Biosecurity Law in the Context of National Security: New Threats and Countermeasures

Rednikova Tatiana Vladimirovna PhD in Law Senior Scientific Associate, Department of Environmental, Land an Agrarian Law, Institute of State and Law of the Russian Academy of Sciences 119019, Russia, Moscow, Znamenka str., 10 trednikova@gmail.com Other publications by this author

The leadership of our state has repeatedly stressed that the main "gold reserve" of Russia are the people living on its territory (See, for example, V.V. Putin. Speech on the "Direct Line" on June 30, 2021) and being one of the most important competitive advantages of the country. The multi-million population of the Russian Federation needs reliable protection from the state from a variety of external and internal threats, including those that can negatively affect people's health and their lives.

An integral part of ensuring human life is his constant interaction with the external environment. The human body is affected by a wide range of environmental factors, including both biological, natural and social factors. At the same time, the human body is designed so that it can withstand many of them, but within certain limits. With their significant impact on the body, there is a violation of the functioning of its physiological systems, up to the complete loss of their functions and death. That is why the problem of ensuring the safety of human life in conditions of multifactorial environmental impact is one of the main tasks in ensuring the comprehensive security of the state. At the same time, the task of ensuring medical and biological safety is inextricably linked with ensuring environmental safety.

The potential for adaptation of people to negative environmental conditions, constantly changing under the influence of climatic, socio-economic and other environmental factors, is not unlimited. Some factors can lead to deterioration of people's health through prolonged exposure to them, others, for example, radiation, chemical and biological effects, can both cause death of a person immediately or within a fairly short period, and have a negative impact on human health for many decades, making huge areas uninhabitable. It is precisely such properties of radiation, chemical and biological agents as a multilateral and multidimensional effect on the object of application, the duration of the damaging factors, the spread of their action beyond the immediate zone of destruction, significant environmental and genetic consequences, complexity in the organization of the protection of people and critical infrastructure, that are used in the creation of weapons of mass destruction. Weapons of mass destruction, even with limited use, can cause large-scale destruction and cause massive losses up to irreversible damage to the environment and States. Despite the fact that the use of weapons of mass destruction since the late XIX – early XX centuries has been prohibited by many international agreements, in recent years some countries, which apparently forgot the bitter lessons of the First and Second World Wars, began to allow the possibility of its use, and not on their own territory, but on the territory of other countries, thousands of kilometers away from them.

Today, the global political situation is tense to an extreme degree that was difficult to imagine until quite recently. The level of escalation of various kinds of political, economic, military and other conflicts has reached such a limit that we live in a completely new reality in the face of such threats, the existence of which we were well aware of, but their practical implementation seemed purely hypothetical. Unfortunately, biological and environmental terrorism is a reality of our time. It has long been no secret that closed biological laboratories funded by the United States have been created on the territory of the former USSR, in which various types of biological weapons are being developed and experiments are being conducted using especially dangerous microbiological agents. Their activities have a dual purpose and are primarily directed against the Russian Federation. One of the goals of the development is to create, by modeling natural strains of infections, the most aggressive variants of them, which, under the guise of natural epidemics of diseases of both humans and animals, primarily agricultural, can lead to significant damage to human health and the economy not only of the country against which the activities of such laboratories are directed, but also of the country, in which they are located, as well as adjacent ones ^{[4, p. 13]}. In addition to cases of deliberate release of such microbiological agents into the environment, accidental leakage of them, as well as leakage due to deliberate sabotage, poses a significant threat to biomedical safety. With regard to ensuring the safety of microbiological research, the World Health Organization operates with the concept of a biosafety level or a level of protection against pathogens (from 1 to 4, where the 4th is the strictest), which defines a list of safety measures that must be taken to isolate dangerous biological agents in a closed laboratory room. Most countries of the world adhere to these recommendations or even introduce stricter ones at the national level, which, however, cannot completely exclude the possibility of leakage of dangerous microorganisms into the environment. So, according to one version, it was a similar leak from the laboratory that led to the COVID-19 pandemic.

The Constitution of the Russian Federation guarantees citizens the right to life, to a favorable environment, as well as to health protection. If we analyze the provisions of regulatory legal acts and strategic planning documents adopted over the past five years, it becomes clear that, despite fixing in them a whole range of threats to counteract which they are aimed at, they are "sharpened" to implement their provisions in peacetime. For almost eight decades, during which our country has not been a direct participant in major armed conflicts, we can say that both the State as a whole and its citizens have relaxed in terms of practical readiness to take active actions and take effective measures to counter various threats, including in the field of ensuring medical and biological security.

It is a great success that the country has survived and preserved a system of academic and military research institutes in the field of medicine and biology, as well as the state sanitary and epidemiological service, which allowed the country to counteract such a biological threat to public health as the COVID-19 pandemic to a sufficiently effective extent. This pandemic has become a vivid illustration of the unrealizability in the modern world community of the ideas of equality and fraternity of the entire population of the globe, the priority of humanitarian considerations over economic ones. Many Western states from among our so-called former partners not only did not assist other countries in solving the problems associated with the pandemic, but also did not provide assistance to each other within their coalition.

