VIETNAM NATIONAL UNIVERSITY OF AGRICULTURE

FACULTY OF BIOTECHNOLOGY

THE ESSAY
GENETIC MODIFICATION IN ANIMALS

Student name: Nguyen Thi Thanh Nga

Class: K65-CNSHE
Student code: 651380

Ha Noi, 2024
Table of Contents
I. Introduction...............................................................................................................
A. Definition of Genetic Modification in Animals....................................................2
B. Significance and Scope of Genetic Modification in Various Fields.....................2
C. Purpose of the Essay.............................................................................................3
II. Historical Development of Genetic Modification in Animals................................
A. Early Experiments and Selective Breeding...........................................................3
B. Discovery of Recombinant DNA Technology......................................................5
C. Advancements in Genetic Engineering Techniques.............................................6
D. Evolution of Techniques and Applications...........................................................7
III. Techniques of Genetic Modification......................................................................
A. Overview of Genetic Engineering Tools..............................................................8
B. Principles and Methodologies of Each Technique................................................9
IV. Applications of Genetic Modification in Agriculture..........................................
A. Enhancement of Livestock Productivity and Quality.........................................13
B. Disease Resistance in Animals............................................................................14
C. Environmental Impacts and Sustainability..........................................................15
V. Biomedical Applications of Genetic Modification in Animals.............................
A. Animal Models in Biomedical Research............................................................16
B. Ethical Considerations in Biomedical Applications...........................................16
VI. Human Health and Safety Considerations...........................................................
VII. Ethical Considerations in Genetic Modification................................................
VIII. International Regulations on Genetic Modification in Animals.......................
IX. Conclusion...........................................................................................................
X. References.............................................................................................................

1
Genetic modification, altering an organism's DNA, has revolutionized various fields,
including agriculture, biomedicine, and research. In animals, genetic modification
holds immense potential for enhancing productivity, and disease resistance, and even
serving as models for human diseases. However, it also raises significant ethical and
environmental concerns. This essay aims to delve into the intricacies of animal
genetic modification, exploring its techniques, applications, impacts, ethics, and
regulatory aspects.
I. Introduction
A. Definition of Genetic Modification in Animals
A genetically modified animal is one whose genetic material has been altered by
adding, changing, or removing certain DNA sequences in a way that does not occur
naturally. This process is carried out to introduce a new trait or change a
characteristic such as the disease resistance of an animal. DNA is the genetic material
of an organism and carries the instructions for all the characteristics that an organism
inherits. Changes introduced in an animal’s genetic make-up can therefore be
transmitted to the next generation.
B. Significance and Scope of Genetic Modification in Various Fields
Genetic modification (GM) represents a revolutionary tool in modern science, with
applications spanning agriculture, medicine, industry, environmental conservation,
and research and development. Through deliberate alterations to an organism's
genetic makeup, genetic modification offers unparalleled opportunities to enhance
traits, address societal challenges, and drive innovation.
Agriculture: GM crops have revolutionized agriculture by conferring traits such as
pest resistance, disease tolerance, and increased nutritional value. These crops
contribute to global food security by bolstering yields, reducing losses, and enhancing
crop resilience in the face of climate change. Moreover, genetically modified
organisms (GMOs) enable sustainable agricultural practices by reducing chemical
inputs, conserving water resources, and mitigating environmental impacts.

Medicine: In medicine, genetic modification plays a pivotal role in gene therapy,

