2/21/2019

Widya Asmara

Center for Bioethics and Medical Humanities

UNIVERSITAS GADJAH MADA

GMO
 What is GMO:
 Any organism which has combination of new genetic
material obtained through the use of modern
biotechnology (UU 21, 2004)
 What is modern biotechnology:
 Application of genetic engineering techniques that
include in vitro nucleic acid techniques and cell fusion
of two or more types of organisms outside taxonomic
relationships (PP 21, 2005)

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GM Crops & GM Foods

 GM Crops:
 Any crops which has combination of new genetic
material obtained through the use of modern
biotechnology
 GM Foods:
 GM foods ~ GE foods ~ bioengineered foods are foods
produced from GMO

GMO Crops Benefits

 Purpose of GM Crops:
 Enhanced plant growth
 Decreased pesticide and fertilizer use
 Increased nutrient potential
 Increased crop yields

 Ultimate Goal (Green Revolution):

 Strengthen Food Security
 Decrease poverty & eradicate resulting infectious diseases

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What we needs:
The availability of adequate food

Food Security

Public welfare

Problems:
 Population growth
• Limited land
• Climate change
 Productivity decreased

 Modern Biotechnology /Genetic Engineering
offer potential ways for providing better food
Any risk?
What risks ?
Undesirable consequences ?
Do we concern about ?

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Concerned questions
 Health care,
 Merchandising,
 Legality,
 Biosafety ,
 Ethics,
 Social & cultural issues

GMO Risks

 Health care:
 Emerging allergens
 Emerging toxins
 Biosafety:
 Herbicide-resistant weeds / “superbugs”
 Decreased biodiversity
 Ethical / Moral Concerns

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Legal organization
 WHO, FAO, Codex Alimentarius Commission,
 First assessed of possible risks of GMO: Asimolar
conference in 1975
 Approving first legal regulation of GM products in 1990’s
 International treaty of biodiversity (Rio de Janeiro 1992-
1993)
 Cartagena protocol:
The Protocol is an international legally binding treaty which sets
procedures and mechanisms to be applied in the transboundary
movements of Living Modified Organisms (LMOs)- that possesses a
novel combination of genetic material obtained through the use of
modern biotechnology (genetic modification).
o Indonesian Biosafety Commission (KKH-PRG)

GM Product in Indonesia?
 Indonesia believes in the potential of Genetically Engineered
Product (GEP) for food production, medicine development
and human health.
 However, biotechnology application may create some risk on
environment, biological diversity, and human health
 Indonesia has been aware of the controversy about the safety
aspects of modern biotechnology, and chooses to take the
precautionary approach to avoid the potential adverse impacts
on food and animal safety as well as the environment

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Arguments for Genetically Engineered Food

 Potential to:  Similar to traditional
 Increase productivity Plant and Animal
 Increase purity breeding
 Increase safety
 Unless misused, outcome
 Improve nutrition
expected to be beneficial
 Improve food quality
 Is a powerful technology
 Improve sustainability
that could help
 Benefit ecosystem
humanity
 Process not inherently
harmful

Criticisms of GM Crops
 Species crossing diseases
 Monopolization of world food supply by multinationals
protected by patents
 Loss of biodiversity
 Ethical / Moral Concern

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ETHICS:
 Ethics identifies a code of values for our actions
 Bioethics – area of ethics that deals with the
implications of biological research and
biotechnological applications, especially regarding
medicine
Ethics in GM-technology: collection of guidelines
which evaluate permitted limits of genetic
experiments applicable on live organisms from
ethical point of view.
A practical strategy for enhancement of benefits &
reduction of risks in genomic technologies.

