UNU-IAS Working Paper No. 152

Review on GM Rice Risk Assessment in China

Yanqing Wang and Sam Johnston

April 2007

Abstract Rice is the staple food for nearly half the world’s population. China is currently the largest rice producer and consumer in the world. China is the biggest rice biotechnology research spender in the world with an annual outlay of US$115 million. The commercialization of GM rice in China would have a major impact on the production of GM rice throughout the world. Experiences and knowledge from rice development and GM rice risk assessment in China should be valuable for the other governments around the world. Key Words: GM Rice, Risk Assessment, China

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1. Introduction

China is currently the largest rice producer and consumer in the world. Rice production

accounts for about 40 per cent of total domestic grain production with one third of total grain

acreage in China.1 To meet the challenges posed by increasing population, increasing

consumption, reducing soil fertility, lack of new agriculture land and increasing shortages of

water and energy, it is necessary for China to develop rice varieties with higher sustainable

yields.

Biotechnology has been promoted as being able to help address the major challenges of food

security and poverty alleviation in an environmentally friendly manner in developing

countries. China, since the mid-1980s, has increasingly been exploring the potential of

biotechnology to these challenges. Investments in public-sector biotechnology research have

risen dramatically to $1.2 billion for 2001-2005, a 400 per cent increase over 1996-2000

levels, with about $120 million allocated for transgenic rice R&D.2 This makes China the

biggest rice biotechnology research spender in the world.3 China has embraced biotechnology

in other agricultural sectors with 6.4 million framers growing 3.3 million ha of GM cotton in

2005.4

Promoted by the rapid advances in genomic studies, development of molecular marker

technologies, identification, mapping and molecular cloning of a large number of

agriculturally useful genes, China’s rice biotechnology research has generated a wide array of

GM rice plants. Field testing of various genetically modified (GM) rice has been in progress

since 1998.5 As of 2005 more than 100 varieties have been tested under restricted, or

enlarged or productive-field testing in accordance with the relevant biosafety regulations. In

2003 53 ha of GM rice was planted for research and risk assessment purposes.6

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China is on the threshold of applying its research into GM rice on a commercial scale.

Although Iran has already taken this step,7 the impacts of China following the same path will

be of major significance for biotechnology internationally, especially in the developing world

and will have a major impact on the acceptance of the technology in other agricultural sectors.

Rice is the most important food crop in the world, grown by 250 million farmers, and the

principal food of the world’s 1.3 billion poorest people, mostly subsistence farmers. The

commercialization of GM rice has enormous implications for the alleviation of poverty,

hunger, and malnutrition. The development in China’s use of GM rice has already been the

subject of international controversy.8-9 This international controversy is only likely to increase

as China further develops its considerable investment in the technology.

Yet many of the facts about this research are not known to the international community due to

language barriers and difficulties in accessing the information. This paper sets out to describe

in an accurate, impartial and comprehensive manner what biotechnological research is

currently being undertaken on rice in China and surveys the literature regarding GM rice

development and risk assessment in terms of environment and food safety in China. The

paper also highlights a number of areas in the risk assessment and management procedures

that merit further attention.

2. GM Rice Research in China

There are two major rice varieties in China, Indica rice (Hsien) and japonica rice (Keng).

Experimental lines of GM rice have been developed with traits such as increased yield,10

quality improvement,11, 12, 13 disease14-23 and insect resistance,24-39 herbicide resistance,40-42

salt and drought tolerant,43-47 and pharmaceutical usages.48 GM rice with disease and insect

resistance are the most developed, accounting for about 80 per cent of all developed GM rice

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varieties. In recent years, scientists are also looking forward to pyramiding of genes into rice

varieties to reduce the likelihood of pest resistance.49 Approaches to prevent gene flow and to

use the rice as bioreactor are also being explored.48 New techniques of genetic transformation

in eliminating the antibiotic marker genes and promoter genes have also been developed and

utilized in rice breeding.50

Table 1: GM Rice Development in China Trait(s) Gene(s) Cultivar References

Increased yield pepc Peiai64S, 2302S, 2304S, 2306S, Shuangjiu A; 5129, 02428, Wanjing97

