BARRIERS AND PROSPECTS FOR THE USE OF NEW GENETIC TECHNOLOGIES FOR FOOD PRODUCTION: REGULATORY OPTIONS IN THE INTERESTS OF THE RUSSIAN ECONOMY

Introduction

The higher accuracy and efficiency of new genomic technologies (NGT), commonly referred to as genomic editing technologies, makes them especially promising in breeding activities. The creation of new domestic crop varieties using NGT methods can reduce dependence on seed imports, expand food production, promote export growth and attract investment in Russian companies in the agro-industrial sector and science-intensive start-ups.

At the same time, although the basic Russian law "On Genetic Engineering Activities" does not formally prohibit the circulation of plants and crops whose genome is modified by NGT methods and does not contain foreign DNA, industry legislation de facto prohibits the industrial breeding of plants and animals if they "contain genetically engineered material, the introduction of which cannot be the result of natural processes¹.

Thus, scientific research in this area is allowed, however, the practical application of varieties obtained with the help of NGT is in the "gray zone". An entrepreneur and a scientist who have taken on the development and introduction of a new variety using advanced genetic methods together face a number of legal and organizational barriers. The main one is the task of proving that, firstly, plants (and food products based on them) obtained using genome editing are not GMOs², and secondly, that genetically engineered modifications are indistinguishable from those that may be the result of natural processes in nature.

Based on Russian and European experience, the presented article explores options for overcoming the mentioned barriers in order to quickly solve the problems of import substitution in seed and crop production, expand commercial food production, and create competitive advantages for Russian innovative firms and agricultural producers.

1. Description of the current situation in Russia

The discovery of NGT made it possible to change the genetic material of organisms faster, easier, and cheaper³ [Doudna and Charpentier, 2014]. With the discovery of these "molecular scissors", gene modification in the laboratory has become the most promising method for creating new crops [Chen et al., 2019; Khalil, 2020]. In all developed countries that have such technologies, including Russia, the question has been raised for a long time whether NGT should be qualified in the legal field differently compared to the previously known traditional methods of genetic engineering that have come into practice since the 1970s⁴.

In the Russian Federation, the field of genomic technologies is regulated by Federal Law No. 86-FL from July 5, 1996 “On State Regulation in the Field of Genetic Engineering Activities” (86-FL). Since 2016, a law on a virtual moratorium on the widespread use of GMOs has been in force in Russia⁵ Cultivation of GM plants (except for laboratory experiments) and breeding of GM animals for food production and other business purposes is illegal.

New genomic technologies are a different tool [Trikoz et al., 2021] compared to the classical methods of genetic engineering, defined in Z86-FL as “a set of methods and technologies, including technologies for obtaining recombinant ribonucleic and deoxyribonucleic acids, for isolating genes from the body, manipulation of genes and their introduction into other organisms. Lawyers and jurists are practically unanimous in the fact that, as a result, NGT are not subject to the regulation of the specified basic law [Tarasov, 2021], that is, they can be used in economic practice.

However, the norms of sectoral legislation adopted several years ago differ in more general and strict, sometimes prohibitive language [Kudelkin, Startsun, 2019]. For example, the cultivation and breeding of plants and animals in our country, "the genetic program of which has been changed using genetic engineering methods and which contain genetically engineered material, the introduction of which cannot be the result of natural processes, is prohibited." The only exceptions are cases of cultivation and breeding of such plants and animals in the course of scientific research or examinations. These prohibitions were included in Art. 21 of the Federal Law from December 17, 1997 No. 149-FL "On seed production" in 2016. Last but not least, one of the main causes became the very resonant publications in the media and public discussions regarding genetically modified food products (up to the denial of genetic technologies in general), which could be summed up as serious public skepticism, and not only in relation to GMOs, but also to the effectiveness of the state regulation of the new technology sector as a whole.

At the same time, the regulation of breeding activities directly related to seed production is actually out of sight of Russian legislation. There is no direct regulatory relationship between genetic engineering and breeding activities, although in fact genomic technologies are a breakthrough tool in breeding work [Vetrova, 2012]. This is another barrier for effective private investment in innovative business to create new breeding achievements by genetic engineering methods, including NGT, since the differences between them are difficult to discern, especially for lawyers in the business community.

We are not talking about direct prohibitions, we are talking about a "gray zone" in legal regulation, the complexity of licensing bureaucratic procedures and, accordingly, high investment risks. Therefore, it is not necessary to count on large-scale private investments in the area under study, as well as on the transition from innovative developments using NGT to the stage of full-fledged pilot introduction of these technologies into the practice of agro-industrial enterprises. But after the pilot implementation stage, there are still many barriers to the transition to widespread implementation and scaling, which is typical for the spread of any new technologies in industry and agriculture [Kuzmin, 2021].

