The need to have an express regulation covering nanotechnology has been the subject of debate in the scientific literature and identified as one of the main subsets of nanotechnology field research. However, most countries still do not have regulatory framework in order to guarantee consumer safety. This is the case of Costa Rica, one of the most promising countries in Latin America in terms of biotechnology and nanotechnology. This article presents a statistical study about the position of industry, academia and government institutions on the need to expressly regulate nanotechnology in Costa Rica. A qualitative study consisting of a survey of 79 forms was done to individuals representing the community involved with nanotechnology and institutions responsible for ensuring the safety of the citizen’s health, to conclude that the nanotechnology regulation should be created to protect the consumer in Costa Rica. The research also proposes aspects that should be taken into account in its drafting as well as the variables on which decisions should be made to authorize the commercialization of nanomaterials based on the findings of the literature.
Nanotechnology presents numerous challenges in terms of designing an adequate regulation. Therefore, this topic has generated numerous research works that help design an appropriate governance, both in generic and specific contexts. These studies assist policy-makers to adjust the regulatory framework. For instance, [
Costa Rica has remarkable position in terms of biotechnology and nanotechnology given the promotion of public policies and the natural context. Nanotechnology is considered one of the priority fields for the development of this country, according to the Strategy of the XXI Century, for the year 2050 [
On the other hand, it must be pointed out that the Costa Rican legal system has other provisions that must be consonant with the promotion of this technology, such as consumer protection. In Costa Rica, consumer protection is included in the Political Constitution, in article 46, which states: “Consumers and users have the right to protection of their health, environment, security and economic interests; to receive adequate and truthful information; to freedom of choice and fair treatment” [
The development of these rights can be found in Act 7472 on Promotion of Competition and Effective Defense of the Consumer; specifically becomes effective through the application of article 32, which incorporates in literal a) the right of consumers to protection against risks that may affect their health, safety and the environment. In the same article through the literal c) is recognized consumer’s right to information: “Access to information, accurate and timely, on the different goods and services, with correct specification of quantity, characteristics, composition, quality and price” [
Within the framework of this regulation, it is aligned with most countries since citizen security is extracted from the Universal Declaration of Human Rights of 1948—numbers 3 and 25—and the International Covenant on Economic, Social and Cultural Rights of 1966—numbers 11 and 12 [
Given this situation of uncertainty, we must ask ourselves if it is appropriate to apply the precautionary principle to reduce risks of lack of protection of the aforementioned rights. The application of the precautionary principle in the area of food is framed in the field of human health and has already been applied and developed in Costa Rica, as reflected in Resolution 2006-017747 of the Constitutional Chamber of the Supreme Court of Justice of Costa Rica: It is necessary to implement the precautionary principle when an activity is posed as a threat to human health or the environment, precautionary measures should be taken even when some cause and effect relationships have not been established in a scientific manner in its entirety […]. The operation of the precautionary principle in this area is very simple and means that when an activity produces or causes threats or probabilities of serious and irreversible harm to human health, precautionary measures should be adopted, the causal effects are not scientifically established [
Under this jurisprudential line, the principle must be applied to nanotechnology when these precepts are given by pertinent and proportional measures [
This, according to the tracking that has been done, is the first article of its kind, involving people representative of the community involved with nanotechnology and institutions in charge of ensuring the safety of the citizen’s health, which uses surveys to find out their opinion not only about the importance of regulating but also about the relevance of it. In this case, the community manifests itself in favor of regulation and in what terms it must be advanced to avoid its possible negative effects. This study should be taken as a first step in Costa Rica, to initiate the planning of a regulation as well as the means of public participation, to count on the commitment of all social strata.
In the literature, surveys have been carried out regarding the perception of the public during the last years. [
In these terms, to deepen the need for regulation, institutions from other contexts are asked to carry out this type of study, due to its economic and legal implications as well as to assess the need for regulatory convergence at an international level.
A survey of 79 people was conducted in the age ranges presented in
80 percent of the participants currently live in Costa Rica and 20 percent in a country other than Costa Rica. Likewise, the exhibition tries to represent the community involved with nanotechnology and institutions in charge of ensuring the safety of the citizen’s health.
Once the sample is delimited, the opinion survey is made to each participant and each answer is analyzed to know the position in front of the debate on the express regulation of nanotechnology, and see if it is possible to enrich it with alternative positions given the characteristics of the Costa Rica context.
