Biosafety and biosecurity

• Treaty: A treaty is a written agreement between two or more countries or international organizations
that is governed by international law and is legally binding. Treaties can be used to address a wide range
of topics, including trade, defence, human rights, environmental matters, and peace.
• Convention: A large meeting of people who come to a place for usually several days to talk about their
shared work or other interests or to make decisions as a group.
• Summit: Any meeting or conference of top-level officials, executives, etc. also called summit.
• Protocol: It is a separate instrument: a protocol must be individually negotiated, signed and eventually
ratified. It is only binding on States that become Parties to it. It thus has its own Parties, and creates
separate rights and obligations for them, as any other treaty.

Living modified organism: LMO means any "living organism that possesses a novel combination of genetic
material obtained through the use of modern biotechnology". This means that only living organisms that
contain 'novel combinations of genetic material', and which have been produced using techniques of
modern biotechnology
are defined as LMOS. Many countries use the term 'LMO' and 'GMO' interchangeably, and consider that the
term refers to same thing. The products of LMO which are 'not living' are excluded from the definition of
LMO,
which are therefore not covered by scope of the protocol. Example; oil produced from genetically modified
(GM) canola or meat from GM animals.
Any potential hazards of industrial use of rDNA organisms are expected to be of the same nature as for
other biological agents, namely:
1. Infection hazard - the potential for disease in man, animals and plants following exposure to the living
organism or virus.
2. The toxic, allergenic or other biological effect of the non-viable organism or cell, its components or its
naturally occurring metabolic products.
3. The toxic, allergenic or other biological effect of the product expressed by the organism.
4. Environmental effects.
Applications of rDNA technique in Large industrial applications: pharmaceutical, chemical, and food
industries. Examples include:
1. Improvements in the energetics of single cell protein (SCP) production which would lower costs;
2. Increased yields of penicillin acylase for the conversion of penicillin's to 6- amino penicillanic acid;
3. Improved production of the vitamin riboflavin;
4. The generation of novel micro-organisms for the degradation and bioconversion of chlorinated aromatic
compounds for treatment of toxic wastes; and
5. Increased methane production from refuse and sewage.
Agricultural and Environmental Applications
1. Recombinant DNA techniques applied to agriculture:
a) Enhancing the nutritional quality of seed storage proteins
b) Increasing resistance to cold temperature and frost damage
c) Enhancing the resistance of crops to chemicals and disease.
d) Replacing chemical pesticides with microbial agents
e) Saving fertilizer through biological nitrogen fixation
f) Diagnosis of plant infections
g) Animal productivity
2. Recombinant DNA techniques applied to control of environmental pollution
3. Microbial metal extraction and recovery 4. Enhanced oil recovery
Safety Considerations Associated with Agricultural and Environmental Applications:
1. General Safety Considerations:
• Human Health Risks: Ensuring that agricultural practices and environmental applications do not pose
direct or indirect health risks to farmers, workers, consumers, and the general public. This includes
minimizing exposure to pesticides, herbicides, and fertilizers, as well as potential zoonotic diseases
(diseases that can transfer from animals to humans).
• Chemical Safety: Proper handling, storage, and disposal of chemicals used in agriculture, such as
pesticides, herbicides, and fertilizers, to prevent contamination of the environment, food sources, and
water supplies.
• Environmental Impact: Assessing and minimizing the environmental impacts of agricultural practices,
including soil erosion, water contamination, and habitat destruction. Sustainable practices such as
crop rotation and integrated pest management (IPM) are often employed to reduce these risks.
• Regulatory Compliance: Adhering to local, national, and international regulations regarding the safe
use of chemicals, genetically modified organisms (GMOs), and other biotechnology-related products.
This includes maintaining records, training workers, and ensuring that safety measures are followed.
2. Considerations Specific to Microorganisms:
• Pathogen Management: Microorganisms, including bacteria, fungi, and viruses, can pose a direct
threat to both humans and animals. In agriculture, biosecurity protocols must be in place to prevent
the spread of harmful pathogens such as Salmonella, E. coli, or foot-and-mouth disease, which could
affect both food safety and public health.
