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Asian Biotechnology and Development ReviewVol. 11 No. 1, pp 79-117

© 2008, RIS. All rights reservedPrinted in India

The Cost of Research andDevelopment for Producing aTransgenic Crop and Its BiosafetyRegulation Compliance in IndonesiaBahagiawati Amirhusin*, Erna Maria Lokollo** ,Supriyati***, and Sutrisno****

Abstract: Since the last decade crop improvement using genetic engineeringtools is one of the alternative approaches to increase and stabiliseagricultural production in the world. However, producing a transgenicplant is a long and expensive process. Even after it led to the successfuldevelopment of a plant with a desired trait, the transgene has to be followedup by a series of risk assessment stages required by the national biosafetycommission. A risk assessment regulation process is required to assure thesafety of food and feed and the environment and this latter activity is notcostless. The objective of this study is to obtain the cost for research anddevelopment of selected transgenic crops engineered in Indonesia. Inaddition, we also investigated the cost of complying with the biosafetyregulation. The result of our survey shows that it took 4-8 years to engineera transgenic plant. Two of the samples’ activities were started from geneisolation, and the rest were started from tissue culture and planttransformation using foreign genes. The R&D cost needed for each activitywas around 1.3 billions IDR to 3.1 billions IDR (with Present Value ofmoney (PV) equal to 2.3 billions IDR to 7.1 billions IDR). Those amountswere equivalent to US$154 thousands to US$522 thousands (US$274thousands to 1.4 million PV). To comply with the regulation requirementsfor Bt-cotton, a multinational enterprise in Indonesia had paid around919 millions IDR (974 millions IDR PV) equivalent to US$ 93 thousands(99 thousands US$ PV). These biosafety costs excluded the food/feedsafety costs. Our survey also indicated that from 31 plant transformationactivities, 16 are still on going, while the rest were either suspended orterminated. Of all 16 activities only two preceded into the regulationphase. Because producing a transgenic plant and complying withregulatory approval for commercial release are expensive and a long

* Researcher, Indonesian Center for Agricultural Biotechnology and GeneticResources Research and Development (ICABIOGRAD)

** Economist, Indonesian Center for Agriculture Socio-economic and Policy Studies*** Research Assistant, Indonesian Center for Agriculture Socio-economic and Policy

Studies**** Director, Indonesian Center for Agricultural Biotechnology and Genetic Resources

Research and Development (ICABIOGRAD).

80 Asian Biotechnology and Development Review

process, it is wise to set the research priorities based upon the countrycapacity and need. Research priorities should also based upon theestimation of the risk and benefit of all activities or stages. This includesthe estimation of the fund needed starting from the initial activity to thelast (release of the new variety).

Keywords: Biosafety regulations, Cost of biosafety, R&D, Transgenic crops,Risk assessment, Socio-economic assessment.

Background

Despite the ongoing debates between the opponents and proponentsof transgenic plants, there is a substantial increase in cultivated areaglobally for transgenic crops. During the eight-year period 1996 to 2003,global areas increased forty fold from 1.7 million ha in 1996 to 67.7million ha in 2003.1 In 2005, the global approved GM crop was 90million ha grown by 8.5 million farmers in 21 countries (10 industrialand 11 developing countries).2

Construction of transgenic plants was initiated in Indonesia inthe mid 1990s. By then, there had been an increase in the number ofGovernment and private institutions that performed research ontransgenic plants. Along with the increasing number of institutions,the target plants and introduced traits have also become more numerousand have diversified.3

Due to the existing controversy on the benefits and risks oftransgenic plants and their derivative products, the Indonesiangovernment recognised the need for application of the technologywith the “cautiousness” principle. This is reflected in variousgovernment regulations and decrees issued either by the President orby related Ministers. In 1996, the Government issued the first Lawon transgenic plant which called “Undang-undang Pangan” no. 7/1996. In 1997, the Minister of Agriculture issued an SK No. 856Kpts/HK330/9/1997, a Ministerial Decree to regulate the biosafety ofagricultural biotechnology products. This new Law/Decree was laterrevised in 1999 in a Joint Decree of the four Cabinet Ministers. Asidefrom biosafety, the new Decree had also made additional regulationson food safety. The Biosafety Commission was formed in 1997. Theseregulations on transgenic plants are continue under revision, andthe Government Regulation No. 21/2005 (PP 21/2005) was the latestdecree on this issue. PP 21/2005 was a modification of the joint-decree previously issued by the four Cabinet Ministers toaccommodate the implementation of Cartagena Protocol, which wasratified by the Indonesian government in 2004.

81

PP21/2005 was issued to attain environmental safety, safety of foodand/or feedstock produced by genetic engineering and their respectiveuses in farming, fisheries, forestry, industries, environment and publichealth. The approach used in assessing the risk is based on the principleof cautiousness, founded on solid scientific methods and also includesreligious, ethical, socio-cultural, and aesthetical value considerations.In order to implement this government regulation, a system guidelineis required to determine which institutions need to be involved, whichprocedures/protocols need to be followed and a clear legal structure.All of these require sufficient funding, whether it is for acquisition,operation, or monitoring. The funding would be required for researchin laboratories, greenhouses, and field work for the purpose of gatheringdata requested by the Biosafety Committee (BC) through its TechnicalTeam (Biosafety Technical Team or BTT) and their operational budgets,and other indirect costs required for fulfilling the aforementionedguidelines.

In some countries that have approved transgenic plants forcommercial release, the total cost of releasing the transgenic plantcommercially has been compiled and analysed.4 One such example isthe release of a mustard plant variety (a close relative of canola) inIndia, which has been transformed with a gene that has been used totransform canola in Canada and the USA. Since such a plant has neverbeen released anywhere in the world, its producer (Bayer Inc) had tospend 3-4 million US $ for food safety tests, which were carried out inthe USA and Europe. Another 1-1.5 million US $ had to be paid forresearch on the environmental risk analysis performed in India. Bayerhad started this process in the early 1990s, but determined to stop itsattempt to release transgenic mustard in India on 2003. This illustrateshow costly it is to conform to and follow the regulations for acommercial release, even when the proponent decided not to continuetrying to commercialise hybrid mustard in India at the end. Such highexpenses clearly bear some consequences:1. Farmers cannot utilise seeds of transgenic plants on their farmlands

since their approvals are cancelled or withdrawn.2. The high cost associated with the approval process would be passed

on to farmers, causing seed price to increase beyond their reach.Another aspect that needs to be considered is whether such

expensive approval cost is within the reach of the public researchinstitutions and universities or whether it is cost economic for one of

The Cost of Research and Development for Producing a Transgenic Crop


their researchers to release transgenic products commercially. Could thismean attempts in constructing transgenic plants that often took yearsto complete and significant investments would reach a stalemate whenthe researchers seek regulatory approval? Many researchers in publicinstitutions as a consequence would not consider conducting researchon creating transgenic plants. So that society will lose the benefit oftransgenic-technology to improve the common welfare.

This study attempts to calculate and analyse the expense for severalresearch projects in four Indonesian government-funded institutionsfor the construction of transgenic plants and other experiments thatneed to be carried out to comply with regulatory requirements forcommercial release of those plants. For comparison, similar expenses inthe commercial release of a multinational company are also calculatedand analysed.

Methodology

This study chose the sample institutions based on the following criteria:(i) institutions that carried out constructions of transgenic plants wherethe resulting plant is already at the stage of application for releasewithin the next 2-3 years with the regulatory body; (ii) institutionsthat have obtained release approval; and (iii) institutions with amandate to assess food and biological safety for commercial releases.The selected institutions are listed in Table 1.

Data were collected by using a structured questionnaire ininterviewing subjects. The questionnaire was a modification of a standardquestionnaire created by Dr Jose Falck-Zepeda for a similar study in severaldeveloping countries. In general, the data sought in the questionnairefor those institutions performing transgenic plant construction was asfollows: (i) description of the institutions; (ii) type of transgenic plantresearch; (iii) direct and indirect costs for constructing the transgenicplants; (iv) description of the stages of transgenic research; and (v)facilities and equipments used for the construction of the transgenicplants. The data scope of the questionnaire for institutions alreadyobtaining approval for release was as follows: (i) description of theinstitutions; (ii) type and research stages of the transgenic plants subjectedto approval; and (iii) direct costs of research/assessment on the transgenicplants that would be released or had already been released. The datascope of the questionnaire for BFSTT (Biosafety and Food Safety TechnicalTeam) included the operational costs of BFSTT and the number andstatus of applications evaluated.

83

Tab

le 1

: Sam

ple

(In

stit

uti

on

) Sel

ecte

d f

or

the

Stu

dy

No

.In

stit

uti

on

Act

ivit

yY

ear

of

act

ivit

y i

nit

iati

on

an

d e

nte

rin

gre

gu

lati

on

ph

ase

1B

iote

chn

olo

gy R

esea

rch

Cen

ter,

Gen

etic

en

gin

eeri

ng

of

rice

pla

nt

for

rice

1996

(st

arti

ng

wit

h r

ice

tiss

ue

cult

ure

sys

tem

Ind

on

esia

n I

nst

itu

te f

or

stem

bo

rer

resi

stan

ce u

sin

g cr

y 1A

gen

eco

inci

ded

wit

h p

lan

t tr

ansf

orm

atio

n a

nd

etc

).Sc

ien

ce, C

ibin

on

g

2D

epar

tmen

t A

gro

no

my,

Bo

gor

Gen

etic

en

gin

eeri

ng

of

po

tato

pla

nt

1994

(st

arti

ng

wit

h g

ene

iso

lati

on

, th

en p

lan

tA

gric

ult

ure

Un

iver

sity

, B

ogo

rre

sist

ance

to

fu

ngi

/nem

ato

de

usi

ng

tran

sfo

rmat

ion

an

d e

tc..

the

pro

ject

was

chit

anas

e ge

ne

tem

po

rari

ly s

usp

end

ed f

or

a ye

ar)

3D

epar

tmen

t o

f Pl

ant

Pest

s an

dG

enet

ic e

ngi

nee

rin

g o

f ci

tru

s p

lan

t fo

r19

97/9

8 (s

tart

ing

wit

h g

ene

iso

lati

on

, th

enD

isea

ses,

Ud

ayan

a U

niv

eris

ty,

viru

s (C

VPD

) re

sist

ance

.p

lan

t tr

ansf

orm

atio

n e

tc.)

Den

pas

ar

4.PT

PN X

I, S

ura

bay

aG

enet

ic e

ngi

nee

rin

g o

f su

garc

ane

pla

nt

1999

(st

arti

ng

wit

h s

uga

rcan

e ti

ssu

e cu

ltu

refo

r d

rou

ght

tole

ran

ce u

sin

g b

etA

gen

esy

stem

, th

en p

lan

t tr

ansf

orm

atio

n,

etc.