10

Quality improvement

antisense Waxy (Wx) gene 11

ferritin gene Wuxiangjin 9 12

antisense Waxy (Wx) gene Long-te-fu B (LTF-B), 13

Disease-resistance Xa21 IR72 14

Xa21 Minghui63, Zhenshan97B, Yanhui559, Taihugeng6, Zhonghua11

15

Xa21 C418, TijinA 16 Xa21 Minghui 63,Wan B 17 Xa21 Pei'ai 64S 18

Xa21 Minghui63, Zhenshan97B, Shanyou63 19

Xa13 20 Xa7+Xa21 Minghui 63 21 Xa23+ IPT GC-1, CBB23, Hexi15 22

chitinase gene+ beta-1,3-glucanase gene Nan29 23

Insect-resistance bt 209 24 bt Zhuanghua11 25 cry1Ab 26 cry1Ac Xiushui 11 27 cry1 Ac Minghui 81 28 cry1Ab+cry1Ac Minghui 63 29 cry1Ab/cry1Ac IR72 30 cry1Ab+pinII+bar Zhongguo 91 31 cry1Ab+bar+Xa21 Zhongguo 91 32 cry2A* GM Minghui 63 33 sck Minghui 86 34 sck Minghui 86 35 sck +cry1Ac Minghui86 36 gna D297B 37 gna+sbti Zhuxian B 38

Xa21 + cry1Ab/cry1Ac Minghui 63, Zhenshan 97A, Maxie A 39

Herbicide bar Jingyin 119 40

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resistance bar + gna 87203, Eyi105 41

VHb+tzs+EPSPS Xiushui-11, Qiufeng, Youfeng, Hanfeng 42

Salt tolerance the mouse calcineurin gene 43

SsNHX1 44 Drought resistance MnSOD 45 codA 46 Drought resistance and salt tolerance SNAC1 47

Biorector NDV F Guanglinxiangjin (GLXJ) 48

Note: pepc: maize Phosphoenolpyruvate carboxylase gene; antisense Waxy (Wx) gene: starch granule-bound starch synthase gene; Xa21 (Xa gene family): confers resistance against the bacterial pathogen Xanthomonas oryzae (Xoo); Chintinase gene: chitinase gene from Phaseolus limensis; beta-1,3-glucanase gene: beta-1,3-glucanase gene from Nicotiana tabacum; cry2A*: a novel synthetic gene, the family of Cry genes from Bacillus thuringiensis (Bt) coding for the d-endotoxins; sck: modfied CpTI gene, the CpTI gene encoding a cowpea trypsin inhibitor a cowpea trypsin inhibitor; PinII: potato proteinase inhibitor gene; gna: snowdrop lectin gene; sbti: soybean trypsin inhibitor gene; bar: hygromycin phosphotransferase gene; VHb: Vitreoscilla hemoglobin gene; tzs: trans-zeatin secretion gene; EPSPS: the modified 5-enolpyruvylshikimate-3-phosphate synthase gene; ferritin gene: cloned from Phaseolus vulgaris; SsNHX1: the Suaeda salsa vacuolar Na+/H+ antiporter SsNHX1; MnSOD: manganese superoxide dismutase gene; codA: choline oxidase gene; SNAC1: stress responsive gene; NDV F: gene of Newcastle disease virus (NDV F).

2.1 Insect-resistant Transgenic Rice

Insect resistant rice has been produced expressing various Bt genes, as well as non-Bt genes

such as the proteinase inhibitor genes (CpTi, SpTi), the mannose-specific lectin gene (gna).

