Ecological and Legal Regulation of Genomic Research: Statement of the Problem

Journal of Environmental Treatment Techniques

2019, Special Issue on Environment, Management and Economy, Pages: 894-897

J. Environ. Treat. Tech.

ISSN: 2309-1185

Journal web link: http://www.jett.dormaj.com

Ecological and Legal Regulation of Genomic

Research: Statement of the Problem

Elena V. Luneva*

Faculty of law, Kazan Federal University, Kremlevskaya str, 18, 420008, Kazan, Russian Federation

Received: 13/09/2019

Accepted: 22/11/2019

Published: 20/12/2019

Abstract

Based on the analysis of the work of Russian and foreign lawyers, geneticists, biochemists, biotechnologists, bioecologists,

molecular biologists, and microbiologists, the article studies the environmental and legal regulation of genomic research in the

Russian Federation. It has been shown that a large number of works deal with the environmental and legal problems of genomic

research abroad, however, with regard to Russian legislation, relevant studies are extremely few. It was revealed that in Russia in

the field of environmental protection, ensuring human environmental safety and rational nature management, the legal regulation

of genomic research is limited only by the legal regime of biotechnologies in general and the legal provision of genetic

engineering in particular. At the legislative level, social relations are recommended to be recognized as homogeneous according

to the genetic and genomic versions of genetics and genomics. A broad understanding of genomic research is defined, consisting

of two groups of social relations: (1) directly genomic research - structural genomics, genomic analysis, functional genomics

(

proteomes and transcripts), genomic polymorphism, mapping and sequencing of genomes, etc.; (2) activities related to genomic

research - genetic research, biotechnology, genetic engineering, experimental mutagenesis, genomic selection, etc.). The question

is raised about the need to develop differentiated environmental and legal regulation of heterogeneous social relations in genomic

research, depending on targeted or non-targeted changes in the genome. The proposed classification is important in terms of

applying various environmental and legal means of environmental protection for the selected groups of public relations on

genomic research.

Keywords: Environmental regulation, Genomic research, Genomics, Environmental safety, Food safety, Environmental risks

World Ocean; counteract the spread of various types of

Introduction

diseases of humans and animals; obtain biomaterials from

renewable raw materials to replace traditional industries; as

well as improve other areas of activity.

Presidential decree No. 899 of July 7, 2011 “On the

approval of priority areas for the development of science,

technology and technology in the Russian Federation and

the list of critical technologies of the Russian Federation”,

classified genomic, proteomic and postgenomic

technologies as technologies necessary for the

modernization and technological development of the

Russian economy and for an increase in its

competitiveness. It has been recognized by domestic

political and legal documents that genomic research can

help resolve a number of major challenges of the Russian

state. For example, the Forecast of Scientific and

Technological Development of the Russian Federation

approved by the Government of the Russian Federation for

the period until 2030 focuses on the intensity of

development of genomic, proteomic, and postgenomic

technologies, which are caused by the need to preserve the

resource potential, including the biological resources of the

The normal functioning and further development of any

sphere of relations, including genomic research, requires

their effective legal regulation. There is almost no legal

regulation of genomic research affecting environmental

protection, human environmental safety, and environmental

management. Practically no environmental and legal

studies have been carried out in the field of the genomic,

proteomic, and postgenomic technologies. Without clear

legal support for genomic research, relevant tasks and

national priorities cannot be implemented at the proper

level. The objective of this research was to identify a circle

of social relations that potentially fall under the

environmental and legal regulation of genomic research in

Russia.

Materials and Methods

The assessment of the possible environmental and legal

regulation of genomic research was carried out on the basis

of an analysis of Russian political and legal documents and

the works by lawyers specializing in the legal regime of

biotechnologies and legal support for genetic engineering

Corresponding author: Elena V. Luneva, Kazan Federal

University, Kremlevskaya str, 18, 420008, Kazan, Russian

Federation. E-mail: vilisa_vilisa@mail.ru. Tel: 8 (843) 2-

33-72-13.