)

5PT

Mo

nsa

nto

(PT

Mo

nag

ro)

Ap

pli

cati

on

fo

r co

mm

erci

al r

elea

se o

fA

pp

lica

tio

n fo

r co

mm

erci

al r

elea

se o

f Bt-

cott

on

Bt-

cott

on

an

d R

ou

nd

up

rea

dy

Co

rn(B

oll

gard

) w

as i

n 1

998

and

RR

co

rn i

n 2

002

6.O

ther

s (B

iosa

fety

an

d F

oo

d S

afet

yR

egu

lati

on

s, l

aw,

dec

ree

rega

rdin

g b

iosa

fety

Tech

nic

al T

eam

’ co

ord

inat

or,

and

fo

od

saf

ety

of

tran

sgen

ic c

rop

s, a

nd

mem

ber

s, s

up

po

rtin

g st

aff,

an

dac

tivi

ty o

f th

e te

chn

ical

tea

m i

ncl

ud

ing

rela

ted

per

son

s in

rel

ated

con

du

ctin

g m

eeti

ng

for

dat

a ev

alu

atio

n,

inst

itu

tio

ns)

nu

mbe

r o

f p

erso

ns

atte

nd

ing

a m

eeti

ng,

fun

din

g so

urc

e to

ru

n t

he

off

ice,

etc

.



Estimation of the cost of research in constructing transgenic plantswas split into direct costs and indirect costs. Direct costs are expensesdirectly spent on research projects. This would include the costs ofmaterials, wages, travel budget, and stationeries. Indirect costs areexpenses not directly related to the research project, such as salaries (20per cent of total wages), electricity, water, gas, equipment maintenance,and depreciation values of research equipments. Since payments forelectricity, water, and gas bills is normally made for the whole institution,the actual cost for this is estimated according to the kind of equipmentused in the project and the size of the lab carrying out transgenic projects.Data on indirect costs is also normally only available for the most recentyear, while the construction of transgenic plants will already startedseveral years before. Thus, the indirect costs for the previous years werecalculated using a discount factor from the available data.

If the project is not handled exclusively by the sampled institutions,then the cost data would be obtained by cross-checking with the otherinstitution participating in the said project.

The following table lists the assumptions used in calculating thecost of research and evaluation of transgenic plants:

Assumption we used in calculating the calculating cost of researchand development and biosafety regulatory is as follows:

Variables Assumed Values

Interest rate 18%New inventory laboratory equipments Estimated of equipment’ valueMaintenance of equipment 1% of equipment’ valueDepreciation 5% of equipment’ valueSalary 20% of salary

To make the data more comparable with data from othercountries, the resulting calculations were converted from theIndonesian currency (IDR) to dollar. In order to obtain the cost ofresearch and evaluation for the current year, we calculate the presentvalue using the following formula:

PV = A*(1 + r)n

Where :A : Cost in year (current – n)r : interest rate

n : number of years.

85

As previously mentioned, information on indirect costs normallyis available only for the most recent year; therefore the cost for theprevious years was calculated using a discount factor (DF) followingthe formula below:

DF = A*(1 + r)-n

Where :A : Cost at a certain yearr : interest rate

n : number of years.The information we collected from institutions that gained

approval for commercial release (Monsanto Inc.) only covered the directcosts, since most research works were subcontracted to the variousinstitutions. Information we obtain from Monsanto are only restrictedto the research and other activities that were carried out in Indonesiaduring their field trials in compliance with the regulation for gainingapproval in this country. Meanwhile, we had not successfully obtainedthe information on costs spent to do research and other activitiesperformed outside of Indonesia (mostly in the USA).

Results and Discussion

I. Indonesian regulatory system for the biosafety of geneticallyengineered productsDuring the course of this study, Indonesia still used the guidelines setby the joint decree of Ministers known as SKB4M (SK Menteri No.998.1/Kpts/OT.210/9/99; 790.a/Kpts-IX/1999;1145A/MENKES/SKB/IX/and 1999 015A/NmenegPHOR/09/1999) for assessing the biosafety ofgenetically-engineered products. The decree set the procedure foranalysing the biosafety and food safety of GM products to be releasedcommercially in Indonesia. In addition, the appendix of the decreespecified the membership of the Indonesian Biosafety and Food SafetyCommission (BFSC). Article 39 stated that BFSC would be assisted bythe Biosafety and Food Safety Technical Team (BFSTT), whosemembership would be determined afterwards. The membership was laterenacted by another joint Ministerial decree, SK No. LB.010.59.1.2000,77/Kpts/9/2000 and KS.01.01.03380. The head, secretary, and membersof the BFSTT are the Executives from the associated Ministries, DirectorGenerals, Head of Directorates, Head of Research Centers, Head of PAUIPB, President of Biotechnological Association and Consortium, Head



of Kehati Foundation (an NGO Representative), Head of IndonesianConsumer’s Foundation, and Head of Indonesian Farmers Association,which added up to 21 members. The head and secretary of the BFSTTare ex-officio, and its membership consists of senior researchers fromresearch institutions and universities from various disciplines. Themembership is divided into five groups, namely: The Plant Group (11members), Animal Group (7 members), Fishery Group (5 members),Microbial Group (11 members), and Food Group (17 members). Theassessment procedures are summarised in Figure 1.

Figure 1: Scheme/Procedure for Risk Assessmentbased on SKB4M

87

Until this paper was written, the BFSC had only met several timesto decide the status of the commercial release of the released Bt cottonfrom Monsanto. Most day-to-day activities were carried out by theBFSTT. The operational costs of the BFSTT were obtained from theproponent/applicants. Table 2 lists the BFSTT operational costs from1998 to 2004.

Table 2: Operational Cost of BFSTT Activities

Year Total Cost Present Value of Cost Present Value of Cost( million IDR) (PV 2005, million IDR) (PV 2005,

thousand US$)

1998 50 159 16.11999 11.5 31 3.92000 10 23 2.92001 38 74 7.22002 104 171 18.42003 32 45 5.22004 12.5 15 1.6

The operational cost mostly covers the expenses for conductingmeetings to assess the collected data, making decisions on the safety ofcertain genetically-engineered products, and creating guidelines for thefood safety. The costs may differ each year, since they depend on thenumber of applications submitted to the team. As BFSTT also consistsof different groups, the attendance level in meetings can also vary,depending on the case being examined. Table 3 lists the attendancelevel of members and their supporting staff.

Table 3: The Frequencies of BFSTT Meeting based on the Numberof Attending Members*

No of members attending No of meeting

5 - 10 5 meetings11 - 15 9 meetings16 - 20 9 meetings21 - 25 4 meetings25 - 30 1 meeting

*(n = 28 meets)

On an average, BFSTT meetings are held eight times per year. Mostof the time, the meeting is attended by one coordinator and one leader,ten researchers, and three supporting staff. The cost of each meetingand the annual budget can be seen in Table 4.



Tab

le 4

: Th

e A

ver

age

Co

st o

f B

FST

T M

eeti

ng

to E

val

uat

e D

oss

ier

and

/or

Ad

dit

ion

al R

equ

ired

Dat

a

Item

sD

irec

t co

stIn

dir

ect

cost

Tota

l co

stT

ota

l co

st o

fp

er m

eeti

ng

(10

% o

f o

ne

mo

nth

per

mee

tin

gm

eeti

ng

per

yea

rsa

lary

) p

er m

eeti

ng

(8x

mee

ts)

IDR

US$

IDR

US$

IDR

US$

IDR

US$

2 m

anag

eria

l h

on

ora

riu

m1,

000,

000

102.

9460

0,00

061

.77

11 r

esea

rch

er h

on

ora

riu

m3,

300,

000

339.

722,

750,

000

283.

10

3 su

pp

ort

ing

staf

fs h

on

ora

riu

m60

0,00

061

.77

450,

000

46.3

2

Mee

tin

g ex

pen

ses

1,20

0,00

012

3.53

Tota

l6,

100,

000

627.

963,

800,

000

391.

199,

900,

000,

-1,

019.

1579

,200

,000

,-8,

153.

18

89

Although the BFSTT was established on 2000, research andassessments on the biosafety have been conducted since 1998. Fourapplications from Monsanto were submitted that year. By then, theactivity was limited to biosafety assessment in a containment facilitylocated in ICABIOGRAD. A small percentage of the budget was used tohold meetings to assess the biosafety issues and recommendations tobe made. In total, there were five applications submitted in 1998, oneapplication in 1999, one application in 2000, five applications in 2002,and two applications in 2003. Among these, only one application, BtCotton (Bollgard from Monsanto), gained approval for limited fieldreleases in seven districts of the province of South Sulawesi. Sevenapplicants have been approved and recommended by the BFSTT as“safe for environment”, but are yet to receive formal approval from theresponsible Directorate Generals/Ministers for their commercial releases.The costs spent by each applicant for the BFSTT approval ranged fromIDR 9 million (PV IDR 28 million) to IDR 51 million (PV IDR 83 million).This is more clearly illustrated in Table 5.

II. Recent Status of Research and Developments on theConstruction of Transgenic Plants Activities in IndonesiaThe purpose of this study is also to upgrade information ontransgenic research in Indonesia so that the results published by theprevious studies done on this topic may be updated.5 The results areshown in Table 6.

Between 1996 and 2005, there were 31 transgenic plantconstruction activities, which were carried out on 20 differentcommodities (food crops, estate crops, horticultures, and forestry)involving 23 different introduced traits. The institutions workingon those projects were Agency for Agricultural Research andDevelopment (Ministry of Agriculture), Center for BiotechnologyResearch, Indonesian Institute of Science (State Ministry of Researchand Technology), universities, several government-ownedcorporations (PTPN), and private corporations. Out of those 31activities, only 16 were still active, while others were either temporarilysuspended or terminated due to several reasons like fundingtermination, lack of progress, and alteration of priorities. Only twoout these 16 activities ever made it to the regulatory process forapproval.



Tab

le 5

: Bu

dge

t fo

r E

nvi

ron

men

tal R

isk

Ass

essm

ent

Act

ivit

ies

(mil

lio

n I

DR

)

Pro

po

nen

tC

omm

odit

yB

iosa

fety

Ex

per

imen

tD

oss

ier

Do

ssie

rE

valu

atio

nR

egis

tra-

Tota

lP

V 2

005

PV

200

5st

atu

sco

nta

in-

bio

safe

tyfo

odfo

r FU

T/

tion

(x 1

(x 1

,000

men

tsa

fety

LU

T d

ata

mil

lion

US$

)fa

cili

tyID

R)

(FU

T)

atIC

AB

IOG

RA

D

Mon

san

toC

orn

-RR

1Sa

fe fo

r5.

5 (1

998)

3.5

(199

8)9

(199

8)28

.67

2.90

and

cor

nen

viro

n-

RR

-2m

ent

Mon

san

toBt

-cot

ton

Safe

for

8.0

(199

8)3.

5 (1

998)

11.5

(199

8)36

.63

3.71

envi

ron

men

t

Mon

san

toR

R-c

otto

nSa

fe fo

r5.

