In 2016, 6 Asian countries produced GM crops; China produced cotton and papaya, India produced pests-resistant cotton, Pakistan produced pests-resistant cotton, Myanmar produced pests-resistant cotton, Philippine and Vietnam produced pests-resistant and pesticide-resistant corns. In the continent of America, USA as the biggest producer of GM products in the world, some countries such as Brazil, Argentina, Canada, Bolivia, Paraguay, Uruguay, Mexico and Burkina Faso produced GM crops. In Africa, South Africa joined countries supporting GM products since 2000 and now is cultivating GM corn, soybean and cotton. Australia is also a leading country in transgenic technology that produced GM cotton in 2016 and added pesticide-resistant canola to its agricultural products in 2018 (32). In 2017, however, 24 countries producing GM crops included 12 countries in America (with 88% production areas in USA, Brazil, Argentina, Canada, Paraguay, Bolivia, Uruguay, Mexico, Colombia, Honduras, Chile and Costa Rica), 8 countries in Asia and Pacific Ocean (with 10% area under the cultivation by India, Pakistan, China, Australia, Philippine, Myanmar, Vietnam, and Bangladesh), two European countries (with 0.5% area under cultivation by Spain and Portugal), and two African countries (1.5% area under cultivation by South Africa and Sudan) (49).
China (unusual acceptance of GM plants)
The Ministry of Agriculture and Rural Affairs of China ordered to publish safety license of modified organism in terms of agriculturally modified organism to 192 plant varieties in 2019 included 189 cotton varieties, two maize varieties, and soybean variety, which led to a possibly better future for seed industry of China and approved 5 new GM crops such as pesticide-resistant canola and pesticide-resistant soybean as well as 26 existing GM crops. It was the second time of issuing health certificate for GM crops to be used as food during the past decade; the first time was 2009 when health certificates had been issued for GM corn and rice.
According to “Regulations on Administration of Agricultural Genetically Modified Organisms” and relevant guidelines, approval of GM seeds in China is subject to evaluation of safety of these products. Seed production should be allowed by Agriculture Administration of Ministry of Foreign Affairs regarding commercial cultivation of GM crops. However, seed producers have progressed industrialization of GM crops in 2019. In February 2019, GM Glyphosate and Glufosinate-resistant soybean was produced under the LTD Argentina license as the first GM crop produced by Chinese company, which tends to acquire international license to cultivate this product in Uruguay and Brazil. China tends to commercialize the GM seed industry but not in China; Chinese companies want to cultivate this crop overseas. In addition, it has been allowed to reimport such products to ensure food security in China (31).
There are few data from many of geographical areas while there are numerous studies on GM products and consumer attitude toward these crops in Europe and North America (40). There are interesting conditions in China where, the government spends high cost to develop GM crops as an investment in food industry. Pests-resistant GM cotton is widely cultivated with more than 90% acceptance rate in China. China started to trade GM rice about 10 years ago. The results of pre-field experiments with pest-resistant transgenic rice showed higher crop yield and sever reduction in the use of pesticides. These factors also led to positive health effects on farmers. Regulations on mandatory labelling foods produced by GM products have been enforcing more than one decade (22). China’s government invested in development of biotechnology products and announced a 3.5 billion dollars-program for GM products in 2008. But in the last five years, people's attitudes toward these products have become more ethically negative Meanwhile, it seems commercialization of GM rice has been stopped in China. In August 2014, biosafety certificates of two GM rice lines issued in 2009 were expired without any renewal leading to illegal cultivation of these plants and raises speculation as to whether the Chinese government will cancel further development of transgenic rice.
Nonetheless, certificates of this product were renewed for 5 years in January 2015 (51). In February 2015, the main document No.1- the first important document of annual policies that was published by central committee of communist party- obliged the government to support researches pertained to GM technologies, particularly for crops. On the other hand, Chinese scientists should conduct more studies to convince people who are concern about advantages of GM products (40, 52). Accordingly, consumer attitudes toward GM plants play a vital role in policies made in the world. Generally, studies conducted in China indicate that consumers have a positive attitude toward GM foods in China, particularly if these products have high quality. However, there has been an increase in number of consumers who worried about GM foods in China so the government acts cautiously (31).