Arguments against
Genetically Engineered Foods
1. Potential safety risk for humans
 Unintended Consequences

 To be confirmed by checking:
 Composition assessment – Substantial equivalence:
 the equivalence of nutritional content with non-GMO
products,
 not contain toxins and allergens

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Arguments against
Genetically Engineered Foods
2. Potential safety risk for environment
 Could spread

 To be confirmed:
 Genetic stability, no gene flow
 No contamination of local non-GM crops
 No adverse risk to biodiversity

Arguments against
Genetically Engineered Foods
3. Benefits multinational corporations
• not consumers or developing nations

 To be confirmed:
Promote the general welfare
Maintain people’s rights (individuals, groups,
corporations)
Ensure justice: burdens and benefits must be fairly shared
(Nagoya Protocol)

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Arguments against
Genetically Engineered Foods
4. Genetic Engineering is playing God
 Not Natural to move genes between species
 Ethically wrong
 Confirmation:
Is it only GM crops really unnatural?
No, because: Any form of plant breeding can be
regarded as unnatural, because almost always
some human intervention when modifying
plants into the desired characters

APPROACHES TO ETHICAL DECISION

MAKING

 The utilitarian approach: is essentially a

moral principle that asserts that morally correct
actions are those that provide the greatest
volume of benefits over harms for the majority
of people
 Deontological approach: is an approach
to Ethics that focuses on the rightness
or wrongness of actions themselves, as opposed
to the rightness or wrongness of the
consequences of those actions

 Which one is more important ?

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Arguments against
Genetically Engineered Foods
1. Potential safety risk for humans
 Unintended Consequences
2. Potential safety risk for environment
 Could spread
3. Benefits multinational corporations
 not consumers or developing nations
4. Genetic Engineering is playing God
 Not Natural to move genes between species

 That’s Why GM-Crops Should be Properly Regulated

Why should be Regulated ?

 Regulations are designed to protect
people, other living organisms, and
the environment

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what “Regulation” for?

 Are intended to allow us to safely use the
benefits of biotech.
 Help in developing and using biotech
products and services.

Responsible Agencies
 Three Ministerial have primary responsibilities for
administering laws related to biotech:
 MoH : BPOM: to assure the safety of food and drugs
 MoA : decide whether products are safe to use on
cultured crops or animals
 MoE&F : to assure quality environment

 KKHPRG

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Regulations Related to Biosafety

 Law No. 23 of 1992 on Health

 Law No. 16 of 1992 on Animal, Fish, and Plant Quarantine
 Law No. 7 of 1996 on Food
 Law No. 41 of 1999 on Forestry
 Law No. 18 of 2002 on National System for Research,
Development and Application of Science and Technology
 Law No. 18 of 2004 on Plantation
 Law No. 32 of 2009 on Environmental Protection &
Management
 Law No 21, 2004 on Ratification of Cartagena Protocol
 Government Regulation No. 21 of 2005 on Biosafety of
Genetically Engineered Product
 Presidential Decree No. 39 of 2010 on Biosafety Commision of
Genetically Engineered Product
 Presidential Decree No. 181 of 2014 on Biosafety Commision
of Genetically Engineered Product

Government Regulation 21/2005

The purpose of this Government Regulation:

 to realize environmental safety, food safety and / or
animal feed safety of GEP and its use in the area of
agriculture, fishery, forestry, industry, environment
and non pharmaceutical health.
 to improve efficiency and effectiveness of GEP use
for people welfare based on principle of health and
biological resource management, consumer
protection and certainty in operating business

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Government Regulation 21/2005

Scope
Modern biotechnology to produce GEP
Type & requirement of GEP;
Research & Development of GEP;
Importation of GEP from abroad;
Assesment, Release and Distribution, and
use of GEP;
Supervision & control of GEP;
Institution.

Government Regulation 21/2005

Principle
 Arrangement applied in this government regulation
is a precautionary approach in realizing
environmental safety, food safety and /or animal
feed safety
 based on an accurate scientific method by
considering religious, ethic, socio- cultural and
esthetic norms.