5 (1

998)

3.5

(199

8)9

(199

8)28

.67

2.90

envi

ron

men

t

Mon

san

toR

R-s

oybe

anSa

fe fo

r5.

5 (1

998)

3.5

(199

8)9

(199

8)28

.67

2.90

envi

ron

men

t

Mon

san

toB

t-co

rnSa

fe fo

r8.

0 (1

998)

3.5

(199

8)11

.5 (1

998)

36.6

33.

71M

on-8

10en

viro

nm

ent

Pion

eer

Bt-

corn

cry

1Ab

pen

din

g8.

0 (1

999)

3.5

(199

9)11

.5 (1

999)

31.0

43.

98

Ros

ind

oR

onoz

yme

Safe

for

10 (2

000)

10 (2

002)

22.8

82.

47en

viro

nm

ent

Mon

san

toB

t/R

R c

otto

nO

nly

for

11.5

(200

1)6.

5 (2

001)

18 (2

001)

34.9

03.

40ex

peri

men

ts

Nov

arti

sB

t-co

rn a

nd

Wit

hdr

awn

20 (2

001)

20 (2

001)

38.7

83.

78Pa

cha-

corn

by p

ropo

nen

t

Mon

san

toR

R-c

orn

NK

603

Wai

tin

g fo

r9.

2 (2

002)

10 (2

002)

10 (2

002)

21.8

(200

2)51

.0 (2

002)

83.7

99.

05bi

osaf

ety

and

food

safe

ty s

tatu

s

Tab

le 5

con

tinu

ed

91

Pro

po

nen

tC

omm

odit

yB

iosa

fety

Ex

per

imen

tD

oss

ier

Do

ssie

rE

valu

atio

nR

egis

tra-

Tota

lP

V 2

005

PV

200

5st

atu

sco

nta

in-

bio

safe

tyfo

odfo

r FU

T/

tion

(x 1

(x 1

,000

men

tsa

fety

LU

T d

ata

mil

lion

US$

)fa

cili

tyID

R)

(FU

T)

atIC

AB

IOG

RA

D

Mon

san

toR

R-c

orn

GA

21Sa

fe fo

r10

(200

2)10

(200

2)16

.43

1.77

envi

ron

men

t

Mon

san

toR

R-s

oybe

anSa

fe fo

r10

(200

2)10

(200

2)16

.43

1.77

envi

ron

men

t

Dup

ont

Bt-

corn

cry

1Ab

Wai

tin

g fo

r10

(200

2)10

(200

2)16

.43

1.77

the

stat

us

IIS

(LIP

I)B

t-ri

ce fo

r6

(200

2)6

(200

2)9.

861.

06pe

rmit

to ru

nco

nfi

ned

fiel

dtr

ials

PTPN

XI

Suga

rcan

e be

t-8

(200

3)4

(200

3)12

(200

3)16

.71

1.95

A fo

r p

erm

it to

run

con

fin

edfi

eld

tria

l

PT B

ehn

Fin

ase

P an

d L

Safe

for

20 (2

003)

20 (2

003

27.8

53.

25M

eyer

envi

ron

men

t

Dup

ont

Bt-

corn

cry

1FO

nly

for

12.5

(200

4)12

.5 (2

004)

14.7

51.

64re

gist

rati

on

(….)

: N

um

ber i

n p

aren

thes

is in

dic

ates

yea

r o

f act

ivit

y.FU

T =

co

nta

inm

ent

faci

lity

at

the

ICA

BIO

GR

AD

; LU

T =

co

nfi

ned

fiel

d t

rial

lega

lly

per

mit

ted

by

the

BFS

TT.

Tabl

e 5

cont

inue

d


92 Asian Biotechnology and Development ReviewTa

ble

6: T

he

Stat

us

of

GM

Cro

p R

esea

rch

es i

n I

nd

on

esia

(2

00

5)

Cro

pL

ead

In

stit

uti

on

Targ

et t

rait

Gen

eSt

atu

s

Ric

eIC

AB

IOG

RA

DR

esis

tan

ce t

o r

ice

stem

bo

rer

cry

Pla

smid

re

con

stru

ctio

n,

pla

nt

tran

sfo

rmat

ion

(o

n-g

oin

g)

RC

B- I

ISR

esis

tan

ce t

o s

tem

bo

rer

cry

Lim

ited

fie

ld t

rial

s fo

r p

lan

t p

hen

oty

pe

(mo

rph

olo

gica

l p

erfo

rman

ce,

leve

l o

fp

lan

t re

sist

ance

to

maj

or

rice

pes

ts a

nd

dis

ease

s )

and

im

pac

t o

n n

on

-tar

get

spes

ies(

on

-go

ing)

RC

B- I

ISR

esis

tan

ce t

o b

last

antc

, p

smp

Bio

assa

y in

gre

enh

ou

se (

con

tain

men

tfa

cili

ty)(

on

-go

ing)

RC

B- I

ISR

esis

tan

ce t

o b

last

chit

inas

eG

reen

ho

use

(su

spen

ded

)

RC

B-I

ISD

rou

ght

tole

ran

ceH

om

eob

ox

Bio

assa

y in

gre

en-h

ou

se (

con

tain

men

tfa

cili

ty)

(on

-go

ing)

RC

B-I

ISB

row

n p

lan

tho

pp

er r

esis

tan

ceSn

ow

dro

p L

ecti

nG

reen

-ho

use

(su

spen

ded

)

Mai

zeIC

AB

IOG

RA

DSt

em b

ore

r re

sist

ance

cry

Gre

en-h

ou

se (

susp

end

ed)

ICA

BIO

GR

AD

Stem

bo

rer

resi

stan

cePi

n I

IG

reen

-ho

use

(su

spen

ded

)

Swee

tpo

tato

ICA

BIO

GR

AD

Inse

ct r

esis

tan

ce (

swee

t p

ota

to w

eevi

l)Pi

n I

IG

reen

-ho

use

(su

spen

ded

)

ICA

BIO

GR

AD

Vir

al r

esis

tan

ceC

oat

pro

tein

Gre

en-h

ou

se (

susp

end

ed)

Soy

bea

n IC

AB

IOG

RA

DPo

db

ore

r re

sist

ance

Pin

II

Gre

en-h

ou

se (

susp

end

ed)

ICA

BIO

GR

AD

Pod

bo

rer

resi

stan

cecr

yG

reen

-ho

use

(su

spen

ded

)

Pap

aya

ICA

BIO

GR

AD

Del

ay r

ipen

ing

An

tise

nse

AC

CSc

reen

ho

use

, p

hen

oty

pe

stu

dy(

on

-o

xid

ase

goin

g)

Cac

aoB

RU

EC-s

emi p

riva

tePo

db

ore

r re

sist

ance

cry

In-v

itro

pla

nle

t (s

usp

end

ed)

Co

ffee

BR

UEC

Fun

gi (

rust

) to

lera

nce

chit

inas

eIn

-vit

ro p

lan

let

(su

spen

ded

)

Suga

rcan

ePT

PXI-

ISR

ID

rou

ght

tole

ran

ceC

ho

lin

e d

ehyd

roLi

mit

ed f

iled

tri

als

for

mo

rph

olo

gica

lge

nas

e (b

et A

)ch

arac

teri

stic

, an

d s

uga

r co

nte

nt

(on

-go

ing)

BA

U-p

ub

lic

Pho

sph

or

abso

rpti

on

eff

icie

ncy

Ph

ytas

eIn

-vit

ro p

lan

let

(on

-go

ing) T

able

6 c

onti

nued

93

Cro

pL

ead

In

stit

uti

on

Targ

et t

rait

Gen

eSt

atu

s

Ch

ili p

epp

erB

AU

Res

ista

nce

po

tato

vir

us

YC

oat

pro

tein

Gre

en-h

ou

se (

Term

inat

ed)

Gro

un

dn

ut

ICA

BIO

GR

AD

Vir

us

PStV

res

ista

nce

Co

at p

rote

inG

reen

-ho

use

fac

ilit

y (s

usp

end

ed)

BA

UV

iru

s PS

tV r

esis

tan

ceC

oat

pro

tein

Gre

en-h

ou

se f

acil

ity

(su

spen

ded

)

Po

tato

BA

UFu

nga

l/n

emat

od

e re

sist

ance

chit

inas

eG

reen

-ho

use

fac

ilit

y(o

n-g

oin

g)

BA

UPo

tato

vir

us

P an

d Y

Co

at p

rote

inG

reen

ho

use

(ter

min

ated

)

ICA

BIO

GR

AD

-La

te b

ligh

t(Ph

ytop

tora

inf

esta

n)R

B g

ene

Plan

t tr

ansf

orm

atio

n (

on

-go

ing)

IVR

I-p

ubl

ic

Tom

ato

ICA

BIO

GR

AD

-IV

RI

Tom

ato

yel

low

cu

rl v

iru

sC

oat

pro

tein

Gre

en-h

ou

se(o

n-g

oin

g)

ICA

BIO

GR

AD

-IV

RI

Cu

cum

ber

mo

saic

vir

us

Co

at p

rote

inG

reen

-ho

use

(on

-go

ing)

Teak

Ban

du

ng

Inst

itu

tePr

olo

ng

vege

tati

ve s

tage

Leaf

y ge

ne

In-v

itro

pla

ntl

et (

susp

end

ed)

for

Tech

no

logy

-p

ub

lic

Orc

hid

Gaj

ah M

ada

Imp

rove

d q

ual

ity

Kn

ox

gen

eIn

-vit

ro p

lan

tlet

(on

-go

ing)

Un

iver

sity

-pu

bli

c

Cit

rus

Ud

ayan

aC

PVD

res

ista

nce

New

ly e

xplo

red

Gre

en-h

ou

se f

acil

ity

(su

spen

ded

)U

niv

ersi

ty-p

ub

lic

Eu

caly

ptu

sPT

Ara

rab

adi-

Ind

ahD

isea

se r

esis

tan

ce U

n-k

no

wn

Gre

en-h

ou

se(o

n-g

oin

g)K

iat-

Pu

lp/f

ore

stry

(co

nfi

den

tial

)p

riva

te c

om

pan

y

Cab

bag

eA

irla

ngg

a U

niv

ersi

ty-

Dis

ease

res

ista

nce

Glu

can

ase

In-v

itro

pla

ntl

et (

term

inat

ed)

Gaj

ah M

ada

Un

iver

sity

-pu

bli

c

Cas

sav

a R

CB

- IIS

Free

am

ylo

seB

len

chin

g en

zym

eG

reen

-ho

use

(on

-go

ing)

(be-

1 an

d b

e-2)

Aca

sia

RC

B- I

ISLi

gnin

co

nte

nt

4CL

Gen

e is

olat

ion

, pla

smid

con

stru

ctio

n, I

n-

vitr

o p

lan

tlet

(on

-go

ing)

Sen

gon

RC

B- I

ISH

igh

gro

wth

Xyl

ola

se a

nd

Gre

en-h

ou

se(o

n-g

oin

g)(P

aras

eria

nthe

sX

ylo

-glu

can

ase

falc

atar

ia)

Tabl

e 6

cont

inue

dThe Cost of Research and Development for Producing a Transgenic Crop


III. R&D Transgenic Plant Construction Activities inIndonesia

III.1. Construction of Transgenic Potatoes Resistant to Fungi/Nematodes at the Department of Agronomy, Bogor AgriculturalUniversity (BAU)The research on transgenic potatoes resistant to fungi/nematodes wasa collaboration between researchers from the Department of Agronomy(Faculty of Agriculture, Bogor Agricultural University), Department ofBiology (Faculty of Mathematics and Science, Bogor AgriculturalUniversity), and Plant Research International (PRI) in Wageningen,The Netherlands.