In addition, from the point of view of the objective of the survey, it is an analytical survey, since although the literature has generally been in favor of regulation, it tries to contrast the hypothesis that in Costa Rica it would be appropriate to have with an express regulation of nanotechnology since it can contribute to the protection of the citizen’s health.
The survey includes 8 questions, each with a purpose, as reflected in
Questions | Purpose |
---|---|
1) Which one(s) do you consider to be the main advantages that the regulation of nanotechnology would generate for the sector to which you belong? | To identify possible advantages of an express regulation of nanotechnology to know its need. |
2) Which one(s) do you consider to be the main advantages that the regulation of nanotechnology would generate for the sector to which you belong? | To identify possible disadvantages of an express regulation of nanotechnology to know its need. |
3) Do you consider that the regulation of nanotechnology for the sector to which you belong is necessary? | To know the opinion of whether the advantages are considered of greater or lesser weight than the disadvantages, to assess their need. |
4) Your answer to question 3 is due to | To understand the reason why the advantages or disadvantages have more weight. |
5) Which institution should be in charge of having the responsibility to control the nanotechnological processes for the sector to which you belong in Costa Rica? | To specify the institution that should assume the control functions of nanomaterials in Costa Rica. |
6) Mention at least five parameters that the institution should consider to authorise or deny the inclusion of nanomaterials in a product. | To identify parameters in the decision-making model. |
7) Do you think that this institution should have a model for decision making in order to guide in the task of authorising the use of nanomaterials in the products of your sector? | To point out the need for the decision-making model to prioritize in the construction of regulation. |
8) Ponder the utility of a model of this type. | To know the utility of the decision-making model to prioritize in the construction of regulation. |
Below are the different results obtained. For this, the first section is the need to regulate nanotechnology in Costa Rica, where the results of the first 4 questions of the survey are addressed. Subsequently, in the following section, the decision-making institution and decision criteria are analyzed, in terms of the parameters of the nanomaterials, encompassing the answers of questions 5 and 6. Finally, in the section of the decision-making model and its importance, the results of questions 7 and 8 will be presented.
In order to know the pertinence of the express regulation of nanotechnology, four questions of
The first question asked is conceived by thinking about the advantages that a new express regulation of nanotechnology can bring, according to the respondents. Therefore, it reads as follows: Which one(s) do you consider to be the main advantages that the regulation of nanotechnology would generate for the sector to which it belongs? Taking into account that the questions are multiple choice test types, 165 total answers were collected. Below the different percentages of each response are presented, see
Among the different possible advantages of an express regulation of nanotechnology is that it could grant greater protection to the consumer [
The second possible advantage included in the questionnaire was to promote the regulation of nanomaterials in specific sectors [
The third proposed advantage is that it would help to improve the information of the consumers before the choice of the product [
The fourth possible advantage is that it would help to control the nanomaterials market by having them identified [
On the other hand, the possible advantages included by the respondents, different from those proposed by the survey, accounted by 5 percent of the responses. They were the following: 1) To have control over the environmental impact of these nanomaterials; 2) to generate support policies for the materials sector; 3) to have control in manufacturing and to know how to make the final disposition of the product; 4) to meet international standards; 5) improve information at the material level; 6) to develop intellectual property issues related to nanotechnology.
It can be concluded that in terms of possible advantages, the main ones pointed out by the respondents are that it would allow the development of regulation in specific sectors and provide greater consumer security. Therefore, they should be fundamental principles over which the express norms are built. Other advantages of less importance, but which should also be taken into account in order to configure an adequate regulation, are the improvement of the information given to the consumer and the increased control of nanomaterials.
The survey, then, addresses the possible disadvantages that prevent the development of legislative processes capable of crystallizing a regulation of nanotechnology. That is to say, in the absence of prior regulation, it is not only difficult to foresee the advantages that would be obtained with a new regulation but also the disadvantages. For this reason, the people questioned are asked the following question: 1. Which one(s) do you consider to be the main disadvantages that the regulation of nanotechnology would generate for the sector to which you belong? A series of possible disadvantages reported in the literature were included. Of the 105 responses obtained, the results are presented below, see
Of the possible disadvantages rescued from the literature and included in the survey, the first one that was included was the provocation of panic among consumers [
The second possible disadvantage included in the survey was that it could be an obstacle to the development of nanotechnology [
The third possible disadvantage proposed was inadequate regulation [
The fourth possible disadvantage included in the survey was the allocation of resources [
When having the option of including other possible disadvantages, the respondents indicated in addition to those expressly collected in the survey, the following: 1) to overload of information to the consumer; 2) to confuse the consumer; 3) undue intervention in each of the fields of action and 4) obstruction of free trade. These concerns are reflected in 10 percent of the responses.
