About food safety.
OECD) 1993 put forward the principle of substantial equality in food safety evaluation. If the products produced by transgenic plants are basically equivalent to traditional products, they can be considered safe. Otherwise, strict safety evaluation should be carried out. In the evaluation of substantive equivalence, the following main aspects should generally be considered: 1, toxic substances: it is necessary to ensure that the transferred foreign gene or gene product is harmless to people and animals. 2. Allergens: There are many allergens under natural conditions. If the gene controlling allergen formation is transferred to the target plant in genetic engineering, it will have adverse effects on allergens.
The safety of drugs produced by transgenic animals is not a big problem, and the safety can be judged according to whether its structure is consistent with that of natural protein. However, in the production process, how to deal with GAP, GLP, GMP and how to prevent the genetic material of transgenic animals from entering drugs should be paid attention to. In addition, once animals as animal pharmaceutical factories stop producing drugs, the subsequent treatment of animals should also be carefully considered.
At present, the major developed countries and some developing countries in the world have formulated their own regulations on the management of genetically modified organisms (including plants), which are responsible for evaluating and monitoring their safety. In the United States, the Animal and Plant Quarantine Bureau (APHIS) of the Ministry of Agriculture, the Environmental Protection Agency (EPA) and the Federal Food and Drug Administration (FDA) are responsible for all aspects of safety assessment and approval of environmental and food associations.
The safety management of bio-genetic engineering in China is relatively backward. So far, there are only two safety management regulations for genetic engineering:
1993 12 Safety Management Measures for Genetic Engineering issued by the State Science and Technology Commission.
Implementation Measures for Safety Management of Agricultural Bioengineering issued by the Ministry of Agriculture in July, 1996.
In addition, the management regulations of departments and industries are not strong enough to meet the work requirements:
It is understood that there are 92 kinds of genetically engineered receptor organisms being studied in Chinese mainland, but only 22 kinds have been declared, and there are more than 80 units engaged in such research, and only 19 companies have declared for safety evaluation. But the most worrying thing is that there is no completely reasonable method for the safety evaluation of genetic engineering.
Beijing Biotechnology and New Medicine Industry Promotion Center held the 7th Frontier Seminar of Life Sciences-Genetic Engineering and Biosafety, and invited some transgenic experts from Beijing to talk about it, aiming at making suggestions for the safety management of genetically modified organisms in China.
The topic of public concern-the safety of genetically modified organisms
The safety of genetically modified organisms is a topic of general concern from national leaders to ordinary people, and it is also a new concept that frequently appears in the media in recent years. Generally speaking, the safety of genetically modified organisms is not just a technical issue. In recent years, the international debate on genetically modified organisms has expanded to political, economic, trade, social and ethical levels, and the hot spot and focus of the debate is the environmental safety and food safety caused by agricultural genetically modified organisms. With the improvement of people's living standards in China, the public has higher and higher requirements for the quality and safety of agricultural products. Is genetically modified food safe? Strictly speaking, no food is absolutely safe. At present, the principle of "substantial equivalence" is widely adopted in the world, that is, the relative safety of genetically modified foods compared with non-genetically modified foods is taken as the evaluation basis, as long as genetically modified foods are "substantially equivalent" to traditional foods, they are safe. At present, there is still debate on the safety of genetically modified food in the world, but there is no clear scientific evidence that genetically modified food is harmful to human body. Although it has not been found that genetically modified food is harmful to human body, many government departments and scientists are concerned about the "possible potential dangers" of genetically modified food. People are worried that genetically modified organisms and their products may have some toxic effects and allergic reactions on the human body after entering the market as food, and the changes in their nutritional components and the changes in the processing of genetically modified components may have some negative effects on the human body. This is just a "possible potential danger", and it has not been proved that these dangers really exist. China implements strict management of agricultural genetically modified organisms, and agricultural genetically modified organisms have to go through a series of safety evaluation and testing before entering the market. Before agricultural genetically modified organisms are put into production and application in China, they should go through safety tests in intermediate test, environmental release and productive test. Those who pass safety evaluation can obtain safety certificates. Before applying for importing agricultural genetically modified organisms used as