The project began in 1994 with isolation of the chitinase genefrom Aeromonas caviea strain W57b, which was obtained from a soilsample from the Island of Bangka. The gene isolation was performedby Dr. Suwanto et al at the Department of Biology, Bogor AgriculturalUniversity, in a three year project funded by RUT. The next phase wasthe construction of plasmids, vectors, and potato transformations,which was completed in 1998-1999 by Dr. Armini Wiendi for her PhDstudy in a sandwich programme between Bogor Agricultural Universityand PRI. The resulting material was transported to Indonesia for furtherresearch. The transformants were subsequently regenerated andacclimatised for growth in a greenhouse. More studies were performedat BAU to confirm the gene integration, and the transgene functionwas also confirmed using enzymatic assays. Greenhouse testing wascarried out at Pasir Sarongge between 2002 and 2004 to assess thephenotype and resistance to pests and diseases. Overall, this projectwas funded by RUT grants for six years (two periods of 3 year grant)and PRI (in the form of scientific training at PRI) for nine months. Thedetails of the project expenditure are listed in Table 7.

It can be seen that during the eight years that the project wascarried out, a total of IDR 1.5 billion (PV 2004 IDR 2.5 billion), whichwas equivalent to US $ 317,000 (PV 2004 US $ 650,000), has been allocatedfor it. However, this project was subsequently stopped or downsizeddue to a lack of funding.

The resulting product has not been registered for approval inaccordance with the joint ministerial decree, but some preliminarystudies have been carried out to obtain some data that would be requiredfor release approval. One example was the greenhouse testing on an

95

Tab

le 7

: Act

ual

an

d P

rese

nt

Val

ue

of

Co

st o

f R

&D

of

Po

tato

Res

ista

nce

to

Fu

ngi

/Nem

ato

de

at B

AU

Yea

rA

ctiv

ity

Act

ual

To

tal

Co

stP

V T

ota

l C

ost

Act

ual

To

tal

Co

stP

V T

ota

l C

ost

(00

0 I

DR

)(0

00

US

$)

1994

Gen

e Is

ola

tio

n13

9,58

641

5,47

264

.504

191.

99

1995

Gen

e Is

ola

tio

n14

6,71

236

5,25

965

.119

162.

12

1996

Gen

e Is

ola

tio

n15

5,12

032

5,07

666

.093

138.

51

1997

/199

8Pl

asm

id/v

ecto

r C

on

stru

ctio

n *

133,

835

236,

624

26.0

3936

.89

1999

/200

0Pl

asm

id/v

ecto

r C

on

stru

ctio

n,

pla

nt

148,

944

294,

969

18.6

6129

.87

tran

sfo

rmat

ion

, an

d a

nal

ysis

in

sert

gen

e *

2001

In v

itro

en

zym

atic

an

alys

is11

1,92

213

9,85

511

.884

17.1

2

2002

Plan

t p

hen

oty

pe

(gre

en h

ou

se)

185,

866

216,

865

19.9

9825

.41

2003

Plan

t p

hen

oty

pe,

pla

nt

resi

stan

ce t

o21

5,10

223

1,12

222

.774

22.5

1Fu

sari

um a

nd

Alt

erna

ria

(gre

en h

ou

se)

2004

Plan

t p

hen

oty

pe,

pla

nt

resi

stan

ce t

o24

4,80

024

4,80

022

.504

26.4

3Fu

sari

um a

nd

Alt

erna

ria

(gre

en h

ou

se)

Tota

l1

,48

1,8

87

2,4

70

,04

33

17

.58

65

0.8

6

Not

es:

- Pr

esen

t V

alu

e (P

V)

for

2004

, w

ith

in

tere

st r

ate

of

18%

- N

ot

incl

ud

e fo

od

saf

ety

asse

ssm

ent/

anal

ysis

- *

Exp

erim

ents

wer

e co

nd

uct

ed a

t PR

I, W

agen

inge

n,

the

Net

her

lan

d (

the

mat

eria

ls a

nd

eq

uip

s w

ere

sub

sid

ised

)



experimental plot owned by Bogor Agricultural University at PasirSarongge to study the phenotype of the plants. According to theresearcher in charge, this is necessary since potatoes are normally plantedat high altitudes, while containment facilities for transgenic plantsthat are available in Bogor and Cibinong were both located at lowaltitudes, which made them unsuitable for growing potatoes. Also, theteam responsible for the evaluation of experiment at the containmentfacility was still dominated by food crop specialists.

III.2 Construction of Transgenic Citrus Resistant to CPVD atthe Department of Plant Pathology, Faculty of Agriculture,Udayana University (Denpasar)The development of Citrus resistant to CPVD began in 1997 with theisolation of a resistance gene toward CPVD from Triphacia aurantolia(jeruk kit kit), a resistant wild citrus species. The gene was later introducedinto some local citrus varieties called jeruk keprok by Kintamani andSoe, using in planta agrobacterium transformation method.6 This projectwas funded by RUT for six years (two periods of three year grant) andJSPS for two years. Part of the research on gene isolation, sequencing,and plasmid construction was performed in Japan (University of Nagoya,Japan). The part of the project carried out in Japan was largely subsidisedby the University of Nagoya, and utilised equipments available at theuniversity laboratories. The total funds consumed by the project aresummarised in Table 8.

It can be seen that this eight year project in total has used IDR 3.1billion (PV 2004 IDR 5.6 billion) of research funds, or equal to US $370,000 (PV 2004 US $ 641,000). Recently, this project was downsizeddue to a lack of funding and the only remaining activity was themaintenance of two transgenic plants in a greenhouse facility atUdayana University. Moreover, the principal investigator does not haveany intention of releasing these plants commercially due to difficultiesin fulfilling the complex regulatory process and its associated high costs.The result of this project is currently directed toward the developmentof biopesticides for CPVD, even though the project has generated twopatents in Indonesia for two open reading frames (patent number P-00200400345 and P-00200400346).

III.3 Construction of Transgenic Drought-ResistantSugarcane at PTPN XI, SurabayaThe construction of drought-tolerant sugarcane was started in 1999.The gene, bet A, was donated by PT Ajinomoto. It encodes an enzyme

97

Tab

le 8

: Act

ual

an

d P

rese

nt

Val

ue

of

Co

st o

f R

&D

of

Cit

rus

Res

ista

nce

to

CV

PD

at

Ud

ayan

a U

niv

ersi

ty

Yea

rA

ctiv

ity

Act

ual

To

tal

PV

To

tal

Act

ual

To

tal

PV

To

tal

Co

stC

ost

Co

stC

ost

(00

0 I

DR

)(0

00

US

$)

1997

/199

8G

ene

Iso

lati

on

, p

lasm

id/v

ecto

r co

nst

ruct

ion

*14

3,13

345

5,94

748

.49

122.

52

1998

/199

9G

ene

Iso

lati

on

, p

lasm

id/v

ecto

r co

nst

ruct

ion

*15

0,89

740

7,35

515

.28

32.4

9

1999

/200

0G

ene

Iso

lati

on

, p

lasm

id/v

ecto

r co

nst

ruct

ion

*16

0,05

936

6,17

620

.50

36.9

9

2000

Plan

t tr

ansf

orm

atio

n**

924,

269

1,79

1,95

310

8.30

202.

18

2001

Plan

t tr

ansf

orm

atio

n**

1,11

0,22

61,

824,

137

108.

1517

2.45

2002

Co

nfi

rmat

ion

of

gen

e, i

nte

grat

ion

, an

d g

ene

177,

481

247,

124

19.1

622

.50

exp

ress

ion

, ge

ne

fun

ctio

n ,

ph

eno

typ

e o

f p

lan

t

2003

Co

nfi

rmat

ion

of

gen

e, i

nte

grat

ion

, an

d g

ene

208,

441

245,

960

24.3

226

.25

exp

ress

ion

, ge

ne

fun

ctio

n ,

ph

eno

typ

e o

f p

lan

t

2004

Co

nfi

rmat

ion

of

gen

e, i

nte

grat

ion

, an

d g

ene

233,

900

233,

900

26.0

326

.03

exp

ress

ion

, ge

ne

fun

ctio

n ,

ph

eno

typ

e o

f p

lan

t

Tota

l C

ost

3,1

08

,40

65

,57

2,5

52

37

0.2

36

41

.42

Not

e: (

i)

Som

e p

art

rese

arch

was

do

ne

(su

bsi

dis

ed)

in N

ago

ya U

niv

ersi

ty (

Jap

an).

(ii)

Res

earc

h w

as f

un

ded

by

JSPS

(Ja

pan

gra

nt)

.-

Pres

ent

Val

ue

(PV

) fo

r 20

04,

wit

h i

nte

rest

rat

e o

f 18

per

cen

t.-

Do

es n

ot

incl

ud

e fo

od

saf

ety

asse

ssm

ent/

anal

ysis

.



called choline dehydrogenase, which oxidizes choline to glycine betaine.7

Glycine betaine is an osmo-protectant. The target plants were localsugarcane varieties. Currently, the transformants are maintainedthrough vegetative propagations (stem cuttings) and release approvalhas already been applied for these. In compliance with the regulation,it underwent evaluations at the containment facility at ICABIOGRADBogor in 2003, and confined field tests were also carried out in EastJava (Asembagus and Jatiroto). The total budget that has been spent infour years reached IDR 1.3 billion (PV 2004 IDR 2.3 billion), or equal toUS $ 154,000 (PV 2004 US $ 255,000). The details can be seen in Table 9.

III.4. Construction of Transgenic Rice Resistant to Stem Borersat the Indonesian Institute of ScienceThe project was initiated in 1996, funded by grants from the RockefellerFoundation and the Indonesian Government through APBN. TheRockefeller Foundation sponsored the research from 1996 to 2000. Thetransgene, cry 1A(b), was a gift from Altosar. Research activities beganin 1996 with the establishment of tissue culture system, followed bythe transformation of rice plants as summarised in Table 10.