India
India had to increase farming productivity and production in order to supply food and income for an increasingly growing population. Department of Biotechnology under the Ministry of Science and Technology of India was established in 1986 to promote and support biotechnological applications. Generally, there is an active scientific trend toward agricultural biotechnology researches (53). The introduction of pest-resistant cotton for commercial production in 2002 was protested by several NGO groups claiming that the product was inefficient or even unsuccessful, however, these public claims were not scientifically examined and GM cotton cultivation became a great success story in India so that about 95% of areas allocated to cotton was cultivated by GM lines in 2014 (16). Genetically modified cotton could reduce dependence on chemical pesticides, increase yield and profit of retail farmers within a sustained and long period, and lead to a positive socioeconomic progress in India. Increasing farmers’ income led to increase in food security for Indian cotton farmers. There are more than 1000 cotton cultivars with resistance to pests and proper genetic backgrounds for available local conditions. Such big choice preserves agricultural biodiversity in India; and available GM products have not led to any reduction in various types of cotton cultivated by Indian farmers. GM species (brinjal) and hybrids were approved in 2009 by the Genetic Engineering Approval Committee of the Ministry of Environment after 9-years extensive agricultural and safety tests such as large-scale field experiments. However, protests of anti-transgenic activist made Minister of Environment of India to declare GM cultivation as an illegal action because there was not any specific self-confidence in studies related to state safety and risk assessment; on the other hand, there were possible health risks caused by GM products and concerns about dominance of foreign technology and missing food sovereignty. Such decision had a highly negative effect on active Indian research society so that only 10 GM plants (cotton, pea, sorghum, sugarcane, castor, rice, and potato) with different specifications were developed during 15 years; however, laboratory tests were illegal and there was not any clear future for GM products test out of the specific laboratory until 2014. Development of GM products was limited in India and the government's approach to cultivating transgenic crops seems to be much more cautious than research, and the need to improve the regulatory framework for biotechnology products is obvious (53). India’s developments are monitoring by the world as they reflect the debates on using GM products in many of developing countries that should keep balance between new technologies and need of agricultural efficiency (54).
Pakistan
The modern biotechnology was performed for the first time in Pakistan in 1985. So far, 56 advanced biotechnology research institutes (50 public and 6 private organizations) have been established in Pakistan; most of these organizations tend to increase genetic potential. The modified products have been used more to help farmers with biotic and abiotic environmental stresses. Genetically modified Cry1Ac-containing cotton (Mon-531) is the only GM product recommended for general cultivation in Pakistan. As Pakistan has signed Cartagena Protocols on Biosafety, national biosafety regulations under the safety rules were approved in 2005 in this country to design researches related to development and commercialization of GM products. The license for first GM plant (cotton) was issued in 2010 in Pakistan; and there has been a considerable progress in plants biotechnology and introduction of GM plants in this country. Pests-resistant cotton was introduced in Pakistan then another version of pests-resistant GM cotton was added in 2012 and two pesticide-resistant and pests-tolerant corn species were introduced in 2017 (55).
Turkey
Turkey benefits from rich genetic resources so “biodiversity degradation” is considered as the most important risk for use of genetically modified products. It is believed in Turkey that it is not possible to restore GM organisms in natures after they were consumed and lack of information in this field may harm genetic resources. Therefore, this substantial issue should be considered in rules. Production and cultivation of GM organisms is forbidden in Turkey. According to Biosafety Act of Turkey, it is banned to produce GM crops. The GM products formulated in foods of children and infants, supplements for infants older than 6 months and children are banned based on the rules enacted by Ministry of Food, Agriculture, and Livestock. Although there are no restrictions on the application of these provisions in all EU countries and the United States, Turkish authorities have banned such use with a precautionary approach to protect future generations. There are severe fines considered for those who violate this rule in the market. According to Article 15 of Turkish Law entitled fines, importers or producers of GMOs in the environment are sentenced to 5-12 years prison and a governmental fine of 10.000-200.000 Turkish Liras based on the type of the crime committed against the law (not notifying the biosafety council). GMOs export from and import to Turkey is monitored. The monitoring system is based on the specific methods and rules for cops with and without genetically alteration. According to this law, GM crops should be labelled based on the decision made by biosafety institution upon arrival. Therefore, it is not possible to introduce or supply GM crops within ambiguous methods against public opinions; in turkey, complete information has been inserted on these products to make consumers aware of the difference between GM and non-GM products. Hence, consumers have right to choose products. Biosafety Act was introduced in Turkey to solve problems related to GMOs law absence. The combined management of pests and weeds with integrated crops control has been considered in Turkey as an option for genetic usages in order to increase quality and efficiency as well as sustainable agricultural development and food safety (18).