It can be concluded that regarding the possible disadvantages, the main concerns are that the regulation is inadequate and that it could decelerate the development of nanotechnology in the country. In this sense, if the process of creating regulation and the inclusion of criteria were raised in a participatory manner, the main possible mistrust could be reduced. Other concerns, of less importance, although not ignorable, are the amount of resources that will be allocated to apply the regulation or the possible effects in relation to the consumer such as the generated panic, over information or confusion. In this sense, it would be significant if a political commitment on the part of the institutions is specifically included in the regulation to disseminate relevant information on nanotechnology so that citizens are aware of it and are not uninformed or over informed.
Once the possible advantages and disadvantages of the express regulation of nanotechnology have been addressed, the question arises whether it is necessary. Despite the advantages, is it better not to regulate given the possible disadvantages or vice versa? The following question was posed: Do you consider that the regulation of nanotechnology for the sector to which you belong is necessary?
The respondents mostly opted for an affirmative answer, as we can see in
Once known the contribution of express regulation of nanotechnology, what are the factors that should be considered in the regulation? That is, what is the justification for this regulation? The question formulated was: “Your answer to question 3 is due to”. The answers are reflected in
The first option included was possible toxicity, given that although advances have been made on the toxicity of nanomaterials, measurement under unrealistic conditions [
The second reason why the regulation of nanotechnology is justified is the number of nanoproducts, given that there is a significative number of products with nanotechnology in the market [
The third proposed reason is the alignment with foreign regulations [
The fourth reason is about legal certainty, since although nanotechnology is not regulated explicitly, companies invest in nanotechnology to improve their products [
Other justifications were indicated by the respondents assuming 4 percent of the total responses: 1) Risk assessment of risk to health and environment; 2) to provide information to the citizen and 3) to ensure that it is applied for peaceful purposes. The only justification given against the regulation of nanotechnology was from the investigative point of view, since regulation should not limit the researcher’s autonomy.
As a result of the previously mentioned concerns, one aspect to be foreseen is the organization in charge of authorizing or denying the commercialization of products with nanomaterials in the market. In Costa Rica there are several institutions capable of assuming this task, so question 5 raises the following question: Which agency should be responsible for having the responsibility to control the nanotechnological processes for the sector to which it belongs in Costa Rica? The answers are reflected in
The preferred option in statistical terms is Laboratorio Nacional de Nanotecnología-Centro Nacional de Alta Tecnología (LANOTEC-CENAT) with 43.4 percent of the answers. However, the Ministry of Science, Technology and Telecommunications as well as the Ministry of Health follows it closely with 26 percent and 25 percent respectively. It must be said that the possible answers are not exclusive since, depending on the sector, different ministries may assume the responsibility of controlling these processes or even involving several bodies in a decision-making process. The fact that LANOTEC-CENAT is the most voted institution being unelected, can also help to give clues about its inclusion in the decision process. For example, the scenario in which LANOTEC-CENAT would be responsible for the study and development of investigations so that according to this opinion, the Ministry in charge can make a decision. Likewise, the possibility of creating a new decision-making institution was also assessed, although if total responses were taken as a reference, the support was not so high compared to the existing institutions (8 percent chose a new decision-making body).
Because the present article does not have the purpose of proposing an organizational structure capable of assuming these functions in an efficient manner, the literature is entrusted to understand mainly the internal structure and the allocation of resources and competences to be able to undertake this function.
