Risk Assessment and Risk Management*

WANG Changyong
Nanjing Institute of Environmental Science, State Environmental Protection Administration

YU Zhidi and WANG Dehui
Biosafety Office, State Environmental Protection Administration

The Research and Development of GMOs and Their Environmental Release
Status Quo of Biosafety Work in China
Develop Capacity in RARM of GMOS
Capability Building in RAMS of GMOs
Regional Cooperation in RAMS of GMOS and Relevant Activity Recommendations
Main References

* The opinions in the paper do not necessarily reflect those of the organizations with which authors worked.

Abstract: This paper first gave an overview of the work in the development of GMOs, the environmental release, the legislation on biosafety, the technical guidelines for the risk assessment and risk management (RARM) of GMOs, the basic research on the RARM of GMOs, the biosafety information exchange, the publicity and training on biosafety, and the main national departments involved with the management of biotechnology in China, then made a description and analysis of the capacity development and building in RARM and finally make some recommendations on regional cooperation in RARM of GMOs in Asia.


The government of China, as a big one among the developing countries, has been paid more attention to the conservation and sustainable use of biodiversity as well as the safety of genetically modified organisms (GMOs). In the past 10 years, a lot of important activities were done for the implementation of The Convention on Biological Diversity (CBD). For example, "China Biodiverstiy Conservation Action Plan" was developed and issued; Three books, entitled "The Report of Country Study on Biodiversty", "Information Network and Data Management on Biodiversity" and "National Biosafety Framework of China", were published. The First and Second National Report for the implementation of CBD were submitted to United Nations Environment Programme (UNEP). In order to effectively coordinate the activities related to the implementation of CBD, which will be done by the departments under the State Council, a "National Coordinating Group for the implementation of CBD" was formed in 1993. The Group   is currently composed of 20 departments, including the Ministry of Education (MOE), the Ministry of Construction (MOC), the Ministry of Science and Technology (MOST), the Ministry of Agriculture (MOA), State Forestry Administration (SFA), State Oceanic Administration (SOA), Chinese Science Academy (CSA) and so on. State Environmental Protection Administration (SEPA) heads the Group.  

  Biosafety is one of important contents in CBD. In the process of the environmental release and marketing of GMOs which will have a threat to biodiversity, environment and human health, Much of potential risk associated with GMOs, for instance, their invasiveness in environment, their effect on non-target organisms and gene pollution have attracted high concerns and attention all over the world. UNEP organized and held many workshops and meeting for the drafting, discussion and negotiation on an International Protocol on Biosafety which was adopted at the extraordinary meeting of the fifth meeting of the Conference of Parties to CBD at January 29, 2000. Chinese government signed the Protocol and is now preparing relevant procedures for its final ratification in this country.

 This paper will first give an overview of the status quo of work in risk assessment and risk management (RARM) of GMOs, then make a description and analysis of the capacity development and building in RARM and finally make some recommendations on regional cooperation in RARM in Asia.

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 Since biotechnology was placed into the list of “Programme 863, a hi-tech one”, set up by Chinese government in 1986, over one hundred of institutions have engaged in the research and development (R&D) of biotechnology, involving with the departments of education, science and technology, agriculture, forestry, ocean, medicine, hygiene, environment and so on. At present, Chinese scientists have use genetic engineering technology to produce many GMOs with traits of herbicide-, insect- virus- resistance or nutrient improvement.

According to the 1996 statistics, 47 genetically modified plants (GMP) have been transformed by use of genetic engineering technology. Among them, there are 7 grain crops, 5 economic crops, 10 vegetables, 11 fruit trees, 3 forest trees, 2 fodder crops, 5 medicine and ornamental plants (Table 1), with an involvement of 103 genes (excluding marker genes) (Table 2). Some of them have still been studied in laboratory and others have proceeded to the stages of immediate trial, environment release and even commercialization. According to data from MOA, 55 applications for the immediate trial, environment release and commercialization were received in 1997, 68 ones in 1998, and 72 ones in 1999 (Table 3). Up to 2000, 6 crop varieties, for example transgenic cotton, tomato and sweet pepper etc., have been planted at commercial scale. It is reported that the area of commercially planted transgenic crops in China reached 10,000 hectare in 1998, over 140,000 hectare in 1999 and 340,000 hectare in 2000 for transgenic cotton only

Table 1  The plants used in genetic transformatiom



Number of Species


Grain crops

Economic & oil crops


Fruits & vegetables









Rice, wheat, corn, potato, sorghum, millets, sweet potato

Cotton, tobacco, sugar cane, sugar beet, soybean, oil rape, peanut etc.