Early in 1989, it was reported that Chinese scientist transformed Bt toxin gene, the

insecticidal delta-endotoxin Bt gene (Cry toxin gene) from Bacillus thuringiensis, into

japonica rice variety 209 by protoplast-fuse techniques.22 In 1991, Bt toxin gene was

transferred into cultivated rice variety Zhonghua 11 by the pollen-tube pathway.23 Since 1993,

transgenic rice plants with enhanced pest resistance have been reported in many experiments.

Transgenic elite rice lines expressing a Bt fusion gene derived from Cry1Ab and Cry1Ac

were developed in 2000.29 The lines used in the transformation were Indica CMS restorer line

of Minghui 63 and its derived hybrid rice Shanyou 63. The Bt rice has shown resistance

against several insect pests, such as the striped stem borer (Chilo suppressalis), yellow stem

borer (Scirpophaga incertulas), leaffolder (Cnaphalocrocis medinalis), and has also shown

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excellent agronomic performance.39, 51

Other lines of insect-resistant GM rice varieties include, for example, a modified CpTi gene

(Cowpea Trypsin Inhibitor gene) named sck, which was introduced into an elite Indica rice

lines used for three-line hybrid breeding in China.52 The homozygous transgenic restorer

MH86 lines, and their combinations expressing both sck and Cry1Ac genes, marker-free rice

lines with sck gene or both sck and bt genes were also developed.34, 50 Bioassay and field test

showed the transgenic insect resistant rice conferred high resistance to lepidopteran insects as

rice stem borer.34

2.2 Disease-resistant Transgenic Rice

The Xa21 gene is useful for breeding bacterial blight resistant rice varieties because of its

wide-spectrum resistance to Xoo (Xanthomonas oryzae pathovar oryzae) blight.53

The cloned Xa21 gene has been transferred into several rice varieties through particle

bombardment, or mediated by Agrobacterium tumefacien.14-17 The homozygous Xa21

transgenic Minhui63 restorer plants were crossed with Zhenshan97A to breed a BB resistant

hybrid, Shanyou63 with the transgene Xa21. The transgenic hybrid rice plants not only

displayed high broad-spectrum resistance to Xoo races but also maintained all the elite

agronomic characters of the hybrid Shanyou63.19 The Minghui63-Xa21 and Shanyou63-Xa21

plants demonstrated resistance to Xoo and maintained their normal elite traits under field

conditions.54

3. Biosafety Regulation and Policies on GMOs Risk Assessment

Environmental release and marketing of GMOs has attracted wide spread concerns about the

environmental and health risks in China. In response to the emergence of these concerns,

Chinese Ministry of Science and Technology (MOST) issued the first biosafety regulation in

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1993, named as Safety Administration Regulation on Genetic Engineering. The Safety

Administration Implementation Regulation on Agricultural Biological Genetic Engineering

issued by the Ministry of Agriculture (MOA) in 1996 covered agricultural use of

biotechnology in more detail. These regulations were updated by the State Council of China

in 2001 when they issued the Regulation on Safety of Agricultural Genetically Modified

Organisms for the purpose of strengthening the safety evaluation administration of

agricultural genetically modified organisms; safeguarding the health of humans and the safety

of animals, plants, and microorganisms; and protecting the environment. To implement this

Regulation, the MOA issued three implementation regulations including Implementation

Regulations on Safety Assessment of Agricultural Genetically Modified Organisms, which

provided the legal basis and technical guidelines in GM crops risk assessment in China (The

English version of these regulations can be found in the Biosafety Clearing-House of the

Convention on Biological Diversity).55

The 2001 Regulations endorses the authority of the MOA over national agricultural GMOs.

To implement the Regulations, the MOA established the Office for Biosafety Administration

of Agricultural GMOs (OBA). A national biosafety committee (NBC) has been established

under the administration of the OBA, and in charge of safety assessment of agricultural

GMOs. Members of the NBC come from different administrative departments, academic

institutions, etc. who are experts in biological research, production, processing, inspection

and quarantine, public health and environmental protection with respect to agricultural GMOs.