• Antibiotic Resistance: The overuse of antibiotics in livestock or agricultural practices can lead to the
development of antibiotic-resistant microorganisms. Monitoring and controlling the use of
antibiotics is essential to prevent the emergence of "superbugs" that could have far-reaching health
consequences.
• Biological Control Agents: When using beneficial microorganisms for pest control (e.g., releasing
beneficial bacteria to combat harmful pests), it is important to ensure that these microorganisms do
not adversely affect non-target species or the ecosystem.
• Containment and Cross-Contamination: In biocontrol or biotechnology applications, ensuring proper
containment of genetically modified microorganisms (GMMs) is crucial to avoid unintended gene
flow or cross-contamination with wild populations.
3. Considerations Specific to Plants:
• Pesticide and Herbicide Residue: Plant safety is heavily influenced by the use of chemicals like
pesticides and herbicides. The safety of crops and the potential for chemical residues to enter the
food supply must be carefully monitored, adhering to established Maximum Residue Limits (MRLs).
 • GMOs and Gene Flow: In the case of genetically modified plants, there are concerns about gene flow
from GM crops to wild relatives or non-GM crops, which may create unintended ecological
consequences, such as the development of herbicide-resistant weeds.
• Invasive Species: Introducing non-native plant species into new environments, whether intentionally
(e.g., for agricultural use) or accidentally, can result in invasive species that may disrupt local
ecosystems, outcompeting native plants and altering local biodiversity.
• Plant Diseases: The spread of plant diseases (e.g., fungal, viral, or bacterial infections) can have
devastating effects on crops and ecosystems. It’s important to monitor for signs of disease and
employ control measures like quarantine, use of resistant varieties, and crop rotation to minimize
risks.
4. Considerations Specific to Animals:
• Animal Welfare: Ethical considerations regarding the treatment of livestock and other animals in
agricultural practices are paramount. This includes providing adequate living conditions, minimizing
stress, and preventing cruelty. There are also considerations regarding the use of antibiotics, growth
hormones, and other substances that might affect animal health.
• Zoonotic Disease Transmission: Agricultural practices often involve interactions with animals, and
these animals can harbour zoonotic diseases (e.g., avian influenza, rabies, or tuberculosis) that can
be transmitted to humans. Monitoring and controlling such risks is essential for public health, and
biosecurity measures must be in place to prevent outbreaks.
• Livestock Feed Safety: Ensuring that animal feed is safe from contaminants like mold, pesticides, or
heavy metals is crucial for both animal health and human food safety. This also includes managing the
use of animal by-products in feed, which has been linked to diseases such as Bovine Spongiform
Encephalopathy (BSE, or "mad cow disease").
• Biodiversity Conservation: In environmental applications, such as wildlife management or habitat
restoration, it's crucial to consider how agricultural practices affect local wildlife populations. This
includes protecting endangered species, maintaining natural habitats, and ensuring that farming
practices do not disrupt the migratory or breeding patterns of animals.
Modern biotechnology promises to improve human wellbeing, for example, by enhancing agricultural
productivity However, there are concerns about the potential risks that LMOs may pose to biological
diversity and to human health.
Environmental concerns (examples)
1. Impacts on non-target organisms
2. Transfer of genes from wild relatives to cultivated species
3. Potential to become super weeds
4. Ripple effects within ecosystems - difficult to predict
Health concerns (examples)
1. Potential allergenicity
2. Antibiotic-resistance
The Cartagena Protocol on Biosafety
The Cartagena Protocol on Biosafety is an international agreement that manages the movement of living
modified organisms (LMOs) across borders. The protocol was adopted in Montreal, Canada in 2000 and
entered into force in 2003. The protocol's goals include:
• Protecting biodiversity from the potential risks of LMOS
• Ensuring the safe use of modern biotechnology
• Providing countries with enough information to make informed decisions about importing LMOS.