894

Journal of Environmental Treatment Techniques

2019, Special Issue on Environment, Management and Economy, Pages: 894-897

(

N.A. Abdallah, E.V. Luneva, V.J. Meretsky, F. Francioni,

Discussion

Z.F. Safin, T. Sovová, J.D. Wolt and others). In addition, the

findings were based on the work by geneticists,

biochemists, biotechnologists, bioecologists, molecular

biologists, and microbiologists (J.M. Alonso, J.R. Ecker,

S.T. Cole, I. Saintgirons, Е.Я. Тетушкин, and others).

The methodological basis of the study was the

dialectical method, which made it possible to learn in

indissoluble unity and in a general connection the specifics

of social relations by genomic research. The achievement

of the objective was also promoted by logical methods in

the form of analysis and synthesis, induction and deduction,

comparison and generalization, analogy and typology. The

system-structural method revealed a broad understanding of

genomic research, consisting of two groups of social

relations.

Abroad, a large number of works has been devoted to

the problems of legal regulation of genomic research,

considering the peculiarities of natural resource (9, 10),

agrarian (11-13), and environmental law (14, 15), but with

regard to Russian legislation, the relevant studies are

extremely few. Basically, the national environmental and

legal science is developing only in two areas of genomic

research: biotechnology and genetic engineering. The

above circumstance is connected with the Federal Law No.

6-FZ of July 5, 1996 (as of July 3, 2016) "On State

Regulation in the Field of Genetic Engineering" and many

by-laws and regulations on biotechnology that have been

adopted long ago.

The legal regulation of relations in the field of

biotechnology aimed at solving relevant socio-economic,

energy, environmental, and other problems were described

by Z.M. Fatkudinov and R.N. Salieva. They proposed to

consider biotechnology as a technological process rather

than a set of objects so that it would be possible to establish

Results

Going beyond the limits of legal science allows us to

understand the features of public relations and to develop

optimal legal regulation. The appeal of lawyers to the

scientific developments of geneticists, biochemists,

biotechnologists, bioecologists, molecular biologists, and

microbiologists is associated with the need to clarify the

scope and essence of social relations in the field of genomic

research affecting environmental protection, human

ecological safety, and sustainable nature management (1-4).

The problems of legal regulation of genomic research

require considerable attention in terms of its complexity

since it is already clear that the results of applying genomic

technologies will affect many aspects of human activity (5).

The legal support of genomic research, to some extent,

begins to be studied and affected by representatives of

almost all branches of law and legislation. The complexity

of the description of the current state of legal research in

the claimed field is due to the vague understanding of the

category of “genomic research” by lawyers. Genetics,

biochemists, biotechnologists, bioecologists, molecular

biologists, and microbiologists cannot fully determine the

area of social relations that form genomic research.

mandatory

safety

requirements

not

only

for

biotechnological products but also for the process of their

creation. They substantiated the importance of identifying

the legal features of each biotechnological product or

process separately, consolidating the legislative

classification of such objects and establishing appropriate

differentiated legal regimes for them. Lawyers have come

to the important conclusion that the specifics of the legal

regulation of biotechnologies should be related to

environmental and food safety and other factors that affect

the health of citizens (16).

A.V. Sheverdin analyzed the legal regulation of the

creation and use of biotechnology in Russian and foreign

legislation. He showed that in domestic legislation the legal

acts regulating the development and use of biomedical

technologies and biotechnologies in the field of agricultural

activity are more represented (17).

The science of environmental law has recognized that

biotechnology allows intervening in the genetic apparatus

and exposing living organisms to targeted modifications,

selecting the best among artificially created genotypes.

Biotechnologies have discovered and shown the special

value of genetic resources, which, in the legal sense, are a

public treasure. Therefore, the state is obliged to ensure the

preservation of national genetic resources, including in the

field of cultivated biological resources (18).

S.Iu. Miroliubova insists on the need to develop and

adopt a State program of national cultured biological

resources that would ensure the collection, processing,

storage, and use, including the dissemination among

scientists, of information about the genetic resources of

living organisms important for the food industry and

agricultural production. She proposes to improve the

regulatory framework in the following areas: 1) protection

of human and civil rights and freedoms in the application of

genetic resources and biotechnologies in the food industry

and agriculture; 2) preparation of standards for cultivated

biological resources and biotechnologies; and 3) the legal

regulation of biosafety, including genetic safety (18).

