Legal Regulation of Commercial Cultivation of Genetically Modified Crops: Foreign Experience

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

Plants are of enormous importance for the existence of the biosphere of the planet. Their functions in the processes taking place on Earth are significant and diverse: the production of oxygen, the absorption of carbon dioxide, participation in food chains, the formation of landscapes, the prevention of soil erosion, and many others. They are also of paramount importance for solving the problems of providing food to the world's population, whose number is increasing annually by more than 90 million per year and currently amounts to more than 8 billion people (URL: https://countrymeters.info/ru/World (accessed: 09/10/2022)). However, of the more than 180 billion tons of biomass produced annually by plants on Earth, the agricultural economy uses only 6% of its total volume. However, in the end, taking into account natural losses (for example, inedible parts of plants that go into production waste, as well as waste generated during processing), only about 1% of the produced biomass is consumed as food ^{[1, p. 251]}.

For hundreds of years, in the process of choosing the species and varieties of plants cultivated by him, man has learned to use the property of plants to variability, determined initially solely by their phenotypic data, and then with the development of scientific knowledge and technology and genetic. Breeders in the process of creating cultivated varieties of higher plants rely on their property such as a huge amplitude of modification and epigenetic variability of quantitative traits ^{[1, p. 252]}. With the development of chromosomal theory and molecular biology, scientists gradually approached the correlation of plant phenotypic traits and their genotype, understanding the role of specific genomic mutations, and subsequently learned to influence the genome itself ^{[2, p. 142]}. Scientific achievements in the field of plant genome research, as well as the results of its decoding and new technologies that are applicable for its modification, are universal knowledge, the theoretical possibility of which does not depend on state borders and nationality of people. At the same time, the risks associated with the widespread use of genetically modified crops in agriculture need to be assessed in detail and minimized, including by legal means. The purpose of improving the legal regulation of the creation and turnover of modified crops is to find a balance between the needs of society for the production of sufficient amounts of food and the acceptability of the use of a particular technology to ensure the safety of public health, a favorable state of the environment and the preservation of natural ecological systems, which ultimately should become a determining factor in the permissibility of such use.

The aggravation in the modern world of competition for natural resources in general and for food in particular leads to an increase in political, social and environmental conflicts of various levels. It is very important to take into account that modern achievements in the field of genomic research can both provide humanity with new advantages and open up new horizons, and cause significant damage not only to people, but also to the planet as a whole. The consequences of the use of genetically modified crops can not only negatively affect the living conditions of future generations and negatively affect their health ^{[3, p. 29]}, but also damage the environment in general and the biological diversity of natural animal and plant species in particular.

It should be noted that the transformation of law accompanying technological development depends not only on the level of natural science knowledge, but also on the socio-political context existing in the modern world. Today, the issue of the transformation of law in response to a global social and humanitarian crisis is particularly acute in the world ^{[4, p. 13]}, one of the components of which is food shortage.

The task of ensuring food security is complex and multidimensional. Various countries are finding new ways to solve it, including by stimulating and regulating agricultural production, including at the legislative level. Arguing in favor of expanding the commercial use of modified crops, its supporters point to the multidimensional economic benefits associated with it, such as increased efficiency of agricultural production; increased yields, reduced spread of diseases of crops, losses from pests and adverse weather conditions; reduced costs of pest control, in particular pesticides; increased production volumes as food and industrial crops; reduction in the cost of production and reduction in the cost of the final product; more intensive development of the livestock feed base. In addition, experts attribute the significant environmental benefits of growing certain GM crops to reducing the negative impact on the environment by reducing the amount of herbicides used ^{[6, p. 115]}.