offering potential cures for genetic disorders through the correction or replacement of
defective genes. GM organisms serve as invaluable tools for drug development,
enabling the production of biopharmaceuticals, vaccines, and personalized medicines.
2
Furthermore, genetically modified animal models facilitate the study of human
diseases, accelerating research and drug discovery efforts.
Industry: The industrial applications of genetic modification are diverse and far-
reaching. Biotechnology harnesses GM organisms to produce enzymes, biofuels,
biomaterials, and pharmaceuticals, driving innovation and sustainability in
manufacturing processes. GM microorganisms are also employed in bioremediation
efforts to clean up pollutants and contaminants, offering environmentally friendly
solutions to industrial waste management.
Environmental Conservation: Genetic modification holds promise for environmental
conservation through initiatives such as bioremediation, species conservation, and
ecosystem restoration. GM microorganisms are engineered to degrade pollutants and
restore degraded habitats, contributing to ecosystem health and biodiversity
conservation. Additionally, genetic modification techniques can aid in the
preservation of endangered species by enhancing genetic diversity and resilience.
Research and Development: GM organisms serve as indispensable tools in scientific
research, enabling investigations into gene function, cellular processes, and
organismal biology. Continued advancements in genetic modification techniques,
such as CRISPR-Cas9, drive innovation across multiple disciplines, fueling
discoveries and technological breakthroughs.
Ethical Considerations: Despite its transformative potential, genetic modification
raises ethical, social, and environmental concerns that must be carefully addressed.
Questions regarding human health and safety, environmental impact, food
sovereignty, and socio-economic equity underscore the need for responsible and
transparent governance of GM technologies. Ethical frameworks, regulatory
oversight, and public engagement are essential for balancing the benefits and risks of
genetic modification and ensuring its equitable and sustainable deployment.
C. Purpose of the Essay
The purpose of the essay is to provide a comprehensive overview of genetic
modification (GM) in animals, elucidating its significance, applications, and ethical
implications across various domains. Through an exploration of advancements in
genetic engineering techniques and case studies, the essay aims to highlight the
diverse applications of GM in animal science, including agriculture, medicine,
biotechnology, and conservation. Furthermore, it seeks to examine the ethical
considerations surrounding GM in animals, fostering a nuanced understanding of the
ethical frameworks and regulatory mechanisms that govern its use.
II. Historical Development of Genetic Modification in Animals
A. Early Experiments and Selective Breeding
Selective breeding, is the practice of mating individuals with desired traits as a means
of increasing the frequency of those traits in a population. In selective breeding, the
breeder attempts to isolate and propagate the genotypes (genetic constitutions) that
are responsible for an organism’s desired qualities in a suitable environment. Such
qualities generally are economically or aesthetically desirable to humans rather than
useful to the organism in its natural environment.