GM crops in USA and Europe (their disagreement as the largest and smallest countries producing and consuming GM crops in the world)
Considering the severe regulatory space in EU, only one type of GM plant (pests-resistant GM corn) is allowed to be cultivated in the EU. Spain is the only European country with many farms growing GM products. Farmers have had good experiences and high economic yield in field of GM corn efficiency compared to ordinary corn in regions contaminated with pests since introduction of this technology in 1998 (56). In 2018, 35% and 6% of total areas of Spain and Portugal, respectively (about 121.000 hectares of lands) has been allocated to GM corn. There is low amount of GM corn cultivated in four other European countries (Portugal, Czech Republic, Romania, and Slovakia).
A study was conducted on economic and environmental effects caused by acceptance and use of pests-resistant GM corn in Spain and Portugal over the 21 years (1998-2018). it was found that of total 1.65 million hectares of cultivated corn (from 1998 to 2018), 1.89 million tons of extra produced corn using less resources and subsequent lower stress on scarce resources such as water led to 285.4 million Euro in farmers’ income compared to growing non-GM corn. Each extra 1Euro spent for GM seed leads to 4.95 Euro extra incomes for farmers obtained from higher yield (11.5% in both countries by using this technology). This seed technology has led to a reduction of 678000kg active substance (37%) and subsequent decline in environmental effects caused by pesticides and herbicides used for crops. Moreover, this technology has contributed to low fuel consumption, less emission of greenhouse gases in the area under the cultivation of GM crops, and water saving (57).
However, total area under the cultivation of GM crops in Europe has been equal to 143000 hectares of lands (a small part of global area allocated to GM products) in 2014. GM corns are not associated with needs of local farmers in other European countries where its cultivation is disappointing or totally banned (36). However, cultivating pests-resistant GM corn in EU has been approved, but many of EU member states have relied on the regulations enacted by EU (412/2015), which allows the countries to ban this technology due to non-scientific reasons (57). Another considerable case was herbicide-resistant GM soybean in Romania, which its cultivation was began in 1999 as a new solution to control weeds that its acceptance by farmers led to an average increase of 30% in product yield making it the most profitable crop in Romania. About 137.000 hectares of lands in Romania was allocated to growing genetically modified soybean in 2006 covering 68% of soybean production in EU. Increased yield of farms led to rise in soybean production in Romania so that it could be exported to other European countries, while soybean meal import was reduced considerably. When Romania joined EU in 2007, GM soybean was not allowed to be grown or consumed; hence, farmers had to cultivate conventional seeds. Due to the sharp decline in the profitability of common seeds, soybean sown area fell by 70% in two years, making Romania, like other European countries, dependent on expensive soybean imports, and in general, Romanian farmers lost a very profitable crop (58). Although GM crops are not cultivated in European countries, farmers have a positive attitude toward crops genetically modified by biotechnology. A survey indicated that more than half of German farmers and almost half of farmers in Czech and UK are willing to obtain the license for herbicide-resistant plants as this technology facilitates weeds control process. More than one third of Spain, French and Hungarian farmers tend to use herbicide-tolerant GM corn (59). Another study showed that many of farmers in UK announced their willingness to cultivate GM corn, canola or sugar beet with the governmental permission (60). However, this does not occur in EU. According to reports proposed by European countries, there is high amount of GM foods imported and consumed because it ultimately helps produce their food. On the other hand, when about 80% of the world's soybean crop is transgenic, European countries, whether they like it or not, import it (40). But GM products were widely consumed in livestock feed and food markets after introduction of these products in USA market in 1996. USA authorities had adopted and approved a permissible policy for GM foods without any need to label GM plants. Furthermore, majority of American consumers were less worried about GM foods and agricultural biotechnology in the years following introduction of these products so that they used to purchase foodstuffs produced from GM plants despite the limited knowledge of consumers about GM foods.