All 31 provinces in China have established provincial biosafety management offices under

the provincial agricultural bureaux. They are responsible for the supervision and

administration of the safety of agricultural GMOs in their respective administrative areas. In

the case of biosafety assessment of GM crop, for example, the field-testing of a specific GM

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crop should be supervised by the provincial biosafety office where the GM crop is planted.

Whether the GM crop is permitted to plant in that province for field–testing or whether go to

next biosafety assessment stage should be approved by the NBC.

Agricultural GMOs in accordance with the 2001 Regulations are divided into four safety

levels from level I (No danger for the time being) to IV (High degree of danger), according to

their potential risk to the human, animals, plants and microorganisms. Safety assessment shall

be conducted for plants, animals, and microorganisms on the basis of science, using case by

case examinations; and under varying degrees of controls depending on the different stages.

Safety assessment of GM plants is divided into five stages: 1) “laboratory research” means

any work of genetic manipulation or GMO research in a laboratory and contained system; 2)

“restricted field-testing” means any small-scale test of GMOs in a contained system or under

confined conditions; 3) “enlarged field testing” means any moderate-scale test in natural

conditions with appropriate safety control measures; 4) “productive testing” means any

large-scale test prior to commercial production and use of GMOs; 5) Application for the

safety certificate. The application for the safety certificate should be after productive testing.

The 2001 Regulations meet the generally accepted risk assessment procedures outlined in the

relevant international instruments, such as Annex III of the Cartagena Protocol on Biosafety

to the Convention of Biological Diversity, the Codex Alimentarius Commission Principles for

the Evaluation of Food Derived from Modern Biotechnology (FAO/WHO, 2003), and

Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant

DNA Plants (FAO/WHO, 2003). Generally the practice in China is to use a comparative risk

assessment approach, in which the transgenic crop is compared with the corresponding

non-transgenic crop in ecological risk assessment and hazard identification in transgenic

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foods.56-57 Although there are no official guidelines in China for risk assessment on food

derived from transgenic crops, the assessments carried out so far on nutrition, toxicity and

allergenicity generally followed the relevant Codex principles and guidelines.

In China, GM rice, along with many other types of agricultural GMOs, also need to satisfy

the procedures governing the release of new seed varieties. These procedures are governed by

the Seed Law in China. Only agricultural GMOs that have previously obtained a biosafety

certificate are eligible to be classified as a new seed variety in accordance with the Seed Law

and relevant regulations. After the GMO has passed seed variety testing and received the

permission for production, it is eligible to enter into the chain of production, and marketing.

Since 1997, many types of transgenic rice varieties have undergone various biosafety

assessment trials. In 2002, 199 GMOs were approved in different stages of biosafety testing

in China, 158 were GM crops, among which GM rice accounted for about 24 per cent.58

In 2003, 235 GMOs were approved in different stages of biosafety testing in China. 67.7 per

cent of approved GMOs were GM crops, 12 per cent of these were rice, which amounted to

19 organisms - mostly were insect-resistant transgenic rice lines.31 Four GM rice varieties

including transgenic rice with the Xa21 gene and the Bt rice varieties are at the stage of

application for biosafety certificate, the final regulatory check before commercialization.

4. Research on GM Rice Risk Assessment

Since 1997, the MOST has invested more than $25 million in the biosafety research. GMO

detection methodologies, technical standards for GMO biosafety assessment, covering basic

biosafety issues to specific questions relevant to a targeted GMO product, monitoring of

long-term effects and questions to be urgently answered are some of the major areas of

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research.59 Most of the risk evaluation on transgenic crops has been on cotton, rice, wheat and

maize. Among the published papers on risk assessment of environment and food safety

reviewed for this paper, insect-resistant transgenic rice lines accounted for about 80 per cent

of materials used in risk assessment including 60 per cent of transgenic rice based on

B. thuringiensis (Bt) endotoxin, 20 per cent of other modifications for insect resistance such

as proteinase inhibitors (SCK) and 13 per cent of risk assessments were herbicide-tolerant

transgenic rice lines.