However, if we turn to the problem of commercial cultivation of genetically modified crops, it becomes obvious that the world is divided into two camps in the issue of allowing or prohibiting such activities. In some countries it is prohibited by law, among them – Austria, Algeria, Belize, Bhutan, Bulgaria, Croatia, Denmark, France, Germany, Greece, Hungary, Italy, Kyrgyzstan, Latvia, Lithuania, Luxembourg, Madagascar, Malta, the Netherlands, Peru, Poland, Saudi Arabia, Slovenia, Turkey, Venezuela, Ecuador(URL: https://translated.turbopages.org/proxy_u/en-ru.ru.6ef2c2f9-633196e8-4cd35fd8-74722d776562/https/worldpopulationreview.com/country-rankings/countries-that-ban-gmos (accessed: 09/10/2022)). At the same time, in some of them, such as Austria, Hungary, Greece, Poland, Bulgaria, Luxembourg and Italy, the use and cultivation of GMOs is completely prohibited.

In the Russian Federation, a ban on commercial cultivation on its territory was introduced in 2016 (Part 4 of Article 21 of Federal Law No. 149-FZ of December 17, 1997 "On Seed Production"// SZ RF. 1997. No. 51. St. 5715; amendments were made by Federal Law of July 3, 2016  No. 358-FZ "On Amendments to Certain Legislative Acts of the Russian Federation regarding the improvement of state regulation in the field of genetic engineering" // SZ RF. 2016. No. 27 (Part II). Article 4291). In our country, this approach is criticized by both representatives of the agricultural industry and some scientists who believe that the ban on commercial cultivation of genetically modified crops may negatively affect the economic growth of the country ^{[5, p. 52]}. Such prohibitions are based on the precautionary principle in the widespread use of genetically modified crops due to insufficient knowledge of its consequences. The legal regulation of risk management of the use of GMOs has been developed at the international level.

On January 29, 2000, the Conference of the Parties to the Convention on Biological Diversity, ratified by the Russian Federation in 1995 (see: Federal Law No. 16-FZ of February 17, 1995 "On Ratification of the Convention on Biological Diversity"), adopted an additional agreement to the Convention, known as the Cartagena Protocol on Biosafety (Cartagena Protocol on Biosafety to the Convention on biological diversity (together with "Information required under notifications in accordance with articles 8, 10 and 13", "Information required in relation to living modified organisms intended for... food or feed or for processing in accordance with Article 11", "Risk assessment"). Signed in Montreal on January 29, 2000, entered into force on September 11, 2003). To date, 173 States are parties to it (URL: https://bch.cbd.int/protocol (accessed: 09/23/2022)). Of the leaders in the development of genomic technologies, the United States did not join it, while China and Japan signed it.

Despite the fact that the Russian Federation has not joined the Cartagena Protocol at the moment, such an aspiration is identified among the main tasks set out in sub-item 9 of item 14 of 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 the Decree of the President of the Russian Federation dated March 11, 2019. No. 97.

The Cartagena Protocol is aimed at protecting biological diversity from potential risks associated with living modified organisms created using biotechnological methods. The purpose of the Protocol is to "promote the provision of an appropriate level of protection in the field of the safe transfer, processing and use of living modified organisms resulting from the use of modern biotechnology and capable of adversely affecting the conservation and sustainable use of biological diversity, taking into account also risks to human health and with particular attention to transboundary movement" (Article 1). The Protocol confirms the legality of States taking precautionary measures in accordance with principle 15 of the Rio Declaration on Environment and Development (adopted by the UN Conference on Environment and Development, Rio de Janeiro, June 3-14, 1992 / URL: https://www.un.org/ru/documents/decl_conv/declarations/riodecl.shtml (accessed: 12.09.2022)).  It also establishes a Biosafety Clearing-House Mechanism to facilitate the exchange of information on living modified organisms and to assist countries in its implementation.

As an example of the development of supranational legislation adopted in the field of prevention of risks of negative impact of genetically modified organisms on the environment, the European Union (EU), which has been a party to the Cartagena Protocol since 2002 (see: Council decision 2002/628/EC of June 25, 2002 on the conclusion of the Cartagena Protocol on Biosafety on behalf of the European Community // OJ L 201. 2002. P. 48), which adopted a number of specialized acts of various legal force and binding for member countries regulating various aspects of the turnover of GMOs. For example, Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on the transboundary movement of genetically modified organisms, Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, Regulation No 1830/2003 of 22 September 2003 concerning traceability and labeling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms, and on the amendment of Directive 2001/18/EC ^{[9, p. 50]}.