In the absence of public investment in new domestic developments, until recently, a high share of imported seeds in the Russian market has become an economic reality, in particular for such mass and critical for food security crops as sugar beet, potatoes, vegetables, sunflower, corn. When importing them, we depend on foreign seed suppliers, often "contracted" by world leaders in the development of GM crops from the USA, Germany and Switzerland⁶.

2. The role of the state in correcting the situation. Overcoming Barriers to the Economic Application of NGT

"Genomic editing, which allows you to change the genome of an organism, is a breakthrough tool that is already being applied in agriculture, industrial biotechnology, medicine and other sectors of the economy in the leading countries of the world." This is one of the key theses of the substantiation of new government approaches in the area under consideration⁷.

It was the state, relying on the analysis and legal justifications of the relevant state authorities, that adopted a whole range of programs related to the development of agriculture, import substitution, scientific and technological developments, in which a prominent place is given to the use of NGT in the coming years.

As an example, we will give two subprograms of the Federal Scientific and Technical Program for the Development of Agriculture for 2017-2025 (approved by the Decree of the Government of the Russian Federation dated from August 25, 2017 No. 996) - “The development of selection and seed production of potatoes in the Russian Federation” and “The development of selection and seed production of sugar beet in the Russian federation".

The text of the last subprogram analyzes in detail the issue of critical import dependence in Russian sugar beet seed production. It is indicated that our country, ranking first in the world in terms of the area under sugar beet crops, is "significantly dependent on import supplies of seeds of sugar beet hybrids." At the same time, the volume of the market for these seeds in the Russian Federation is from 5.7 to 5.8 billion rubles.⁸

The high share of seeds of sugar beet hybrids of foreign selection in the Russian market is due to a number of reasons, including the “low level of state support for breeding and seed production of sugar beet and the lack of interest on the part of business in investing in this sector of agricultural production.” The developers of the program specifically point out that when creating new domestic varieties of sugar beet, “the use of modern, but rather costly methods of molecular biology and biotechnology, has practically ceased”, and new methods of “genomic selection and genome editing technology in the breeding process of sugar beet in the Russian Federation today are practically not applied. The conclusion is obvious: the competitiveness of domestically bred sugar beet hybrids is very low.

In the context of this program, it should also be noted that in terms of annual funding, specialized Russian scientific organizations are significantly (20-40 times) inferior to the research structures of foreign seed companies.

Despite increased state funding (mainly in terms of pilot projects), without an influx of corporate and private investment, the situation in this sector is unlikely to change dramatically.

3. Solving the problems to overcome barriers: taking into account foreign experience and analyzing the competitive advantages of Russian market players

Scientific research in the field of application of NGT in crop production in Russia is quite active. In accordance with WTO rules, the import of food products with GMOs is allowed. However, seeds of GM plants are not allowed to be imported. The government has the right to ban the import of GM food into Russia⁹.

In all likelihood, the time has come for a substantive analysis of alternatives and making strategic decisions to justify the possibility and necessity of introducing new technologies for genome editing of plants and crops into legal and economic circulation.

The main motivation for the development of Federal Law No. 358-FL of July 4, 2016 “On Amendments to Certain Legislative Acts of the Russian Federation in Part of Improving State Regulation in the Field of Genetic Engineering Activities” (hereinafter referred to as 358-FL) was public concern about the possible harm of GMOs to humans, unpredictable impact on the environment, in particular the hypothetical threat of the transfer of new genes into the wild. What is more, even when growing already available, permitted varieties of GM corn or GM soybeans (dominant on international markets), there is an environmental threat: GM plants are resistant to herbicides, and if the cultivation technology is violated, the amount of herbicides used is often exceeded several times¹⁰.

In Russia, as already noted, genetic editing is not within the jurisdiction of FL-358, since organisms obtained using NGT (genome editing) are not formally GMOs and are not subject to the basic Federal Law FL-86¹¹, which regulates exclusively transgenesis technologies (gene transfer), rather than spot editing.

Due to the absence of a law regulating breeding activities, it can be considered that the use of genomic editing methods for breeding plant varieties, animal breeds and strains of microorganisms for agricultural production purposes are legal and can be used by the breeder in his activities.

It should be noted here that genetic editing techniques can change DNA in a variety of ways: change the pointwise DNA sequence, turn genes on and off without changing the DNA code.¹², etc., however, as a rule, the final product does not contain fragments of foreign DNA (DNA another organism). This is why NGT products are currently not considered GMOs from a legal standpoint. Since foreign genetic information is not introduced, NGT can be conditionally classified as “nature-like” technologies [Kovalchuk et al., 2019; Zhironkin et al., 2019]. However, such a conclusion, made by the “method of exclusion”, by analogy with the well-known principle “everything that is not prohibited is allowed”, giving Russia a potential competitive advantage in the innovative development of oil and gas pipelines and their economic application, is insufficient. The confidence of academics, legal professionals, and even the adoption of government programs in this area is not sufficient to effectively attract business players. The question arises about the direct mentioning and clear definition of NGT in the legislation.

