y medio ambiente “Lecciones de Derecho de Medio Ambiente” coord. Luis Ignacio Ortega Álvarez, 2002, p 459.
Conde Antequera also understands that the liability of the Administration would arise only when the authorization given exceeded the levels set forth in the laws or when the licenses granted were illegal. See Conde Antequera, J.: “La responsabilidad de la Administración por daños al medio ambiente….”
34
Conde Antequera says that if the damage was caused by an activity that was in compliance with the administrative legal prescriptions and the conditions of the license, it would be necessary to differentiate the action of the Administration, whereby it grants the authorization, and the regulatory action, whereby the Administration regulates the damage-causing activity, in case the possibility of attributing liability to the Administration would be considered fitting, which would mean extra efficiency in protecting the environment by pressuring the Administration to exercise its regulatory powers. In this case, the causal relation would be determined by the lack of administrative diligence in preventing the damages, having sanctioned a rule that would authorize an activity under insufficient determining factors. Conde Antequera, J.: “La responsabilidad de la Administración por daños al medio ambiente….”
35
Those activities compiled in Annex III, and especially those involving genetically modified organisms. The European Union has addressed the problem only superficially, without regulating the issue of liability arising from possible damages caused by this type of contamination, leaving the matter to be dealt with by the member states.
36
For a deeper analysis, consult “La Responsabilidad Derivada de los Daños…” p 109 ff.
I want to point out one thing regarding the sanction of the Spanish Act on Environmental Liability. The Spanish lawmakers did not take into consideration the possibility offered by the Guideline to the states of excluding the liability of the perpetrators in the cases provided for in its Section 8 of possibly establishing a system of subjective liability for some cases related to damage caused by genetically modified organisms.
37
It must be pointed out that the Guideline, as well as the Spanish law to which I have made reference, do not contemplate damage to private property, as they consider this system valid exclusively for the environment, understood as a generic or overarching entity we are all entitled to enjoy.
38
Martínez García, G.: “La responsabilidad patrimonial de las administraciones públicas por daños al medio ambiente, in Revista de Derecho Agrario y Alimentario, n° 31, July–December 1997.
39
Carlucci, A.K. and Parellada, C.: Responsabilidad civil. Hammurabi. S.R.L. Buenos Aires, 1997, p 188.
40
This was enshrined in Roman law by the maxim ubi emolumentum ibi ius, which means that where benefit is, there is liability. This maxim has been used in modern law to support the accusation on risk–benefit. See Duarte Machado, J.S. and Pintos Sabedra, L.: “La responsabilidad derivada de la ingeniería genética” in Proceedings of the 7th World Congress on Agricultural Law. Ed. Dykinson. Almería 2002.
41
This author points out that what comes together in everyday life (meaning risks and benefits) should not be separated by the law; if this relation were broken by honoring the rule that who caused the risk and who benefited from its exploitation can transfer it to others, we would find companies that could make profits at the expense of transferring elements of their liabilities to society—companies socially and economically protected by a system of liabilities that reduces their real liabilities at the expense of injured people. Quoted by Ghersi, C.A.: Teoría general de la reparación de daños. Ed. Astrea. Buenos Aires, 1997, p 145.
42
Compare Duarte Machado, J.S. and Pintos Sabedra, L.: “La responsabilidad derivada de la ingeniería genética….”
43
See Kershen, D.L.: “Legal liability issues in agricultural biotechnology,” An Agricultural Law Research Article. Arkansas, 2002.
44
See Guerra Daneri, E. “Aspectos jurídicos de la responsabilidad en la agricultura Transgénica….” p 216.
45
See Lappé Marc-Bailey, B.: Against the Grain, Ed. 1988, p 95 ff.
46
Gamarra, J.: Tratado de Derecho Civil Uruguayo, V. XIX, p 165 ff.
†
Despite the legal ban on planting genetically modified crops, only the United States has more acres of such crops than Brazil. Numerous patent infringement suits have been filed against Brazilian farmers, as all of the seeds used there have been acquired illegally.
47
See Guerra Daneri, E. “Aspectos jurídicos de la responsabilidad en la agricultura Transgénica….” Pp 221 and 222.
48
See Statement number 3 of the “Recommendation of the Committee (23 July 2003) on the Guidelines for drafting strategies and improved national practices in to order to guarantee the coexistence of genetically modified organisms and conventional, green agriculture.”
49
Among other documents that deal with the controversy on this matter, you can consult “Consideraciones básicas a incluir en las normas españolas sobre coexistencia entre cultivos modificados genéticamente, cultivos convencionales y ecológicos,” drafted by Coag, Ugt, and Facua, 29 March 2005.
50
The Statement of the Committee of the European Parliament to the Council, the Economic and Social Committee, and the Committee of the Regions, “Ciencias de la vida y biotecnología Una estrategia para Europa,” highlights the importance of compliance with the subsidiary principle, although it is later said that it should not be an obstacle for Europeans in the fulfilment of common goals. It also advocates the establishment of strategic clear objectives and global, coherent approaches based on new ways of collaboration and control, especially by means of open coordination and comparative assessment, within the framework of a common approach to the global long-term opportunities and challenges.
51
If necessary, the final stage of the authorization-granting process can include coexistence measures to protect the environment and human health pursuant to Guideline 2001/18/EC of the European Parliament and of the Council, entailing the legal obligation of putting them into practice.
52
Compare Jiménez Liébana, D. Biotecnología y Medio ambiente: Aspectos jurídicos. Proceedings of the 7th World Congress on Agricultural Law, Volume II, Veracruz, 2003, p 1422.
53
See Pregunta Escrita E-1902/00 de Baroness Sarah Ludford (ELDR) a la Comisión (16 June 2000)(2001/C 103 E/035).
54
According to Statement number 8 of the “Recommendation of the Committee (23 July 2003), “the European Commission should back and advise member states in this process, publishing guidelines on coexistence.”
55
Jiménez Liébana reminds us of the validity of the principle “whoever pollutes has to pay,” although European Community laws leave open the question of its applicability: first, because these issues are not discussed in the Community; and second, because, according to the recently passed rules of the Community, farmers are the ones who have to prove that their products comply with the rules in order not to be labeled. Compare Jiménez Liébana, D. “Biotecnología y medio ambiente….” p 1424 ff.
56
See Decision of the Committee (21 June 2005), which creates a network group for the exchange and coordination of information related to the coexistence of genetically modified and conventional and “green” crops. In its Recommendation 2003/556/EC (23 July 2003) on the Guidelines for drafting strategies and improved national practices to guarantee the coexistence of genetically modified and conventional and “green” agriculture, the Commission supported the idea of leaving the drafting and application of coexistence management measures to member states. In this respect, the Commission announced it aims at facilitating the exchange of information on future and ongoing investigation projects at the national and community levels.
57
Royal Decree Bill, which sanctions the regulations on the coexistence of genetically modified and conventional and “green” crops. Ministry of Agriculture, Fishery and Food.
58
“Consideraciones básicas a incluir en las normas españolas sobre coexistencia entre cultivos modificados genéticamente, cultivos convencionales y ecológicos,” drafted by, among others, Coag, Ugt, and Facua, 29 March 2005.