IV. The Total Cost to Comply With the BiosafetyRequirements for Commercial Releases

IV.1 Government Research Institutions

IV.1.1 Drought-Resistant Transgenic Sugarcane (PTPN XI)In 2003, PTPN XI registered the transgenic sugarcane to BFSC throughBFSTT, to evaluate its phenotype and invasiveness at the containmentfacility in ICABIOGRAD. Evaluation of the stability of the transgenewas simultaneously carried out in greenhouses and laboratories at PTPNXI. Authorisation for the confined field trials were granted by BFSTTin 2003, and was implemented in two locations in East Java (Jatirotoand Asembagus). By 2005, the total expense paid by PTPN XI to fulfillthese regulatory requirements was IDR 178 million (Table 11).

IV.1.2. Transgenic Rice Resistant to Stem Borers (Indonesian Instituteof Science)After seven years of development, the resulting transgenic plants weresubjected to a confined field trial in 2003. That year, the Bt-rice was

99

Tab

el 9

: Act

ual

an

d P

rese

nt

Val

ue

of

Co

st o

f R

&D

of

Suga

rcan

e D

rou

ght

Tole

ran

t at

PT

PN

XI

Yea

tA

ctiv

ity

Act

ual

To

tal C

ost

PV

To

tal

Co

stA

ctu

al T

ota

l Co

stP

V T

ota

l C

ost

(000

IDR

)(0

00 U

S $)

1999

(Ju

l-D

ec)

Tis

sue

cult

ure

sys

tem

for s

uga

rcan

e13

0.48

137

0.88

316

,71

47,4

920

00 (J

an- J

un

)*Pl

ant t

ran

sfor

mat

ion

773.

774

1.07

9.69

490

,67

126,

5220

00/2

001(

Jul-

Jun

)C

onfi

rmat

ion

of g

ene

inte

grat

ion

237.

036

468.

833

23,0

945

,67

2001

Lin

es s

elec

tion

143.

651

246.

917

13,9

924

,05

2002

Con

firm

atio

n o

f gen

e ex

pre

ssio

n b

y95

.417

105.

706

10,3

011

,41

in v

itro

en

zym

atic

an

alys

isTo

tal

1.38

0.35

92.

272.

024

154,

7625

5,14

* In

200

0 PT

. Aji

no

mo

to s

po

nso

red

th

e re

sear

ch a

vtiv

ity

by d

on

atin

g eq

uip

men

ts a

nd

ch

emic

als

valu

ed a

s ar

ou

nd

600

mil

lio

n ID

R.

Tab

le 1

0: A

ctu

al a

nd

Pre

sen

t V

alu

e o

f C

ost

of

R&

D a

nd

Reg

ula

tory

of

Bt-

Ric

e, R

CB

-IIS

Yea

tA

ctiv

ity

Act

ual

To

tal C

ost

PV

To

tal

Co

stA

ctu

al T

ota

l Co

stP

V T

ota

l C

ost

(000

IDR

)(0

00 U

S $)

1996

Tis

sue

cult

ure

sys

tem

for r

ice

352.

716

1.25

7.10

515

0,28

453

5,62

1997

Plan

t tra

nsf

orm

atio

n a

nd

rege

ner

atio

n39

3.55

21.

185.

332

133,

317

401,

5419

98Pl

ant t

ran

sfor

mat

ion

an

d re

gen

erat

ion

633.

879

1.76

3.52

664

,190

178,

5819

99C

onfi

rmat

in o

f gen

e in

tegr

atio

n, e

xpre

ssio

n,

492.

190

1.14

3.94

863

,028

146,

49an

d s

tabi

lity

of g

ene

inte

grat

ion

2000

Con

firm

atin

of g

ene

inte

grat

ion

, exp

ress

ion

,63

3.94

11.

285.

474

68,5

7115

0,63

and

sta

bili

ty o

f gen

e in

tegr

atio

n20

01C

ross

ing

betw

een

tran

sgen

ic V

s p

opu

lar

202.

753

259.

079

19,7

5025

,24

vari

ety,

Gen

e St

abil

ity

2002

Cro

ssin

g be

twee

n tr

ansg

enic

Vs

pop

ula

r21

5.98

025

4.56

223

,321

27,4

9va

riet

y, G

ene

Stab

ilit

yTo

tal

2.92

5.00

97.

149.

026

522,

462

1,46

6

(i) D

oes

no

t in

clu

de

foo

d s

afet

y as

sess

men

t/an

alys

is.

Not

e:-

Pres

ent V

alu

e (P

V) f

or 2

005,

wit

h in

tere

st r

ate

of 1

8 p

er c

ent

- T

he

rese

arch

was

fun

ded

by

the

Ro

ckef

elle

r in

th

e fi

rst

5 ye

ars

apar

t fr

om

Ind

on

esia

n g

ove

rnm

ent

fun

din

g.T

he

tota

l bu

dge

t sp

ent d

uri

ng

the

seve

n y

ear

bt-r

ice

con

stru

ctio

n p

roje

ct (1

996-

2002

) was

IDR

2.9

bil

lion

(PV

IDR

7.1

bil

lion

), o

r eq

ual

to U

S $

522,

000

(PV

US

$ 1.

5m

illi

on

).


100 Asian Biotechnology and Development ReviewTa

bel

11:

Dir

ect

Co

st o

f D

rou

ght

Tole

ran

ce T

ran

sgen

ic S

uga

rcan

e B

iosa

fety

Reg

ula

tory

Ph

ase

Act

ivit

yTo

tal

actu

al c

ost

Tota

l PV

Tota

l ac

tual

co

stTo

tal c

ost

PV

(mil

lio

n I

DR

)(m

illi

on

ID

R)

(US

$)

(US

$)

Do

ssie

r fi

llin

g fo

r l

risk

ass

essm

ent

(200

3)4

7,8

47

09

05

Co

nta

inm

ent

faci

lity

Tes

t at

IC

AB

IOG

RA

D (

2003

)8

13

,19

33

1.5

34

Gen

e st

abil

ity

and

pla

nt

ph

eno

typ

e at

PT

PN X

I’ g

reen

-ho

use

(20

03)

50

69

,65

.83

48

.12

3C

on

fin

ed f

ield

tri

als

(pla

nt

ph

eno

typ

e, d

rou

ght

tole

ran

ce,

58

68

,46

.45

57

.61

7su

gar

con

ten

t et

c) i

n E

ast

Java

(20

03/2

004)

Co

nfi

ned

fie

ld t

rial

s (p

lan

t p

hen

oty

pe,

dro

ugh

t to

lera

nce

,5

85

8,0

5.9

61

5.9

61

suga

r co

nte

nt

etc)

in

Eas

t Ja

va (

2004

/200

5)Su

b-t

ota

l b

iaya

17

82

16

,91

9.6

49

24

.13

9G

ene-

flo

w?

No

n-t

arge

t sp

esie

s?

Foo

d s

afet

y?

Feed

saf

ety

?D

ata

eval

uat

ion

?To

tal

?

Tab

el 1

2: D

irec

t C

ost

of

Tra

nsg

enic

Ric

e R

esis

tan

ce t

o S

tem

bo

rer

Bio

safe

ty R

egu

lato

ry P

has

e

Act

ivit

yA

ctu

al T

ota

l co

stTo

tal

cost

PV

Act

ual

To

tal

PV 2

005

(mil

lio

n I

DR

)(m

illi

on

ID

R)

cost

(U

S $)

(US

$)

Do

ssie

r u

ntu

k p

engk

ajia

n k

eam

anan

hay

ati

6.0

9.8

65

01

,06

0N

on

tar

get

imp

act

(ser

angg

a p

enge

nd

ali

hay

ati)

60

.08

3.5

.7

,00

09

,75

0N

on

tar

get

imp

act

(ser

angg

a p

enge

nd

ali

hay

ati)

70

.08

2.6

7,7

90

9,1

90

No

n t

arge

t im

pac

t (b

akte

ri t

anah

)9

00

90

.09

,25

09

,25

0Su

b-t

ota

l2

66

.02

66

.02

4,2

50

29

,25

0G

ene-

flo

w*

50

.04

2.4

5,1

40

4,3

50

Uji

mu

lti

loka

si*

(2 m

usi

m t

anam

, 10

un

it @

20

juta

ru

pia

h)

40

0.0

28

7.3

41

,11

02

9,5

20

Eval

uas

i d

ata-

dat

a (n

on

-tar

get

imp

act)

*1

0.0

8.5

1,0

30

87

0Ev

alu

asi

dat

a-d

ata

(gen

e-fl

ow

)*1

0.0

72

21

,03

07

40

Tota

l6

96

.06

11

.37

3,0

00

64

,73

0

Not

e: *

esti

mat

ion

co

st (

the

acti

vity

no

t ye

t d

on

e).

101

also registered to get approval for commercial release. The approval processbegan with an authorization from the BFSC through the BFSTT forconducting confined field trial studies in West Java (held in Sukamandi,Karawang, Pusakanegara, and Indramayu). The field study was carriedout in three years to evaluate the effect of Bt toxin carried by the transgenicplants on non-target species, especially insect predators and soil microbes.On 2006, there will be more studies on gene flow from the transgenic rice(Table 12). All the costs listed in Table 12 below were direct costs.

Table 12 shows that up to 2004, IIS had spent IDR 226 million (PVIDR 266 million), which equals US $ 24,200 (PV US $ 29,000). Accordingto Dr. Inez S. Loedin, IIS would need an additional IDR 470 million tocomplete all the requirements of the approval processes listed in Table12. That additional fund would be required for gene flow studies, multi-location testing, and for facilitating meetings of BFSTT and the Teamfor Varietal Release to evaluate the collected data from theaforementioned studies.

IV.2 Multinational Companies

IV.2.1 Bt-Cotton Resistant to Bollworm (Monsanto)Indonesia was the first country in South East Asia that approvedcommercial field releases of transgenic plants. To obtain a permit torelease their Bt-cotton, Monsanto had to comply with the regulatoryprocesses by conducting evaluations and research on Bt-cotton at thecontainment facility owned by the ICABIOGRAD. The approval for alimited field release at seven districts in South Sulawesi was obtained in2001. The total to complete the process was approximately IDR 919million (PV IDR 974 million) of direct cost or approximately US $ 93,000(PV US $ 99,800), as summarised in Table 13. The time spent on additionalresearch and assessments was merely 2-3 years. It only took less than ayear to attain a safe for environment status from the BFSTT, but it tooklonger to actually get the permit from the BFSC and the Minister ofAgriculture. A limited permit was finally issued with the followingconditions:(i) The permit was only valid for one year(ii) Bt cotton could only be planted at seven districts in the province

of South Sulawesi.(iii) The release must be monitored by an appointed team.(iv) Harvested seeds and other byproducts must not be used for feed

nor food.



Tab

le 1

3: D

irec

t C

ost

of

Tra

nsg

enic

Co

tto

n R

esis

tan

ce t

o C

ott

on

Bo

ll w

orm

Yea

rA

ctiv

ity

Act

ual

To

tal

PV

To

tal

Act

ual

To

tal

PV

To

tal

Co

stC

ost

Co

stC

ost

(mil

lio

n I

DR

)(U

S $

)

1998

Do

ssie

r fo

r ri

sk a

sses

smen

t10

.016

.41,

010

1,66

0M

orp

ho

logi

cal

char

acte

rist

ic (

con

tain

men

t fa

cili

ty16

.026

.31,

620

2,66

0at

IC

AB

IOG

RA

D)

1999

Co

nfi

ned

Fie

ld T

rial

s30

.041

.83,

840

5,35

020

00M

ult

i-lo

cati

on

tri

als

140.