The Cartagena Protocol was established as a supplement to the Convention on Biological Diversity and it
aims to safeguard biological variety by regulating the transfer of Live Modified Organisms (LMOS) between
countries as a result of contemporary technology. It was adopted on 29 January 2000 and entered into force
on 11 September 2003. It sets a mechanism for prior informed consent to guarantee that nations have all
of the information they need to make informed judgments regarding importing LMOs into their jurisdiction.

Objectives of the Cartagena Protocol : The Cartagena Protocol is related to the safe handling and
transboundary movement of living modified organisms (LMOs). It has the following goals:
• The Protocol aims to keep living modified organisms (LMOs) from harming plants and animals.
• It works to prevent the unintentional introduction of LMOs into the environment.
• It wants to prevent any risks to human health and the environment caused by moving LMOs between
countries.
• The Protocol encourages countries to exchange information and work together on biosafety. It wants
countries to cooperate and share knowledge about biosafety.
• It believes that everyone should have a say when decisions are made about LMOS.
• The Protocol helps countries learn and develop the necessary skills to handle biosafety.
• The Protocol helps countries make their own laws and guidelines to protect Biosafety.

Scope of the Cartagena Protocol: The Cartagena Protocol primarily governs the following:
• It applies to the transboundary movement, handling, and use of LMOs that may harm biodiversity
conservation.
• It regulates the LMOs intentionally released into the environment. This might include trees, seeds, or
fish.
• Genetically modified (GM) farm products are also covered. This includes grain and corn for animal
feed, food, or processing.
• It does not cover drugs for humans under other international agreements. It neither covers products
derived from LMOs like GM maize cooking oil.
Parties and Non-Parties to the Cartagena Protocol: The Cartagena Protocol has a wide range of participating
parties from around the globe, though not every country is a party to it.
Parties to the Cartagena Protocol: Include countries like India, Japan, Canada, Brazil, and the European
Union which have ratified the protocol and are committed to its provisions. Together, they work to enhance
biosafety and manage biotechnology risks.
Non-Parties to the Cartagena Protocol: Some major countries, such as the United States and Australia, have
not ratified the protocol and therefore are not bound by its rules. Non- parties might have their biosafety
regulations but are not part of the international agreement framework provided by the Cartagena Protocol.
How does the Protocol work?
The Protocol establishes rules and procedures to regulate the movements of LMOs from one country to
another. Some of the measures include:
• Risk Assessment-scientific, case by case
• Risk management
• Safe handling, transport, packaging and proper identification of LMO shipments
• Information sharing through Biosafety Clearing-House (BCH)
• Capacity-Building
• Public Awareness and participation
• Liability and redress
Risk Assessment: Estimation and determination of risk associated with the handling and production of a
recombinant DNA molecule.
Risk Management: The process of analysing possible prevention measures to minimize the risk and
designing policies accordingly including implementation of them.
Risk assessment: Concept The concept of risk assessment revolves around answering three basic questions
like
• What might go wrong?
• How likely is to happen? and
• What are the consequences?
These questions can be answered by the assessment process of risk which has a potential to cause an
adverse effect or hazard, through (a) hazard identification, (b) hazard characterization, (c) exposure
assessment, and (d) risk characterization.
Thus, Risk = Hazard X Probability of its occurrence X Consequence of its use or release or
commercialization.
Definition of Risk Assessment: Risk assessment is a
process of gathering diverse data to identify possible
risk in research and development involving GMOs or
processes. Risk assessment is, inter alia, used by
Competent Authorities to make informed decisions
regarding GMOs. Risk assessment is a science-driven
"process of obtaining quantitative or qualitative
measures of risk levels, including estimates of
possible health effects and other consequences as
well as the degree of uncertainties in those estimates"
free of the emotive factors that influence risk
perception.