Tomato, cabbage, carrot, pepper, sweet peeper, Chinese cabbage, cauliflower, broccoli etc.

Polar, alfalfa etc.

Table 2  Genes that are used in plant genetic transformatiom

Modified traits

Foreign Gene of interest




Insect- resistance



TMV-cp, TMV-rep, CMV-cp, PVX-cp, PVY-cp,RSV-cp, BYDV-cp, BYDY-rep, MDMV-cp, TuMV-cp

Cecropin B, Shiva A, Lysozyme gene, Xa21, Chitinase, Glucanase

Truncated  cryIA(b), synthetic CryIA(b), CpTI, Pin2, GNA, AHPI

Bar, tfd A, psb A

Pro A, BADH, mtl D, gut D, barnase, anti-sense ACC, anti-sense PG

Table 3  GMOs applied for intermediate experiment, environment release and

Commercial production









Total Applications




Applications for GMP

Applications for GM microorganisms (GMM) used for plants 







Applications for GMM used for domestic animals




Applications for GM aquatic organisms




Applications for intermediate experiment (IE) which were approved




Applications for environment release (ER) which were approved

Applications for commercial production (CP) which were approved

Applications for the IE, ER, CP which were not approved in that time










In the R&D of genetically modified animals, the transgenic mouse, rabbit, goat, chicken, cattle, pig and fishes have been developing. These transgenic animals are currently in the contained conditions without any species which has been released into the environment in consideration of environmental safety.

GMM include three groups: the nitrogen fixation bacteria, the microorganisms used for killing pest insects or disease protection, and the microorganisms used in the production of animal food additives or animal vaccines. The genetically modifies nitrogen fixation bacteria and rhizobia have been approved for field resease.

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  In recent years, Chinese government has token administrative, legal and technical measures to regulate and monitor the GMOs which are intended to be released into the environment, commercially planted and put into marketplace. In the meantime, The activities in the capability-building, the scientific research and the information communication on the biosafety management have also been launched.

 3.1 Strengthen legislative work on biosafety

To legally strengthen the management of GMOs, the relevant departments under the State Council have formulated and issued in the past years several departmental regulations on biosafety. These administrative regulations include “Safety Administration Regulation on Genetic Engineering”, issued by former State Science and Technology Commission in December, 1993; “Safety Administration Implementation Regulation on Agricultural Biological Genetic Engineering”, issued by the MOA in July, 1996; “Safety Administration Implementation Regulation on Tobacco genetic Engineering”, issued by State Tobacco Monopolistic Administration in March, 1998; “Regulation on Approval of New Biological Products”, issued by the State Drug Administration in April, 1999. These regulations played positive roles in the management of the research, development, environmental release and commercialization of GMOs.

However, in view of the fact that most of existing GMOs and their products mainly centralized on agricultural species and drugs, the State Council of China first issued the “Safety Administration Regulation on Agricultural GMOs” in May 23, 2001. The regulation established four basic management systems aimed at the safety management of agricultural GMOs:

(1)    A joint meeting system on the safety management of agricultural GMOs was established under State Council. The meeting is composed of responsible officials from MOA, MOST, SEPA, Ministry of Public Health (MOPH), State Inspection and Quarantine Administration (SIQA), and relevant departments. The important issues on agricultural GMOs will be discussed and coordinated on the meeting.

 (2)    The management of agricultural GMOs was implemented in line with their safety level. That is that agricultural GMOs will be divided into four safety levels from level I (the most safety), II, III, to IV (the lowest safety), according to their potential risk to the human, animals, plants and microorganisms.

 (3)    Safety assessment system of agricultural GMOs was established. The activities concerning the GMOs which are intended to conduct intermediate trial, environmental release and commercialization need to make safety assessment and to obtain the approval from the competent department.

(4)    Label system of agricultural GMOs was established. The species which are written into the “The List of Agricultural GMOs” need to be labeled by manufacturers and distributors before they are placed into marketplace.

 In addition, The Regulation also included the provisions related to the research and experiment, the production and processing, the operation, the import and export, the supervision and inspection of agricultural GMOs.