Another so-called camp includes countries that have allowed the commercial cultivation of modified crops on their territory. It should be noted that some of them, for example, the PRC, are parties to the Cartagena Protocol, the provisions of which are reflected in the national legislation of these countries.

The very idea of obtaining the necessary properties of cultivated plant varieties faster than traditional breeding methods against the background of the ever-increasing need of mankind for food seemed extremely attractive. By modifying the genome, including by introducing genetic information of other biological species into it, plants are given the desired properties. For example, such as resistance to herbicides and pesticides, nutrient content, taste properties, yield, resistance to adverse weather conditions and pests.

The first experiments on obtaining genetically modified plants in order to give them the desired qualitative characteristics dates back to the mid-1980s. So, in 1986, the first field studies of modified tobacco resistant to herbicides were conducted in the USA and France, and in 1992, China became the first country to allow commercial cultivation of genetically modified tobacco resistant to viruses. The first GM plant, the sale of which was allowed, was a tomato of the Flavr Savr variety in the USA in 1994 (see: URL: https://www.romerlabs.com/ru/centrznanii/bibliotekaznanii/stati/news/kak-gm-rastenija-pokorili-mir / (date of circulation: 09/10/2022)), after which large-scale industrial cultivation of genetically modified crops began, the area of which by 1996 amounted to 1.7 million hectares ^{[6, p. 107]}.

According to the International Service for the Acquisition of Agrobiotechnical Technologies (International Service for the Acquisition of Agri-biotech Applications – ISAAA), about 190 million hectares were occupied by GM crops in 2018, and more than 18 million farmers were employed in their production. The vast majority of the areas (99%) used for the production of such plants are occupied by five main crops: soybeans, corn, cotton, rapeseed and alfalfa.  The top five countries with the largest areas of genetically modified crops are the USA, Brazil, Argentina, Canada and India, and their commercial cultivation is allowed in more than 25 countries around the world (see: URL: https://glavagronom.ru/articles/gmo-kultury-vyrashchivat-ili-zapreshchat (accessed: 09/10/2022)). The report of the Coherent Market Insights analytical agency recorded that the modified crops market is growing by 8.7% annually and its turnover, according to the forecasts contained in the report, should reach 37.46 billion US dollars by 2027 (see: URL: https://finance.rambler.ru/markets/43883099-mirovoy-rynok-gmo-kultur-k-2027-godu-dostignet-stoimosti-37-46-mlrd-dollarov-ssha-faktory-rosta / (accessed: 09/10/2022)).

In a number of states that are major producers of agricultural products, commercial cultivation of GM agricultural products is allowed both for solving food security problems and for the production of products that are raw materials for other industries. An analysis of the experience of the PRC shows that a centralized system of legal regulation is in effect with respect to the turnover of GM crops, and the development of biotechnologies in general and technologies related to GMOs, in particular, is fixed as a priority in China's strategic planning documents. To ensure food security in a country with more than a billion people, the state pays increased attention to the intensive development of agriculture, including the intensification of agricultural production.

The Ministry of Agriculture, a member of the State Council of the People's Republic of China, is the authorized governing body in the field of agriculture and related sectors of the economy. In particular, among other things, its functions include the development and implementation of policies and strategies for economic development, medium- and long-term plans, the development of measures to deepen the reform of the agricultural sector of the economy and improve the existing management system ^{[7, p. 183]}. In China, scientific research in the field of biotechnology receives significant amounts of government funding. According to the level of introduction of GMOs, China is one of the world leaders. In China, a fairly wide range of GM crops are grown for commercial purposes, for example: poplar, cotton, papaya, tomatoes and sweet peppers ^{[8, p. 143]}.