Remarkable point is that the entrance of the first carriage of GM soybean from USA to Europe in 1996 faced a severe protest by environmental NGOs. There has been a considerable change in social and regulatory framework at both side of Atlantic Ocean leading to a direct impact on consumer attitude. In contrary to USA, EU approved strict requirements in this case. It has been approved in EU to label GM foods- even if genetic modification in final product was identified- since 1997 (61). Moreover, foods purified from GM plants such as oils or sugars have been labelling since 2003 even if these products are physically or chemically similar with non-GM products (50, 43). EU now has set a certain regulatory framework for cultivating, consuming and importing GM products for livestock feed and foodstuffs (62, 63). There is a challenging issue about permissions pertained to growing and importing GM crops and plants owing to domestic disagreements between EU member states and lack of a consensus on the case (64). Such challenge has led to prolonged decision-making process to issue license for biotechnological products. Major food exporters in EU should spend on average 15 to 20 months more than required time in USA, Brazil and Canada to acquire permission; this has led to import disruption in EU (36). Although NGOs usually play lesser role in USA, these organizations have performed successfully in introducing GM plants as a threat to biodiversity, farmers' independence and food safety in Europe (40, 65). These groups and supporters of political green parties and organic movement have focused on possible risks and negative effects of GM foods. These groups and parties use such orientations in election campaigns, papers and media. In general, social and political conditions of Europe justify the negative attitude of European consumers toward GM foods compared to consumers in Northern America (61, 65). There is a low acceptance of GM plants among European politicians and consumers, in particular in Germany while the rules governing the market licensing and labelling foods produced from GM products in USA are based the scientific logic and "basic equivalence" concept. If there is an unmodified substance in composition of a new GM food, it does not require labelling as such label does not include the information about product specifications. Federal Food and Drug Administration of USA has set binding labelling only if the GM food has different nutritional properties and allergies (61, 65). There are fewer rules related to GM foods in USA relative to EU and these regulations are more permissive in USA than in EU (66). A few numbers of social American activists protest against biotechnological demands for food production. The first public initiative for GM foods labelling in Oregon State in 2002 was rejected due to votes given by more than 70% of voters. Seemingly, the end of anti-GM plants in USA in 2008 led to expansion of GM products cultivation and consumption (67). However, anti-GMOs movement has been experiencing a considerable trend since then leading to social discussions on GM crops and foods. Opposition to GM crops and foods is beyond the scientific concerns about food safety including a wide range of environmental and sustainability as well as social and economic aspects. It seems that GMOs has raised extensive ethical concerns about sustainable agriculture and foodstuffs. The powerful coalition of NGOs, environment and consumers, organic farming proponents and food producers and ethic-based retailers asks for mandatory labelling of GM products and modern biotechnology-based foods. They argue that consumers have right to know about the nature of foods they consume; they should be able to choose whether buy foods with or without GMOs based on a transparent food system. Respect for consumer rights, however, cannot provide the only legal basis for mandatory food labelling in the United States. Majority of food industries in USA are opposed to mandatory labelling as it increases unessential costs without any advantage for consumer safety. In fact, the consumer will have fewer options by removing GM products from USA market like Europe conditions (40).
GM food labelling in USA and other countries (to ensure consumers rights)
GM foods have been the most debatable global issue over the recent decade so that EU insists on information disclosure for consumers while USA is against such request. It seems there is changing trend in global concern from primarily concerns about risk toward democratic sovereignty of "right to know" versus "need to know" (68). GM food labelling policy includes forbidden labelling, voluntary labelling (indicating that a product is GM ingredient-free), or mandatory labelling that shows a GM ingredient-contained product. Legal threshold is determined through labelling process, which is different in countries leading to complex goods commerce and transportation (41). For instance, there is 5% tolerance threshold for foods and livestock feed in USA, Canada, and Japan, while this rate is about 1% in Australia, New Zealand, Southern Africa, Brazil and China. In EU, however, a marketed product containing greater than 0.9% of GM ingredients is labelled as a GM product and consumers should know this information (69). Most countries have set the mandatory labelling rules, while USA authorities consider the nature of product more important that the production process so voluntary labelling is accepted for GM products (70). According to existing rules, it is not mandatory to label GM product- including products prepared from livestock fed by GM feed (such as mean, milk and egg)- and GM supplements and enzymes (such as rennet for cheese production) (71). However, some of EU countries have set rules and regulations on voluntary labelling of livestock products as GM products allowing consumers to choose products producing without direct use of GM ingredients (72). In 2016, President Obama signed an act entitled national bioengineering foodstuffs standard, which ended the debate on labelling GM foods in USA. This act became binding in 2020 and will be enforcing up to January 2022. According to this Act, any product containing GM ingredients or byproducts should be labelled inserting this information. After January 2022, any GM labelled product is considered as GM ingredients container. In 2019, Bioengineered (BE) labels stuck on sold products in food stores of USA could be found. According to the new law, the products manufactured by new techniques such as CRISPR, TALEN and RNAi should also be labelled. Moreover, livestock feed are not exceptions, while meat, egg and dairy products containing GM ingredients are not bind to labelling standard. Moreover, it is not required to express or disclose the foods purified and extracted from GM products unless they contain traceable GMOs. Beet sugar, soybean oil and corn sweeteners that are generally produced from GM seeds should not be labelled as GM constituents. In 2019, the GM products approved for marketing in USA include Salmon fish (AquAdvantage), apple, Canola, corn, cotton, eggplant, papaya, pineapple, potato, soybean, pumpkin, and sugar beet (31).