4.1 Environmental Risk Assessment

The possible environmental risks that have been considered in the risk assessments examined

for the purposes of this paper include (1) non-target and biodiversity risks, which include

non-target pests, natural enemies, and etc., and effects to ecosystem; (2) risks associated with

gene flow and recombination; and (3) risks associated with the evolution of resistance in the

target organisms.60

4.1.1 Effects on Non-target Pests

The non-target effect studies are mostly focused on bt and CpTi genes in rice. The Bt protein

is known to be toxic to only a narrow spectrum of Lepidopteran species. Consequently, the

effect of these transformations on non-target species is difficult to measure and will if there is

any effect only be indirect. The effects on non-target pests, the brown plant hopper (BPH)

(Nilaparvata lugens) and the white-back plant hopper (WBPH) (Sogatella furcifera) have

been investigated using Bt transgenic Indica rice (B1 and B6) carrying the Cry1Ab gene, the

transgenic restore line of hybrid rice (MSA and MSB) carrying the sck gene or both CpTi and

bt genes, the Bt rice lines (TT9-3, TT9-4) as experimental materials.61-63 The studies found

that under selection conditions of host plants, transgenic Indica rice B1, B6 and transgenic

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restored line of hybrid rice (MSA), the loading percentage, oviposition preference and

number of eggs on the transgenic plants of the two insects were not significantly different

from those on the control, whereas the total number of probing wound caused by the BPH

was higher in the transgenic plants than in the control.61 The studies found that transgenic rice

lines MSA containing both CpTi and bt genes showed no significant effect on the biological

parameter of the BPH compared with the parent line. MSB rice with CpTi and bt genes did

not significantly influence most of the biological indices of the two species of

plant-hoppers.62 The studies found that there were no significant differences between the

densities of adult S. furcifera and N. cincticeps in the plots of the two Bt rice lines (TT9-3,

TT9-4) and their parental control (IR72) during the whole growing season of rice.63

The studies concluded that the ecological risk of transgenic rice causing the outbreak of rice

plan-hoppers seemed small compared with the non-GM controls.

4.1.2 Effects on Natural Enemies

Although the effects of Bt plants have been investigated in China for a limited number of

predator and parasitoid species under confined conditions, these investigations have found no

evidence of direct effects of Bt plants on natural enemies.64 Laboratory and field studies with

Bt rice provide a similarly positive results. Under laboratory condition, predation by 2 spiders

(Pirata subpiraticus and Oedothorax insecticeps (Ummeliata insecticeps) fed on

planthoppers N. lugens reared on the transgenic rice cultivars (KMD1, RBS and II-32/RBS)

were not significantly affected compared to planthoppers reared on non-transgenic rice.65

Bt toxin expressed in transgenic Cry1Ab rice pollen had no evident negative impacts on the

fitness of Propylea japonica (Thunberf), an important predator of rice insect pests when the

pollen was used as a food by this beetle.66

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The impacts of transgenic Bt rice (TT9-3 and TT9-4) on the field population dynamics of the

dominant spider species, Tetragnatha maxillosa, Dyschiriognatha quadrimaculata,

Ummeliata insecticeps, Pardosa Pseudonannulata and P. subpiraticus were similar to those

in control field, where the population of most of spiders showed no significant difference.63

The results indicate that the two Bt rice lines have no adverse effects on the dominant spider

species in rice paddies.