processing raw materials to enter the market, the technical testing institutions recognized by the Ministry of Agriculture have to go through three stages: applying for safety certificates, applying for import labels and applying for domestic labels. At present, genetically modified foods approved by government departments have not found any side effects on human health. The development trend of genetically modified organisms Although the international debate on genetically modified organisms and their safety continues, the global research on genetically modified organisms has never given up. The planting area of transgenic crops increased from10.7 million hectares in 1996 to 52.6 million hectares in 2006, an increase of more than 30 times in six years. By 2000, nearly 50 countries had cultivated more than 200 kinds of genetically modified crops, including 149 kinds of genetically modified crops approved for marketing in various countries, and 42 kinds in the United States alone. More than 4,000 kinds of genetically modified foods and food ingredients were produced and processed by using genetically modified crops. The market sales of genetically modified crops and their products increased from $75 million in 654.38+0.995 to $3 billion in 2000. The development trend of transgenic crops is irreversible. In recent years, the government of China has continuously increased its support for biotechnology research projects. At present, there are more than 130 kinds of genetically modified organisms being studied in China, involving more than 100 kinds of genes. Among them, in the field of cotton research, 45 excellent varieties were released to the environment, and 13 insect-resistant cotton passed the national examination and approval, and was popularized in 12 provinces across the country. In 2006, the planting area reached 600,000 hectares, 5438+0. From 1997 to 200 1, after safety evaluation, the Ministry of Agriculture approved the release of rice, corn, cotton, soybean, rape, potato, poplar and other 10 transgenic plants into the field environment, and approved the commercialization of transgenic cotton, Petunia and other plants and veterinary microbial genetic engineering vaccines. In recent years, China has also implemented major high-tech industrialization projects, such as "industrialization of genetically modified cotton seeds" and "industrialization of genetically engineered vaccines", and started to bring benefits into play in production. The government is responsible for the safety of agricultural genetically modified organisms, which not only bring great benefits to agricultural production, human life and social progress, but also pose potential risks to the ecological environment and human health. Therefore, scientifically speaking, the safety of genetically modified organisms in agriculture needs long-term follow-up research. As a big agricultural country, a country with great biodiversity and the origin of major crops such as soybeans and rice, China attaches great importance to biosafety while developing biotechnology. The policy of "active research, cautious promotion, strengthened management and steady progress" is adopted for agricultural genetically modified organisms. For important varieties originating in China, such as soybeans, rice, bulk grain and oil crops, we should strengthen management, promote them cautiously, and steadily promote industrialization. Therefore, according to the practices of relevant international organizations and most countries, the Government of China has formulated and promulgated the Regulations on the Safety of Genetically Modified Organisms, so as to strengthen the safety management of genetically modified organisms and standardize the healthy development of related industries. On May 23rd, 20001year, the China Municipal Government promulgated the Regulations on the Safety Management of Agricultural Genetically Modified Organisms (hereinafter referred to as the Regulations). The Regulations extend the safety management of agricultural genetically modified organisms from research and testing to production, processing, management and import and export on the basis of the Implementation Measures for Safety Management of Agricultural Biogenetic Engineering promulgated by the former Ministry of Agriculture. The regulations stipulate the implementation of safety evaluation system, label management system, production and business license system and import safety approval system for agricultural genetically modified organisms, which indicates that China has begun to implement comprehensive management of research, testing, production, processing, management and import and export activities of agricultural genetically modified organisms. On June 5, 2002, 65438, the Ministry of Agriculture issued three supporting management measures, namely, Management Measures for Safety Evaluation of Agricultural Genetically Modified Organisms, Management Measures for Import Safety of Agricultural Genetically Modified Organisms and Management Measures for Labeling of Agricultural Genetically Modified Organisms, which came into effect on March 20. From the perspective of maintaining global biodiversity, protecting ecological environment and human health, the Regulations and its supporting regulations embody the principles of science, transparency and justice, are applicable to agricultural genetically modified products from any country, including China, give full consideration to MFN treatment and national treatment for foreign enterprises, conform to international practices, and are responsible to the people. Since the implementation of the three supporting management measures of the