Strategy of Strategy of Biotechnology Biotechnology

Development and Development and Biosafety ManagementBiosafety Management

in Chinain ChinaLiu Yan, Wang Changyong

Nanjing Institute of Environmental Sciences

State Environmental Protection Administration, China

1. Status quo of biotechnology research and development in China

2. Blueprint strategy of biotechnology industry development in China

3. Regulations on biotechnology management in China

4. Emphases on biosafety management in China

1. Status quo of biotechnology research and development in China

China has made big headway in China has made big headway in developing modern Biotechnology developing modern Biotechnology and its industry through the and its industry through the implementation of implementation of ““863863”” ProgramProgramPriority in the field of biotechnologyPriority in the field of biotechnology

Agriculture Agriculture

MedicineMedicine

Other government funding Other government funding

Private sectorsPrivate sectors’’ contribution is small.contribution is small.

Up until now, there were more than 100 Up until now, there were more than 100 different kinds of living modified organisms different kinds of living modified organisms under research and 191 different genes were under research and 191 different genes were used to transform those organisms. used to transform those organisms.

Among these, Among these, •• more than 100 more than 100 GMOs varieties of crops and treesGMOs varieties of crops and trees in in

research and 103 genes for transformation; research and 103 genes for transformation; •• more than 30 kinds of transgenic fish, domestic animal, more than 30 kinds of transgenic fish, domestic animal,

poultry that has been studied poultry that has been studied in research and 32 genes in research and 32 genes in use, and in use, and

•• 51 strains of engineering 51 strains of engineering microorganisms in research microorganisms in research and 89 genes in use.and 89 genes in use.

From 1997 to 2001, the Ministry of Agriculture (MOA) received a total of 695 applications of agricultural GMOs from domestic or foreign institutes and companies.

695

503

192

0

100

200

300

400

500

600

700

total

approved

disapprove

d

316128

59 12 field testing

environ

al releas

m ent

e

com m er

product

cial

ion

Biosafet

Certifica

y

te

GMOs approved by MOA have fallen GMOs approved by MOA have fallen into four categories:into four categories:

insectinsect--resistant Cotton, resistant Cotton, delayed ripening tomato, delayed ripening tomato, diseasedisease--resistant sweet pepper, resistant sweet pepper, colorcolor--altered petunia, altered petunia, animal feed additive and,animal feed additive and,microbial pesticide productsmicrobial pesticide products

One of the most visible and successful One of the most visible and successful achievements is the development and achievements is the development and commercial application of transgenic cotton commercial application of transgenic cotton (Bt cotton).(Bt cotton).

Field test of the Bt cotton Field test of the Bt cotton lines first began in 1995.lines first began in 1995.Commercial planting of the Commercial planting of the new cotton variety was new cotton variety was approved by MOA in late approved by MOA in late 1997. 1997. 13 kinds of Bt cotton13 kinds of Bt cotton have have been developedbeen developedPopularized in 12 Popularized in 12 provincesprovincesAccounting for 51% of the Accounting for 51% of the total area of cotton

0 1000000 2000000 3000000

2001

2002

cultivation areatotal area of cotton

biotechnology has gradually become a research biotechnology has gradually become a research focus and a investment focus of science, technology focus and a investment focus of science, technology and business circle.and business circle.

more than 200 organizations and nearly 10,000 more than 200 organizations and nearly 10,000 senior researchers engaging in education, R&D senior researchers engaging in education, R&D and management in the field of biotechnology,and management in the field of biotechnology,about 500 modern biotechnological enterprises about 500 modern biotechnological enterprises employed over 50,000 people, and employed over 50,000 people, and nearly 100 listed companies dealing with nearly 100 listed companies dealing with biotechnology, among which 40 companies are biotechnology, among which 40 companies are engaged in modern biotechnology R&D. engaged in modern biotechnology R&D.

2. Blueprint strategy of biotechnology industry development in China

Since 1991, China has emphasized the Since 1991, China has emphasized the development of modern biotechnology and listed development of modern biotechnology and listed it in National Fiveit in National Five--year Plan.year Plan.

The key fields of modern The key fields of modern biotechnology development in biotechnology development in China are: China are:

basic biology, medicinal biotechnology,agricultural biotechnology,environmental biotechnology, biodiversity and biosafety.