That is why one of the primary tasks of ensuring the medical and biological safety of the population of the Russian Federation is to create an effective and comprehensive national system that functions technologically independently, regardless of the participation of any other countries that in the modern world can refuse any supply of technologies, materials, equipment at any time. At the same time, special attention should be paid to the creation of a truly effective system of legal regulation of these public relations.

When creating a legal system for countering biological threats, it is necessary to take into account a number of their characteristic features. First of all, biological threats are characterized by a high degree of uncertainty in the appearance, detection, and spread of consequences for the population and the environment, as well as the difficulty of establishing causal relationships between the fact of biological contamination and its source, between factors contributing to or preventing the spread of danger (and the cause of infection). The assessment of the degree and reality of a biological threat depends, among other things, on the psychological characteristics of the reaction of the population and employees of authorized bodies making certain decisions to counteract them. It is also necessary to take into account the high risks of possible consequences when making incorrect and unsystematic decisions, large-scale organizational and legal measures and high costs (total costs) for prevention, identification, monitoring and elimination of biological hazards that have manifested themselves ^{[1, p. 190]}.

Today in the Russian Federation, a number of strategic planning documents, federal laws, subordinate regulations, SanPiNs and GOST standards are in force in the field of ensuring the medical and biological safety of the population. Many of them have been in force for several decades, and their norms are regularly amended to reflect the new objective realities of the changing world and public relations, while others have been adopted in the last five years.

Among the federal laws regulating security in general, it is necessary to mention Federal Law No. 390-FZ of December 28, 2010 "On Security". The country also has sectoral laws. Among them are Federal Law No. 116-FZ of July 21, 1997 "On Industrial Safety of Hazardous Production Facilities", Federal Law No. 3-FZ of January 9, 1996 "On Radiation Safety of the Population", Federal Law No. 16-FZ of February 9, 2007 "On Transport Safety", Federal Law of July 21, 2011 No. 256-FZ "On the safety of fuel and energy complex facilities" and others.

The system of environmental legislation and legislation in the field of health care and sanitary-epidemiological support has been largely developed, the norms of which regulate issues of ensuring medical and biological safety to one degree or another, for example, such as Federal Law No. 7-FZ of January 10, 2002 "On Environmental Protection", Federal Law of May 4 1999 No. 96-FZ "On the Protection of Atmospheric Air", the Water Code of the Russian Federation, Federal Law No. 323-FZ of November 21, 2011 "On the basics of protecting the health of citizens in the Russian Federation", Federal Law No. 52-FZ of March 30, 1999 "On the sanitary and epidemiological welfare of the population", etc. Separately, it is necessary to highlight the recently adopted Federal Law No. 492-FZ of December 30, 2020 "On Biological safety in the Russian Federation".

Among the strategic planning documents, in addition to documents devoted to various aspects of ensuring state security, in the area we are considering, there are also sectoral documents – the Fundamentals of the State Policy of the Russian Federation in the field of Chemical and Biological Safety for the period up to 2025 and beyond (approved by Presidential Decree No. 97 of March 11, 2019) and the Strategy environmental safety of the Russian Federation for the period up to 2025 (approved by Presidential Decree No. 176 of April 19, 2017).

Without stopping at a detailed description of the entire body of legislation regulating various aspects of ensuring biomedical safety, I would like to note a number of inherent problems that require priority solutions by consolidating the efforts of the state and representatives of legal and sectoral sciences, as well as civil society. At the same time, the development of new regulatory legal acts should be carried out in close cooperation with the entities involved in their implementation in practice, with a view to their examination of their compliance with the modern level of public relations and technologies in the sphere regulated by them. A characteristic feature of legislation in the field of ensuring medical and biological safety is that in most cases it develops in response to threats that have already occurred or realized, although in the modern world, more than ever before, it is necessary to advance its development taking into account the predicted risks.

         A large number of norms regulating relations in the field of ensuring medical and biological safety and often conflicting with each other greatly complicate their enforcement. Here is just one small, but very illustrative example. Such a document as SanPiN 3.3686-21 "Sanitary and epidemiological requirements for the prevention of infectious diseases" (approved by Resolution No. 4 of the Chief State Sanitary Doctor of the Russian Federation dated January 28, 2021 "On approval of sanitary rules and norms of SanPiN 3.3686-21 "Sanitary and epidemiological requirements for the prevention of infectious diseases diseases" (together with SanPiN 3.3686-21 "Sanitary rules and regulations ...")), has only 880 pages of text, which, as implied, law enforcement officers should know practically by heart. Moreover, this is far from the only legal act used in the activities of, for example, a researcher at the institute who carries out research and comes into contact with particularly dangerous infections. With each change made, its volume only increases, while the norms concerning outdated methods are not promptly excluded, and new ones are not promptly introduced. For example, it does not require the use of exclusively plastic, not glass, laboratory utensils when working with dangerous infections, although the use of the latter, due to the fragility of such a material as glass, significantly increases the risk of infection in emergency situations. Such examples can be cited endlessly. It seems that industry standards should be subjected to a detailed analysis and examination for their applicability. And subsequently upgraded to take into account the new level of threats and the need to ensure an immediate response to them, in other words, to contain understandable for all involved subjects and applicable rules and regulations.