4.1.3 Effects on Soil Microorganisms

Soil microbiological and biochemical properties have often been proposed to be an early and

sensitive indicator of anthropogenic effects on soil ecology both in natural and

agroecosystems.67 Studies showed the residue of Cry1Ab protein in Bt transgenic rice (KMD)

rhizosphere soil was undetectable, the half-lives of the Cry1Ab protein in the soils amended

with transgenic rice straw were no more than 35d depending on soils under laboratory

studied.68-69 Under laboratory conditions, Cry1Ab toxin in straws of Bt-transgenic rice

(KMD) appears to be toxic to the cultural microrganisms in upland soil, and a change in some

important biological properties was reported but was not toxic to a variety of culturable

microorganisms in the studied flooded paddy soil.69-70

4.1.4 Gene Flow

Gene flow is referred as the movement of genes from one organism to another. Gene flow is

possible through pollen from open-pollinated varieties crossing with local crops or wild

relatives. The likelihood that a transgene will spread in the environment depends on its

potential fitness impact. Rice is a self pollinating plant, and there are no known insect

pollinators. It was reported that gene flow between traditional variety (Huangkenuo) and

hybrid rice Shanyou 63 showed an average frequency of 0.04 per cent in Huangkenuo and

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0.18 in Shanyou 63. It was also reported that gene flow from a rice cultivar (Minghui-63)

with high pollen production to wild O. rufipogon had a maximum frequency of less than 3

per cent.71

Gene flow from Bt/CpTI rice lines to their non–GM control cultivated with different mixed

planting patterns in the field was detected at a low frequency (0.046-0.833 per cent) even if

the GM rice is planted at close spacing with non-GM rice. High densities of GM rice

cultivated in the neighborhood of non-GM rice will increase the probability of outcrossing

with the non-GM rice.72 While, the bar gene in a transgenic herbicide resistant rice moved

from GM to non-GM rice through pollen- mediated gene flow at a low frequency within a 3m

distance.73

Gene flow study of transgenic rice (Y003 and 99t) carrying bar gene to wild rice

(O. officinalis Wall) and barnyard grass (Echinochloa crusgalli var. mitis) concluded that it

was not possible for the bar gene to move from the GM rice to these wild species. The

germination rate of pollen grains of transgenic rice on the stigma of O.officinalis was lower

than that of self-pollination.74 Pollen grains of transgenic rice on the sitgmas of barnyard

grass could neither germinate or grow normally after crossing, nor penetrate the stigmas of

barnyard grass.75 Emasculated barnyard grass pollinated with the rice pollen grains under

mentor pollen inducement conditions did not produce seeds.76 It indicated the low gene flow

maybe due to the strong reproductive barriers between rice and the wild species.

4.1.5 Resistance Risk and Management

Insect adaptation to conventional insecticides and crop cultivars has been a pervasive and

costly problem in pest management.77 Studies showed that expression of Bt toxic protein

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differs with the growth stage, and segment of Bt rice.78-79 Geographic variation in

susceptibility of C. suppressalis to Bt toxins was observed in China.80 However, none of the

Bt crops used so far has suffered a resistance failure despite widespread use.81 Whether this is

because of effective resistance management such as plant refuges or other factors is not

generally known.82 Refuges may be of the same crop or another crop that the insect pest feeds

on. Since most farmers in China are small scale householders, it is difficult to design and

implementation of resistance management strategies for Bt rice. Assumptions of

intercropping between rice and Water Bamboo or Eleocharis dulcis, and other farming

systems to manage resistance risk have been raised as a possible approach.83 Recently, Bt

rice cultivars with two or more toxin genes for producing a high dose of toxin protein have

been proposed to defer the development of resistance.84 For examples, a transgenic elite rice

lines expressing a Bt fusion gene derived from Cry1Ab and Cry1Ac were developed in

China.29 Combining CpTi with bt gene also improved rice resistance against insect pests and

delayed the mergence of resistance.34, 50

4.2 Food Safety Assessment

In China the food safety of trangenic rice has been largely studied based on the principle of

substantial equivalence. There were no significant differences in major nutritional

components between the transgenic rice (KMD) and the wild-type (Xiushui 11), or between

the transgenic rice (Huachi B6) and the parent Jiazao 935.85 Although a small amount of

