BIOSAFETY, REGULATION, AND

INTELECTUAL PROPERTY OF
GENETIC MODIFIED ORGANISM
 Work Safety in Biotechnology

• Safety for the researchers and the workers

• Safety for the chemicals/reagents and
instruments being used
• Safety for the organism being used or
produced
• Safety for the environment
 Safety for the researchers ,workers, and the environment
• In the Biotechnooogy Laboratory, there are many
chemicals/substances which are irritative or cause mutation
when they are in contact directly with our skin/organs
- phenol is heavily irritative to your skin
- chloroform is harmful to your eyes and conscious
- ethidium bromide cause DNA mutation
- radioactive substances, UV light cause canker etc.
• All researchers and workers have know and understand the risk
of exposing to any harmful substances, therefore they have to
be careful, protect their skin, hands, eyes, never put and mess
any dangerous substances / instruments/tools
• Any harmful substances/tools have to be discharged into special
containers or safety boxes and never thrown away in the
environment
 Safety for the sensitive substances / instruments
• Many substances and instruments used in biotechnology labs
are quite sensitive toward temperature change (higher temp),
light, humidity etc, therefore store or use then in the right
condition
- Enzymes, antibiotics etc have to stored in low temp (-20 oC),
put them on ice when you use them
- Micro pipetes need to be adjusted properly not to be out of
access range
- Micro centrifuge, ultra centrifuge etc have to be use in balance
for the samples
etc
 Safety for any organism being used

• In biotechnology labs several strains/species of bacteria (E.

coli, Bacillus ), fungi (yeast, actinomyces dsb), virus
(Bacteriophage, CMV etc.) that have be carefully managed
for the sensitivity and viability
• The organism may be harmful or dangerous when they are
release to the environment, keep them properly and
sterilize them when you have to stop using them
 GMO and its biosafety
• GMO or genetic modified organism is an organism
that has been genetically modified to be more useful
and beneficial
• GMOs are created by transferring genetic material
from one organism to another.
• The release of GMO to the environment or for
commercial production has been doubtfully for pro
and contra with some worry to the negative effect
and impact include:
- Out of control distribution of the modified genes to
non target environment may cuase in balance
population of a certain organism
- Allergenic reaction to the consumers or non
consumers
- Resistance against any antibiotics used for
genetic markers in producing GMO
- Disappearance of any germplasm due to
dominated by the transgenic organism
- Etc
 Biotechnology vs Biosafety
• “Biotechnology is essentially the use of living
organisms (often minute micro-organisms) and
their products for health, social or economic
purposes.”
• Biosafety refers to the “development and
implementation of administrative work practices,
facility design and safety equipment to prevent
the transmission of biologic agents to workers,
other persons or the environment.”
 Genetic Engineering

• Has the potential to improve human health,

nutrition and comfort
• but…….
• It carries social, ethical and environmental
risks, many of which may be presently
unforeseen
• How can we manage such a huge and
complex issue?
 Genetic Engineering, are there
negatives?
• Unknown side effects
• Crop failure
• Allergies
• No long term testing
• Gene pollution
• Antibiotic resistant bacteria
• Toxins
Utilization of Micro-organisms
in Biotechnology
Micro-organisms are used to:
• Turn milk into cheese and
yogurt.
• To ferment beer and wine.
• Yeast is used in bread to make
it rise.
• Rhizopus is used to make
tempe

Yes Biosafety risks are associated with

these products as well!!!
 Insulin
•First major product of Biotechnology
•From the 1920’s Insulin could be
isolated from the pancreas pigs & cows
•Allergic reactions to bovine by some
people
•Using Molecular Biology techniques an
insulin – producing gene was inserted
into bacteria. (1970’s)
Human Insulin (From U. •The bacteria then could produce
of Arizona)
human insulin.
Cloning – Dolly and Beyond!!
•1997 - First cloned sheep

•Since Dolly, mice, goats cows and other

mammals have been cloned.

•The result of splitting an embryo into 2 at a

very early stage results in mammal clones.

•Dolly was produced by a technique called

somatic cell nuclear transfer. DNA from the
nucleus of a cell from the body is put into
another sheep’s egg which had the nucleus
removed. Then implanted. Only success in 277
attempts.

