China＇s Biotechnology Regulation Regime:Trade in Agricultural GMOs and Biosafety
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China＇s Biotechnology Regulation history relating to trade and biosafety can be divided into 2 phrases: Prior to and after the year of 2001, which marked by the promulgation of Regulation on the Safety Administration of Agricultural GMOs by State Council in May, 2001. This classification is based on the following two reasons: firstly, there is a conversion of national policy regarding the biotechnology from"whole hearted embracing '' to a more"cautionary approach" indicated by the Regulation＇s publication; Secondly, it can be inferred from the content of regulation that major regulatory entity has been shifted from Ministry of Science and Technology to Ministry of Agriculture since the year of 2001.
I Before 2001
On December 24, 1993, State Science and Technology Commission issued Safety Administration Regulation on Genetic Engineering, which is regarded as the first biotechnology regulation of China.
This Regulation is aimed at"promoting research and development of biotechnology" and manage genetic engineering related works. Genetic engineering work is divided into four safety classes, namely, no threat to human health and environment; low level risk; intermediate-level risk and high level risk. This 4-grade classification model is inherited by the forthcoming legislations.
Pursuant to this Regulation, Ministry of Agriculture issued Implementation Rules on Safety Administration of Agricultural Genetic Engineering in July 1996, which was nullified in March 2002 by Administration Rules on the Safety Evaluation of Agricultural GMOs.
II After 2001
On May 23, 2001，the State Council published Regulation on the Safety Administration of Agricultural GMOs ,the most important legislation of China so far in the field of safety-controlling of biotechnology . With a broad coverage ranging from research and experiment, commercialization, to labeling, import and export, the regulation serves as a framework to provide policy guidance.
As mandated by the regulation, an Inter-Ministry Joint meeting on Safety Administration of Agricultural GMOs was established which involves the cooperation work among the Ministries of Agriculture, Science and Technology, Environment Protection, Public Health, Foreign Trade and Economic Cooperation, Quality Supervision, Inspection and Quarantine, etc.
Allocation of administration power is clarified between Ministry of Agriculture (responsible for safety evaluation of and labeling requirements for agricultural GMOs) and Ministry of Health (responsible for GM food).
The 4-grade risk classification model created by 1993′s regulation is inherited by this Regulation .
Following the regulation from the State Council, The Ministry of Agriculture (MOA) published, on the same day of January 5, 2002, three implementing rules regarding safety assessment, import control and labeling requirement of agricultural GMOs respectively.
1.Risk Assessment
According to the Administration Rules on the Safety Evaluation of Agricultural GMOs, Agricultural GMO Safety Committee was established under MOA as the decision making body, as well as the setting up of Agricultural GMO Safety Administration Office under the MOA which responsible for administering the safety evaluation of agricultural GMOs. Agricultural GMOs are classified into four safety categories and subject to different procedural and safety requirements. The safety assessment carried out, as prescribed by the Rule, twice per year in March and September.
2.Import
The Administration Rules on the Safety Importation of Agricultural GMOs classifies GMOs into three categories by intended purposes: experiment and research; production and raw material for processing, each involves different documentation requirements. Principally, the approval process will last 270 days and a simplified procedure is available provided that the GMOs in question is from the same company which has obtained approval in previous application.
The implementation of this Rule is, however, far from smooth. The Rule, which intended to come into force on March 20, 2002, was not formally executed until April 2004 after three time suspensions. During this interim period, provisional certificates (granted within 30 days since application) had been issued to GMO varieties of soybean, corn and cotton from US. exporters.
3.Labeling
According to the Administration Rules on the Labeling of Agricultural GMOs, five agricultural GMO varieties in the first published category are subjected to mandatory labeling requirement (soybean, corn seeds, rape seeds, cotton seed and tomato seeds).However, compared with the EC＇S minimum of "0.9%" standard, there is no specific threshold for GMO containment which entails a labeling liability. This legislative defectiveness, together with the laggard detection technology and the absence of uniform detection methods, will undoubtedly undermine the effectiveness of the Rule.
For the regulation of GM food, Ministry of Health published Administration Rules on Hygiene of GMO Foodstuffs on April 8, 2002.
Ⅲ Comments
Pragmatism without long-term and integrated strategy;
Consideration in policy making: Biotechnology or Biosafety? ;
Competition for and overlap of regulatory power;
Difficulties in implementation, which was best illustrated in Zhu Yanling V.Nestlé Corporation (Shanghai Second Intermediate People＇s Court and Shanghai Higher People＇s Court ,2003). Focusing on the labeling requirement for the GM ingredients in the milk powder from the Swiss-based food giant, the judiciary demonstrated deficiencies in China＇s current Biotechnology legislation .
