DEALING WITH RISKS IN BIOTECH

CLASSIFICATION OF GMOs
• They can be classified in a number of ways depending on the purpose of
classification.
BY THE TYPE OF ORGANISM MODIFIED
• Genetically modified plants
• Genetically modified animals
• Genetically modified microorganisms
BY GENETIC MODIFICATION TECHNIQUE
• Transgenic organisms: contain genes from another organism inserted into their
DNA.
• Cisgenic organisms : contain genes from the same species inserted into their DNA
• Intragenic organisms : they have their own genes edited or modified .
CLASSIFICATION CONTINUATION
BY THE INTENDED USE OF THE GMO
• Food crops :GMOs made to improve nutritional value,yield or resistance to pests and
disease.
• Industrial crops: GMOs modified to produce specific chemicals or materials such as
biofuels or pharmaceuticals.
• Medical products : GMOs modified to produce drugs,vaccines or other medical
treatments.
• Environmental applications : GMOs modified to clean up pollution , improve soil
quality,or produce renewable energy.
CLASSIFICATION
BY THE RISK ASSESSMENT CATEGORY
• Class 1:these pose no or neglible risk to human health or the environment.

• Class 2 : these pose a low risk to human health or the environment

• Class 3 :these pose a moderate risk to human health or the environment

• Class 4 : pose a high risk to human health or the environment

APPLICATION PROCEDURES
• They vary from country to country hpwever there are general steps that are common
in most countries .

1. Submit an application to the relevant regulatory body

2. Undergo risk assessment

3. Obtain a permit or authorization

Information required for one to apply for GMO
manufacture
• Description of the gene including identity, genetic modification and intended use.
• Description of the proposed activities including locatiom , facilities, and equipment
that will be used.
• Description of containment measures that will be used to prevent escape of the
GMO into the environment.
• Description of the personell who will be involved in the activities and their training
qualifications .
• A plan to deal with any accidents or incidents that may occur.
Legislation and necessary permits when working with bioagents and modified organisms

• Main legislation governing the use of bioagents in Zimbabwe is the National Biotechnology Policy
and Regulatory framework.
• it wa developed in 2016 and it sets out principles and procedures for the safe and responsible
development, use and management of bioagents and GMOs.
• The policy framework includes a number of requirements for those who wish to work with
bioagents and GMOs
• The requirements include :
1. Obtaining a permit fron the Biotechnology regulatory authority .
2. Conducting a risk assessment of the proposed activities .
3. Implementing appropriate containment measures
4. Training personell in the safe handling of the bioagents and GMO
5. Reporting any accidents or incidents to the BRA
• BRA is responsible for overseeing the implementation of the policy framework and for issuing
statements.
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• Bra has the power to investigate and take enforcement against those who violet the
policy framework.
• There are a number of other laws and regulations that apply to the use of bioagents
and GMOs in Zimbabwe and these include :
• The environment management act
• The plant protection Act
• The food safety act
• The biosafety protocol
Performing hazard identification and risk
assessment
• Hazard identification and risk assessment are essential steps in the safe handling of bioagents.
• Hazard identification involves identifying all of the potential hazards associated with a particular
bioagent or GMO.
• Risk assessment involveds evaluating the likelihood and severity of each hazard and determine the
appropriate control measures to reduce the risk.
• To perform a hazard identification and risk assessement follow the following step .
1. Identifying the bioagents or GMOs that you wil work with
2. Gathering info about the agents or GMOs ,such as their properties, potential hazards and routes of
exposure.
3. Identifying all of the potential hazards that are associated with bioagents pr GMOs . This includes
hazards to human health ,environment and the economy
4. Evaluate the likelihood and severity of each hazard . This can be done by considering factors as
infectivity or toxicity of he bioagents or GMOs the route of exposure , the presence or control measures
5. Determining the appropriate control measure to reduce the risk . This may include physical barriers ,
biological controls, PPE and training
Examples of how to perform hazard identification and risk assessment for a specific bio agent

• Bioagent : Bacillus anthracis , the causative agent of anthrax

Potential hazards
Inhalation of spores can cause inhalational anthrax which is fatal.
Cutaneous exposure to the spores can cause cutaneous anthrax , a less severe form of
the disease.
Ingestion of the spores can cause gastrointestinal anthrax which is fatal
Likelihood severity of hazards
Inhalation is the most likely and most severe hazard.
Cutaneous is less likely and less severe than inhalation.
Ingestion of the spores is the least likely hazard but it is still fatal.
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Control measures
Physical barriers : lab workers should work inside a biological safety cabinet.
Biological controls : Bacillus anthracis spores can be inactivated with autoclaving or
other sterilization methods.
Wearing PPE
Training : lab trainers should be trained on the safe handling of bacillus anthracis
spores .
CONFINED FIELD TRIALS
• Confined field trials, also known as confined field experiments or confined releases,
refer to studies conducted under controlled conditions in an enclosed environment to
assess the safety and potential impacts of genetically modified organisms (GMOs) on
the environment and human health.