The latest agrobiotechnologies, in particular, include 1)

the creation of new highly productive, resistant to

a result of a review of existing scientific

developments in this field of jurisprudence, the broadest

understanding of genomic research is proposed, which

includes two blocks of social relations: 1) directly genomic

research - structural genomics, genomic analysis, functional

genomics

polymorphism, mapping and sequencing of genomes, etc.;

) activities related to genomic research - genetic research,

biotechnology, genetic engineering, experimental

(proteomes

and transcripts),

genomic

mutagenesis, genomic selection, etc.). The formulated

scientific position is confirmed by the reasoning of

specialists in genomic research, who recognize the

interdisciplinary relations between the genetic and genomic

versions of genetics and genomics as essentially the same

(

6-8). Consequently, in order to build effective

environmental and legal regulation, it is advisable at the

legislative level to recognize homogeneous public relations

by genetic and genomic “variations”, as well as to

consolidate a broad understanding of genomic research.

895

Journal of Environmental Treatment Techniques

2019, Special Issue on Environment, Management and Economy, Pages: 894-897

pathogens and adverse environmental conditions varieties

of hybrids of agricultural plants based on biotechnologies;

Summary

The environmental and legal regulation of genomic

2) the improvement of breeding by using genetic selection

research in Russian legislation is poorly developed.

Therefore, it is of primary need to formulate and introduce

into the conceptual and categorical apparatus of

environmental law basic terms adapted from jurisprudence

from the field of genomic research such as “genome”,

methods for farm animals; 3) the creation of databases

containing information on the genome of breeds of farm

animals for the introduction of cloning and genetic

certification methods in breeding. For Russia, there are a

number of threats in this area such as 1) low agricultural

productivity; 2) a critical lag in the research and production

and technological base in the field of biotechnology; 3) low

demand for practical applications; 4) insufficient business

investment in the development of biotechnological

industries; 5) high barriers to entry into the global market

for biotechnological products; and 6) the risk of turning the

country into a raw material base for world leaders in the

biotechnology market (19).

A.V. Sheverdin investigated the mechanism of legal

regulation of genetic engineering activity. In the structure

of this legal mechanism, he included licensing,

certification, registration of genetically modified

organisms, and control (17, 26).

Most scientific legal developments in the field of

genetic engineering concern the safety of introducing

genetically modified organisms into the environment and

using them as food. This situation has been a result of food

problems.

A.O. Malofeev writes about the consolidation of a

number of legal constructions that ensure the consideration

of moral ideas of society regarding the use of genetically

modified organisms in the economy. He proposes 1) the

legal construction of the state registration procedure of

genetically modified organisms themselves and their

producers; 2) the legal design of the licensing of the

production of genetically modified organisms; 3) the legal

design of the state environmental review, mandatory for all

producers of genetically modified organisms, carried out to

determine the level of negative impact of the corresponding

production on the environment )20, 25(. The indicated legal

constructions should ensure the balance of private and

public interests in legal regulation, and express the socio-

humanistic content of the law.

“

genetic manipulation”, “waste resulting from genomic

research”, and others. In order to increase the effectiveness

of the relevant legal impact, it is advisable to enforce the

legal principles and specific measures to ensure the

environmental safety of genomic research in environmental

legislation.

Differential legal regulation of heterogeneous social

relations on genomic research is required depending on the

targeted (genetic research, biotechnology, genetic

engineering, experimental mutagenesis, genomic selection,

etc.) or non-targeted (under the influence of the

consequences of negative impact on the natural

environment) changes in the genome. The specified

delimitation is important in terms of applying various

environmental and legal means of environmental protection

for the selected groups of public relations on genomic

research.

Conclusion

The field of genomic research for a long time will be

one of the most promising and attractive areas not only for

the legal but also for other sciences, both natural and

humanitarian. The plans include a separate legal assessment

and legal analysis of DNA manipulations of various

organisms, cloning, the impact of genetically modified

products on humans and the environment in general, and

ensuring of biosafety.

Conflicts Of Interest

The author declares that the provided information has

no conflicts of interest.

Acknowledgments

The work is performed according to the Russian

Government Program of Competitive Growth of Kazan

Federal University

The benefits of using genomic technologies are obvious

today, however, the side effects of the progress of

genomics, humanity can only evaluate in practice after

several decades )21,27(. Researchers are faced with the task

of predicting possible environmental risks of introducing

genomic technologies into human economic activity )22,

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