Regulations on March 20, 2002, the Ministry of Agriculture has received a total of nine applications 19 for safety certificates of agricultural genetically modified organisms imported as processing raw materials by five overseas companies, including Monsanto, DuPont, Dow Yinong, Bayer of Germany and Syngenta of Switzerland, involving four crops of genetically modified soybeans, corn, rape and cotton, and three crops of herbicide resistance, insect resistance and male sterility. As an important part of the safety of genetically modified organisms, food safety is as important and indispensable as environmental safety. Therefore, the Ministry of Agriculture started the food safety inspection in the second half of 2002, and organized the Institute of Nutrition and Food Safety of China Center for Disease Control and Prevention, Tianjin Center for Disease Control and other units to formulate the Food Safety Inspection Standard for Genetically Modified Plants and Their Products (Draft for Comment), and studied the feedback from five overseas companies. According to the needs of safety evaluation and experts' opinions, the Ministry of Agriculture has determined two verification tests: the analysis of anti-nutritional components of agricultural genetically modified organisms imported as processing raw materials and the feeding of rats for 90 days. According to the "Regulations" and supporting management measures and procedures, the Ministry of Agriculture has arranged environmental safety testing and food safety testing. Environmental safety inspection includes three indicators: survival competition, impact on biodiversity and gene drift, which are undertaken by Institute of Plant Protection of Chinese Academy of Agricultural Sciences, Shandong Academy of Agricultural Sciences, Nanjing Agricultural University, Jilin Academy of Agricultural Sciences, Petroleum Institute of China Academy of Agricultural Sciences and Huazhong Agricultural University respectively. Food safety testing includes two indicators: 90-day feeding of rats and analysis of anti-nutritional components, which are undertaken by China Center for Disease Control and Prevention, Tianjin Center for Disease Control and Prevention and China Agricultural University. In April and May of 2002, China's soybean imports were basically at a standstill, and the annual soybean imports dropped sharply. According to the statistics of the General Administration of Customs, in 2002, China imported 1 1.32 million tons of soybeans, a decrease of 2.62 million tons or 18.8% compared with 2006. What is the reason? Relevant comrades of the Ministry of Agriculture analyzed that the implementation of the Regulations on the Safety Management of Agricultural Genetically Modified Organisms has curbed the surge in soybean imports to some extent. It is reported that the total amount of soybeans imported from China has been rising in the past few years. The implementation of the Regulations on the Safety Management of Agricultural Genetically Modified Soybeans in 2002 has effectively and orderly managed the entry of foreign genetically modified soybeans into China. Due to the decrease in soybean imports, domestic soybean prices rose, stocks decreased, and soybean prices rose at harvest time. The price of main producing areas increased by 0.35 yuan/kg compared with the same period of last year, and the yield per mu reached about 1 10 yuan. This not only greatly improved the enthusiasm of farmers to plant soybeans, but also promoted the implementation of the soybean development and revitalization plan of the Ministry of Agriculture. In order to ensure the effective implementation of laws and regulations, the Ministry of Agriculture has established a leading group for the safety management of agricultural genetically modified organisms and an office for the safety management of agricultural genetically modified organisms. An inter-ministerial joint meeting system for the safety management of agricultural genetically modified organisms has been established, which consists of the heads of the Ministry of Agriculture, the Ministry of Foreign Trade and Economic Cooperation, the Ministry of Health, the Ministry of Science and Technology, the General Administration of Quality Supervision, Inspection and Quarantine and the State Environmental Protection Administration. Inter-ministerial liaison meeting, responsible for studying and coordinating major issues in the safety management of agricultural genetically modified organisms; The office is responsible for the comprehensive coordination and management of the safety of agricultural genetically modified organisms. Safety evaluation of genetically modified organisms is the core of implementing safety management. To this end, China has established the National Agricultural Genetically Modified Organisms Safety Committee, which is composed of 58 experts from various departments and scientific research and teaching units engaged in biotechnology and biosafety research and management, and is responsible for the safety evaluation of agricultural genetically modified organisms. In order to meet the needs of China's accession to the WTO and make the application and approval of safety evaluation, import and labeling of agricultural genetically modified organisms transparent and fair, the Ministry of Agriculture has also formulated three normative documents, namely, Management Procedures for Safety Evaluation of Agricultural Genetically Modified Organisms, Management Procedures for Import Safety and Approval Procedures for Labeling, which clearly stipulate the links and time requirements for application, acceptance and approval, and released them to