In the European Union, the situation is reversed: there is a Directive¹³ on genetically modified organisms (hereinafter referred to as the Directive), which effectively prohibits the introduction of GM plants on the market without going through an expensive and lengthy risk assessment and monitoring procedure. In July 2018, the European Court of Justice ruled that all crops modified with NGT, including CRISPR-Cas9, are also subject to the GMO Directive. It should be noted that several years ago, after lengthy discussions, the Directive was amended, according to which individual EU Member States were given the right in their national legislation to either prohibit or allow the cultivation of GM crops, based on social, cultural and ethical prerequisites¹⁴. This significantly expanded the possibilities for including social and ethical factors in the discussion about possible directions for improving the legal regulation of the use of NGT.

Thus, the Russian legislation regarding the regulation of oil and gas wells is not harmonized with the international one. This, on the one hand, makes it possible to borrow experience in the development of new legal acts and procedures for licensing, monitoring and control. On the other hand, when modernizing Russian legislation, it seems expedient to follow our own path, which allows us to achieve competitive advantages for Russian agricultural producers, consolidate and develop the successes of domestic scientists and breeders, and make it more sustainable and safe to provide Russian consumers with high-quality and inexpensive food products.

To implement this approach, it is necessary at least to consider briefly possible scenarios for the legal regulation of NGT, as well as the arguments that are given in public discussions, both in Russia and abroad, on the issues related to regulatory control of biotechnology application.

4. Assessment of technologies in the field of NGT and a general review of scenarios for regulating the sphere of biotechnology according to a study by foreign technology assessment centers

In 2019, the independent Rathenau Institute (Netherlands), which specializes in technology assessment, published the report "Editing the genome of plants and crops: towards a modern biotechnology policy focused on differentiated risk assessment and broader considerations" [Habets et al., 2019] (hereinafter referred to as the report of the Rathenau Institute). The report discusses the main options for maintaining the GMO Directive in relation to NGT, as well as the possibilities for amending the Directive to exclude new genome editing methods from its scope (in cases where the final product is free of foreign DNA).

A hypothetical third option is also being considered, requiring new legislative regulation. Under this option, specific applications of NGT would have to be assessed on a case-by-case basis, based on a graded risk assessment, as well as using an assessment of the product's potential value to society and its ethical acceptability.

The key points of the Rathenau Institute's report were then developed and supplemented by a wide range of expert judgments in the course of the foresight study carried out by the Council for Science and Technology Assessment (STOA, technology assessment body of the European Parliament), the report of which was published in December 2021 [Woensel et al., 2021] (hereinafter referred to as the STOA Report).

The method of an online survey of interested organizations and experts (stakeholders) was used in preparation of the STOA report. It included two stages and was aimed at exhaustively identifying the pro and contra arguments of the main scenarios for the legal regulation of NGT, which put forward key stakeholders from various fields of activity related to NGT¹⁵.

It should be noted that this methodology for evaluating options and arguments can be largely (albeit with necessary adjustments) used in Russia. This would give a more reliable scientific character to the current and future discussions about the regulation of oil and gas treatment - both in society and in parliamentary and government circles, and would help to avoid excessive politicization and populism in the adoption of legislative and economic decisions.

The analysis of the mentioned reports, as well as the above considerations and conclusions regarding the Russian situation, made it possible to formulate firefly the following main options, pro and contra arguments, as well as scenarios for the legal regulation of new genome editing methods offered to Russian legislators and key economic players in order to make strategic decisions in the field of application of NGT in agricultural business. Under public support and consent solutions would provide: sustainable growth in the production and export of food products; overcoming import dependence; successful development of the innovation process based on domestic achievements in science and bioengineering.

5. Main results of the study: an exhaustive list of scenarios

and the main arguments

for decision making

The main options for regulating oil and gas wells in the field of their industrial application, taking into account the above considerations, include:

– strict regulation - bans, the use of burdensome licensing procedures for business, that is, a scenario similar to the case of GMOs;

– deregulation - a permissive policy in relation to NGT, subject to a number of conditions, the main of which is the absence of foreign DNA in the final product;

– a new regulation that will potentially combine the advantages of the first and second options and implies a balanced assessment of both each specific NGT product and each specific technology for its production in two key areas - assessment of the potential hazard of the product and assessment of the product and technology, taking into account social and ethical criteria.

