Regulation of GMOs in China 2nd France-China Bioethics Workshop Paris, 22 February 2007

1. Regulation of GMOs in China2nd France-China Bioethics WorkshopParis, 22 February 2007 Yinliang Liu Dr. of Laws, M.S. in Biology, Associate Professor Vice Director, Institute of Intellectual Property Law Director, Bio-law research Centre China University of Political Science and Law Beijing, P.R. China yinliangliu@gmail.com

2. Development of biotech in China • Since 1980s, biological sciences and biotech have been supported as one of the main themes by national projects for enhancement of science and technology, including, e.g., the 863, 973, Torch, Projects, and, Agricultural Transgenic Program • Progresses have been made in biotech fields of agriculture, medicine, environment protection, etc. • China is now one of the leading developing countries in biotech R&D • There are cooperative programs in biotech between China and France & other EU countries

3. GMOs developed in & imported to China • Developed GMOs: cotton, tobacco, tomato, soybean (agriculture); poplar (forestry); GM cell, microbe or its product (medicine, vaccine, diagnosis product, etc.) • Imported GMOs: cotton, soybean, corn, rapeseed. They imported as processing materials for food oil or feed, and from companies such as Monsanto, Syngenta, Du Pont, and Bayer

4. Administrations of GMOs • Ministry of Science and Technology: funding and managing R&D of GMOs • Ministry of Agriculture: GM crops, biosafety • State Forestry Administration: forestry GMOs • State Environmental Protection Administration: biosafety /CBD, Cartagena Biosafety Protocol • Ministry of Health: administration of GM food, medication

5. State Food and Drug Administration: registration of GM food or medicine • Ministry of Commerce: GMO trade • State Administration of Quality Supervision, Inspection, and Quarantine: inspection and quarantine of GMOs at customs • IP issues: SIPO (patent), MOA / State Forestry Administration (new plant varieties)

6. Laws and regulations may involve GMOs • Regulation on Protection of Nature Reserves (1994) • Food Hygiene Law (1995) • Regulation on Protection of Wild Plants (1997) • Forest Law (1998 revised) • Environmental Protection Law (1999) • Marine Environmental Protection Law (2000) • Seed Law (2000) • Drug Administration Law (2001 revised)

7. Grassland Law (2002 revised) • Wild Animal Protection Law (2004 revised) • Animal Husbandry Law (2005) • Patent Law (2000 revised) • Regulation on Protection of New plant Varieties (1997) International treaties applied to China involving GMOs • Convention on Biological Diversity (CBD) • Cartegena Protocol on Biosafety (ratified by China on 8 June 2005, coming into force for China since 6 September 2005)

8. Regulations and rules involving GMOs • Administrative Measures for Safety of Genetic Engineering (1993, MOST) • Regulation on Safety Administration of Agricultural GMOs (2001, State Council) • Administrative Measures for Safety Assessment of Agricultural GMOs (2002, MOA) • Administrative Measures for Safety of Imported Agricultural GMOs (2002, MOA) • Administrative Measures for Labeling of Agricultural GMOs (2002, MOA)

9. Administrative Measures for Hygiene of GM Food (2002, MOH) • Administrative Measures for Inspection and Quarantine of GM Products (2004, State Administration of Quality Supervision, Inspection and Quarantine)

10. Definition and scope of GMO • Those transgenic animals, plants, microbes, whose genomes have been modified by genetic engineering; • Their products; • The processed products derived directly from them, such as, herbicide, animal medicine, fertilizer, food, feed, or their additives

11. Biosafety assessment of GMOs • On a case-by-case basis • Judged by risk or potential risk for human health, animal, plant, microbe, & ecological environment • 4 levels: I (no risk), II (low), III (moderate), IV (high) • Assessment process: includes, assessing the (1) safety level of receptor/host, I-IV; (2) types of transgenic manipulation, 1-3; (3) safety level of GMOs, I-IV; (4) effect of processing; (5) safety level of GMO products, I-IV

12. Actions involving agricultural GMOs • Producing, processing, transporting, stocking • Producers of GMOs shall (1) get safety certificate and producing license from MOA; (2) establish files to record information, including the transferred gene and its resource, transgenic method, producing place, flow of the reproduc-tive materials of the GMOs; (3) provide report of information regularly; (4) furnish necessary safety control measures during transportation

13. Import of agricultural GMOs • In harmonization essentially with the Biosafety Protocol • GMO could be used: for research and test; for processing; as products directly • Safety certificate from MOA • Simplified procedure: first approval, then simplified

14. Labeling of agricultural GMOs • Compulsory label: listed kinds of GMOs by MOA, totally 17 kinds of products belong to 5 varieties of GMOs (soybean, corn, rapeseed, cotton, tomato) • Voluntary label: for GMOs not listed by MOA • Labeling could be one of the followings: (1) “transgenic (organism or product)”; (2) “transgenic (organism) processed product”; (3) “this product is processed from transgenic (organism), but it now does not have any transgenic components”

15. Labels shall be in standard Chinese, marked apparently, fixed to products or their package or by plate; • Labels shall be approved before use by administration of agriculture at county level or above; labels of the imported GMOs shall be approved by MOA • Negative label, i.e., “GM free product”, has not been encouraged or prohibited

16. GM food • GM food includes the food or its additives, made of/from GMO or its processed products or the materials derived from them • Must be safe, have nutrient value not less than its non-GMO equivalence • Principle for assessing GM food: substantially equivalent; case-by-case • MOH is responsible for administration of GM food • All GM food must be labeled: in either “transgenic (organism) food”, or, “made of the transgenic (organism) food”, or, additionally, “persons allergic to (certain) food should be alerted”

17. Inspection and Quarantine of GMOs • All the imported and exported GMOs for trade, processing, post, carrying, producing, reproducing, research, exchange, exhibition, aid, donation, etc., should receive the inspection and quarantine at the customs • Notification: the agent shall provide safety certificate and other necessary documents • For export of non-GMOs, if asked, the responsible organization could issue a certificate of non-GMO according to relevant rules and inspection procedures

18. GMO as medication • Shall register at and have a license for clinical use from SFDA • Must comply with the Drug Administration Law and its regulations • Safety and efficacy must be guaranteed • Example: the recombinant human p53 adenovirus is the first medicine used for gene therapy clinically in China, and also in the world

19. Conclusion • A framework has been established in China for regulation of GMOs • May reflect an approach mixed with elements adopted in the EU and the USA • May still lack certain aspects, such as, a harmonized system of regulation of all kinds of GMO and regarding all kinds of activities • Development of detailed rules for administration of GMOs is needed

20. Thank you for attentions!