• These trials are an essential component of biosafety regulations and are conducted to
evaluate the potential risks associated with the release of GMOs into the environment.
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• Purpose
• Controlled environment
• Monitoring and reporting
• Gradual release
Regulatory authorities involved in CFTs
• Public Health Agencies
• Research Ethics Committees
• International Organizations (WHO, FAO)
• Ministry of Agriculture
• Ministry or Department of Environment
• National Biosafety Authorities (Cartagena protocol)
GENERAL REQUIREMENTS FOR CFTs
• The general requirements for controlled field trials can vary depending on the
country and the specific regulations in place.
Regulatory Approval
• This involves submitting an application that includes detailed information about the
proposed trial, such as the purpose, location, duration, and potential risks and
benefits.

Risk Assessment
• A thorough risk assessment of the trial is usually required to evaluate potential
environmental, health, and socio economic impacts. This assessment may involve
considering factors such as gene flow, potential harm to non target organisms, and
impacts on biodiversity.
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Research Protocol
• A well defined research protocol should be developed, outlining the objectives,
methods, and procedures of the trial. This protocol should cover aspects like
experimental design, planting techniques, monitoring and data collection procedures,
and safety measures.

Containment Measures
• Specific containment measures must be implemented to prevent the unintended spread
of GMOs outside the trial site. These measures can include physical barriers, isolation
distances, and techniques to prevent pollen and seed dispersal.
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Monitoring and Reporting
• Effective monitoring and reporting mechanisms are essential during the trial
period. This involves regular evaluation of plant growth, phenotypic
characteristics, and potential environmental impacts. Any adverse events or
unexpected effects must be documented and reported to the relevant authorities.

Compliance with Ethical Standards

• Trials involving human subjects or potentially sensitive areas require
compliance with ethical standards and obtaining informed consent from
participants. This applies to trials involving GMOs with medical or
pharmaceutical applications.
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Qualified Personnel
• Conducting controlled field trials requires a competent and trained team of scientists,
researchers, and technicians. They should possess the necessary expertise and skills to
implement the trial effectively while ensuring safety and compliance.

Data Management
• Proper data management procedures should be in place to collect, store, and analyze
trial data. This ensures accurate record keeping and facilitates the evaluation of trial
outcomes and potential impacts.
Commercialization of GM plants
Research and Development
• The development of GM plants begins with scientific research to identify desirable
traits that can be improved through genetic modification. This involves identifying
target genes, introducing them into the plant's genome, and conducting laboratory and
greenhouse experiments to validate the desired trait expression.

Regulatory Approval
• Before commercializing a GM plant, regulatory approval must be obtained from the
relevant authorities. This process typically involves rigorous risk assessments to
evaluate potential environmental, health, and socio-economic impacts. The specific
requirements vary by country, but they often include demonstrating that the modified
plant is safe for human consumption, does not pose risks to the environment, and meets
established standards for performance and efficacy.
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Crop Production and Distribution
•This involves producing and distributing the modified seeds or transplants to
farmers or growers who cultivate the plants. Companies may collaborate with
seed producers, breeders, or other partners to ensure widespread availability of
the GM crops.

Market Acceptance
•This involves educating stakeholders, including consumers, retailers, and food
processors, about the benefits, safety, and sustainability aspects of genetically
modified crops. Building trust and fostering transparent communication is
essential in addressing public concerns and facilitating market adoption.
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Field Trials
• Controlled field trials are conducted to assess the performance and behavior of GM
plants under real world conditions. These trials help gather data on agronomic
characteristics, potential impacts on non target organisms, and environmental
interactions. They also help ensure that the modified plants can be successfully grown
on a large scale.

Intellectual Property Protection

• Developers of GM plants may seek intellectual property protection for their inventions
to safeguard their investments in research and development. This can involve filing
patents or obtaining plant variety protection rights, which enable companies to control
the use, production, and sale of their genetically modified seeds or plant materials.
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Post-commercialization Monitoring
• Even after commercialization, ongoing monitoring and assessment of the GM plants'
performance, environmental impact, and potential long-term effects are important.
This helps ensure the continued safety and effectiveness of the modified crops and
allows for any necessary adjustments or improvements.
CASE STUDIES
Drought Tolerant Maize in Africa
• Climate change and drought pose significant challenges to agriculture,
particularly in regions like Sub-Saharan Africa. To address this issue, scientists
have developed genetically modified maize varieties with enhanced drought
tolerance.

Hawaiian Rainbow Papaya

• In the 1990s, the ringspot virus severely impacted Hawaii's papaya industry. To
combat this devastating disease, researchers developed a genetically modified
rainbow papaya that expressed a fragment of the virus's genome, providing
resistance. This case study illustrates how GM technology saved the papaya industry
from collapse by offering an effective and sustainable solution against viral diseases.
THANK YOU