Argentina
Argentina was ranked as the third country with about 100% of acceptance rate among 10 countries in the world 2018 in terms of cultivating GM products with 23.9 million hectares under cultivation including 18 million hectares of GM soybean, 5.5 million hectares of GM corn, and 0.37 million hectares of cotton. In the last few years, a few number of GM products have been approved in Argentina. However, governmental support has accelerated cultivation rate so that about 25 new GM traits in plants have been introduced and approved in this country. Eight GM crops such as corn, soybean and alfalfa were approved in 2018 and this number reached to 12 in 2019, which one third of global approvals in this year cover six GM corn traits, three GM soybean traits and three GM cotton traits. On October 2019, the sixtieth GM product was introduced and approved after the first approval in 1996. In addition, Argentina pledged to support intellectual property rights and introduction of advanced technologies for GM cotton in favor of domestic cotton production in order to remove the technological gap between Argentina and Brazil; in this case, three new Glyphosate herbicide-resistant GM cotton traits were approved. The first registration of GM potato in Argentina (PVY-resistant SPT TICAR) was begun in 2021 to start producing GM potato (31).
Generally, there has been an increasing trend in acceptance of GM crops by millions of farmers over the recent decades in countries where GM species are available. A considerable amount of globally marketed GM products is based on the GM plants. Since 1994, 65 countries have issued GM import and export licenses (36). Apparently, there is a high acceptance rate in market for global use of GM products as livestock feed. Even according to reports given by European countries, high amounts of GM feed are imported to and consumed in Europe, which has contributed to increase in foodstuffs production (43).
About 525 various GM lines in 32 products was approved in different regions of the world up to 2019. It has been proved that GM technology has led to rise in product yield, decline in pesticides and herbicides, reduction in CO2 emission, and decline in production cost of crops. However, there are serious barriers to the high acceptance of GM external genes-containing products due to concerns about possible toxicity and allergic effects on human, probable environmental risks such as negative effects on non-target organisms, and strengthening weeds and pests. Such concerns have led to emergence of other types of modifications such as cisgenesis, intragenesis, and genome editing as an alternative to trangenesis. In cisgenesis and intragenesis, genetic elements being deployed for crop improvement via transformation belong to same or closely related species, i.e. from sexually compatible gene pool. Genome editing can also be developed using gene knockdown or gene knockout to alter the genetic makeup of a plant without incorporating genes from other plants. Creation of a strain of wheat that is resistant to powdery mildew is an example of the use of this method. Hence, it is expected that these products obtain more acceptance rate by consumers and acquire regulatory approvals more rapidly compared to GM products (6).