The key technology in The key technology in biotechnology development biotechnology development includes: includes: functional genome, proteomics, biochip,animal and plant bioreactor,genetic engineering medication

and vaccine,gene diagnose and therapy,transgenic technology of animals

and plants,bio-pesticide, bio-fertilizer,biosafety.

Recently, MOST has defined Recently, MOST has defined policiespolicies, , principlesprinciples, , aimsaims,,focal pointsfocal points and, and, guidelinesguidelines for biotech development for biotech development of China in of China in ““National Compendium of National Compendium of Biotech DevelopmentBiotech Development””(draft to be (draft to be revised).revised).

GuidelinesGuidelines

The guideline to accelerate the strategic transformation in The guideline to accelerate the strategic transformation in biotech R&D is as followings:biotech R&D is as followings:

•• to change from imitation to active invention & to change from imitation to active invention & innovation, innovation,

•• from single technological breakfrom single technological break--through to allthrough to all--round round harmonious development, harmonious development,

•• from promoting domestic market to extending from promoting domestic market to extending international market, international market,

•• from government investment to enterprises investment.from government investment to enterprises investment.

PrinciplesPrinciples

•• First, the development of biotech should conform to First, the development of biotech should conform to national situation and calls for the breakthroughs in national situation and calls for the breakthroughs in some key industry, some key industry,

•• Secondly, the development of biotech should base on Secondly, the development of biotech should base on the combination of independent exploration with the combination of independent exploration with technology importation,technology importation, and and

•• Finally, the development of biotech should base on the Finally, the development of biotech should base on the joint efforts of governmental guiding and marketjoint efforts of governmental guiding and market--mechanism.mechanism.

AimsAims

The aim of biotech development of China is to catch up The aim of biotech development of China is to catch up with or get close to the most advanced technology in with or get close to the most advanced technology in overall research fields and catch up with the leading overall research fields and catch up with the leading level in several important fields, which can be level in several important fields, which can be illustrated as followings:illustrated as followings:

•• making great breakthrough in strategic, basic and making great breakthrough in strategic, basic and frontier of biotechnological research fields,frontier of biotechnological research fields,

•• establishing and perfecting the biotech innovation establishing and perfecting the biotech innovation system,system,

•• setting up a highsetting up a high--level R&D team, and level R&D team, and •• propping up a group of biotech enterprises with strong propping up a group of biotech enterprises with strong

international competitiveness.international competitiveness.

33. Regulations on . Regulations on biotechnology management in biotechnology management in ChinaChina

1993, the first law on biosafety in China 1993, the first law on biosafety in China was issued by the State Science and was issued by the State Science and Technology Commission. Technology Commission.

Safety Administration Regulation Safety Administration Regulation on Genetic Engineeringon Genetic Engineering

On 10On 10thth July, 1996, the July, 1996, the Safety Safety Administration Implementation Administration Implementation Regulation on Agricultural Regulation on Agricultural Biological Genetic EngineeringBiological Genetic Engineeringwas issued by MOA in accordance was issued by MOA in accordance with the Regulation.with the Regulation.

On 10On 10thth June, 1998, the June, 1998, the Provisional Provisional Administration Regulation on Administration Regulation on Human Genetic ResourcesHuman Genetic Resources was was issued by General Office of the State issued by General Office of the State Council, which formulated by MOST Council, which formulated by MOST and the Ministry of Public Health and the Ministry of Public Health (MOPH).(MOPH).

A series of regulations play positive role in A series of regulations play positive role in the administration of research, the administration of research, development, environmental release and development, environmental release and commercialization of GMOs.commercialization of GMOs.

•• Safety Administration ImplementationSafety Administration ImplementationRegulation on Tobacco Genetic EngineeringRegulation on Tobacco Genetic Engineering

•• Regulation on Approval of New BiologicalRegulation on Approval of New BiologicalProductsProducts

On 23th May, 2001, the On 23th May, 2001, the Safety AdministrationSafety AdministrationRegulation on Agricultural GMOsRegulation on Agricultural GMOs was issued by was issued by the State Council. the State Council.

The GMOs Regulation comprises such detailed rules as:The GMOs Regulation comprises such detailed rules as:the system of administration at different levels,the system of administration at different levels,the safety assessment system, the safety assessment system, the labeling system, the labeling system, the safety certification system of agricultural GMOs and,the safety certification system of agricultural GMOs and,the managing license system of transgenic seeds, the managing license system of transgenic seeds, domestic animals, poultry and aquatic organisms.domestic animals, poultry and aquatic organisms.