Cry1Ab protein was detected in raw rice, no transgenic protein was detected in the cooked

rice due to the denaturation of Bt toxin protein after cooking.86 Toxicological evaluation has

also been investigated on Bt transgenic rice on the development of silkworm (Bombyx mori)

larvae and rats. The silkworms had a slight loss of body weight, but no lethality was

recorded.87 The submicrostructure of the midgut of silkworm larvae in the Bt trangenic rice

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raw flour treatment changed.88 However, results demonstrated that Bt rice flour at a dosage of

64g Kg-1 BW, Bt toxin and NPTII and HPT proteins have no toxic effects on rats at 90 day

feeding test.89 Transgenic rice line with sck gene was another example. There was no

difference in the nutritional indices between rats fed with transgenic rice and non transgenic

rice for 90 day test.86 No significant difference was detected between minipigs fed in GM rice

and non-GM rice for 62 days in all measured variables.90 Toxicity evaluation on transgenic

rice lines containing mtlD/gutD gene, or cod gene on rats in a 30 day feeding test indicated no

significant differences on the physiological metabolism between the treatment and

control.91-92

5. Gaps in the Risk Assessment Procedures

This review of the various risk assessment procedures and assessments in China illustrates a

number of areas that merit further attention.

5.1 Field Testing.

More than 70 per cent of studies were conducted under laboratory condition. Laboratory

studies have limited predictive ability regarding large-scale, long-term effects in the

imperfect conditions of the real world. For example, human activities and agricultural

practices have not been adequately incorporated into the risk assessment process. One

example of this gap is that although there has been a considerable amount of research on

natural pollen dispersal in China, under some conditions human-mediated seed dispersal may

have a stronger influence on the risks associated with gene flow.93 A landmark study in risk

assessment was the ‘Farm-Scale Evaluations’ study in the UK. The studied gene flow from

oilseed rape (Brassica napus) to bargeman’s cabbage (Brassica rapa) on a national scale in

the UK involved remote sensing, field ecology, plant molecular biology and mathematical

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modeling.94 The data had great statistical power and direct relevance for the decision-making

process of the UK regulators. The study highlights the need for this type of multidisciplinary

field testing to be undertaken in China.

5.2 Compliance and Risk Management

Rice is still largely a small scale endeavour in China where the average farm size is one acre.

Millions of farms pose compliance problems for any coordinated management effort.

Indeed, even in the early testing phase of GM rice compliance issues have arisen. For

example, The Implementation Regulations on Risk Assessment of Agricultural Modified

Organisms of the MOA requires that risk management measures should be adopted during

risk assessment of Agricultural GMOs. However, for one assessment of productivity and

health effects of two insect-resistant transgenic rice varieties, farmers cultivated GM rice

without the assistance of technician, contrary to the Regulations.95 Conducting biosafety trails

without technicians ̀ support raised serious issues about whether the safeguards to prevent

GM contamination were properly followed.96

More importantly, questions have been raised about the extent that farmers are using GM rice

illegally. This has proven to be a major problem with other GM crops in other countries –

effectively forcing Brazil and India to legalise the use of GM crops. The recent banning of

US rice exports by the EU, Japan and Korea demonstrate the significant international

consequences of not properly ensuring compliance with risk management procedures.