Risk Analysis: The foundation of any safety program is the use of control measures appropriate for the risk
posed by the activities and the agents in use. The process of analysing and determining the risk associated
with recombinant DNA work is called as Risk analysis. The principle behind biosafety regulations is to
minimize the risk to human health and safety, and the conservation of environment including safe handling
of hazardous material. Risk analysis consists of three components: risk assessment, risk management and
risk communication.
Risk Management: The process of analysing possible prevention measures to minimize the risk and
designing policies accordingly including implementation of them.
Risk Communication: The exchange of information and opinions on risk management between academic
parties, industry, consumers and policy makers.
Risk Assessment: The biosafety level is determined based on the risk associated with the work. The
principle investigator is responsible for implementing the necessary safety requirements in his/her
laboratory. Risk assessment process accounts the following criteria to determine biosafety level:
a. Pathogenicity- The ability of an organism to cause disease in human system.
b. Virulence - The severity of the disease (lethal/non lethal, availability of cure etc) in a healthy adult.
c. Proliferation- the subsequent multiplication, genetic reconstruction, growth, transport, modification
and die-off of these micro-organisms in the environment, including possible transfer of genetic material
to other micro- organisms.
d. Transmission route -The possible route of transmission (mucous membrane, inhalation etc) to
establish the disease in human or other organism.
e. Infectious dose (ID) - The amount of infectious agent required to cause disease in healthy human.
f. Antibiotic/disinfectant resistance -The resistance acquired by the infectious agent to available
antibiotic/disinfectant.
RISK ASSESSMENT:
• The Protocol empowers governments to make its decisions in accordance with scientifically sound risk
assessments.
• These assessments aim to identify and evaluate the potential adverse effects that a LMO may have on
the conservation and sustainable use of biodiversity in the receiving environments.
• They are to be undertaken in a scientific manner using recognized risk assessment techniques.
• While the country considering permitting the import of a LMO is responsible for ensuring that a risk
assessment is carried out, it has the right to require the exporter to do the work or to bear the cost.
• This is particularly important for many developing countries.
RISK MANAGEMENT:
The Protocol requires each country to manage and control any risks that may be Identified by a risk
assessment. Key elements of effective risk management include monitoring systems, research programmes,
technical training and improved domestic coordination amongst government agencies and services. The
Protocol also requires each government to notify and consult other affected or potentially affected
governments when it becomes aware that LMOs under its jurisdiction may cross international borders due
to illegal trade or release into the environment.
This will enable them to pursue emergency measures or other appropriate action. Governments must
establish official contact points for emergencies as a way of improving international coordination.
Biosafety Clearing House (BCH)
• To facilitate the exchange of scientific, technical, environmental and legal information on, and experience
with, LMOs and to assist Parties to implement the Protocol.
• Enabling governments to inform others about their final decisions regarding the import of LMOS
• BCH contains information on national laws, regulations, and guidelines for implementing the Protocol.
• The BCH also includes information required under the AIA procedure, summaries of risk assessments
and environmental reviews, bilateral and multilateral agreements, reports on efforts to implement the
Protocol, plus other scientific, legal, environmental and technical information.
SAFETY CONSIDERATIONS
• The purpose of this chapter is to propose a range of scientific considerations to be taken into account
when assessing potential risks of industrial and environmental applications of micro-organisms, plants
and animals and selecting appropriate safety measures. Micro- organisms are associated with man,
animals, plants and the environment, and their influence is often beneficial.
• Scientific considerations for safe use of these micro-organisms are needed as some of them are
pathogenic and others may have a negative impact on the environment.
• The potential applications of both conventional and modern biotechnology encompass a wide spectrum.
• They range from well-contained industrial uses of genetically-altered microorganisms with specific traits
or which synthesize desired products, to organisms intended for uncontained applications in agriculture
or the environment.
• A number of existing scientific methods can be used to assess the potential risks associated.
Technical issue to consider Depending on the case, risk assessment takes into account the relevant technical
and scientific details regarding the characteristics of the following subjects:
• Recipient organism or parent organism (taxonomic status, common name, origin, centers of origin and
centers of genetic diversity, if known, and a description of the habitat where the organisms may persist
or proliferate).