This regulation is promulgated to:This regulation is promulgated to:

Strengthen the administration of Ag Strengthen the administration of Ag GMOsGMOs, ,

Safeguard the health of humans and the safety Safeguard the health of humans and the safety of animals, plants and microorganisms,of animals, plants and microorganisms,

Protect the ecological environment and,Protect the ecological environment and,

Promote research.Promote research.

Compared with the Regulation issued Compared with the Regulation issued in 1993, the GMOs Regulation covers:in 1993, the GMOs Regulation covers:

Expanded concept of GMOs to include Expanded concept of GMOs to include theirtheirproducts, products, labeling and,labeling and,import/export affairs.import/export affairs.

At the same time, the GMOs Regulation established At the same time, the GMOs Regulation established four basic administration systems aiming in safety four basic administration systems aiming in safety management management of Agriculture GMOsof Agriculture GMOs ::

A joint meeting system on the safety management A joint meeting system on the safety management of agricultural GMOs was established under State of agricultural GMOs was established under State Council.Council.The management of agricultural GMOs was The management of agricultural GMOs was implemented in line with their safety level. implemented in line with their safety level. A safety assessment system of agricultural GMOs A safety assessment system of agricultural GMOs was established.was established.A labeling system of agricultural GMOs was A labeling system of agricultural GMOs was established.established.

Management systemJoint-ministry conference

MOACenter for

Assessment and Detection

National Biosafety Committee

Biosafety Office

3 different inspection institutions

Local biosafety offices (30)

In January 2002, three departmental regulations on In January 2002, three departmental regulations on Safety AssessmentSafety Assessment, , Import/ ExportImport/ Export, and , and Labeling Labeling of Agricultural GMOsof Agricultural GMOs were issued by MOA.were issued by MOA.

In addition, MOA issued the In addition, MOA issued the Announcement on the Announcement on the Implementation of the GMOs Regulation and Implementation of the GMOs Regulation and Relevant RulesRelevant Rules, accompanying with three Procedures:, accompanying with three Procedures:the Management Procedure for Safety Assessment of the Management Procedure for Safety Assessment of Agricultural GMOs, Agricultural GMOs, the Management Procedure for Import/Export of the Management Procedure for Import/Export of Agricultural GMOs and , Agricultural GMOs and , the Censoring and Ratifying Procedure for Labeling of the Censoring and Ratifying Procedure for Labeling of Agricultural GMOs.Agricultural GMOs.

The category of the first group of The category of the first group of agricultural GMOs under the labeling agricultural GMOs under the labeling system includes:system includes:

Soybean seeds, soybean, soybean powder, Soybean seeds, soybean, soybean powder, soybean oil and soybean meal;soybean oil and soybean meal;Maize seeds, maize, maize oil and maize Maize seeds, maize, maize oil and maize powder;powder;Rape seeds, rape, rape oil and rapeseed meal;Rape seeds, rape, rape oil and rapeseed meal;Cotton seeds;Cotton seeds;Tomato seeds, fresh tomatoes and tomato sauceTomato seeds, fresh tomatoes and tomato sauce

From Mar 20 to Aug 8, 2002, Biosafety Office of MOA received 1435 pieces of application including:

33%

6%

60%

1%

provisional certificate

labeling licenses

safety certificate for material processing

safety assessment for experimentation and production

4. Emphases on biosafety 4. Emphases on biosafety management in Chinamanagement in China

4.1 Establishing technological supporting 4.1 Establishing technological supporting system of biosafety management.system of biosafety management.

Strengthen the research on biosafetyStrengthen the research on biosafety

Since 2000, Chinese government has strengthened the Since 2000, Chinese government has strengthened the support and investment in biosafety research. support and investment in biosafety research.

In In ““973973”” Program, Program, ““863863””Program, National Key Program, National Key Projects and Natural Science funds Projects and Projects and Natural Science funds Projects and National Technological Criterion, special subjects of National Technological Criterion, special subjects of biosafety research were listed.biosafety research were listed.

Establish the national technological platform of Establish the national technological platform of biosafety assessment, as well as a group of biosafety assessment, as well as a group of authoritative, equity and professional teams and authoritative, equity and professional teams and organizations of risk assessment and monitoring.organizations of risk assessment and monitoring.

Up to now, there are 21 organizations were confirmed as Up to now, there are 21 organizations were confirmed as the first group of preparatory organizations for the first group of preparatory organizations for agricultural GMOs inspection by MOAagricultural GMOs inspection by MOA..