Greenpeace International has also reported in 2005 that GM rice had entered into Hubei

(where a GM rice variety was being field tested) and Guangdong (near to Hubei) markets.97

In March 2006, Greenpeace alleged that insect-resistant Bt transgenic rice has been found in

Heinz' nutritious rice flour in China.98 In response to these arguments, the MOA instructed

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the Hubei Provincial Agricultural Bureau to conduct an investigation. The Hubei Provincial

Agricultural Bureau confirmed three companies had illegally enlarged their plantings of GM

rice, but advised all illegal GM rice had been eradicated. The Hubei Provincial Agricultural

Bureau denied that rice sampled in Hubei and Guangzhou market contained GM rice.99

On 31 March, 2006, the MOA based on results provided by entrusted GMO detecting

institutes clarified that Heinz' nutritious rice flour sampled does not contain GM rice.100

Even so, the MOA issued the Guidelines of Biosafety Investigation on Field-Testing of GM

Crops on 12 May, 2006 to safeguard the field-testing of GM crops.101 Illegal use and

contamination are likely to be ongoing problems that will require a high degree of vigilance

by MOA if they are to avoid farmers taking matter into their own hands. Clearly greater

awareness about the requirements of the Regulations amongst farmers using GM crops would

be helpful. Greater vigilance by MOA is also needed. If compliance problems persist then

stronger sanctions will need to be considered. But as a first step a more independent

investigation of compliance and illegal use is called for in China.

5.3 Science Uncertainty

In practice, relationships linking environmental effects to GMOs, even when they exist, are

difficult to discern due to compounding factors, various sources of uncertainty and scientific

limitations. In food safety assessment, although the array of analytical and epidemiological

techniques available has increased, there remain sizeable gaps in the ability of scientists to

identify compositional changes that result from genetic modification of organisms intended

for food; to determine the biological relevance of such changes to human health; and to

devise appropriate scientific methods to predict and assess unintended adverse effects on

human health.102 These shortcomings are as evident in China risk assessment procedures as

elsewhere.

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5.4 Socio-economic Consideration

Socio-economic considerations refer to a broad spectrum of concerns about the actual and

potential consequences of GM rice, such as impacts on farmers’ incomes and welfare, cultural

practices, community well-being, traditional crops and varieties, rural employment, trade and

competition, ethics and religion, consumer benefits, and ideas about agriculture, technology

and society.103 Taking such considerations into account during the risk assessment process is

not legally required in China. Nevertheless they are considered important factors in China

and there have been a number of empirical economic studies on GM cotton that tend to reveal

income gains for farmers who plant GM seeds.10. Much more attention needs to be given to

this issue if GM rice is to be commercialized in a sustainable way.

5.5 Studies on Pest Resistance to GM Rice

The development of resistance by insect and pathogen to GM rice is a potential risk.

No studies on pathogen resistance to GM rice in China have been reported. For Bt rice grown

extensively in China, as mentioned at the part of resistance risk and management, there is a

risk for the development of insect resistance. Prudence suggests that some exploration of the

issue should be undertaken before commercialization of GM rice.

6. Conclusion

Rice has been cultivated for more than 10,000 years, grown around the world and is the staple

food for nearly half the world’s population. Due to the need to increase rice yields, China has

invested heavily in biotechnology and varieties of GM rice. Although commercial release of

GM rice has not so far happened in China, field testing of various types are in their final

stages. Moreover, in 2005 Iran used GM rice at a semi-commercial level. The

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commercialization of GM rice in China would have a major impact on the use of GM crops

around the world.

This review shows that the development of GM rice in China has been monitored by detailed

risk assessments. Risk assessment procedures are improving and evolving in China as more

experience is gained in the technology and the procedures. Even so more attention needs to

be paid to some critical areas such as field testing, more sophisticated risk management

procedures, and the need for long term studies and socio-economic considerations, to ensure

that these risk assessment procedures are adequate.

GM rice risk assessment also is being conducted in several countries, like the U.S., Japan,

India, and etc.105-106 In each of the world’s major rice-growing countries, information about

the geographic distribution, population ecology, and reproductive biology of sympatric wild

relatives of the crop could be useful for evaluating the ecological effects of new transgenic

traits. Much could be gained if more systematic cooperation was established between the

relevant authorities in these countries about the various risk assessments that have been

undertaken and the various techniques that have been developed.

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