016

5.2

16,4

0019

,360

Tech

nic

al T

eam

mee

tin

g fe

e10

.011

.81,

170

1,38

020

01EI

A(e

nvi

ron

men

t Im

pac

t A

sses

smen

t)-G

ene

Flo

w12

5.0

125.

012

,180

12,1

80EI

A-N

on

tar

get

imp

act

193.

019

3.0

18,8

0018

,800

EIA

-so

il m

icro

bes

395.

039

5.0

38,4

8038

,480

Tota

l91

9.0

974.

593

,500

99,8

70

Not

e:Pr

esen

t V

alu

e (P

V)

for

2005

, wit

h i

nte

rest

rat

e o

f 18

per

cen

t.

103

Tab

le 1

4: A

ctu

al a

nd

Pre

sen

t V

alu

e o

f R

egu

lato

ry C

ost

of

Co

rn- R

R N

K6

03

(M

on

san

to)

Yea

rA

ctiv

ity

Act

ual

To

tal

PV

To

tal

Act

ual

To

tal

PV

To

tal

Co

stC

ost

Co

stC

ost

(mil

lio

n I

DR

)(U

S $

)

2002

Do

ssie

r fo

r ri

sk a

sses

smen

t10

.016

.41,

080

1,77

020

02M

orp

ho

logi

cal

char

acte

rist

ic1.

No

n t

arge

t im

pac

t, i

nva

sive

nes

s in

co

nta

ined

fac

ilit

ies

16.0

26.3

1,73

02,

840

2.Li

mit

ed t

rial

at

3 lo

cati

on

s30

.049

.33,

240

5,32

020

02D

oss

ier

for

foo

d s

afet

y10

.016

.41,

080

1,77

020

02te

chn

ical

mee

tin

g (t

wic

e)15

.024

.61,

620

2,66

0To

tal

Ex

pen

ded

Co

st8

1.0

13

3.1

8,7

50

14

,37

0Es

tim

ated

fu

ture

exp

ense

s :

?1.

Mu

lti-

loca

tio

n t

rial

s (1

0 u

nit

s, 2

sea

son

s, a

pp

9 m

illi

on

)18

0.0

180.

018

,530

18,5

30?

2.V

arie

ty r

elea

sed

Tea

m m

eeti

ng

to e

valu

ate

mu

lti-

15.0

15.0

1,54

01,

540

loca

tio

n t

rial

s d

ata

?3.

Co

nfi

ned

Fie

ld T

rial

sa.

EIA

-Gen

e Fl

ow

125.

012

5.0

12,8

7012

,870

b.EI

A-N

on

tar

get

imp

act

193.

019

3.0

19,8

7019

,870

c.EI

A-s

oil

mic

rob

es39

5.0

395.

040

,660

40,6

60?

4.Fe

ed s

afet

y st

ud

ies

(fis

h,

po

ult

ry)

15.0

15.0

1,54

01,

540

?5.

Ad

dit

ion

al T

ech

nic

al m

eeti

ng

(3 t

imes

)30

.030

.03,

090

3,09

0T

OT

AL

1,0

34

1,0

86

10

6,8

50

11

2,4

80

Not

e :

-Pr

esen

t V

alu

e (P

V)

for

2005

, w

ith

in

tere

st r

ate

of

18 p

er c

ent.

-?

no

t ye

t m

enti

on

ed.



(v) The permit would be reevaluated if some unintended negativeconsequences that could harm the environment and humanhealth were found.In 2001, about 6,639 farmers planted Bt-cotton over a 4,363 hectare

area with an average yield of 1.2 tons/hectare. By 2002, the plantationarea increased to 5,124 hectares and 10,424 farmers were involved. Theaverage yield also increased to 2.2 tons/hectare, which was 2-3 timeshigher than the average yield of non-transgenic cotton varieties.8

However, for some reasons Monsanto decided not to continue theplantation of Bt-cotton in 2003.

IV.2.2 Roundup-Ready NK603 CornMonsanto started the application process for the herbicide-resistantcorn in 2002. Originally, approval application was made for tworoundup-ready corn varieties: RR GA21 and RR NK603. However,Monsanto subsequently decided to focus on RR NK603 for theIndonesian market. Table 14 shows that since 2002 the company hasspent around IDR 81 million (PV IDR 133 million), which equals US $8,700 (PV US $ 14,000). Until this paper was written, a release permithad not been issued for RR NK603. It is expected that more researchand evaluations would need to be carried out to get the approval, whichmeans that around IDR 953 million or US $ 106,000 would be neededto pay for the whole regulatory processes.

Discussions

Based on the tables presented previously, it can be seen that the researchcost for constructing and releasing transgenic plants is varied. Thisvariation was caused by differences in the commodities used as thetarget plants, the trait-introduced, the type of research, the locationof the research, the institutions performing the research (government-owned companies, universities, independent public institutions), andthe source of funding. Variations can also happen on very similarresearch projects due to differences in approach, methods, and/orparameters to be studied. Table 15 lists the budget needed for both theconstruction and approval processes.

Table 15 shows in this case that the construction of transgenicplants required an actual budget of IDR 1.4-3.1 billion (PV IDR 2.4-7.1billion), which equals to US $ 171,000-522,000 (PV US $ 641,000-1,500,000). These numbers clearly mean that constructing transgenic

105Ta

ble

15

: Est

imat

ed C

ost

fo

r R

&D

an

d B

iosa

fety

Reg

ula

tory

of

Sev

eral

Tra

nsg

enic

Cro

ps

in I

nd

on

esia

*

Cro

pYe

ar o

fIn

itia

ted

Pres

ent a

ctiv

ity

stat

us

(200

4/20

05)

Esti

mat

ed c

ost

acti

vity

step

of

Act

ual

PVA

ctu

alPV

acti

vity

(mil

lio

n(m

illi

on

(th

ousa

nd

(th

ousa

nd

IDR

)ID

RU

S$)

U$$

)

Pota

to re

sist

ance

1994

-04

Gen

eG

reen

hou

se (p

lan

t ph

enot

ype

dan

1.43

12.

470

317,

565

0,8

to fu

ngi

/is

olat

ion

con

firm

atio

n o

f gen

e in

tegr

atio

n a

nd

nem

atod

eex

pre

ssio

n a

nd

fun

ctio

n)

Cit

rus

resi

stan

ce19

97-0

4G

ene

Gre

en-h

ouse

(pla

nt p

hen

otyp

e da

n3.

108

5.57

237

064

1to

CV

PDis

olat

ion

con

firm

atio

n o

f gen

e in

tegr

atio

n,

expr

essi

on, f

un

ctio

n)

Suga

rcan

e to

lera

nt

1999

-02

Plan

tC

onfi

rmat

ion

of g

ene

inte

grat

ion

1.38

02.

272

154,

7625

5,14

to d

roug

ht

tran

sfor

-an

d e

xpre

ssio

nm

atio

n

2002

-05

Bio

safe

tyC

onfi

ned

fiel

d tr

ials

(pla

nt p

hen

otyp

e,17

821

6,9

19,6

24,1

regu

lati

onsu

gar c

onte

nt,

dro

ugh

t tol

eran

ce)

Ric

e re

sist

ance

to19

96-0

2Pl

ant

Con

firm

atio

n o

f gen

e in

tegr

atio

n,

2.92

57.

149

522,

51,

466

stem

bore

rtr

ansf

or-

exp

ress

ion

, an

d tr

ansf

orm

atio

nm

atio

nst

abil

ity

2002

-05

Bio

safe

tyC

onfi

ned

fiel

d tr

ials

for

non

-tar

get

226

266

24,2

29,2

5re

gula

tion

imp

act

(nat

ura

l en

emie

s an

dso

il m

icro

bes)

Bt-c

otto

n19

98-0

2B

iosa

fety

Co

nta

ined

faci

lity

test

(pla

nt

mo

rph

olo

gy),

919

974,

593

,599

,9re

gula

tion

con

fin

ed fi

eld

tria

ls, m

ult

ilo

cati

on

test

s,en

viro

nm

ent i

mp

act a

sses

smen

t (n

on-t

arge

tim

pac

t-n

atu

ral e

nem

ies,

soi

l mic

robe

s)–

gen

e-fl

ow).

Th

e tr

ansg

enic

Bt-

cott

on c

rop

had

been

rel

ease

d fo

r co

mm

erci

al u

se in

200

1, 2

002,

but t

he

pro

pon

ent d

id n

ot e

xten

d th

e ap

pro

val

or c

onti

nu

e bt

-cot

ton

bu

sin

ess

in In

don

esia

in 2

003

RR

-Cor

n20

02-0

2B

iosa

fety

Con

tain

men

t Fac

ilit

y Te

st (p

lan

t mor

ph

olog

y)81

133

8,7

14,4

regu

lati

onat

ICA

BIO

GR

AD

, co

nfi

ned

fiel

d t

rial

in 3

loca

tion

s, a

sses

smen

t for

en

viro

nm

ent a

nd

food

saf

ety.

No

t yet

gai

ned

the

rele

ase

app

rova

l

Not

e: *

Dir

ect

cost

on

ly.



plants is neither a cheap nor trivial activity. The project can take morethan four years just for the construction stage, and further time andresources would need to be allocated to comply with the regulatoryprocedures to obtain the permit so that farmers can plant these ontheir fields.