         Regarding the content of strategic planning documents aimed at stimulating the development of legislation in response to the new realities of modernity and new threats, it should be noted that they should not be general and descriptive and create additional uncertainty, but include, first of all, specific tasks, understandable goals, as well as a specific list of entities responsible for their implementation. Strategic planning documents in this area should take into account the full range of modern threats, including new levels of development of bio- and information technologies, the state of the environment, climate change and related new opportunities for the implementation of bio- and ecoterrorism acts.

Another problem of legislation in this area is that the adopted regulations do not define the legal basis of security itself as a certain state of protection of subjects and objects from various threats (dangers), but regulate exclusively the activities to ensure it. The legal science faces an urgent need to develop a strategy (content) and tactics (implementation mechanism) of state legal policy in the field of ensuring both medical and biological and inextricably linked environmental security of the state, adequate to the realities of the current stage of social development ^{[2, p. 118]}.

In the field of ensuring biomedical safety, great importance should also be paid not only to the development of a system of legal regulation, but also to the creation of a system of self-regulation within the industry, containing the so-called codes of conduct and ethical standards implemented by the professional community.

         Special attention should be paid to the relatively recently adopted Federal Law No. 492-FZ of December 30, 2020 "On Biological Safety in the Russian Federation", which contains a set of measures aimed at protecting the population and protecting the environment from the effects of dangerous biological factors, preventing biological threats (hazards), creating and developing a system for monitoring biological risks. It regulates issues that cannot be part of sectoral legislation due to their complex nature, including health protection and sanitary-epidemiological welfare of the population, protection of animals and plants, environmental protection, countering the emergence of biological threats, organization of public protection and environmental protection, as well as elimination of the consequences of exposure to dangerous biological factors. The law reveals the content of the basic concepts in the field of biological safety. Thus, according to its norms, biological safety is understood as the state of protection of the population and the environment from the effects of dangerous biological factors, which ensures an acceptable level of biological risk (Article 1).

For comparison, in the Law of the People's Republic of China "On Biosecurity" (See: Biosecurity Law of the P.R.C. // URL: https://www.chinalawtranslate.com/en/biosecurity-law / (date of appeal: 07.12.2022)) it means a state of society in which the nation effectively prevents and reacts to the threat of dangerous biological and related factors, and life and human health and the ecosystem are in a state of relative absence of dangers and threats. This definition indicates a broader interpretation of this concept, and therefore the possibility of a wider range of measures applied within its framework.

It should be noted that the list of measures contained in the law of the Russian Federation and aimed at protecting the population and protecting the environment from the effects of dangerous biological factors, preventing biological threats (hazards), indicates their incompleteness, covering only a few groups of public relations ^{[3, p. 42]}. One of the important aspects of ensuring medical and biological safety is the clarity and transparency of the measures taken by the state, as well as the need to increase the level of confidence of individual citizens and the whole society in such measures.

In the modern world, the issues of biosafety are given the closest attention. In addition to microbiological agents, the list of threats to biological safety often includes genetically modified organisms. For example, in some European countries, the requirements for handling genetically modified organisms are even stricter than for biological agents in general. Despite the existence at the level of the European Union of a number of directives regulating certain aspects of biosafety, at the national level there are significant differences in the definition of certain concepts in the field under consideration, including those applied to countering biological threats. The lack of uniform reporting requirements for laboratory incidents and accidents in the EU also creates a certain complexity. Constant attention in the field of legal regulation of biosafety issues in the EU is also required by the need to revise the classification list of microorganisms and the definition of harmonized best practices. At the same time, the different interpretation of the provisions of the EU guidelines in the field of biosafety gives scope at the national level for the implementation of various approaches to biosafety and laboratory biosecurity ^{[5, p. 2]}. According to French researchers, regulations in the field of biosafety and biosecurity in the EU countries have been sharply tightened over the past two decades, however, with the inclusion of each new requirement, the rules introduced at the EU level are becoming more and more difficult to implement, including due to the lack of agreed practical guidelines for their implementation in national legislation. member countries ^[6]. As can be seen from the above examples, scientists both in Russia and abroad face similar problems in applying requirements in the field of biological safety. It seems that every new knowledge about new threats in this area and known methods of countering them should be legislated only after an expert assessment of law enforcement officers (representatives of the scientific community, by virtue of their profession in contact with dangerous bioagents) about the possibility of practical implementation of the proposed norms.

  In conclusion, it should be noted that ensuring medical and biological safety is not only a national, but also a global problem. And despite the critical level of international tension, it is necessary to look for ways to establish relations and develop further cooperation with all countries of the world. First of all, international agreements prohibiting the use of weapons of mass destruction should be "reanimated" from the point of view of their practical implementation.