         The legal regulation of the quality and safety of agricultural products in China is carried out in accordance with the Law of the People's Republic of China on the Quality and Safety of Agricultural Products adopted in 2006 (adopted on April 29, 2006 at the 21st meeting of the PC of the National People's Congress of the 10th convocation), which was amended in 2018. Most recently, an updated version of it was adopted (The Law of the People's Republic of China on the Quality and Safety of Agricultural Products // Adopted at the 21st meeting of the Standing Committee of the National People's Congress of the Tenth Convocation on April 29, 2006 in accordance with the documents "On Amendments to the Resolution on Fifteen Laws, including the Law of the Republic on the Protection of Wildlife", as amended on September 2, 2022, at the 36th meeting of the Standing Committee of the National People's Congress of the 13th Convocation // URL: https://ru.chinajusticeobserver.com/law/x/law-on-quality-and-safety-of-agricultural-products-20220902/chn (date of application: 09/19/2022)), which comes into force on January 1, 2023. The Law applies to the production and operation of agricultural products, as well as to supervision and management activities related to their quality and safety. The State establishes a system for monitoring the risks of quality and safety of agricultural products (Article 13 of Chapter 2).

The Agricultural Department of the State Council of the People's Republic of China should establish an Expert Committee on Risk Assessment of the Quality and Safety of agricultural products to analyze and assess potential hazards, which should include representatives of such industries as agriculture, food production, biology, environmental protection, medicine, chemical industry, etc., which to a large extent should provide a comprehensive assessment on an interdisciplinary basis.

When developing safety standards, the results of the quality and safety risk assessment should be fully taken into account, and the opinion of producers and operators of agricultural products, relevant departments and industries, consumers, etc. should be taken into account (Article 17).

The first kind of "brick" in the building of agricultural product safety is the state system of control over its origin. The Law pays special attention to zoning and delineation of territories where products are produced (Article 21), as well as compliance by all subjects with environmental protection requirements (Article 22). Pesticides, veterinary drugs and feed additives, fertilizers and veterinary instruments that may affect the quality and safety of agricultural products are subject to licensing in accordance with the norms of the legislation of the People's Republic of China (Article 28) and are used strictly in accordance with applicable legislation. The Law also contains norms providing for administrative and civil liability for a fairly wide range of offenses in the area under consideration, the types and amount of sanctions for specific offenses, as well as a reference norm to criminal legislation.

In accordance with the requirements of Article 43 of the Law under consideration, agricultural products related to agricultural genetically modified organisms are processed in accordance with the applicable safety management rules for agricultural genetically modified organisms. These include, in particular, the Regulation on the management of the safety of GMOs in agriculture (approved by Order of the State Council of the People's Republic of China No. 304 dated May 23, 2001), according to which a subject planning to grow or breed GM agricultural products must obtain a safety certificate of agricultural genetically modified organisms and pass the necessary examinations in this regard, carry out planting or breeding in designated areas, take appropriate safety measures and precautions, as well as comply with other conditions provided for by the regulations of the competent agricultural administrative department of the State Council (Article 19).

Genetically modified food products are subject to the provisions of the Law of the People's Republic of China "On Food Safety" dated February 28, 2009, according to which, taking into account the results of the assessment of relevant risks in the field of product quality and safety, the state develops and approves mandatory technical standards that establish appropriate requirements for agricultural production sites, production process technology, accounting and the control carried out in its process, as well as to the packaging and labeling of manufactured products.