  3.2 Develop technical guidelines for the RARM of transgenic organisms

A technical guideline for RARM of release of transgenic organisms into environment was drafted to provide a technical guidance to RARM of general GMOs. In addition, MOA issued three departmental rules: “Management Rule on the Safety Assessment of Agricultural GMOs”, “Management Rule on the Safety of the Import of Agricultural GMOs” and “Management Rule on the Labeling of Agricultural GMOs”. The rules fully described the procedures and methods of the RARM of agricultural GMOs, the test of imported GM products, and the label method of Agricultural GMOs.

 3.3 Pay more attention to basic research work on risk assessment of GMOs

Biosafety is new environmental issues. At present time, the scientific data available to risk assessment of GMOs is very limited. Besides, The environmental and health risk posed by GMOs is long-term, potential and large-range. Hence, It is necessary to conduct basic research into GMOs. In the past 3 years, MOST, SEPA, MOA, CSA and National Science Foundation of China have funded relevant scientific institutes and universities to conduct a research on the risk assessment of GMOs. These research themes mainly focused on comparative ecology of transgenic and non-transgenic crops, the effect of insect-resistance transgenic crops on the microorganisms and invertebrates in soil and insects as well as the test of gene flow.

In the next five years (from 1990-1995), relevant departments under the State Council have set up many projects and provide financial assistance for the research activities of following three directions:

The first direction is about the assessment of environmental risk associated with GMOs, including the ecological fitness and invasiveness of GMOs in natural ecosystem, the impact of the products expressed by foreign transgene on target and non-target organisms, the mechanisms and the consequences of the transfer of gene from GMOs to other organisms, the indicators, methodology, model test system and experiment protocols for the risk assessment.

 The second direction is about the monitoring of environmental impact of GMOs, including the environmental behavior and ecological effect of products of transgene, the adverse influence of GMOs by means of the food web and gene transfer on the population of the species which are conserved at the national level, the development of the indicators and methodology of environmental impact of GMOs.

 The third direction is about the prediction and control of the harms caused by GMOs, including the development and application of the models which can predict the potential harms in environment, the technologies for prevention, control, handling of the harms and other measures aimed at the emergence, the strategy and technical countermeasures for the control of the potential harms.

 3.4 Establish biosafety information clearing- house

In order to reinforce the information sharing on biosafety and implement the obligation for the establishment of biosafety information clearing-house under Article 20, paragraph1, of the “The Cartagena Protocol on Biosafety”, SEPA has organized the experts to develop “the web site of biosafety information in China”. Up to now, the system design for the web site and the application for domain name have been completed and submitted to SEPA for review. The information contents in the web site include: “The Cartagena Protocol on Biosafety”, the national focal points, the competent national authority, the policies and regulations on biosafety, the technical guidelines for biosafety, the databases of contained use, field trial and commercialization of GMOs, the database of transboundary LMOs, the list of biosafety experts, the biosafety news, and other biosafety web sites. What is to be done next is to survey, collect and reorganize the data and information and transform them into the databases.

3.5 Enhance the education, publicity and training on biosafety

To improve the expertise in RARM of GMOs, some departments under the State Council held in the past several years a lot of workshops and training seminars on biosafety. In the period of the implementation of “National Biosafety Framework ” project, funded by UNEP through GEF from 1998 to 1999, SEPA held three workshops attended by the officials and the scientists from different departments. On the these workshops, the advances in biotechnology, the principles, procedures and methodology on RARM of GMOs and the biosafety legislation in the world were presented and discussed; In 1998, SEPA, in collaboration with Biotechnology Advisory Center, Stockholm Environment Institute of Sweden, held a workshop concerning the regulation and practice on biosafety. The officials and the scientific experts from Sweden, USA, UK, Japan, Germany, Netherlands and domestic representatives from relevant departments attended the workshop and made presentations and discussion on the biosafety legislation and its implementation, the risk assessment of GMOs and their environmental monitoring, and capacity building in biosafety. In 2001, SEPA and Canadian Food Inspection Agency jointly implemented a project, entitled “Capacity Building on Legislation and Technical Guidelines in China”. During the implementation of the project, the officials and the scientists in biotechnology from Canada came to China to hold a training seminar on RARM of GMP for the trainees from the environmental protection agencies at provincial level and the researchers from national institutes and the universities. In addition to SEPA, MOA, MOST, MOE and other departments also held workshops and training seminars on GMOs and GM food.