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Regulation on GMO / LMO

 GMOs are carefully tested and documented before
products are available.
 GMOs must be labeled and used according to
instructions
 Agricultural producers must segregate GMO crops
from other crops.
 Harvested crops must be kept separate

ASSESSMENT, RELEASE AND

DISTRIBUTION, AS WELL AS USE OF GEP

 Assessment of GEP shall be conducted prior to release

and distribution
 Biosafety Commision: to conduct assessment
 In the event that the assessment relates to technical
evaluation, Biosafety Commision assign Biosafety
Technical Team to conduct assessment of technical
document and advanced test.
 Biosafety Clearing House: to publicize the summary of
the result of GEP assessment conducted by Biosafety
Technical Team through mass media both printed and
electronic in addition to official news

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ASSESSMENT, RELEASE AND

DISTRIBUTION, AS WELL AS USE OF GEP

 Based on the result of Biosafety Technical Team’s

assessment and input from the community,
Biosafety Commision shall propose its
recommendation
 Competent Minister or Competent Head of Non
Ministerial Government Agencies shall use the
certificate and recommendation as basis for
consideration for the issuance of Decree on the
Release and /or Distribution of the said GEP, in
accordance with applicable legislations.

institutional arrangemant

M.o.Env.

Biosafety Biosafety Commission Economics,

clearing Social,
house Ethics &
Biosafety Technical Teams Religion
aspects

Environment Food Feed

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Competent Authority

 Environmental safety: Ministry of Environment

(MoE)
 Variety Release, Feed biosafety: Ministry of
Agriculture
 Fish Release: Ministry of Marine and Fisheries
 Trees Release : Ministry of Forestry
 Food biosafety: Food & Drug Control Agency,
Ministry of Health

Law 32/2009

Every activities that may create important risk on

environment, biodiversity and human health and human
safety have to carry out Environmental Risk Analysis
Risk Assessment
Risk Management

Risk Communication

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Biosafety Approval

 11 Food Biosafety Certificates:

 (1) Corn event MON 89034 lepidoptera tolerance (2) Corn event
MON NK 603 glifosat tolerant (3) Soybean event GTS 40-3-2 glifosat
tolerant (4) Soybean event MON 89788 glifosat tolerant (5) Corn
event MIR 162 pest tolerant (6) Corn Event GA 21 glifosat tolerant
(7) Corn Event MIR 604 corn boarder tolerant (8) Corn Bt 11
lepidoptera tolerant (9) Corn Eevent 3272 enzim α-amilase, (10)
Sugarcane event NXI-1T drought tolerant (11) Ice Structuring
Protein (ISP), (11) Soybean event MON 87701, (12)Soybean event
MON 87705
 1 Feed Certificate:
 Ronozym AX (CT) feed additive
 2 Limited used:
 (1) Transgenic mice PVR21 for Polio Neurovirulence Test- Biofarma;
 (2) Koslov –strain S.cereviciae – PT.Ajinomoto indonesia

Biosafety Approval

 1 Env. Biosfety Certificate :

 Sugar cane drought tolerance (NXI-1T , NXI-6T)
 5 Prosp. Biosfety Certificate :
 Genetically modified Corynebacterium glutamicum (Kozlov)- PT
Ajinomoto
 Genetically modified Herpes Virus, Vectormune HVT-ND
 Genetically modified Circovirus, Ingelvac circoflex , PT. Boehringer
Ingelheim Indonesia
 Genetically modified NDV (LaSota+Genotype7), Dalguban N plus Oil
Vaccine-PT. Blue Sky Biothech
 Transgenic mice PVR21 for Polio Neurovirulence Test

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Conclusion
 Concerning ethical/moral issues:
 Concerning issues of unnaturalness: GM-Crops not differ
to such extent from conventional breeding, which until
now can also be accepted
 Concerning ethical-religion issues: to be assessed on a
case-by case basis
 In making assessment of possible costs-benefits
ratio, possible risks for human health &
environment, etc., it is necessary to proceed on a
case-by-case basis.

Safe & higher yield more foods

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Safe & Sustainable use

Conservation of Fair and equitable

biodiversity sharing of benefits

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