GM plants in Iran (Challenges, Practical and Legal Solutions)
Agriculture sector in Iran has been one of important and relatively stable economic sector of Iran with about 14-15% share of GDP despite the unprecedented sanctions over the recent years. Moreover, this sector includes about 20% of employment rate in Iran while only 5% of direct employment of individuals in developing countries allocates to agriculture sector. Hence, agriculture sector is the most important part of Iran's economy (73). On the other hand, along with the increase in life expectancy, the population of Iran is expected to reach 95.3 million at the lowest level and more than 112 million at the highest level in 2031. Therefore, it is essential to develop various crop species with enriched nutrients and high resistance to biotic and abiotic stresses considering the increasing population rate, small arable lands, high employment rate in agriculture, increasing climate change rate, global warming and current droughts (74). In Iran similar oppositions may be seen in NGOs, eco-friendly institutions, and high management levels. opponents of genetic engineering development are trying to prevent from such technology although national law on biosafety forces the government to facilitate GM products release, cultivation, production, consumption, import and export. This means that the conventional method for crops production is going to be continued. Iran has been one of leading countries in Asia not only in transferring genetic engineering knowledge but also in developing biosafety science. Iranian experts participated in first meetings of advisory committee of Cartagena biosafety protocol and Iran has been one of first Asian countries joined this protocol (74). Some biosafety actions have been done in Iran including establishment of the first scientific biosafety association among Asian countries, designing and approving Biosafety Act, establishing National Biosafety Council, forming specialized secretariats in three ministries, founding a governmental organization, enforcing assessment mechanism, issuing environmental release, import and export licenses for GM products. Although there have been numerous infrastructures and achievements in field GM products commercialization and production, Iran cannot be named as a success story (5). Despite the successful production of several GM plants in field experiments by Iranian researchers, there has not been any GM product with release permission expect for GM rice that was formally released in 2004 but its production was banned after government change. Lack of scientific governance and national benefits-based approaches to plant genetic engineering as well as debatable issues in this field can be named as reasons for such significant inconsistency between Iran's capacities and genetic engineering technology achievements (74). More than 99% of crops are produced in Iran using conventional agrochemical methods. There is lower than 1% organic production rate in Iran. Therefore, chemical toxins are essentially used in Iran's farming technology. Despite the dramatic growth of GM plants in the world and excessive use of chemical pesticides by Iranian farmers and legal emphasis on the government's obligation to provide required facilities for GM plants production and consumption (Biosafety Law), this is still a debatable issue due to opposition of some Iranian managers who are not aware of this technology. These managers argue that GM products may have negative impacts on human health and environment. Adeli and Ghareyazi (9) carried out a study and found that 90% of pesticides are used to control crop pests while these pests are controlled by GM plants in the world. Moreover, reduction in these toxins (human health and environment) brings numerous advantages for farmers who use these seeds. Moreover, repetitive use of insecticides makes insects resistant to previous forms. Cultivation of GM rice in Iran is the practical example for controlling Asiatic rice borer. There are several GM rice species to control this pest. There was a global rise in GM products in 1996 and Iran also began to produce Asiatec rice borer-resistant GM rice, (highest amount of toxin is used in rice cultivation to combat it). Such achievement in Iran received a considerable attention from the world as this rice called "Taram Moulaee" is the first GM version of rice released in the world and the first GM product produced in Muslim countries and Middle East which has reached the field. Hundreds of Iranian farmers have produced this rice but it has been banned due to biosafety concerns; therefore, farmers used a higher concentration and new compositions of insecticides- due to resistance of pests and inefficiency of pesticides- to control these pests. Accordingly, these GM seeds could reduce the use of pesticides and environmental contaminations and control natural and useful insects living in rice fields such as ladybirds and fishes. In particular, these seeds could solve the problems of farmers due to contact with such toxins (41). The issue of monitoring the type and amount of pesticides used in agricultural products is an important and sensitive issue that is not done in Iran as it should be. Rice cultivation in north provinces of Iran is one of main source for livelihood of farmers. Numerous pests existing in rice fields have led to sever crop loss in this area (75); hence, it is essential to use pesticides and other chemical toxins in current rice cultivation so that 60% of total use of pesticides in Iran allocates to north provinces that its dominant cropping pattern is rice (76). Reports indicate that pests control is usually done using chemical toxins among farmers in north of Iran. Excessive use of pesticides is harmful for useful living insects and organisms in farms so that a high rate of gastrointestinal cancer caused by chemical toxins used in agriculture might be seen in these provinces. On the other hand, chemical pesticides are using increasingly due to their economic benefits, availability, efficiency and flexibility and there might not be any possible reduction in their use rate (9). In addition, their effectiveness in controlling pests indicates their acceptable function; hence, farmers tend to use chemical pesticides because they are not aware of negative effects in human health and environment (76). Since the Asiatec rice borer cause a 4-6% hurt to the produced rice and 2.9 million tons rice had been produced during 2018 (with 36 Kg consumption per capita), 1000 tons of rice should be imported to keep market equilibrium and support strategic storage of country (77). Accordingly, this rate of GM rice varieties (Bt) can supply strategic rice reserves and prevent from rice import and currency outflow. Iran became one of producers of GM products in 2004. Although GM rice production was stopped in 2006, two GM goats called Shangool and Mangool were born by diligent researchers in Royan Institute under the supervision of Iran’s leader in 2009 and this was a success for researchers of modern biotechnology in agriculture sector (78). Iranian researchers have achieved some successes in the field of GM plants including Bt gene transfer to Iranian Rice (Taaram Moulaee), GM cotton and potato production, and pests-resistant gene transfer to sugar beet and alfalfa. GM alfalfa that generates cry3A gene and resists against alfalfa weevil was created for the first time in 2014 by Tohidfar et al. (79). In case of GM animals, Iranian researchers could access to the technology of coagulation factor protein IX existing in milk of Iranian goat for Hemophilia B patients and another protein in Iranian goat’s milk to generate heart attack medicine (78).