(This article is based on the presentation at the World Trade Institute, University of Berne, Switzerland on 27 November 2006. The author can be contact at 15 Shatan beijie Beijing PR.China,100720;huilicass@yahoo.com.cn.
本文根据作者2006年11月27日在瑞士伯尔尼大学世界贸易研究所第九项目组（IP9,生物技术与国际贸易）例会上的发言整理而成。）
I Before 2001
On December 24, 1993, State Science and Technology Commission issued Safety Administration Regulation on Genetic Engineering, which is regarded as the first biotechnology regulation of China.
This Regulation is aimed at"promoting research and development of biotechnology" and manage genetic engineering related works. Genetic engineering work is divided into four safety classes, namely, no threat to human health and environment; low level risk; intermediate-level risk and high level risk. This 4-grade classification model is inherited by the forthcoming legislations.
Pursuant to this Regulation, Ministry of Agriculture issued Implementation Rules on Safety Administration of Agricultural Genetic Engineering in July 1996, which was nullified in March 2002 by Administration Rules on the Safety Evaluation of Agricultural GMOs.
II After 2001
On May 23, 2001，the State Council published Regulation on the Safety Administration of Agricultural GMOs ,the most important legislation of China so far in the field of safety-controlling of biotechnology . With a broad coverage ranging from research and experiment, commercialization, to labeling, import and export, the regulation serves as a framework to provide policy guidance.
As mandated by the regulation, an Inter-Ministry Joint meeting on Safety Administration of Agricultural GMOs was established which involves the cooperation work among the Ministries of Agriculture, Science and Technology, Environment Protection, Public Health, Foreign Trade and Economic Cooperation, Quality Supervision, Inspection and Quarantine, etc.
Allocation of administration power is clarified between Ministry of Agriculture (responsible for safety evaluation of and labeling requirements for agricultural GMOs) and Ministry of Health (responsible for GM food).
The 4-grade risk classification model created by 1993′s regulation is inherited by this Regulation .
Following the regulation from the State Council, The Ministry of Agriculture (MOA) published, on the same day of January 5, 2002, three implementing rules regarding safety assessment, import control and labeling requirement of agricultural GMOs respectively.
1.Risk Assessment
According to the Administration Rules on the Safety Evaluation of Agricultural GMOs, Agricultural GMO Safety Committee was established under MOA as the decision making body, as well as the setting up of Agricultural GMO Safety Administration Office under the MOA which responsible for administering the safety evaluation of agricultural GMOs. Agricultural GMOs are classified into four safety categories and subject to different procedural and safety requirements. The safety assessment carried out, as prescribed by the Rule, twice per year in March and September.
2.Import
The Administration Rules on the Safety Importation of Agricultural GMOs classifies GMOs into three categories by intended purposes: experiment and research; production and raw material for processing, each involves different documentation requirements. Principally, the approval process will last 270 days and a simplified procedure is available provided that the GMOs in question is from the same company which has obtained approval in previous application.
The implementation of this Rule is, however, far from smooth. The Rule, which intended to come into force on March 20, 2002, was not formally executed until April 2004 after three time suspensions. During this interim period, provisional certificates (granted within 30 days since application) had been issued to GMO varieties of soybean, corn and cotton from US. exporters.
3.Labeling
According to the Administration Rules on the Labeling of Agricultural GMOs, five agricultural GMO varieties in the first published category are subjected to mandatory labeling requirement (soybean, corn seeds, rape seeds, cotton seed and tomato seeds).However, compared with the EC＇S minimum of "0.9%" standard, there is no specific threshold for GMO containment which entails a labeling liability. This legislative defectiveness, together with the laggard detection technology and the absence of uniform detection methods, will undoubtedly undermine the effectiveness of the Rule.
For the regulation of GM food, Ministry of Health published Administration Rules on Hygiene of GMO Foodstuffs on April 8, 2002.
Ⅲ Comments
Pragmatism without long-term and integrated strategy;
Consideration in policy making: Biotechnology or Biosafety? ;
Competition for and overlap of regulatory power;
Difficulties in implementation, which was best illustrated in Zhu Yanling V.Nestlé Corporation (Shanghai Second Intermediate People＇s Court and Shanghai Higher People＇s Court ,2003). Focusing on the labeling requirement for the GM ingredients in the milk powder from the Swiss-based food giant, the judiciary demonstrated deficiencies in China＇s current Biotechnology legislation .
(This article is based on the presentation at the World Trade Institute, University of Berne, Switzerland on 27 November 2006. The author can be contact at 15 Shatan beijie Beijing PR.China,100720;huilicass@yahoo.com.cn.
本文根据作者2006年11月27日在瑞士伯尔尼大学世界贸易研究所第九项目组（IP9,生物技术与国际贸易）例会上的发言整理而成。）