The cost of the regulatory process can be inferred from the case ofMonsanto and the Indonesian Institute of Science when they attemptedto gain approval for their transgenic plants. Bt-cotton, which is neithera food nor feed crop, had to undergo three years of evaluation with asteep cost of IDR 919 million (equal to US $ 99,000). It is potentiallyworse for food crops, as in the case of RR NK603 corn. After five yearsof evaluation for approval that cost IDR 81 million (PV IDR 133 million),it has not even met the requirements set by the BFSC through theBFSTT for its commercial release. It is estimated that IDR 900 million ofadditional fund would be required for completion of the regulatoryprocedures. It should be noted that this RR NK603 corn has alreadybeen released commercially in several countries, including ThePhilippines.9

The cost of the regulatory processes leading to commercial releaseof transgenic plants that must be paid by institutions (private andgovernment-owned) in other countries will be described as acomparison. In India, the cost of government approval to releasethe Bt-cotton (which had already been released in the USA) was US$ 900,000 (excluding salaries). The process took 3-4 years and onlyconsists of additional trials conducted in India. Assessments ontransgenic plants that have never been released in other countrieswould cost more and need a longer period of evaluation. Nevertheless,the cost incurred to government-owned institutions would be lower.It is estimated that the cost of approval for transgenic Bt-eggplantconstructed by a government institution would be around US $53,000. In the future, releasing transgenic plants in India, like Bt-corn,for example, would cost around US $ 500,000 to comply with theregulatory requirements.10

China, on the other hand, is likely to charge less than India. Theexpenses paid by private companies to gain approval in China wereonly US $ 65,000 to 89,000, while the government institutions in Chinawould only need US $ 53,000 to 61,000. Only a small fraction of thoseapproval cost were needed for the biosafety evaluation/assessment(around US $ 15,000), while the rest was mainly used for breeding

107

purposes. Meanwhile, the cost of food safety assessment is relativelymore expensive. For example, the cost of food safety assessment fortransgenic mustard (a close relative of canola) was US $ 3-4 million inthe USA and Europe. In China, a similar process carried out on Bt-cotton and Xa-21 rice would cost US $ 600,000 .11

It is difficult to make a cost comparison between private companiesand the government institutions in Indonesia because there have notbeen any commercial releases of transgenic plants produced bygovernment institutions. However, some comparisons could be done ifwe break the regulatory processes down into stages, such as dossier filling.Private companies like Monsanto were expected to pay around IDR 10million for dossier filling, while government institutions like IIS andPTPN XI are only expected to pay IDR 6 million and IDR 4 million,respectively. For an environmental risk assessment study like the effectof Bt on non-target organisms, IIS only paid IDR 80 million whereasMonsanto had to shell out IDR 193 million. For gene flow studies, IISalso would pay around IDR 80 million compared to Monsanto thathad to pay IDR 125 million (Table 16).

For Table 16, we were also attempting to obtain some information/data from several laboratories performing part of the evaluation studies.From our discussion with one of the members of the BFSTT, it wasconcluded that a standardised test or a minimal requirement systemfor risk evaluation is definitely required, like the number of samples,replicates, observed parameters, the length of experiment, and thenumber of seasons over which the experiment should be conducted.Therefore, the result is more universally applicable in deciding the safetyissues of the genetically-engineered products.12

Like the cost of research in transgenic construction, there is alsoa significant variation in the cost of the approval process. It dependson whether the applicant is a private company or a government-affiliated institution. This holds true for many countries. The approvalcost is also contingent on the number of additional evaluations thatneed to be carried out in the country where the application is lodged(in-house assessments). There is no available standard for the type ofinformation/data that needs to be supplied in this in-house assessmentprocess, technical and cost-wise. As an example, the following tablesummarises the type of data that needs to be supplied for risk assessmentsin other countries.



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109

Tabel 17: Type of Data and Experiment Needed for RiskAssessment (Environment, Food, Feed Safety) for Transgenic

Crops (Dr. Jose Falck-Zepeda, 2003*)

Data

Product characterization Unique identifier, reference material, validation, genestability, protein purification, mechanism of action,homology, digestability, etc

Food/feed safety Toxicology (acute and repeated oral, mutagenicityand developmental, sub-chronic and chronic),oncogenicity, effect on immune and endocrinesystem, dietary characteristic, norwegian ratallergenicity studies, monkey feeding, dog feeding,nutritional value, micotoxin analysis, anti-nutrient

Feeding studies Poultry, fish, cow, buffalo feeding studies

Compositional analysis Proximal studies, aminoacid sequence

Ekspression studied Leaf, stem, floral, seed, oil etc

Environmental safety Non-target impact (predator, parasites, bee, ants, soilmicrobes, herbivore, storage pests, weeds), gene-flow(develop model, field studies of pollen flow,development of insect resistance strategy (baselineresistance studies).

Note: *Summary from the questionare template that we used in this survey

There was also no consensus on the number of years andreplications of the tests necessary for the risk assessment. The sameapplies for food safety evaluations. What types of information/datawere needed to be supplied? Would the information/data collected fromother countries be applicable as well? What conditions are necessaryfor in-house assessments?

Apart from data that originated from Indonesian researchers andlaboratories, we also tried to review the cost of biosafety and food safetyassessments in other countries like India and China (Table 18) in orderto estimate the necessary costs required to gather the necessary data forthe risk assessment process.

Prospects and Challenges for Research, Development, andApplication of Transgenic Plants in Indonesia

A continuous expansion of the plantation area of transgenic plantsworldwide indicates that there is a significant increase in public



acceptance of transgenic crops. There is also an increase on the numberand variety of transgenic plants being constructed and released forcommercial applications. This was accompanied by growth in theamount of investments in this field as well. By 2005, a total of 90 millionhectares of land in 21 countries was cultivated with transgenics grownby 8.5 million farmers.13 The number of applications for field trial inseveral developing countries has also increased. For example, in 1997China has received 1044 applications for confined field trials and 777 ofthose were approved, which consisted of 60 different transgenic plants.By 2003, approvals for commercial releases were granted for 30 varietiesof Bt-cotton, and this number further increased to 140 in 2004.14 In thePhilippines, four varieties of transgenic corn (NK603, Bt11, Mon810,and NK603xMon810) have been approved for commercial release.15

As an agrarian country, Indonesia is keen to implement geneticengineering to further improve the agricultural output and the welfareof its citizen. This is reflected in the willingness of the government toadopt the application of transgenic plants, even though everythingwas carried out under the principle of cautiousness. In the current eraof globalisation, it is difficult to isolate one country’s policy from theothers. This is even more pronounced under the regime of internationalconventions like CBD (Cartagena Protocols), GATT, WTO, and others.

Table 18: Estimation of Cost of Several Test forRisk Assessment in India and China

Type of experiment Estimated cost (US$) References

Goat feeding study-90 day 55,000 India (Pray et al., 2005)Cow feeding study 10,000 India (Pray et al., 2005)Water buffalo feeding study 10,000 India (Pray et al. 2005)Pollen flow 40,000 India (Pray et al. 2005)Poultry feeding study 5,000 India (Pray et al. 2005)Fish feeding study 5,000 India (Pray et al. 2005)Brown Norway rat allergenicity study 150,000 India (Pray et al. 2005)Socio economic study 15,000 India (Pray et al. 2005)Baseline resistance study 20,000 India (Pray et al. 2005)Limited field trial 5,000 India (Pray et al. 2005)Resistance study 20,000 India (Pray et al. 2005)IPM package 10,000 India (Pray et al. 2005)Food safety-anti nutrients 120 China (Pray et al 2006)Food safety-rat feeeding (90 day) 14,500 China (Pray et al 2006)Environment safety 32,800 China (Pray et al 2006)Environment field trial 1,500-5,000 China (Pray et al 2006)

111

Consequently, in order to increase its competitiveness in the globalarena, Indonesia needs to put in place a solid research and regulatorysystem to encourage positive developments and applications of thetransgenic plants.

Prospects and Challenges of Research for ConstructingTransgenic Plants in IndonesiaConstructions of transgenic plants have been initiated since 1996 inIndonesia. At the same time, regulations on genetically engineeredproducts were also issued. However, the progress of research andapplications of transgenic plants in Indonesia has not been as rapid asexpected.

Several developing countries have also constructed their owntransgenic plants. There have been 209 transformation projects carriedout in 76 institutions from 16 developing countries.16 Like Indonesia,generally these countries initiated the projects at the beginning or middleof the 1990s. Indonesia is one of the most active developing countriesin building up its plant genetic engineering programme, with 11 percent of the total transformation events taking place in its laboratories(209 transformation events). As a comparison, among other most activedeveloping countries, China performed 14 per cent of thetransformation events, South Africa did 13 per cent, Argentina 10 percent, and India also had 10 per cent. However, the success of suchprogrammes would be indicated by the number of transformants thatare actually registered for commercial release. In this regard, Indonesiais classified as being not as successful as other countries like China andIndia. In India, in 2003 commercial release application were made for34 events, while in that same year the Chinese National Commissionof Biosafety received 1044 applications for confined field trials.17

Meanwhile, there was only one approval issued in Indonesia, and thatpermit was only valid for one year. The proponent had to renew thepermit each year, but after three years elapsed, Monsanto decided notto extend it any further.

Research on transgenic plant constructions in Indonesia duringthe period of 1996-2004 are listed in Table 6. There were 20 differentcommodities being targeted for transformation, with several differentintroduced traits. But they were largely or mostly unsuccessful. Out of31 different construction activities, only 16 of them were still active(going-on) and only two of these 16 actually resulted in application



for for release approval. There were several reasons given by theresearchers for these projects being terminated, such as lack of progress;termination of grants; etc. It would be interesting to look further intothe actual cause of such low success rates of transgenic research inIndonesia. Was it caused by a lack of technology transfer or by a non-conducive research environment? Or was it because of limited andirregular fund availability?

There were several institutions performing transgenic constructionsin Indonesia, such as government institutions whose mandateexclusively pertains to conducting research; universities; government-owned corporations; and private companies.18 Government institutionswith exclusive research mandates tend to have an easier time in gettingresearch grants, but this is not the case with the universities, whosemain mandate is education. Consequently, most research activities inthe universities have a shorter lifespan and rely heavily on competitivedomestic grants like RUT and grants from overseas. Once the fundingis terminated, research activities associated with it will also cease to exist.A good example, of this unfortunate condition is found to be in thedevelopment of citrus resistant to CPVD and potatoes resistant to fungi/nematodes, which were the results of at least five years worth of researchthat cost between IDR 1.4 - 3.1 billion. These activities were simplyterminated, because there was no funding available for the principalinvestigators to apply for the expensive and complicated regulatory processrequired for the approval. This clearly set a negative precedent for futuredevelopments of transgenic plants. On the other hand, a stringentregulation that complies with international standards is required to ensurethe safety and health of the public and the environment. This is an absoluteprerequisite in gaining public acceptance of genetically-engineered products,as also in the winning of acceptance from other countries of Indonesianagricultural products with genetic modifications (personalcommunication with the Director General of Food Crops, 2006). Sohow thorough should the evaluation process be? What types of testsneed to be conducted? And who will foot the bill? These questionsneed to be considered before starting a research in developing transgenicplants, so that the result of all the hard works can be utilised by farmersand all Indonesian citizens in general.

The results of the surveys also indicate that priorities must be setto decide on which commodities will benefit most from geneticengineering. The priorities can be set by considering all the available

113

information/data, both on technical and socio economical aspects.Socio economic assessment is needed (i) to get real beneficiaries of thetransgenic plants; (ii) to get real benefit-cost involve in R&D activities;(iii) to get tolerance level; (iv) as a back up for policy direction onprioritisation; and (v) as a transparency tool for accountability ofactivities. Once the priorities are set, a commitment needs to be madeso that resulting research activities would be guaranteed continuousfunding and supportive research environment. The funding andrequired facilities can be obtained through cooperation with anappointed institution that is both competent and has a strongcommitment to produce transgenic plants that can be utilised by farmersand consumers in general.19

Prospects and Challenges of the Applications of TransgenicPlants in IndonesiaIn order to win public acceptance for transgenic plants and theirderivative product for domestic uses or exports, a set of regulationsthat comply with international standards and guarantee the food, feed,and environmental safety is needed. Several regulations on this matterhave been issued in Indonesia, from the ministerial level to PresidentialDecrees. The regulations continuously evolved since their inception in1996, in the form of Food Law and other kinds of regulations, until thepublication of Government Regulation No. 28 (2004) on food safetyof genetically-modified products and Government Regulation No. 21(2005) on the biosafety of genetically-modified products.