On the other hand, Iran is the importer of oil, forage, and corn that are sold as GM products in the global market. It should be noted that only about 10% of soybean derivatives including vegetable oils, soybean flour, lecithin, and soybean protein is non-GM in market of many countries. Moreover, GM grains exist in 20% of marketed cereals and their derivatives such as starch and cereal flour and more than 90% of these foods are produced supplied out of the labelling EU processes and standards, which are the most binding rules in the world. GM foods are going to be produced in future; for instance, rice, sugar, tea, and sugar beet will be added to the list. However, livestock feed is the main market of GM products (80, 81). On the other hand, Iran highly depends on import of the main global GM products (soy, cotton, corn, and canola) and more 90% of vegetable oil with the highest area under cultivation in the world is imported. According to statistics, about 2300 thousand tons of total 2700 thousand tons of vegetable oil consuming in Iran include imported oil and oilseeds (about 2 million and 150.000 tons of soy, 80.000 tons of canola, and about 55 tons of sesame seed). In 2018, 78% of globally cultivated soybean and 29% canola were genetically modified so that even EU countries have imported the oil produced from GM plants despite the strict rules adopted for GM plants in Europe. Therefore, vegetable oil-importing countries- such as Iran- have to import these foodstuffs. On the other hand, more than 8 million tons of livestock corn has been imported to Iran in 2019. This livestock feed has been exported from 18 countries of the world such as USA that is livestock corn exporter. Accordingly, 2225 tons of livestock corn has been imported to Iran from USA, which equals 500.000 USA dollars. USA is the largest producer of GM products in the world by allocating about 30% of global market share to itself during 2019 (82).
Ministry of Health and Medical Education of Iran declared in 2019 only three transgenic of genetically modified products including oilseeds of canola, soybean and corn as allowed products; there is not any other GM product in Iran’s market and the named products also should have been labelled. It was also reported that total soybeans imported to Iran are genetically modified and Iranian people are consuming GM plants over 15 years. On the other hand, more than 6 million tons of corn, livestock and poultry feed imported to Iran are genetically modified; however, there is also GM cottonseed for oil production in Iran’s market. Hence, the Head of Department of Environment and main member of Biosafety Council (2019) explained that there is not any scientific document on risky effects of GM foods on human health in Iran and world arguing that excessive pressure on resources is riskier than production and consumption of GM foods (83). Now, Iran’s food and drug administration has predicted to main provisions on import of GM products to Iran; first, the GM product should be used in producing country and second, the product should have an international license with a transparent GM and genetic manipulation process. For example, even a corn byproduct imported to Iran that is GM or non-GM should have a valid license in both cases. In the case of GM product, it should present a license to prove the type of GM as well as consumption permission in producing country. A GM product should have an international license obtained from USA FDA or European Food Safety Authority (EFSA) (84). Furthermore, about 50-60% of cotton is imported to Iran while 80% of the lands under the cotton cultivation in world are allocated to GM varieties (31). Moreover, international organizations such as Food and Agriculture Organization, WHO (World Health Organization), EU Commission, French Academy of France, American Medical Association, and American Toxicology Association have examined the safety of foods produced from GM plants and approved their food safety for human health (85, 74). According to the economic and environmental advantages and human health of GM plants, the required licenses for cultivation of these products should be given to farmers based on the biosafety law approved by Islamic Parliament, global food standards and protocols, and tasks assigned to beneficiaries by Biosafety Act to track and test food security of GM products. Furthermore, consumer has right to know which product is genetically modified. GM labelling is a solution used to alleviate concerns about these products. Although there are disagreements on labelling GM foods and microorganisms, it seems that GM food producers and microorganisms as well as biotechnology owners will insists on GM labelling as these labels can represent the high quality of GM foods (25). For instance, high oleic acid-containing GM soybean producers claim that their product contains less saturated fat so is more suitable for consumption. Therefore, the consumer’s trust will be won if there is accessibility to real and neutral information about GM foods and GMOs given to consumers (86).