Donor organism
• Vector Characteristics, including its identity and its source or origin, and its host range.
• Insert characteristics of modification of the inserted nucleic acid and the function
• differences between the biological characteristics of the modification introduced.
• Detection and identification of the genetically modified organism Suggested detection and identification
methods and their specificity, sensitivity and reliability.
• Information relating to the intended use Information relating to the intended use of the genetically
modified organism, including new or changed use compared to the recipient organism
• Receiving environment Information on the location, geographical, climatic and ecological characteristics,
including relevant information on biological diversity and centers of origin of the likely potential
receiving environment.
Key Features of the Cartagena Protocol:
• Advance Informed Agreement (AIA): Requires notification and consent before LMOs are first exported
for intentional introduction into the environment. Importing countries must be notified in advance of
shipments and have the right to approve or reject them.
• Risk Assessment and Management: Obliges parties to assess and manage risks to biodiversity and
human health. Provides a framework for evaluating and mitigating potential risks associated with
LMOS.
• Biosafety Clearing-House: Facilitates information exchange about LMOs and biosafety regulations. Acts
as a platform where parties can access information on risk assessments, national laws, and decisions
related to LMOS.
• Public Awareness and Participation: Promotes the involvement of the public and civil society in the
decision-making process. Ensures transparency and education about LMOs and biosafety issues.
Safe handling, transport, packaging and proper identification of LMO shipments
• Parties are required to take measures for the safe handling, packaging and transportation of LMOs that
are subject to transboundary movement.
• The Protocol specifies requirements on identification by setting out what information must be provided
in documentation that should accompany transboundary shipments of LMOS.
• It also leaves room for possible future development of standards for handling, packaging, transport and
identification of LMOs by the meeting of the Parties to the Protocol.
• providing contact details of persons responsible for such movement.
PUBLIC AWARENESS AND PARTICIPATION

• Individual citizens understand and are involved in national decisions on LMOS

• The Protocol therefore calls for cooperation on promoting public awareness of the safe transfer,
handling and use of LMOs.
• It specifically highlights the need for education, which will increasingly have to address LMOs as
biotechnology becomes more and more a part of our lives
• The Protocol also calls for the public to be actively consulted on LMOs.
• Individuals, communities and non-governmental organizations should remain fully engaged in this
complex issue. This will enable people to contribute to the final decisions taken by governments,
thus promoting transparency and informed decision-making.
Why is it important?
1. The Protocol is a key agreement contributing to biodiversity conservation and sustainable
development.
2. Biodiversity is the basis of human wellbeing.
3. As biodiversity declines, so too does the Earth's capacity to support human life.
4. All humanity must safeguard biodiversity from all threats and to stop or reduce its loss.
Examples of GMO/LMO plants
1. Bt Cotton (Gossypium hirsutum L.): This cotton has been genetically modified to express a protein
from the Bacillus thuringiensis bacterium, which protects it from certain pests, like the cotton
bollworm.
2. Golden Rice (Oryza sativa): Genetically modified to produce higher levels of provitamin A (beta-
carotene) to help combat vitamin A deficiency, particularly in developing countries.
3. Rainbow Papaya (Carica papaya): Developed to resist the ringspot virus, this papaya variety is a
significant agricultural product, especially in Hawaii.
4. Bt Corn(Zea mays): like Bt cotton, this corn has been modified to produce a toxin that kills certain
insect pests, reducing the need for chemical pesticides.
5. Herbicide-resistant Canola(Brassica napus):Genetically modified to be resistant to herbicides like
glyphosate, making weed control easier for farmers.

GMOs/LMOs in Animals:
1. GloFish(Danio rerio) These are genetically modified zebrafish that express fluorescent proteins, making
them glow in various colors under UV light. The glow is due to genes from jellyfish or sea anemones.