On a global scale, the existence of regulations on biosafety andfood/feed safety in different countries will improve the acceptance oftransgenic plants by the majority of the population as long as thoseregulations have consistent implementation and are strictly enforced.This was partly responsible for significant increase of the plantationarea of transgenic plants worldwide. There are several benefits that canbe reaped from planting transgenic crops. Available scientific datasuggests that transgenic crops have improved agricultural production,increased farmer income, and reduced the usage of pesticides.20 Thiscan be illustrated by the following points:1. China has started planting the Bt-cotton since 1997. By 2004, the

total plantation area of Bt-cotton has increased to 5.7 millionhectares, which is roughly 65 per cent of the total plantation areafor cotton. Bt-cotton produced 8-10 per cent more yield compared



to non-Bt cotton. There are also additional savings from reducedinsecticide use, which was around US $ 94.10 per hectare. Chinesenational income derived from Bt-cotton was US $ 1.1 billion in2004.

2. Mexico began planting Bt-cotton in 1996. Farmers who plantedthe cotton gained additional income from US $ 113 per hectareto US $ 354 per hectare compared to farmers who did not plantthe Bt-cotton.In the case of Indonesia, farmers started planting Bt-cotton in

seven districts in the Province of South Sulawesi in 2001. Monsanto, asa multinational company, could only obtain a limited permit that hadto be renewed each year. However, Monsanto decided to stop sellingthe Bt-cotton (Bollgard) in 2003 due to various reasons. One amongthese was that it was not profitable for them. Cotton is one of themajor raw materials for the textile industry, but 99 per cent of thedomestic requirements for cotton in Indonesia were still imported. Astudy conducted by Siregar and Kolopaking (2002) showed that thenet income of farmers planting Bt-cotton was IDR 1,386,706 per hectare(equal to US $ 138 per hectare) while the net income of farmers plantingother varieties of cotton on average was IDR 765,299 per hectare (equalto US $ 76.5 per hectare). The difference extended to the labour used aswell; farmers planting Bt-cotton used less labours compared to thefarmers planting non-Bt cotton.21

The fact that the plantation of Monsanto’s Bt-cotton wasterminated has impeded the development toward widespread plantationof other genetically-modified plants. Until this paper was written, noother transgenic plants have been commercially released in Indonesia,even though there has been an increase in the type of plants and theirarea of plantation in neighbouring countries like China, India, andthe Philippines.

In order to facilitate and accelerate the development of transgenictechnologies in Indonesia, a regulatory apparatus that can beimplemented easily, economically, and consistently is required so thatpublic acceptance of transgenic plants can be further improved. A simplelegal framework is essential and necessary. However, the regulation hasto be based on an international standard, be founded on a solidscientific basis, and should be accompanied by clear operational andtechnical guidance so that it can be easily implemented. The regulationwould be implemented by the Biosafety and Food Safety Commission

115

(BFSC) and BFSTT. The organisation should be composed of expertsand decision makers from several government institutions and privatesectors. The system/framework of the commission must be clearly definedto prevent it from impeding the implementation of the regulations.This study found that under the old regulation (the joint ministerialdecree), the BFSC’s membership consisted of 21 high-rankinggovernment officials, who due to their busy schedules always haddifficulty in scheduling a meeting among them. Since its inception,the BFSC has only held 3-4 meetings. The BFSC was assisted by theBFSTT in their decision-making processes. But actually, it was the BFSTTwho ran the day-to-day operation of the regulatory system. The BFSTTis an ad hoc committee, whose membership consisted of experts fromdifferent scientific backgrounds. It does not have a full time secretaryfor its daily operations. Its activities are scheduled according to thenumber of applications received by the technical team, and are mostlyfunded by the proponent/applicants. Each member of the BFSTT alsohad many other commitments so they often had difficulties in attendingto their duties as Member of the Biosafety and Food Safety TechnicalTeam. To illustrate this, it took the BFSTT less than one year to giveapproval to Monsanto’s Bolgard cotton, but it took more than twoyears for the BFSC and the Minister of Agriculture to issue the permiteven though the plant in question had already been certified as safe bythe BFSTT.

This study also found that the BFSTT has not issued a standard (aSOP) on what kind of tests would need to be performed for evaluatingthe release of transgenic plants. For example, is it really necessary fordifferent types of transgenic plants like the drought-resistant sugarcane(PTPN XI), Bt-rice resistant to stem borer (IIS), and potatoes resistantto fungi/nematodes (BAU) to supply all the information/data listed inTable 17?

Any existing regulations must clearly state whether data on foodsafety obtained overseas was also applicable in Indonesia, so thattransgenic plants that have been released in other countries no longerneed to be subjected to in-house data collections. Similarly, what kindof environmental impact assessment was necessary for plants that havebeen released in other countries and those that have never been releasedanywhere in the world? What kinds of parameters need to be measuredin an environmental impact assessment? The applicants can carry outa food safety and biosafety evaluation according to the requirements



set by the law/regulation once these issues are clear so that, there willnot be any dispute or ambiguity when the information/data obtainedfrom the evaluation process does not meet the required standards. Forexample, in an impact study on non-target insects, what kind of non-target insects would need to be evaluated? Or which soil would microbesneed to be studied? Such details would need to be worked out becausethey would influence the cost of the approval process (without anydisregard to the scientific/evaluative aspects). Ideally, the onlyinformation/data that need to be gathered in-house are those thathave not been evaluated anywhere else, while data that are alreadyavailable should not be gathered by in-house experiments. Any additionalin-house experiments that may need to be performed should be doneto answer standard questions set by the regulations for commercialrelease.

Endnotes1 James (2003).2 ISAAA (2005).3 Moeljopawiro and Falconi (1999); Bahagiawati et al. (2003).4 Pray et al. (2005; 2006).5 Moeljopawiro and Falconi (1999); Bahagiawati et al. (2003).6 Wirawan IPG (2000; 2004).7 Murdiyatmo et al. (2004).8 Bermawie et al. (2003).9 Halos (2006).10 Pray et al. (2005).11 Pray et al. (2006).12 Dedi Fardiaz (2006), personal communication).13 ISAAA (2005).14 Pray et al. (2006).15 Halos (2006).16 Atanassov et al. (2004).17 Pray et al. (2006).18 Moeljopawiro and Falconi, (1999); Bahagiawati et al. (2003)19 Personal communication with the Director General of Horticultures, 2006.20 Graham and Barlofoot (2005).21 Lokollo (2001).

ReferencesAtanassov, A., A. Bahieldin, J. Brink, M. Burachik, J. I. Cohen,V Dhawan, R. V. Ebora,

J. Falck-Zepeda, L. Herrera-Estrella, J. Komen, F. C. Low, E. Omaliko, B. Odhiambo,H. Quemada, Y. Peng, M. J. Sampaio, I. Sithole-Niang, A. Sittenfeld, M. Smale,Sutrisno, R. Valyasevi, Y. Zafar, and P. Zambrano. (2004). “To Reach the Poor-Results from the ISNAR-IFPRI Next Harvest Study on Genetically Modified Crops,Public Research, and Policy Implications. EPTD Discussion Paper No. 116.

Bahagiawati, A.H., Sutrisno, S. Budihardjo, Karden Mulya, Djoko Santoso, SonySuharsono, H. Rizjaani, E. Juliantini, A. Estiati, S. Muljopawiro, A. Rahayu, danS. Saono. (2003).”Capacity Building Development of Biotechnology and Biosafety

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in Indonesia”, A National Biosafety Framework GEF-UNEP research report. 33pp.(Indonesian with English summary)

Bermawie, Nurliani, A. H. Bahagiawati, Karden Mulya, Djoko Santoso, BudihardjoSugiarto, Evy Juliantini, Syahyuti, Erizal, Hasnam, and Andi Trisyono. (2003).“Development and Impact of the Release of LMOs and their Commercial Products:The Case of Bt Cotton and Imported Soybean”. A National Biosafety FrameworkGEF-UNEP research report. 54 pp.

Halos, S. (2006). “Philippines Experience: Biosaety Policy, Development andImplementation”. Apec Conference on Biosafety policy options. Manila,Philippine, 16-18 January.

ISAAA (2005). “Executive Summary Global Status of Biotech/GM Crops 2005”. ISAAABriefs No. 34-2005.

Graham, B. and P. Barlofoot (2005). “GM Crops: The Global Socio-economic andEnvironmental Impact-The First Nine Years 1996-2004”. PG Economics Ltd,Dorchester, UK. 79p

James, Clive (2003). Executive Summary. Preview. Global Status of CommercialisedTransgenic Crops. ISAAA.

Lokollo, E. M., A. Syam, A.K. Zakaria (2001). “Kajian sosial ekonomi pengembangankapas transgenic di Sulawesi Selatan MT”. Pusat Penelitian dan PengembanganSosial Ekonomi Pertanian.

Moeljopawiro, S and C. Falconi (1999). “Agricultural Biotechnology ResearchIndicators: Indonesia”. Discussion paper No. 99-07 April, ISNAR

Murdiyatmo, U., A. Nurmalasari, Suminingrum, Kusamawati and H. Miwa (2004).“Expression of Gene Choline Dehydrogenease From E. Coli and R. Meliloti inTransgenic Sugarcane”. Second Indonesian Biotechnology Consortium Meeting,Denpasar, Dec 1-3.

Pray, C. E., P. Bengali and B. Ramaswami (2005). “The Cost of Regulation: The IndiaExperience”. Quarterly Journal of International Agriculture 44 (3): 267-289

Pray, C. E., B. Ramaswami, J. Huang, R. Hu, P Bengali, and H. Zhang (2006). “Costsand Enforcement of Biosafety Regulations in India and China”. InternationalJournal Technology and Globalization 2 (1/2): 137-157.

Siregar, H. dan L. M. Kolopaking (2002). “Telaahan Sosial Ekonomi Usahatani KapasBt: Temuan Awal Dari Propinsi Sulawesi Selatan”. Makalah disampaikan pada“Seminar evaluasi penanganan kapas transgenik MT 2002 di Sulawesi Selatan,Hotel Salak, Bogor, 14 November.

Wirawan, I Gde Putu (2000). “Isolation of Resistance Loci of CVPD (citrus vein phloemdegeneration) using Agrobacterium Plant Transformation method”. Final Reportof RUT Grant.

Wirawan, I Gde Putu (2004). “Molecular Level Mechanism of Infection of CVPDDisease in Citrus and Role of Diaphorina Citri Kuw as a Disease Vector”. FinalReport of RUT Grant.


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