•Many ethical issues concerning human

cloning!!!!!!!!
 Application areas
Medical Biotechnology : Protein therapeutics,
Vaccine development, Gene therapies, Controlled
drug delivery systems, Tissue engineering in vitro
diagnostic tests and chip detection arrays
Energy and Environment : Biofuels, Artificial
photosynthesis, Detection of pollutants,
Bioremediation, Agricaltural applications
Chemical industry : Production platforms for
chemicals, Protein engineering
Academia : Multiple profile projects in fundamental
science and applied research
Value Chain Biotechnology
Gene optimization works – if done right
Synthetic genes have many applications
 LMO and GMO
• Living modified organism (LMOs) resulting
from modern biotechnology are broadly
equivalent to genetic modified organism.
• The difference between an LMO and a GMO is
that a Living Modified Organism is capable of
growing, and typically refers to agricultural
crops.
• Genetically Modified Organisms include both
LMOs and organisms which are not capable of
growing
 Rio Declaration on Environment
and Development
• The Rio Declaration on Environment and
Development, often shortened to Rio
Declaration, was a short document produced
at the 1992 United Nations "Conference on
Environment and Development" (UNCED),
informally known as the Earth Summit. The
Rio Declaration consisted of 27 principles
intended to guide future sustaianable
development around the world
Convention on Biological Diversity
(CBD)
• has three main goals:
- conservation of biological diversity (or
biodiversity);
- sustainable use of its components; and
- fair and equitable sharing of benefits arising
from genetic resources
• to develop national strategies for the
conservation and sustainable use of biological
diversity.
 Cartagena Protocol on Biosafety
• The Cartagena Protocol on Biosafety is an international
agreement on biosafety, as a supplement to the Convention
on Biological Diversity (CBD)
• The Biosafety Protocol makes clear that products from new
technologies must be based on the precautionary principle
and allow developing nations to balance public health against
economic benefits
• It will for example let countries ban imports of a living
modified organismif they feel there is not enough scientific
evidence that the product is safe and requires exporters to
label shipments containing genetically altered commodities
such as corn or cotton.
 CPB cover
• The Protocol applies to the transboundary
movement, transit, handling and use of all
living modified organisms that may have
adverse effects on the conservation and
sustainable use of biological diversity, taking
also into account risks to human health
(Article 4 of the Protocol, SCBD 2000).
• It will for example let countries ban imports of
a LMO if they feel there is not enough
scientific evidence that the product is safe and
requires exporters to label shipments
containing genetically altered commodities
such as corn or cotton.
The need for Institutional Biosafety Committees
(IBC)
Roles of the IBC :

• Direct contact with the Office of the Gene Technology

regulator (OGTR). Legal obligations.
• Facility inspections and compliance responsibilities
• Biosafety manual – regularly updated
• Training strategies: Reviewing at present - on line
training.
• Lecture given to 3rd year Science students on Biosafety
and IBC
• Material Transfer agreements (MTA’s)
• May include control of radiation and hazardous
substances within the area institution. (Radiation and
Laboratory Safety Sub – committee)
Regulation on the development, release, and use of
GMO
• Regulated by international rules eg.:
- Cartagena agreement: the agreement declared
in Cartagena for all counties to develop rules
that have to obeyd by all members with some
punishment for any disobey to the rules of the
development, release, and the use of GMO
• Regulated by national rules within a country to
protect for the safety and health of the peoples
and sustainability and safety of the
environment of the country.
The Genetically Modified Organisms (Contained
Use) Regulations 2000:

• require risk assessment of activities involving genetically

modified micro-organisms and activities involving organisms
other than micro-organisms. All activities must be assessed
for risk to humans and those involving GMMs assessed for risk
to the environment;
• introduce a classification system based on the risk of the
activity independent of the purpose of the activity. The
classification is based on the four levels of containment for
microbial laboratories;
• require notification of all premises to HSE before they are
used for genetic modification activities for the first time;
• require notification of individual activities of Class 2
(low risk) to Class 4 (high risk) to be notified to the
Competent Authority (which HSE administers).
Consents are issued for all Class 3 (medium risk) and
Class 4 (high risk) activities. Class 1 (no or negligible
risk) activities are non notifiable, although they are
open to scrutiny by HSE's specialist inspectors who
enforce the Regulations.
• Activities involving GM animals and plants which are
more hazardous to humans than the parental non
modified organism also require notification;
• require fees payable for the notification of
premises for first time use, class 2, 3 and 4
activities notifications, and notified activities
involving GM animals and plants.
• require the maintenance of a public register of
GM premises and certain activities.
 USA Environmental and Food Safety