 To improve the understanding of biotechnology and the awareness for biosafety, the domestic media, such as newspaper, TV, radio, introduced and reported the development in biotechnology at abroad and home, the roles of biotechnology played in the social progress and economic growth  , and its potential risk to our environment and human health. In addition, The media made the general public know the news on biosafety.

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In China, biological resource are managed by different departments under the State Council. MOA is in chare of crops, domestic animals, grasslands and fishery resources; SFA is responsible for forest and wildlife; SOA is responsible for marine biological resources; SEPA is responsible for comprehensive environmental issues; MOST is responsible for the research and development of biotechnology; SDSA is responsible for the drugs produced by biotechnology. Hence, the work on the RARM of GMOs in China is currently related to many administrative departments under the State Council, such as MOST, MOE, MOA, MOPH, SDSA, SEPA, SFA, SOA and CSA. At present time, these departments function as follows in the management of GMOs: MOST is in charge of the organization of important research projects on RARM of transgenic organisms; MOA is responsible for production and application of agricultural GMOs; MOPH is responsible for GM food; SEPA is responsible for the environmental safety of GMOs; SFA is responsible for the research and use of GMP in forestry; SOA is responsible for the research and the research and use of marine GMOs; SIQA is responsible for the test of imported and exported GMOs; CAS is responsible for the implementation of the important basic research projects on biosafety.

Based on the institutional reform plan formulated by the State Council in 1998, SEPA was appointed as the competent authority for national biosafety management. However, It must be acknowledged that the responsibilities of different departments in the management of biosafety somewhat overlap. So SEPA currently is preparing to draft a higher layer of “Biosafety Law” for clearly determining the rights and responsibilities of different departments in biosafety in the environmental safety of all GMOs. At present, the general framework for biosafety management in China is that SEPA is responsible for the report to and the contact with CBD Secretariat as a national focal point and a competent national authority under the Protocol. In the meantime, SEPA is also responsible for the united supervision for domestic biosafety affairs and the activities, while other departments under the State Council manage relevant activities on biosafety based on their responsibilities. SEPA has established a Biosafety Office to be responsible for the national biosafety activities.

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The capacity development in RARM of GMOs mainly include the development of the technical guidelines for RARM, the establishment of risk assessment institutions, the improvement of expertise in RARM, and the establishment of biosafety laboratory as well. The existing capacity development and its needs in RARM of GMOs in China are showed in table 4.

 Table 4  The capacity development and its needs in RARM of GMOs

Contents of capacity development

Capacity developed

Capacity to be developed and to be perfected

The legislation on RARM




The technical guidelines for RARM




Institutions of risk assessment



Expertise in RARM



Basic research on RARM



Information and data on RARM


Methodology for the monitoring of environmental impact of GMOs



Establishment of biosafety laboratory


Technologies for the prediction and control of environmental harms caused by GMOs




























Existing regulations was formulated  for only agricultural GMOs, and hence its scope need to be widen to include all GMOs


The existing guidelines need to further harmonize with the regional and international ones


Need to issue the certificates for the institutions which make risk assessment


Need to hold training seminars to scientifically improve assessment level


Need to do long-term basic research on RARM of GMOs


There is a little data available to RARM


Need to develop the indicators and methods to monitor of the environmental impact of GMOs


The labs are be establishing, but the  numbers is few and the funds is not enough.


Need to develop relevant predictive model and control technologies

* indicates the capacity has been developed but is not necessarily perfect; ** indicates the capacity need to developed.

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In order to scientifically assess the risk posed by the domestic and transboundary GMOs, conserve and use biodiversity in sustainable way, promote the sound development of biotechnology, Capability building in RARM of GMOs needed to be strengthened mainly following five aspects:

  (1) Develop the parameters and methods at the experiment level for the risk assessment of GMOs. Because the conclusions of risk assessment are based on scientific information and experiment data which mainly originate from the results of lab experiments and field trials, it is necessary to seek proper parameters and methods to describe and measure the risk of GMOs. The development of the parameters and methods have two ways: The first way is to utilize ones from related disciplinary subjects; The second way is to do long-term research for GMOs.

 (2) Collect, reorganize and develop the fundamental information on RARM of GMOs. The RARM need to know and be familiar with the information on recipient, genetic manipulation, vector, donor and GMOs, Apart from the information on GMOs which must be provide on the basis on experiment, other relevant information can generally obtained through scientific papers, databases and expert experience.