the public. At present, the Ministry of Agriculture has completed the formulation of technical specifications for safety evaluation and detection of agricultural genetically modified organisms, is actively strengthening the construction of safety research and technical support system for agricultural genetically modified organisms, and organizes the identification of technical detection institutions for agricultural genetically modified organisms. Related links According to the instructions of the leaders of the State Council and the legislative requirements of the Legislative Affairs Office of the State Council, the Ministry of Agriculture took the lead in drafting the Regulations on the Safety Management of Agricultural Genetically Modified Organisms. On May 23rd, 20001year, Decree No.304 of the State Council was promulgated and implemented. The Regulations stipulate five agricultural genetically modified organisms management systems that should be followed in the research, testing, production, processing, management and import and export activities of agricultural genetically modified organisms in People's Republic of China (PRC). Specific provisions are as follows: (1) safety evaluation system. The national safety evaluation of agricultural genetically modified organisms is based on three categories: plants, animals and microorganisms, based on science and based on the principle of case review, and is managed by stages. (2) Production license system. The production of genetically modified plant seeds, livestock and poultry and aquatic fingerlings shall obtain the production license for seeds, livestock and aquatic fingerlings issued by the Ministry of Agriculture. To apply for the production license of genetically modified plant seeds, breeding livestock and poultry, and aquatic fingerlings, you must first obtain the safety certificate of agricultural genetically modified organisms and meet the conditions stipulated by relevant laws and administrative regulations. (3) Business license system. Units and individuals engaged in the business of genetically modified plant seeds, breeding livestock and poultry and aquatic fingerlings shall obtain the business license for seeds, breeding livestock and aquatic fingerlings issued by the Ministry of Agriculture. To apply for a business license, in addition to meeting the conditions stipulated in relevant laws and administrative regulations, it shall also meet other conditions stipulated in the Regulations. (4) Identification system. The sale of agricultural genetically modified organisms listed in the Catalogue of Agricultural Genetically Modified Organisms in People's Republic of China (PRC) shall be clearly marked. Production and sub-packaging units and individuals are responsible for labeling, and those that are not labeled may not be sold. (5) Import safety management system. For imported agricultural genetically modified organisms, safety management shall be implemented according to three purposes: research and experiment, and production and processing of raw materials. The importing entity or overseas company shall apply to the port entry-exit inspection and quarantine institution for inspection with the safety certificate of agricultural genetically modified organisms issued by the Ministry of Agriculture and relevant approval documents, and only after passing the quarantine can it apply to the customs for handling relevant formalities.
From "Xinglian Corn Incident" in the United States, "Super Weeds of Transgenic Rape" in Canada to "Corn Genetic Pollution Incident" in Mexico, more and more facts show that the threat of "genetic pollution" cannot be ignored. Experts worry that what happened to Mexican "corn mom" may happen to China soybeans. Some foreign companies may take advantage of China's imperfect legislation and inconsistent management to regard China as a "testing ground for genetically modified organisms".
Genetically modified products have entered people's lives in China, and consumers' right to know and health has been paid more and more attention. Following the implementation of the Measures for the Administration of Labeling of Agricultural Genetically Modified Organisms by the Ministry of Agriculture on March 20th, the Measures for the Hygienic Administration of Genetically Modified Foods by the Ministry of Health will also take effect on July 1 day.
At the same time, experts warned that the impact of genetically modified organisms on the environment needs more attention from all walks of life. From "Xinglian Corn Incident" in the United States, "Super Weeds of Transgenic Rape" in Canada to "Corn Genetic Pollution Incident" in Mexico, more and more facts show that the threat of "genetic pollution" cannot be ignored.
"The Holy Mother Corn has been defiled"
Corn is the food and clothing parents of Mexicans, and the local natives affectionately call it "corn mother". But now, they are surprised to find that "the sanctity of Mother Corn has been defiled".
On June 3, 2002, at the symposium on genetically modified organisms and the environment held in Beijing, Maria, an independent legal adviser from the Law Department of the National University of Mexico. Ms. Colin told the story that made her sigh.
Mexico is the origin of corn and the concentration of variety diversity. 5,000 years ago, corn was first planted here as human food. From 65438 to 0998, the Mexican government banned the cultivation of genetically modified corn in order to protect its genetic resources. However, due to the North American Free Trade Agreement and other factors, Mexico imports a large number of genetically modified corn from the United States as food or feed every year.