When analyzing the main arguments of scientists, experts and groups of influence, possible future scenarios for the regulation of oil and gas, the following general considerations were taken into account (which must be considered a priori, bearing in mind the experience of public discussions in the Russian Federation, the need for a reliable assessment of the socio-economic prospects for the use of oil and gas to launch new domestic food products on the market):

1) significant public skepticism regarding genetically modified products (up to their demonization);

2) objectively existing uncertainties and unknown consequences of the use of NGT, not very long period of their use (about 10 years);

3) an "innate" contradiction when considering the problems of applying genetic (molecular and cellular) engineering methods between taking into account safety issues and stimulating the progress of science and innovation, between the attractiveness of a conservative, protective approach to breeding methods and the need to achieve an innovative breakthrough, competitiveness of domestic science and Russian business¹⁶;

4) genome editing is, in a certain sense, a continuation of the methods of traditional plant breeding, which has made a significant contribution to ensuring food security in Russia;

5) Russia has excellent schools of scientists and breeders who are able to create new domestic varieties using genetic editing methods, subject to strict control conditions and “natural similarity” criteria (absence of foreign DNA, making changes that are possible in wildlife);

6) the resonance of the still not finally resolved problem of labeling products containing GMOs: in the future, NGT products need a different labeling, which, on the one hand, will ensure the freedom of choice for the consumer and the traceability of the product, and on the other hand, will remove social phobias and will contribute to the attractiveness of the product ;

7) the legislator must provide a clear and understandable policy for the public to regulate the market use of NGT products, establish transparent and effective procedures for assessing risks and benefits with a clear scheme of responsibility for this assessment, based on the simple truth that after the release of new varieties into the open environment, plants can no longer be “returned back”;

8) legislation regulating relations in the field of genomic research should, if possible, be proactive in nature, so as not only not to create obstacles to scientific research and innovation, but to serve as their driver, indicating key growth targets in advance and designating deliberate prohibitions and restrictions dangerous to humans and the environment.

Below is an analysis of the main arguments of experts and influence groups, based on the experience and publications of Russian experts, discussions in the legislative and public institutions of the Russian Federation, reports of the Rathenau Institute and STOA on the above scenarios.

1. Scenario of strict regulation - NGT products are equated to GMOs (Table 1). Scenario 1 for the EU implies maintaining the status quo, the GMO Directive does not change. For Russia, scenario 1 implies the introduction of tougher amendments to FL-358 and to the basic Federal Law FL-86.
2. The deregulation scenario (permissive policy for oil and gas) is shown in Table 2. Scenario 2 for the EU implies an amendment to the GMO Directive that removes NGT products from its scope. For Russia, scenario 2 implies at least the maintenance of the status quo, and at the maximum, the “legalization” of NGT in the basic law 86-FL and in industry legislation (provided that there is no foreign DNA in the final product).
3. The new legislative regulation (complex scenario, risk assessment and consideration of social and ethical aspects) is presented in Table 3. regarding social and ethical criteria.

A number of specialists from the Norwegian Advisory Council for Biotechnology (Bioteknologirådet) proposed a model that can be considered one of the options for a new comprehensive legislative regulation¹⁷. The Norwegian model is based on a balance of methods for assessing risk levels and socio-ethical factors. Unlike the model discussed in the Rathenau Institute report, this approach prioritizes social and ethical criteria in a complex regulatory scenario. Under this scenario, the assessment of the technology and the level of risk of NGT product is carried out mainly according to the criteria of social goals and ethical justification, and the specification of the risk category for the use of a new product occurs at the second stage (Table 4).

Conclusions

Russia will have to change the legislation on the circulation of genetically modified organisms, providing for a differentiated risk assessment depending on the technology used and social aspects, giving, in particular, real opportunities for the widespread use of new genetic technologies in food production.

It is necessary to adopt a new version of the Federal Law dated from July 5, 1996 No. 86-FL “On State Regulation in the Field of Genetic Engineering Activities”, which will clearly spell out the concept of genome editing. It is necessary to develop and adopt a federal law “On Breeding Activities”, which will contain information on selection using bioengineering, as well as the introduction of corresponding changes in the legislation on the environment, on seed production, and in by-laws of the Government of the Russian Federation.

Taking into account the current international experience in the legal regulation of oil and gas in Europe and the United States, the existing risks due to sanction pressure on Russia, China's plans for a well-known liberalization of legislation on GMOs¹⁸ Russia needs new domestic crops obtained by the "molecular scissors" methods. Currently, the legislation of the Russian Federation is prohibitive in relation to GMOs and implicitly liberal in relation to products of new genomic technologies. This situation creates a number of competitive advantages that must be preserved and strengthened, implying the need to improve the regulatory framework for genetic engineering activities.

The main scenarios for oil and gas pipeline regulation, pro and contra arguments, comparison of Russian and foreign approaches can be applied in making strategic decisions by both regulatory authorities and economic players. In general, the initial situation is in favor of the fact that the Russian innovation sphere and the food production industry can realize their existing competitive advantages in the coming years.