RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of March 22, 2022 No. 161

About the Concept of national system of ensuring biological safety

For the purpose of realization of state policy in the field of ensuring the biological safety aimed at providing protection of the population, animals, plants and the environment from impact of dangerous biological factors, the Council of Ministers of the Republic of Belarus DECIDES:

1. Approve the Concept of national system of ensuring biological safety it (is applied).

2. To the Ministry of Health, Ministry of Agriculture and Food, Ministry of Natural Resources and Environmental Protection, National academy of Sciences of Belarus:

provide coordination of activities of state bodies and other organizations, citizens of the Republic of Belarus on implementation of the Concept of national system of ensuring biological safety;

submit in accordance with the established procedure for consideration of the Government of the Republic of Belarus of the offer on implementation of the Concept of national system of ensuring biological safety;

take other measures for implementation of the Concept of national system of ensuring biological safety.

3. This resolution becomes effective after its official publication.

Approved by the Resolution of Council of Ministers of the Republic of Belarus of March 22, 2022 No. 161

Concept of national system of ensuring biological safety

Introduction

The problem of prevention of biological threats is priority for the world community now. It is fully necessary to estimate reality and degree of the danger proceeding from biological threats and to use all opportunities and resources for taking measures to their prevention and liquidation.

Biological safety can be reached by implementation of measures of economic, political, organizational nature, answering to the existing and potential types of internal and external biological threats.

The basis of necessary level of security from biological threats is constituted system of the precepts of law governing the relations in the field of biological safety, the approved activities of republican state bodies, and also activities of authorized bodies of ensuring biological safety.

It should be noted availability of the possible threats concerning biological safety connected as with negative impact of biological factors directly on human health, animals and plants, and with destructive action on the environment. Certain extent of threats is connected with progress of biological science, first of all molecular biology and practical use of its achievements, such as genetic engineering, gene therapy, molecular management of development that creates additional sources of biological danger.

Permanent growth in the world of the new or repeatedly arising infectious diseases including representing the emergency situation in the field of public health care having the international value is noted. Risks of origin and distribution of pathogenic biological agents (further - PBA) owing to natural processes and their deliberate creation as a result of bystry development of the biotechnologies and scientific research having the potential of double application increase.

So, infectious diseases, general for the person and animals (high-pathogenic avian flu, anthrax, brucellosis, tuberculosis, rage, foot-and-mouth disease and others), are capable to render direct (to cause disease) and mediated (through causing social and economic damage) negative impact on health of the person.

The problem of deliberate application of PBA does not lose relevance. The acts of biological terrorism directed to creation of artificial dangerous biological situations for the purpose of direct or the mediated negative impact on the habitat and life activity of the person, represent intentional application by individuals, terrorist groups or the organizations of biological weapons of destruction of the people, farm animals and cultural plants causing destabilization of functioning of ecosystems. Real nature of biological threats forces the leading countries of the world to increase priority of biological protection of the population and the territories within system of ensuring national security.

Along with direct impact on the population of PBA options of the mediated negative impact of biological factors on public health by creation of the artificial dangerous biological situations connected with defeat of farm animals, cultural plants, harming ecological system for the purpose of causing extensive social and economic damage to the country, comparable to threat of homeland security are also possible.

In agricultural industry risks in the field of biological safety are caused generally by import of animals and plants, products of animal and plant origin, genetically engineered (transgene) plants, animals and microorganisms. Besides, risks can be caused by migratory processes in the wild nature and availability of PBA sources in it, development of medicinal stability, emergence of epizooty in the adjacent territories. At the same time the mediated risks for the person in the field of biological safety consist of safety in production process of forages and feed additives, food products of plant and animal origin, their storage, transportation, realization and utilization. The diseases of plants and animals caused by viruses, bacteria, mushrooms and other harmful organisms cause huge social and economic damage, worsening quality of agricultural products, leading to considerable yield losses, defeat of seed material, reducing livestock of animals and decrease in their productivity. Phytosanitary quarantine control (supervision) and veterinary control in case of cross-border movement of goods, introduction of restrictions for movement of the agricultural products coming from the territories, unsuccessful by diseases, or struck with harmful objects make impossible export of such products that also leads to considerable economic losses for the country.

Implementation (invasion) of aggressive alien types also is global environmental and social and economic problem in the world now. Invasive types force out native types of plants and animals, transform and destroy local ecosystems, cause significant economic damage to the countries and constitute health hazard of people. Development of measures for prevention of biological invasions, to mitigation of their effects and monitoring are obligation of all countries which signed the Convention on biological diversity.

The synthetic biology is the direction of genetic engineering which is violently developing around the world. Such organisms are not similar to the previous generations of genetically engineered organisms (further - GIO). These are organisms with the reconstructed system of metabolism or completely synthesized genomes, life forms with unknown biochemistry and genetic code. Number of such organisms is in development stage, separate of them are commercialized and can bring big benefit for different industries of economy. As methods of indication of objects of synthetic biology differ from methods of identification of the known GIO, they can be brought on the territory of the Republic of Belarus. There is real danger of use of separate organisms in goods quality of dual purpose.

Now, in addition to production of biological products for medicine, veterinary science and crop production, genetically engineered technologies are used for production of some medicines (insulin, cytokines and interleykina), and also wide range of fermental medicines and amino acids. Application of genetically engineered means solves number of problems, increases efficiency of agricultural production. Most of them should be bought abroad.

The concept of biological safety conceptually covers all sphere of sanitary and epidemiologic wellbeing of the population, and also areas, adjacent to it, - veterinary and sanitary, phytosanitary wellbeing, ecological safety, safety of the habitat (production, social and economic, geopolitical, ecological and others) and is performed for the purpose of the prevention and liquidation of biologo-social emergency situations of natural and artificial nature.