In conclusion, as shown in
Regarding the parameters to be able to authorize or deny the commercialization of a nanomaterial, there are several properties that may be related to the level of toxicity expressed by a certain nanomaterial, being advisable as indicated [
like purity [
Of the proposed parameters, 22 percent of the responses indicate the composition of the nanomaterial followed by the purity of the same, with 18 percent. The size and the process to which it is submitted have 16 percent of the votes. The form accumulates 12 percent and density, the least voted with 11 percent. Regarding the aggregated parameters, they represent 5 percent of the answers, including the following: 1) Persistence in the soil and its bioconcentration; 2) application of the nanomaterial; 3) physicochemical properties; 4) concentration; 5) cytotoxicity studies; 6) biocompatibility; 7) bioavailability; 8) life cycle of the nanomaterial; 9) aggregation; 10) agglomeration; 11) particle size distribution; 12) standardization; 13) sterilization.
On the other hand, as seen in
Once considered the need to regulate nanotechnology, given its advantages and disadvantages, and its justification, it is convenient to ask if there should be a model of decision making to authorize or deny the commercialization of a nanomaterial. Some of the advantages that a model can provide are the improvement of efficiency in time and resources so that the best decision can be made with the information available [
Therefore, question 7 is: Do you think that this body should have a model for decision making that can guide you in your task of authorizing the use of nanomaterials in the products of your sector? 77 out of 79 responses were affirmative, representing 97.5 percent of the total, even being higher than the percentage that supports the creation of a specific regulation. They are represented by
Once the question about the need of the decision-making model has been answered, it is interesting to know the estimated utility of this model on the respondents. In this sense, a last question was introduced that reads as follows: “Ponder the utility of a model of this type.” As can be seen in
From questions 7 and 8, it can be inferred that the model should be the pillar on which the decision to authorize or deny nanomaterials is made, which is a fundamental aspect of regulation. The interest on the part of the community in this model is high given the great convergence of opinions. The construction of this model should be established as one of the main specific objectives of regulation. Studies should be carried out on the different alternatives of the model, fulfilling the required criteria taking advantage of the value of the main findings of this study, given that it is the first time that the community of experts in the Costa Rica context has been investigated.
Through this study, the different regulatory aspects discussed in the literature have been proposed in the context of Costa Rica and thus to know if the opinion of the expert’s community is favorable or unfavorable to create a regulation, based on the precautionary principle, and if so, on what terms.
In the first place, the community surveyed—constituted by people involved in nanotechnological processes and consumer health protection through academia, companies and the government—considers that the express regulation of nanotechnology is necessary, mainly due to its possible toxicity and the increasing exposure to which the citizen is subjected. Although possible disadvantages are pointed out—mainly, generating inadequate regulation or a possible brake on the development of nanotechnology—they are compensated with the possible advantages that can arise, which are mainly to protect the consumer and provide specific regulations to the different productive sectors.
It should be considered that the regulation is applied by institutions in a distributed manner, with considerable weight given to the opinion of specialized technical bodies. With existing bodies and the absorption of functions efficiently should be sufficient to apply it to the context of Costa Rica, although studies should be conducted on the allocation of resources and skills to optimize how these functions should be assumed to reduce unnecessary expenses and structures, another of the possible disadvantages indicated by the respondents.
Due to the high number of weight parameters as well as concerns regarding toxicity and increased exposure to citizens, it is important to have a model in which decisions are supported; it must be a sufficiently robust and validated model so that it does not slow down the advance of nanotechnology or that it constitutes inadequate regulation in terms of inconsistencies or lack of incentives.
Avoid the stilted expression, “One of us (R. B. G.) thanks …” Instead, try “R. B. G. thanks”. Special gratitude is extended to the CYTED NANOCELIA Network for its financial support in order to carry out research in the Laboratorio Nacional de Nanotecnología (LANOTEC-CENAT-CONARE), San José, Costa Rica. On the other hand, it is also grateful to COLCIENCIAS for the scholarship of doctorate studies of one of the authors within their competence; in particular, the financial support is granted by this institution through the open call: “Convocatoria para Doctorado Nacional 757” of 2017. This original research is part of the project “Investigación en Derecho Internacional y Nanotecnología” registered in the Research Center of the Universidad Pontificia Bolivariana with registration number 766B-06/17-37.
The authors declare no conflicts of interest regarding the publication of this paper.
Cabello, R.S., Vega-Baudrit, J., Zuluaga, R. and Gañán, P. (2020) Statistical Approach to Regulation of Nanotechnology: Need, Advantages and Disadvantages. Journal of Biomaterials and Nanobiotechnology, 11, 14-32. https://doi.org/10.4236/jbnb.2020.111002