Constitute the guidelines and methods of risk Constitute the guidelines and methods of risk assessment and risk management of GMOs at assessment and risk management of GMOs at experimental level .experimental level .

In March, 2003, a series of protocols for detecting In March, 2003, a series of protocols for detecting genetically modified component in import/export genetically modified component in import/export GMOs were issued by AQSIQ, covering GM crops such GMOs were issued by AQSIQ, covering GM crops such as soybean, maize, rape, potato, cotton, tobacco, food, as soybean, maize, rape, potato, cotton, tobacco, food, plant feed, edible grease and their products. plant feed, edible grease and their products.

These protocols have come effect since 1These protocols have come effect since 1stst September, September, 2003.2003.

Strengthen capability building for risk Strengthen capability building for risk

assessment and risk management in laboratoryassessment and risk management in laboratory

In MOA, MOPH, SEPA, AQISQ, a number of biosafety In MOA, MOPH, SEPA, AQISQ, a number of biosafety laboratories has already been set up.laboratories has already been set up.

4.2 Enforcing supervision and inspection4.2 Enforcing supervision and inspection

In November, 2003, a joint inspection on species In November, 2003, a joint inspection on species resources protection led by SEPA, assisted by MOST, resources protection led by SEPA, assisted by MOST, MOA, MOE, SFA, SIPO, SDA, SAIC and CAS.MOA, MOE, SFA, SIPO, SDA, SAIC and CAS.

A supervision and inspection of regulations A supervision and inspection of regulations enforcement led by MOA, assisted by departments enforcement led by MOA, assisted by departments concerned was also conducted in later 2003, focusing on concerned was also conducted in later 2003, focusing on manufacture, sales, labeling and safety assessment of manufacture, sales, labeling and safety assessment of GMOs.GMOs.

4.34.3 Establishing biosafety information Establishing biosafety information system of Chinasystem of China

Supported by international organizations, the national Supported by international organizations, the national biosafety information clearing house and the biosafety information clearing house and the biodiversity information clearing house have been set biodiversity information clearing house have been set up. up.

The biosafety information nexus of network system The biosafety information nexus of network system among departments (including MOFA, MOST, MOA, among departments (including MOFA, MOST, MOA, MOE, SFA, GAC, MOPH) have been set up. MOE, SFA, GAC, MOPH) have been set up.

4.4 Promoting international cooperation on 4.4 Promoting international cooperation on biosafetybiosafety

The first panThe first pan--departmental project in the field of biosafety departmental project in the field of biosafety in Chinain China-- ““National Biosafety Framework of China National Biosafety Framework of China (NBFC)(NBFC)”” has satisfactorily accomplished the project in has satisfactorily accomplished the project in 1999.1999.

The UNEP/GEF project on the Implementation of the The UNEP/GEF project on the Implementation of the National Biosafety Framework of China was formally National Biosafety Framework of China was formally launched in September 2002, aiming at solving the urgent launched in September 2002, aiming at solving the urgent problems specified in the problems specified in the ““National Biosafety Framework National Biosafety Framework of Chinaof China””..

4.54.5 Strengthening education and Strengthening education and popularization on biosafetypopularization on biosafety

Although the public is rather familiar with Although the public is rather familiar with biotechnology, they know little about the concept of biotechnology, they know little about the concept of biosafety. biosafety.

Compared with European countries, the public in Compared with European countries, the public in China has very little knowledge on the safety of the bioChina has very little knowledge on the safety of the bio--technological products. technological products.

SummarySummary

The policy of modern biotechnology development The policy of modern biotechnology development of China is toof China is to

carry out research positively, carry out research positively, encourage technological innovation and,encourage technological innovation and,heighten the overall level of transgenic heighten the overall level of transgenic technology research. technology research.

SummarySummary

The general objective of national biosafety The general objective of national biosafety management is to protect human health and management is to protect human health and environment through establishing relevant environment through establishing relevant policy and regulatory system, mechanism, policy and regulatory system, mechanism, technological criterion and supervisory system technological criterion and supervisory system for environmental impact assessment, and in the for environmental impact assessment, and in the meanwhile China promotes the sound and meanwhile China promotes the sound and orderly research, development and orderly research, development and commercialization of biotechnology.commercialization of biotechnology.

Thanks for your attentionThanks for your attention••

Your Comments Are Appreciated.Your Comments Are Appreciated.