3
Selective breeding results from the inheritance of gene-associated traits and, more
specifically, from changes in the frequencies with which desired traits occur in
populations. The latter in turn alters gene frequencies in the population.
Since evolution is based on shifts in gene frequency, selective breeding is considered
to be a driver of evolution.
Humans have been modifying the traits of plant and animal species through selective
breeding for thousands of years. More than 9,000 years ago in Mesoamerica, for
example, humans began selectively breeding teosinte plants that had greater numbers
of kernels, and this practice eventually gave rise to corn (maize; Zea mays), which is
today one of the most widely distributed of the world’s food crops. Many other plants
that are used by humans have undergone similar selection processes. Cruciferous
vegetables, examples of which include kale, broccoli, and cauliflower, share a
common ancestor: wild mustard (Brassica). Selection of wild mustard for specific
traits, beginning at least 2,000 years ago, led to the emergence of different versions,
or cultivars, of the species. Selection for wild mustard plants with large leaves, for
example, resulted in kale, whereas selection for enlarged flower buds led to
cauliflower. Likewise, domestic dogs (Canis lupus familiars) first emerged possibly
as early as 30,000 years ago in Southeast Asia—and more certainly between 29,000
and 14,000 years ago in Eurasia—as a result of selective breeding of wolves with
companionable traits. Since then, selection for fur color fur thickness, and length, as
well as for body type and temperament, has resulted in more than 400 distinct breeds
of dogs.
Scientific understanding of selective breeding expanded particularly in the 19th
century when English naturalist Charles Darwin used his experience with selective
breeding of captive pigeons to form his insights about natural selection and evolution.
Beginning in the second half of the 20th century, advances in
genetic technology enabled researchers to modify traits across generations of
organisms by introducing novel genetic variations, rather than by breeding. True
selective breeding, through the mating of individuals, however, continues to be a
valuable tool in research and agriculture. In particular, it has provided critical insight
into mechanisms of inheritance, genetic disease, and genetic diversity. For example,
selection has been so intense in some dog breeds as to reduce genetic diversity in
small breeding populations, which has manifested in various ways, including
increased risk of disease and decreased survival. These effects are strikingly evident
in French Bulldogs, which have been selected for compact features, resulting in
narrow nostrils and a flat face, causing the animals to experience breathing problems
that affect their quality of life and survival.
Heritability of traits
Heritable traits become more frequent in populations at varying rates. The ease with
which a trait becomes more frequent across generations is referred to as heritability.
Scientists can measure the heritability of distinct traits to help breeders estimate how
long it will take for a trait to increase in frequency within a population. In some
instances, traits are determined by a single gene. This occurs when the alleles (any of
one or more genes that can occur at the same site on a chromosome) have a
4
dominant/recessive relationship, wherein both alleles affect the
same inherited characteristic but one allele is expressed in an observable manner over
the other. Dominant traits are highly heritable, and their frequency in a population
can be changed throughout a single generation. In other cases, multiple genes
contribute to the expression of a trait. Often, the trait is also partly influenced by the
environment. In such cases, selective breeding over many generations is required to
dramatically change the frequency of the trait in a population.
B. Discovery of Recombinant DNA Technology
Recombinant DNA technology comprises altering genetic material outside an
organism to obtain enhanced and desired characteristics in living organisms or as
their products. This technology involves the insertion of DNA fragments from a
variety of sources, having a desirable gene sequence via an appropriate vector.
Manipulation in an organism's genome is carried out either through the introduction
of one or several new genes and regulatory elements or by decreasing or blocking the
expression of endogenous genes through recombining genes and elements. Enzymatic
cleavage is applied to obtain different DNA fragments using restriction endo-
nucleases for specific target sequence DNA sites followed by DNA ligase activity to
join the fragments to fix the desired gene in a vector. The vector is then introduced
into a host organism, which is grown to produce multiple copies of the incorporated
DNA fragment in culture, and finally, clones containing a relevant DNA fragment are
selected and harvested. The first recombinant DNA (rDNA) molecules were
generated in 1973 by Paul Berg, Herbert Boyer, Annie Chang, and Stanley Cohen of
Stanford University and the University of California San Francisco. In 1975, during
“The Asilomar Conference” regulation and safe use of rDNA technology was
discussed. Paradoxically to the view of scientists at the time of Asilomar, the
recombinant DNA methods to foster agriculture and drug developments took longer
than anticipated because of unexpected difficulties and barriers to achieving
satisfactory results. However, since the mid-1980s, several products like hormones,
vaccines, therapeutic agents, and diagnostic tools have been developed continually to
improve health.
A quick approach is offered by recombinant DNA technology to scrutinize the
genetic expression of the mutations that were introduced into eukaryote genes
through cloned insulin genes insertion inside a simian virus fragment. Similarly,
tumor growth was inhibited by an adenoviral vector that encodes endostatin human
secretory form through antiangiogenic effects. The anti-angiogenic effect can be
enhanced by dl1520 through rescuing replication of Ad-Endo. Targeted gene
disruption has been used to produce antitumor derivatives in other hosts that were
structurally similar for the production pathways. Besides, longer-acting therapeutic
proteins have been developed through recombinant DNA technologies; for example,
sequences containing additional glycosylation sites are one of the most followed
approaches. A new chimeric gene has been developed through this technique which
contains the FSH β-subunit coding sequences and the C-terminal peptide of the
hCG β-subunit coding sequences. Researchers have also developed vectors and
combined vectors for gene therapy and genetic modification approaches. Viral
5
vectors have received immense consideration in clinical settings, some of which have
also been commercialized. In principle, viruses are modified to be safe for clinical
purposes. They have several applications including treatment of severe diseases
including cancer either through in vivo or gene therapy (ex vivo), vaccination, and
protein transduction approaches. The production of clinical-grade viral vectors
improvement has become possible due to advanced manufacturing technologies. At
present, due to the severe adverse effects, retroviral vectors are losing their
importance although the viral entities transfer genes quickly and correctly into several
species. The simplest nonviral gene delivery system uses “naked” DNA, when
injected directly into certain tissues, particularly muscles, produces significant levels
of gene expression with the least side effects. More recently, a P1 vector has been
designed to introduce the recombinant DNA into E. coli through electroporation
procedures. This new cloning system is used for establishing 15,000 clone libraries
initially averaging 130−150 kb pairs insert size. PAC cloning system is considered
useful for complex genome analysis and mapping. The construction of low-copy
number vectors, for example, pWSK29, pWKS30, pWSK129, and pWKS130, was
carried out using PCR and recombinant DNA technology. These vectors can also be
used for generating unidirectional deletions with exonuclease, complementation
analysis, DNA sequencing, and run-off transcription. A broad range of applications
of recombinant DNA technology has been summarized in Fig. 1.

Fig. 1 Illustration of various applications of recombinant DNA technology.