• USDA : US Dept. of Agriculture

• EPA : Environmental Protection Agency
• FDA : Food and Drug Administration
• APHIS : Animal and Plant Health Inspection Service
• USDA through APHIS oversees the field-testing crops
• University/company must request a permit from APHIS before it
can field-tests its crops
• Prior to crop commercialization the company must receive USDA
clearance . APHIS must be assured that the new crop variety has
no potential to cross with wild relative or become weeds, no
impact on non target organism
 Department of environment of RI
• Has the regulations similar to those of USA
• Ministry of Agriculture and related Ministries
established a rule SK Menteri Pertanian
Nomor 856/Kpts/HK.330/9/1997 on the
development, regulation and the use of GMO
 Guideline on the development, release and
the use of Agricultural GMO of RI for

• Animal
• Fish
• Microbe
• And Plant
 Areas associated with biosafety
• The application of biotechnology to food and agriculture can bring not
only potential risks and benefits as any technology can, but also concerns
about the human dimensions coupled with biotechnology. These include
both positive and negative impacts on stake holders, social institutions,
economy and communities.
• Different areas associated with biosafety include:
• (i) Agriculture and food system issues
• (ii) Market and consumer issues
• (iii) Institutional issues, business issues and
• (iv) Social issues
 Intellectual Property Rights (IPRs)
/ Hak Pekayaan Intektual
• Intellectual property (IP) refers to creations of the
mind: inventions, literary and artistic works, and
symbols, names, images, and designs used in
commerce for which a set of rights are recognized
under the corresponding fields of law
• Intellectual property rights are the rights given to
persons over the creations of their minds
• There are two conceptual justifications for IPRs: the
personal property argument and incentive
mechanism use. Modern IPR systems typically
emphasize the incentive factor.
 IPRs
• Copyrights is a right conferred on the owner of a literary or
artistic work
• Trademarks is a symbol generally used to identify a particular
product, which indicates its source
• Patents are rights related to new inventions. Such rights are
conferred on persons who invent any new machine, process,
article of manufacture or composition of matter, biological
discoveries, etc
• Industrial Design Rights, protect the visual design of objects
that are not purely utilitarian, but have an aesthetic or
ornamental value
• Trade Secrets are the designs, practices, formulas,
instruments, processes, recipes, patterns, or ideas which are
used by a company to gain an economic advantage over its
competitors
 Patents:
• Patents, operate as a balance between the
inventor and society.
• Society grants a temporary, partial monopoly
to the inventor. Temporary refers to the
duration of protection, generally about 20
years; and partial describes the scope of
protection, the degree of difference required
before a related development is not covered by
the patent
 IPRs in Agriculture Biotechnology
• For example, patents and plant variety protection
certificates—are frequently used to protect technological
advances
• These rights allow their owners to exclude competitors
from "making, using, offering for sale, or selling" an
invention for a limited period of time.
• As the peace of scientific discovery in agricultural
biotecnology has accelerated over the past few decades,
the use of patents and other intellectual property rights to
protect these discoveries has increased tremendously
• Intellectual property rights are a complex,
multifaceted area and one in which corporate
strategies are very poorly understood.
• Fundamentally, IPRs are essential for the
incentive to create easily copied products
 Plant Variety Protection (PVP)
• New plants and plant products have an increasing impact on
modern agriculture, horticulture, industry and medicine. If the
development of improved varieties results in, for example,
stronger resistance to diseases, better adaptation to extreme
climates, higher nutritional value or plants that produce added
pharmaceutically active components, then plant breeders must
be able to obtain protection for their breedings
• The protection of new plant varieties is a result of the
procedures based on the International Convention for the
Protection of New Varieties of Plants ( UPOV Convention).
 Plant Breeders’ Rights
• Plant Breeders’ Rights is a specialized patent-
like system for cultivated plants.
• International Union for the Protection of New
Varieties of Plants (UPOV)
• In place of the novelty, non-obviousness, and
utility requirements of patent law, PBRs use
distinctness, uniformity, and stability (DUS).
• PBRs are generally considered to provide less
protection than patents
• PBRs are further distinguishable from patents by the
allowance of so-called “farmers’ privilege” and
“research exemption,” sometimes called “breeders’
privilege.”
• The farmers’ privilege is the right to hold materials as
a seed source for subsequent seasons (farmer saved-
seed or bin (competition)
• The research exemption refers to the right to use
protected materials as the basis for developing a new
variety or other research use