         Disputes about the safety or potential danger of growing genetically modified crops on a commercial scale, despite the existence of this problem, have not subsided for several decades. Proponents of one or another approach in disputes give reasonable and weighty arguments in favor of their point of view. It seems that a certain wariness about the long–term consequences of the influence of genetically modified organisms on the state of both the ecosystems of the territories directly occupied for their production and those located around them is justified, taking into account the fact that negative consequences, on the one hand, can be unpredictable, on the other hand, manifest themselves after a significant number of years. Indicative in this regard is the example of growing genetically modified cotton in China. In the early 1990s, the country experienced an unprecedented outbreak of one of the main types of cotton pests - the cotton scooper (Helicoverpa armigera), associated with the appearance of butterflies resistant to the chemical insecticides used, which led to a significant decrease in crop yields. In response to the epidemic, Chinese scientists have created a genetically modified variety of cotton containing the gene of the bacterium Bacillus thuringiensis. The Cry1Ac protein produced by the plant and encoded by this gene was toxic only to the caterpillars of some butterflies and, apparently, harmless to all other animals, including humans. Mass commercial cultivation of modified cotton began in 1997 and led to a steady decline in the number of cotton scoops (from 1997 to 2006 approximately 3.5 times). At the same time, the number of this pest decreased not only in cotton crops, but also in other crops of which it was a pest (See: URL: https://elementy.ru/novosti_nauki/430841/Transgennyy_khlopok_pomog_kitayskim_krestyanam_pobedit_opasnogo_vreditelya (accessed: 01.09.2022)). The ten–year experience of cultivating transgenic cotton in China was recognized by scientists as successful - in addition to reducing the number of the main pest due to a decrease in the use of insecticides, the ecological situation in the regions of cotton cultivation improved ^{[10, p. 1678]}. However, a side effect of reducing the use of pesticides was an increase in the number of secondary pests. In particular, an uncontrolled increase in the number of horsefly bugs of the Miridae family was observed in modified cotton crops. Another negative consequence for ecosystems was the decline in the number of other butterfly species. The results of research conducted in recent years, taking into account 20 years of experience in growing modified cotton in different countries (China, Mexico, India), show that its use in commercial agricultural production is not a panacea, and the future, according to scientists, is seen in the integration of various tactics in pest control, including with the use of biological control through the use of natural enemies ^[11].

In the information material published in 2021 by the Australian Ministry of Health concerning the cultivation of genetically modified cotton in the country, it is noted that, according to the information available as of the date of publication of the material, both in Australia and internationally there is no evidence of the potential danger of modified cotton to human health and the environment, which could serve as the basis for revoking the relevant previously issued licenses for the commercial cultivation of its modified varieties in the country. However, authorized state bodies should carry out appropriate monitoring of research data published in the scientific literature confirming or refuting the safety of commercial cultivation of genetically modified crops. The appearance of data proven by scientific research on their negative impact in a particular area should be the basis for revoking licenses (See: URL: https://www.ogtr.gov.au/resources/publications/genetically-modified-gm-cotton-australia (accessed: 01.09.2022)).

I would like to note that, despite the goal of providing sufficient food and other resources produced by agriculture, the world's population, which is steadily growing and, according to forecasts published in July by the United Nations Department of Economic and Social Affairs, was expected to reach 8 billion people by November 15, 2022 (See: URL: https://www.rbc.ru/rbcfreenews/62cc7b4d9a794762a83e17bc (date of application: 01.09.2022)), and in reality exceeded this value already in September 2022, nevertheless, you should not abandon reasonable precautions for commercial cultivation of genetically modified crops. As the practice of securing the precautionary principle in legislation and applying it abroad, in particular in the EU, shows, an anthropocentric approach is widespread in this matter, in other words, the task of ensuring human security and his rights is at the forefront, and environmental protection tasks are perceived by people as tasks of protecting their habitat, and not nature itself. ^{[12, pp. 35-36]}. At the same time, the integrity and stability of natural ecosystems are the key to the stability of the biosphere as one of the main components of the human habitat. That is why humanity's careful attitude to biodiversity in general and its individual components in particular is the key to the existence of both its current and future generations.

It seems that the existing approach in the Russian Federation to introduce a moratorium on the commercial use of genetically modified organisms is appropriate as long as the tasks of ensuring the country's food security can be solved by other methods and means. However, in order to prevent the lag of Russian science and technology in the field under consideration, the state should pay increased attention to their development and allocate sufficient amounts of funding, subject to strict state control over the safety of research.