2. Genetically Modified Cows (e.g., "Enviropig")(Bos taurus.) The Enviropig is genetically engineered to
digest phosphorus more efficiently, reducing the environmental impact of pig manure on waterways.
3. GM Mice( Mus musculus)for Research: Transgenic mice are widely used in biomedical research. For
example, mice with modified genes are used to study diseases like cancer, Alzheimer's, and heart
disease.
4. GM Mosquitoes (e.g., Oxitec mosquitoes)( Aedes aegypti or Anopheles gambiae,): These mosquitoes
have been modified to carry a self-limiting gene that causes them to die before reaching adulthood,
reducing populations of disease-carrying species like Aedes aegypti, which spreads dengue fever and
Zika virus.
5. GM Goats (e.g., "Spider Goats")(Capra aegagrus hircus): These goats are engineered to produce silk
proteins in their milk, which can be used to create materials like biosteel for medical or industrial uses.
GMOs/LMOs in Microbes:
1. Genetically Modified Bacteria (e.g., E. coli in Insulin Production): Escherichia coli bacteria have been
engineered to produce human insulin, which is then harvested and used in the treatment of diabetes.
2. GM Yeast (e.g., for Biofuel Production): Yeast has been genetically modified to produce biofuels like
ethanol or to synthesize other chemicals like pharmaceutical compounds.
3. GM Bacteria for Bioremediation: Some bacteria have been engineered to break down environmental
pollutants, such as oil spills, heavy metals, or pesticides, more efficiently than their natural
counterparts.
4. Bacillus thuringiensis (Bt): This bacterium is used in genetically engineered crops, like Bt corn and Bt
cotton, to produce proteins toxic to certain insect pests. It is also used as a biopesticide in organic
farming.
5. Genetically Modified Algae: Certain strains of algae are modified for biofuel production, carbon
capture, or even food and cosmetic products due to their ability to produce oils or other useful
compounds.
6. GM Fungi: Fungi have been genetically engineered for various industrial uses, including the
production of enzymes used in detergents or food processing, or to produce drugs like penicillin or
other antibiotics more efficiently.
Golden Rice and Bt Brinjal are both genetically modified (GM) crops, each with its own set of potential biological
safety issues.
Golden Rice
Golden Rice is a GM crop that has been engineered to produce beta-carotene, a precursor of vitamin A, in
its grains. This is intended to address vitamin A deficiency, a major public health problem in many
developing countries.
Potential Biological Safety Issues of Golden Rice:
• Unintended Effects: The introduction of new genes into the rice genome could have unintended
effects on the plant's physiology, growth, or nutritional composition.
• Allergenicity: There is a concern that the new proteins produced by the inserted genes could be
allergenic, causing adverse reactions in some individuals.
• Gene Flow: There is a risk that the inserted genes could spread to wild or weedy relatives of rice
through pollen or seed dispersal, potentially creating herbicide-resistant "superweeds."
• Environmental Impact: Golden rice cultivation could have unintended environmental
consequences, such as changes in biodiversity or soil ecology.
Bt Brinjal
Bt Brinjal is a GM variety of eggplant that has been engineered to produce a natural insecticide called Bt
toxin, which is derived from the bacterium Bacillus thuringiensis. This is intended to protect the crop from
insect pests, reducing the need for chemical pesticides.
Potential Biological Safety Issues of Bt Brinjal:
• Insect Resistance: There is a concern that the widespread use of Bt brinjal could lead to the
evolution of insect pests that are resistant to the Bt toxin, rendering the GM crop ineffective.
• Non-Target Effects: The Bt toxin could potentially harm non-target organisms, such as beneficial
insects or other animals that feed on the eggplant.
• Gene Flow: As with Golden Rice, there is a risk of gene flow from Bt brinjal to wild or weedy
relatives of eggplant, potentially creating herbicide-resistant "superweeds."
• Environmental Impact: Bt brinjal cultivation could have unintended environmental consequences,
such as changes in biodiversity or soil ecology.