Transcript Regulation of GMOs in China

Regulation of GMOs in China
2nd France-China Bioethics Workshop
Paris, 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
[email protected]
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
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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
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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
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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
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IP issues: SIPO (patent), MOA / State Forestry
Administration (new plant varieties)
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)
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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)
Regulations and rules involving GMOs
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Administrative Measures for Safety of Genetic
Engineering (1993, MOST)
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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)
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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)
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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
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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
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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 reproductive materials of the GMOs;
(3) provide report of information regularly;
(4) furnish necessary safety control measures
during transportation
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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
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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”
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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
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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”
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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
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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
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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
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Thank you for attentions!