2001165438+1On 29 October, two researchers from the Department of Environment of the University of California, Berkeley published a paper in the British magazine Nature, saying that the wild corn in the remote Oaxaca mountain area of Mexico was contaminated by DNA fragments of genetically modified corn. Because the packaging of genetically modified corn imported from the United States has no genetically modified logo, the researchers speculate that some unsuspecting farmers planted it in the field.
After the paper was published, it was like a stone stirring up a thousand waves. Greenpeace and other forces opposed to genetically modified crops immediately called on Mexico to ban the import of genetically modified corn from the United States, while many scientists questioned the reliability of this research.
On April 4, 2002, Nature published two questioning articles and the author's reply, and admitted that the existing evidence was "insufficient to prove the original article".
Mexicans are convinced that their corn is polluted. From June 5438 to/kloc-0 to October 23, 2002, the research results presented by the Mexican environmental department at an academic seminar said that the pollution rate of wild corn in Oaxaca mountain area was as high as 35%. On April 23, Ezkula, director of the National Institute of Ecology of Mexico, revealed that the Mexican government is still investigating the genetic pollution of corn, and relevant research results will be published in academic journals soon, and stressed that "if measures are not taken as soon as possible, the precious biodiversity resources of Mexican corn will be destroyed".
Lessons from Soybean in China
Some experts worry that what happened to Mexican "corn mother" may happen to China soybeans.
There are many similarities between soybeans in China and corn in Mexico: Mexico is the origin and variety diversity of corn, while China is the origin and variety diversity of soybeans, with more than 6,000 wild soybean varieties, accounting for more than 90% of the world; About 14 of Mexican corn was imported from the United States, while China imported nearly140,000 tons of soybeans last year, which was the same as domestic soybeans, most of which were genetically modified soybeans.
China has not yet approved the commercial production of genetically modified soybeans. However, from transportation to processing, some genetically modified soybeans may be left in the wild or planted privately by farmers.
"For example, there are many migrant workers in the processing factory. If they like to import soybeans, they will secretly take some home for planting, "said Chang Ruzhen, chairman of the Soybean Professional Committee of China Crop Society and a researcher at the Institute of Quality Resources of China Academy of Agricultural Sciences. "This situation is very dangerous."
Xue Dayuan, chief scientist of China of the United Nations Convention on Biological Diversity and researcher of Nanjing Institute of Environmental Sciences of the State Environmental Protection Administration, also pointed out that if genetically modified soybeans are planted, the genetic diversity of soybeans in China may be lost once wild soybeans are polluted.
There are also differences between soybeans in China and corn in Mexico: corn is a cross-pollinated plant, while soybeans are self-pollinated. This means that the possibility of soybean genetic contamination in China is much lower.
Chang Ruzhen said, but this does not mean that soybeans in China will not be genetically contaminated. He is conducting an experiment of intercropping genetically modified soybeans with wild soybeans to study the possibility of genetic pollution.
Super weeds in farmland in Canada
In fact, in nature, it is very common for genes of one species to drift to another species through pollination, or to achieve hybridization. However, because the foreign gene transferred into transgenic crops usually has some special characteristics, such as insecticide resistance and herbicide resistance, if this gene drifts to another species, it may bring obvious environmental impact.
In February 2002, a report submitted by the British government's environmental consultant "Nature UK" specifically described the threat of super weeds in genetically modified rape in Canada.
In today's grassland farmland in Canada, it is very common to have transgenic rape with more than three herbicides at the same time. Their rapeseed has fallen into the farmland and will germinate next year. If a field is not planted with the same species, it will become an unwelcome super weed, and farmers have to turn to old herbicides that are more harmful to the environment.
At the same time, super weeds resistant to more than three herbicides are obtained by cross-pollination between transgenic rape plants resistant to different herbicides. The emergence of this super weed is only two years from the first planting of genetically modified rape in Canada. In addition, in Canada, the genes of genetically modified crops have drifted to farmland where organic food is produced by pollination. One of the standards of so-called organic food is that it does not contain genetically modified organisms. Therefore, in the eyes of farmers engaged in organic agriculture, these genetically modified crops are super weeds that affect the reputation of their products and are genetic pollution to their farmland.