Foreign experience in the field of biological safety can be successfully adapted for conditions of the Republic of Belarus and is used for enhancement of national system of its providing.

Chapter 1. Main terms and determinations

For the purposes of this Concept the following main terms and determinations are used:

the analysis of biological risk - the process including identification, assessment, management of biological risk;

biological safety - condition of security of the population, animals and plants, the environment from impact of dangerous biological factors in case of which the admissible level of biological risk is provided;

biological protection - package of measures for ensuring biological safety, performed for the purpose of prevention or weakening of adverse effect of dangerous biological factors;

biological diversity - variety of live organisms within type and between types, and also variety of ecosystems;

biological risk - combination of probability of damnification (taking into account its weight) to health of the person, animals, plants, products of animal, plant origin and (or) the environment as a result of impact of dangerous biological factors and effects of this impact from the biological, social and (or) economic point of view;

the genetically engineered organism (which is genetically changed (modified, transgene) organism) - the live organism containing new combination of the genetic material received by means of genetic engineering;

genetic engineering - technology of receipt of new combinations of genetic material by the manipulations which are carried out out of cage with molecules of nucleic acids and transfer of the created designs of genes in live organism as a result of which inclusion and their activity in this organism and at its posterity are reached;

genetically engineered activities - the activities connected with creation of genetically engineered organisms, implementation of works with genetically engineered organisms in the closed systems, their release to the environment for carrying out testing, use in the economic purposes, import to the Republic of Belarus, export from the Republic of Belarus, en route through its territory of genetically engineered organisms, their transportation, storage and neutralization;

admissible level of biological risk - the level of biological risk in case of which conditions for protection of health of the person, animals, plants are provided, to products of animal, plant origin and (or) the environment from impact of dangerous biological factors;

identification of risk - detection process (identification and recognition) of risk and determination of its characteristics;

invasion - invasion on any territory or in ecosystem of species, not characteristic of them, which occurs without conscious participation of the person;

invasive types are plants, animals or microorganisms outside their natural geographical area, the introduction and (or) distribution of which create threat to preserving to biological and landscape diversity, threat of life or to health of the person, do harm to separate industries of economy;

source of biological danger - the natural or artificial source containing the PBA existing in the territory of the Republic of Belarus, or created or which resulted from implementation of separate types of activity or uncontrolled use of genetic materials, technologies of genetic engineering and synthetic biology, or brought on the territory of the Republic of Belarus;

informing on biological risk - process of exchange of information about risk;

high-quality determination of biological risk - risk identification in case of which probability of damnification (taking into account its weight) to health of the person, animals and plants, to products of animal, plant origin and (or) the environment and its effects as a result of impact of dangerous biological factors are expressed in such quality categories as high, average and low;

quantitative determination of biological risk - risk identification in case of which probability of damnification (taking into account its weight) to health of the person, animals and plants, to products of animal, plant origin and (or) the environment and its effects as a result of impact of dangerous biological factors are expressed in numerical values;

microbiota - set of communities of the microorganisms (symbiotic, opportunistic and (or) pathogenic) inhabiting different sites of live organisms with homogeneous living conditions;

monitoring - complex system of observations, assessment and the forecast of changes of condition in the environment and society under the influence of dangerous biological factors for the purpose of establishment of causal relationship between dangerous biological factor and adverse effect which results serve for reasons for management decisions about safety of people, plants, animals and the environment;

the environment - set of components of the environment, natural and natural and anthropogenous objects, and also anthropogenous objects;

dangerous biological factor - the event, condition, property, processes which are the reason of possible impact of PBA and other organisms including created by method of genetic engineering and synthetic biology which are capable to do harm to health of the person, animals, plants, products of animal and plant origin and (or) the environment;

assessment of biological risk - determination of probability of negative impact of dangerous biological factor and biological, social and (or) economic effects of this impact;

pathogenic biological agents - microorganisms, viruses, belkovopodobny infectious particles (prions), poisons of biological origin (toxins) and other biological agents including created as a result of genetic manipulations, use of technologies of genetic engineering and synthetic biology or other directed activities capable to cause pathological process in human body, animal or in plants, and also biological materials which can contain the listed pathogens;

the plan of response to biological threats - operations procedure of public authorities, local executive and administrative organs in case of biological threats (dangers), including acceptance of administrative, organizational and technical and other measures on ensuring readiness for such threats (dangers) and response to them, maintenance of admissible level of biological risk;

potentially dangerous biological object - object in which there is source of biological danger and (or) is performed the activities connected with use of pathogens on which accident or destruction of which can create danger to life or health of the person, animals and plants or to do harm to the environment;

synthetic biology - the cross-disciplinary scientific direction connected with designing and creation of not having analogs in the nature of biological systems and objects with the set properties and functions;

management of biological risk - taking measures to minimization of level of biological risk or decrease in level of biological risk to admissible;

biologo-social emergency situation - condition in case of which as a result of emergence of source of biologo-social emergency situation in certain territory health hazard and life activities of people is created arises the damnification threat to animal, plants and the environment involving considerable economic losses;

emergency situation in the field of biological safety - the extraordinary event which is taking place under the influence of dangerous biological factor, representing risk for health of the person, animals, plants, products of animal and plant origin and (or) the environment.

Other concepts of this Concept are used in the values determined by the legislation.

Chapter 2. Reasons for need of adoption of the Concept of national system of ensuring biological safety

Relevance of problem of biological safety in modern conditions is determined:

availability of modern challenges and threats, connected including with active distribution of biotechnologies;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info