Privilege : hak istimewa, exemption: pengecualian

 Positive and negative aspects of PPV and FRA.
Positive
Farmers get a legal right to sell seed of
varieties
Farmers are recognized as breeders
Researches will have right to conduct
experiments with patented varieties
No varieties with terminator genes will be
registered
Any government agency or NGO can file a
claim on a variety developed by local
community
Farmers rights proposed for the first time
any where in the world
Negative
Uncertainly about whether farmers can
trade in seeds
A bureaucratic authority to monitor
implementation of the Act
The procedure for registration of varieties
is lengthy, expensive and stringent for
farmers (as also for breeders)
Filing of law suits against farmers possible
Researcher's use of protected varieties
may allow entry of GM crops by the' back
door
 Intellectual Property Rights Proliferation:
The Downside

• Biotechnology patents are the strongest

incentive to research when there are no
prior intellectual property claims on the
research results.
• Second round:
– Reduced “free ride” on prior research
– Proliferation of competing claims:
“Tragedy of Anticommons”
 Patenting of Agricultural Biotechnology
• Crucial rulings
– Living organisms: Diamond v. Chakrabarty (1980)
– Plants: ex parte Hibberd (1985)
• Protects
– Breeding technology: genes, markers, methods,
seeds
– Hybrid parent varieties
• Made enforceable by concurrent biotechnology
 Holdup Examples

• University of California: long shelf-life

tomato
• Michigan State University: transgenic
turfgrass
• CLIMA (Australia): herbicide tolerant lupin
• University of California: herbicide tolerant
barley
• UGM ….???
 Arms-Length Licensing as Means of
IPR Transfer
• Some successes
• Many failures
• High transaction costs
• High uncertainty:
– Who owns what?
– Will patent remain valid?
• Holdup problem
• Trademarks: Trademarks are the reservation
of a word, symbol, or phrase in association
with a product or service.
• Trade Secrets: Trade secrets, to describe
them in their simplest terms, assist in the
maintenance of secrets by imposing penalties
(the recovering of costs) when information
held as secret is improperly acquired or used
 World Trade Organization (WTO)
• The new World Trade Organization was
instituted to administer three agreements, the
GATT, the TRIPs and the General Agreement
on Trade in Services (GATS).
• The WTO structure allows retaliation against
the import of goods through the GATT for
violations of intellectual property rights
protection in the TRIPs.
 Trade-Related Aspects of IPRs (TRIPs)
• The TRIPs agreement requires signature states, including some
70 developing countries, to provide for the following protection
(MTN/FA II-A1C):
• · Contracting parties shall provide for the protection of plant
varieties by patents and/or by an effective sui generis system
(Section 5, Article 27(3b).
• · Patents may be prohibited to protect ordre public or morality,
provided there is a justification exceeding the mere prohibition
in domestic law (Section 5, Article 27(2)).
• Plants and animals other than micro-organisms and “essentially
biological processes for the production of plants and animals”
may be excluded from protection (Section 5, Article 27(3b)).
• Compulsory licenses may be issued in limited cases of due
diligence to make a licensing agreement, adequate
remuneration, and subject to judicial review (Section 5,
Articles 30 and 31).
• For process patents, the burden of proof of infringement may
in some specified circumstances be shifted 9 to the defendant
to prove that the patented process was not used (Section 5,
Article 34).
• Persons shall have the option of preventing others from using
without permission information of commercial value so long
as reasonable efforts have been made to keep it secret
(Section 7, Article 39).
 Monopoly returns to IPRs
• Monopoly returns to intellectual property that
is traded internationally are appropriated in
three ways:
• (1) directly through the prices of exports;
• (2) fees for use; and
• (3) profits of subsidiaries (Maskus, 1990).
 "Terminator" Genes
• To make them produce sterile seeds (and thus force the farmer to
buy fresh seeds for the following season rather than saving seeds
from the current crop).
• The process involves introducing three transgenes into the plant:
• A gene encoding a toxin which is lethal to developing seeds but not
to mature seeds or the plant. This gene is normally inactive because
of a stretch of DNA inserted between it and its promoter
• A gene encoding a recombinase — an enzyme that can remove the
spacer in the toxin gene thus allowing to be expressed.
• A repressor gene whose protein product binds to the promoter of
the recombinase thus keeping it inactive.
 How they work

• When the seeds are soaked (before their sale) in a solution

of tetracycline, synthesis of the repressor is blocked
• the recombinase gene becomes active
• the spacer is removed from the toxin gene and it can now
be turned on.
• Because the toxin does not harm the growing plant — only
its developing seeds — the crop can be grown normally
except that its seeds are sterile
• The use of terminator genes has created much
controversy:
• Farmers — especially those in developing
countries — want to be able to save some
seed from their crop to plant the next season.
• Seed companies want to be able to keep
selling seed.