As it was mentioned, religious attitude of individuals may affect the GM product acceptance. This is an important challenge in using results obtained from genetic engineering studies and production of GM plants or organisms consumed by people. Despite the concerns raised in Islamic principles, there is not any dissuasive rule for genetic alteration in plants and animals. There have been various opinions about consumption of GM products in Islam and there is not any consensus on acceptance of these products. According to research results, in Islam (Shia religion) referring to Islamic experts’ viewpoints, consumption of GM products is unrestricted, provided that these are safe and health produces as natural foods. In addition, bioethics has been considered by Islamic authorities. They believe that GM products and relevant studies and technologies to them are permissible if safety and ethical aspects are respected. Such provisions are based on the proper structures and mechanisms. Seemingly, there are suitable structures such as Department of Environment, Plant protection Organization and other executive organization in Iran that play a vital role in this field. The abovementioned organizations cooperate with national biosafety council and Biotechnology Development Headquarter. It is hoped to achieve a proper mechanism in executive acts due to approval of national biosafety law.
Genetic Modification and associated standards in the world and Iran
Many of international organizations have paid attention to challenging issue related to GM product consumption by proposing some principles, standards and guidelines to increase safety and decrease concerns about these products. Cartagena Protocol on Biosafety can be named as the most important international binding standard and now 158 countries (such as Iran) are parties to the protocol (78). Cartagena Protocol on Biosafety associated with biological diversity convention is an international convention ruling over the behavior of GMOs resulting from modern biotechnology from one country to another one. This convention was accepted as an agreement attached to Biological Diversity Convention. The protocol defines a “living modified organism” as any living organism that possesses a novel combination of genetic material obtained using modern biotechnology, and “living organism” means any biological entity capable of transferring or replicating genetic material including sterile organisms, viruses, and bacteria. The objective of this protocol is to protect biological diversity against potential risks of living modified organisms resulting from modern biotechnology. This protocol creates an informed agreement to ensure countries with required information about entrance of such organisms to their territories before making informed decisions. Briefly, protocol covers options including required formal declaration on GMOs export, specific license before primary actions of transferring GMOs to other countries, essential information about public and international parties in case of a sudden reproduction, rule on exported processed food, nutrition or GMOs and identification of GMOs for export. According to Cartagena Protocol on biosafety, all of genetically modified organisms should be tested in terms of laboratory analysis, greenhouse and field assessments for product specifications, considered use, environmental impacts, and possible risks for human and animal health to make decision on their application, import and export. This decision is expressed in form of risk management including preventive measures. Countries should follow these regulations, approve safe use of GMOs, adopt required measures through control process and transportation, and enact some rules on GMOs’ labelling and packing. This protocol has predicted some limits on regulations of free trade of GMOs through signing agreements with world trade organization (74). Primary mechanisms of Cartagena Protocol on Biosafety can be identified as information exchange, pre-announcement agreement, simplified process, risk assessment, documentations, decision-making, and risk management. Biosafety measures are done based on the possible interaction between GMOs and environment to preserve biological diversity in Cartagena Protocol on Biosafety. To ensure biosafety, pre-announced agreement is signed between exporting and importing countries. All of countries are informed about converting food waste into animal feed and processed foods. Some statements and documentation should be inserted on the label or next to the lable of these products Which clearly indicate the following sentence "may contain genetically modified organisms" and should be noted that should not be left in the environment. Applicable regulations on GMOs are informed to countries and they can share this information with other countries. Domestic use of GMOs is not subjected to a pre-announced agreement and each country sets some standards based on their own conditions and informs the exchange method. The sign of “Genetically Modified” should be inserted on the label of these products besides information about how to use, keep, and transport cautiously. According to the existing laws, the safety assessment of such products is based on proving their comprehensive equivalence with unmodified types, as well as conducting specific tests in the field of sensitivity to proteins, toxicity of metabolites and food. Following Iran's accession to the Cartagena Biosafety Protocol, the process of drafting the Biosafety Law of the Islamic Republic of Iran began, and finally in 2009 this law was approved by the Islamic Parliament. Not only has this law allowed all of affairs associated with GMOs but also obliged the government to facilitate release, cultivation, production, consumption, export and import of Gm products regarding local technology based on the legal regulations (87, 88). Hence, an organization called “Biosafety Council” has been established in Iran by forming a secretariat in Department of Environment responsible for producing and supplying GM products (5).