Therefore, in early 2002, the Organic Food Committee of Saskatchewan, Canada, sued Monsanto and Avantis, demanding that these two genetically modified technology companies from the United States compensate for their losses.
Uninvited guests in the human food chain
The most worrying genetic pollution is that a genetically modified ingredient that has not been approved for food production has entered the human food chain under the condition of poor management and control.
The "Star Alliance Corn Incident" in the United States is the best example.
A kind of "Xinglian" transgenic corn produced by Avandis Company, because it may have allergic reaction to human body, the US Environmental Protection Agency only approved it for animal feed and prohibited it from being used in food production. However, in September 2000 and subsequent tests, it was found that many corn foods actually contained Xinglian.
Although the planting area of Xinglian accounted for less than 65,438+0% of the total planting area of corn in the United States in that year, about 65,438+00% of the corn harvested in the United States was polluted by Xinglian because it was mixed with other corn varieties during processing and storage. The U.S. government also pointed out that Avandis did not comply with the regulation of keeping a certain space as a buffer zone between the land where Starlink corn was planted and the land where ordinary corn was planted to prevent cross-pollination.
In March 2002, Avandis paid $9 million for the class action lawsuit of consumers. In addition, Avandis and related insurance companies paid about US$ 654.38 billion, and recovered more than 300 kinds of foods that may contain Star Alliance in the market.
In June, 2002, a commentary published in the British journal Nature Biotechnology said that fortunately, the food mixed with Star Alliance has not been found to affect consumers' health, but what if a genetically modified variety used for biopharmaceuticals is mixed into the human food chain?
Solutions to genetic pollution
Since 1980s, various transgenic crops have been tested in the field. Today, there are about 790 million mu of genetically modified crops in the world, equivalent to the area of Spain.
It should be said that the safety of genetically modified crops, which have been commercialized at present, has been seriously considered in the examination and approval. However, Zhu Xinquan, chairman of China Agricultural Biotechnology Society, said that at present, it is generally believed that agricultural biotechnology has great potential at home and abroad, and a lot of research work has been carried out, but there is relatively little research on the safety of genetically modified organisms released in the natural environment, and there is still a lack of convincing scientific evidence for the safety evaluation of genetically modified organisms released in the environment.
It is precisely because of the lack of safety research that there are not many effective measures that human beings can take in the face of the threat of genetic pollution.
For example, in order to reduce the risk of genetic pollution, scientists put forward the idea of establishing "shelters", that is, planting some non-GM crops as isolation zones between GM crops. But this idea is usually unpopular because many farmers think it is too much trouble.
Under such circumstances, some people even think that the only solution is to completely ban the cultivation of genetically modified crops; But many scientists think that new solutions can be found.
For example, several researchers from the University of Saskatchewan in Canada wrote in the journal Nature Biotechnology in June 2002 that a promising solution is to develop sterile transgenic crops to prevent gene drift. In this way, farmers can only buy new seeds from transgenic technology companies once a year, and the cost of transgenic crops is expected to increase by about 10%. However, transgenic technology companies that lost more than 10% of their intellectual property rights expressed their willingness to bear such costs.
China will become a testing ground?
For human beings, the so-called genetic pollution is still vague in understanding.
On March 1 day, 2002, the American magazine Science said that many scientists believed that whether the DNA of genetically modified corn penetrated into wild corn, even if it really posed a threat to wild corn, needed more scientific evidence.
"It is not clear what kind of harm genetically modified crops will cause to the environment, and the situation of different crops is different, but the impact is definitely there," Chang Ruzhen said. "The problem now is that many people in China, including some researchers, have not realized the importance of biosafety."
In 200 1 year, Chang Ruzhen was surprised to find that the researcher introduced genetically modified soybeans from Argentina and distributed them to other units for trial planting without the approval of the competent authorities.
A document of the State Environmental Protection Administration also warned that some foreign companies may use China's imperfect legislation and inconsistent management to use China as a "testing ground for genetically modified organisms".
Genetically modified crops contain foreign genes transferred from unrelated species. For example, the genetically modified soybean of Monsanto in the United States contains the herbicide-resistant gene of Petunia. These foreign genes may spread to other species through pollination, which biologists call "gene flow". Environmentalists like to use the concept of "gene pollution": foreign genes spread to other species, leading to the mixing or pollution of natural gene pools.