 (3) Improve expertise and the numbers of qualified experts in RARM. The risk assessment is technically complicate, which requires the experts with different professional backgrounds and experience in GMOs. According to “UNEP International Technical Guidelines for Safety in Biotechnology”, at least ten branches of biology, for instance molecular biology, population genetics, ecology, taxonomy, microbiology, virology, botany, zoology, biochemistry, entomology etc., are need for a scientifically sound risk assessment of GMOs. Besides, The practice of RARM is also related to computer modeling, the management science, legislation, economy and politics. Expertise in RARM may been improved through following approaches: Firstly encouraging the experts in relevant disciplines to engage in the research and the management work on RARM; Secondly conducting the cooperative research with the countries well experience in RARM to transfer skills and methodologies; Thirdly training managers and professionals who engage in RARM. The training is helpful not only to improve their knowledge and awareness, but also to increase the numbers of the people who are trained.

(4) Promote information exchange in RARM. Information exchange can improve the sharing of the data, information and experience in RARM among different countries or among regions or among different institutions within the country. The exchange of the information on biosafety can be made through the information clearing-house mechanism at global, regional and national level. In addition, It is very useful and effective to hold workshops, training seminars, make a study tour to the developed countries and use Internet resources.

(5) strengthen the infrastructure of biosafety laboratory in RARM. Because RARM is new research field, existing experiment facilities and equipments can not completely meet the requirements for RARM of GMOs. So It is very necessary and urgently to raise money to improve the existing experience conditions and train relevant professionals.

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Compared with the western developed countries, Asia countries exists a big gap in the field of biotechnology. In order to solve such issues as the food shortage and the improvement of environment, GMOs from the developed countries are inevitably imported into some of the Asia countries. In fact, a lot of Asia countries have token biotechnology as a mainstay industry in century 21 and many GMOs have been released into open environment for field trial and commercial production. Therefore, it is necessary to set up appropriate Regional cooperation mechanisms in RARM to prevent GMOs from the harms. Possible Regional cooperation mechanisms mainly include following four aspects: 

(1) Strengthen the harmonization of the framework for RARM of GMOs. The main activities include the general principles, methods and standards in RARM of GMOs. The work may be done by an ad hoc experts from Asia countries. 

(2) Establish an information center of RARM of GMOs in Asia region. The main activities include the investigation for the R&D of biotechnology and existing biosafety work in Asia countries, the development of the databases for environmental release, commercial production and the marketing of GMOs. The activities may be conducted by the experts appointed by IUCN Regional Biodiversity Programme, Asia, in cooperation with the relevant governments in Asia countries . 

(3) Conduct a scientific cooperation in the field of RARM of GMOs. The main activities include the joint research on RARM of GMOs, the establishment of joint biosafety laboratory, and scholar exchange. The activities may be implemented by relevant scientific institutes and universities and international research bodies. 

(4) Hold workshops and training seminars on RARM of GMOs. The activities may be implemented by IUCN Regional Biodiversity Programme, Asia, UNEP, CBD Secretariat and other international organizations and NGOs, in cooperation with the relevant governments in Asia countries.

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1.    Levin, Morris A. and Struss, Harlee S. Risk Assessment in Genetic Engineering. McGraw-Hall Inc, 199119-31.

2.    Ivar Virgin and Frederick Robert J. Biosafety Capacity Building: Evaluation Criteria Development. Biotechnology Advisory Commission of SEI, 19961-1759-70.

3.    State Environmental protection Administration of China. National Biosafety Framework of China. China Environmental Science Press, 2001, 12-87.

4.    Wang Changyong. National Capacity Building for Risk Assessment and Management of Transgenic Organisms. In Dayuan Xue and Ivar Virgin, Regulation and Practice on Biosafety, The Proceedings of the International Workshop on Biosafety, 2-5, November,1998, Nanjing, China. China Environmental Science Press 1999, 130-136.

5.    Wang Guoying. Advances in Agrobiotechnology and the Safety Evaluation of Transgenic Organisms in China. In Dayuan Xue and Ivar Virgin, Regulation and Practice on Biosafety, The Proceedings of the International Workshop on Biosafety, 2-5, November,1998, Nanjing, China. China Environmental Science Press 1999, 7-9.

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7.    The State Council of China. “Safety Administration Regulation on Agricultural GMOs”, 2001.

8.    CBD Secretariat. The Cartagena Protocol on Biosafety to CBD”, Montreal, 2000, 1-30.

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