C. Advancements in Genetic Engineering Techniques
Advancements in genetic engineering techniques have revolutionized our ability to
manipulate and engineer DNA, driving innovation and discovery across multiple
fields. One of the most significant breakthroughs is CRISPR-Cas9 technology, which
allows precise editing of specific DNA sequences with unprecedented ease and
accuracy. This versatile tool has applications ranging from correcting genetic
mutations associated with human diseases to engineering crops for improved traits.
Additionally, advancements in DNA synthesis and assembly techniques have enabled
the creation of custom-designed DNA constructs for gene expression and synthetic
biology applications. Gene delivery systems, including viral vectors and non-viral

6
methods, facilitate the introduction of foreign DNA into target cells or organisms,
crucial for gene therapy and biomedical research. High-throughput sequencing
technologies have transformed genomics research by enabling rapid and cost-
effective sequencing of entire genomes, leading to insights into genetic variation and
gene expression profiles. Directed evolution techniques harness natural selection to
engineer proteins with desired properties, offering solutions for enzyme engineering,
drug discovery, and biocatalysis. These advancements underscore the transformative
potential of genetic engineering in addressing societal challenges and improving
human health and well-being.

D. Evolution of Techniques and Applications

The evolution of genetic engineering techniques and their applications has been a
dynamic and transformative journey, marked by continual innovation and discovery.
Initially, genetic engineering relied on rudimentary methods such as restriction
enzyme-based DNA cloning and bacterial transformation. However, advancements in
molecular biology and biotechnology have led to the development of increasingly
sophisticated techniques with diverse applications.

Early techniques, such as restriction enzyme digestion and DNA ligation, paved the
way for the creation of recombinant DNA molecules in the 1970s. These techniques
allowed scientists to isolate, manipulate, and recombine DNA fragments from
different sources, laying the foundation for genetic engineering. Subsequent
7
developments, including the polymerase chain reaction (PCR), enabled the
amplification of specific DNA sequences, revolutionizing molecular biology
research.
The advent of recombinant DNA technology in the 1980s facilitated the production
of genetically modified organisms (GMOs) with desired traits for agriculture,
medicine, and industry. Techniques like gene cloning and expression vector systems
allowed for the production of recombinant proteins, vaccines, and pharmaceuticals in
microbial hosts such as bacteria and yeast. Genetic engineering also enabled the
development of transgenic plants with improved agronomic traits, such as herbicide
resistance and pest resistance.
In the 1990s and 2000s, the completion of the Human Genome Project and
advancements in DNA sequencing technologies ushered in the era of genomics.
High-throughput sequencing platforms, such as next-generation sequencing (NGS),
enabled rapid and cost-effective sequencing of entire genomes, transcriptomes, and
epigenomes. These technologies revolutionized genetics research by facilitating
genome-wide association studies, gene expression profiling, and functional genomics
analyses.
The emergence of genome editing technologies in the 2010s, particularly CRISPR-
Cas9, has revolutionized genetic engineering. CRISPR-Cas9 allows precise and
targeted modification of DNA sequences in a variety of organisms, offering
unprecedented opportunities for gene editing and manipulation. This versatile tool
has applications in gene therapy, disease modeling, crop improvement, and synthetic
biology, among others.
Furthermore, advancements in gene delivery systems, such as viral vectors and
nanoparticles, have improved the efficiency and specificity of gene transfer in
biomedical applications. Directed evolution techniques, including error-prone PCR
and DNA shuffling, enable the engineering of proteins with novel functions and
properties, facilitating drug discovery and biocatalysis.
III. Techniques of Genetic Modification
A. Overview of Genetic Engineering Tools
Genetic engineering tools encompass a diverse array of techniques and technologies
that enable scientists to manipulate and modify DNA with precision. These tools have
revolutionized molecular biology and biotechnology, facilitating a wide range of
applications in fields such as medicine, agriculture, industry, and environmental
science. Here is an overview of some of the key genetic engineering tools:

8
Restriction enzymes, also known as restriction endonucleases, are proteins that can
recognize specific DNA sequences and cleave the DNA at or near these sites. These
enzymes are essential for DNA cloning, as they allow for the precise cutting of DNA
molecules at specific locations, facilitating the insertion of foreign DNA fragments
into vector molecules.
DNA ligases are enzymes that catalyze the joining of DNA fragments by forming
phosphodiester bonds between adjacent nucleotides. These enzymes are used in DNA
cloning to ligate together DNA fragments generated by restriction enzyme digestion,
allowing for the creation of recombinant DNA molecules.
Polymerase Chain Reaction (PCR): is a technique used to amplify specific DNA
sequences in vitro through repeated cycles of DNA denaturation, annealing of
primers, and DNA synthesis by a DNA polymerase enzyme. PCR is widely used in
molecular biology research, diagnostic testing, and forensics for applications such as
DNA sequencing, genotyping, and gene expression analysis.
Cloning vectors are DNA molecules used to transport foreign DNA fragments into
host organisms for replication and expression. Common cloning vectors include
plasmids, bacteriophages, and artificial chromosomes, which can carry large DNA
inserts and confer selectable markers for screening transformed cells.
Expression vectors are specialized cloning vectors designed for the expression of
foreign genes in host cells to produce proteins of interest. These vectors typically
contain regulatory elements such as promoters, enhancers, and transcription
terminators, along with selectable markers for identifying cells that have successfully
incorporated the vector.
CRISPR-Cas9 is a revolutionary gene-editing technology derived from bacterial
immune systems. It allows for precise targeting and modification of specific DNA
sequences by guiding the Cas9 nuclease to the desired genomic location using a short
RNA molecule. CRISPR-Cas9 has revolutionized genetic engineering by enabling
efficient and versatile genome editing in a wide range of organisms, with applications
in gene therapy, disease modeling, and crop improvement.
RNA Interference (RNAi): RNAi is a mechanism for gene regulation in which small
RNA molecules, such as short interfering RNAs (siRNAs) or microRNAs (miRNAs),
bind to complementary mRNA molecules and induce their degradation or inhibit
translation. RNAi is used for gene knockdown experiments to study gene function
9
and as a therapeutic approach for treating diseases caused by aberrant gene
expression.
B. Principles and Methodologies of Each Technique
Genetic engineering techniques encompass a suite of methodologies built upon
fundamental biological principles, enabling precise manipulation of DNA for various
applications. These techniques have revolutionized molecular biology,
biotechnology, and biomedical research, shaped our understanding of genetics, and
offered solutions to complex challenges. Here is an essay outlining the principles and
methodologies of each major genetic engineering technique:
Restriction Enzymes: Restriction enzymes, also known as restriction endonucleases,
are enzymes that recognize specific DNA sequences, known as restriction sites, and
cleave the DNA at or near these sites. The principle behind their function lies in the
enzyme's ability to recognize a specific nucleotide sequence and cut the DNA
backbone at specific phosphodiester bonds. Methodologically, DNA samples are
incubated with restriction enzymes under optimal conditions, resulting in the precise
cleavage of DNA molecules into fragments with cohesive or blunt ends.

DNA Ligases: DNA ligases are enzymes that catalyze the formation of
phosphodiester bonds between adjacent nucleotides in DNA molecules, joining DNA
fragments together. The principle of DNA ligase activity revolves around its ability to
recognize and covalently link the 3' hydroxyl and 5' phosphate ends of adjacent DNA
fragments. Methodologically, DNA fragments with compatible ends, generated by
restriction enzyme digestion or PCR amplification, are mixed with DNA ligase and
incubated under appropriate conditions, resulting in the ligation of the fragments into
larger DNA molecules.

10
Polymerase Chain Reaction (PCR): PCR is a molecular biology technique used to
amplify specific DNA sequences in vitro through repeated cycles of denaturation,
primer annealing, and DNA synthesis. The principle of PCR relies on the ability of a
DNA polymerase enzyme to synthesize new DNA strands complementary to a
template DNA strand. Methodologically, PCR involves the design of sequence-
specific primers that anneal to the target DNA sequences, allowing DNA polymerase
to amplify the region of interest through repeated cycles of temperature-mediated
denaturation, annealing, and extension.

Cloning Vectors: Cloning vectors are DNA molecules used to transport foreign DNA
fragments into host organisms for replication and expression. The principle
underlying cloning vectors is their ability to replicate independently of the host
genome and carry foreign DNA inserts for propagation and expression.
Methodologically, foreign DNA fragments and cloning vectors are cleaved with the
same restriction enzymes to generate compatible ends, facilitating the ligation of the
DNA fragments into the vector. The resulting recombinant DNA molecules are then
introduced into host cells, where they replicate along with the host genome.
Expression Vectors: Expression vectors are specialized cloning vectors designed for
the expression of foreign genes in host cells to produce proteins of interest. The
11
principle of expression vectors involves the incorporation of regulatory elements,
such as promoters, enhancers, and transcription terminators, along with selectable
markers, into the vector backbone. Methodologically, the foreign gene of interest is
inserted into the vector downstream of the promoter sequence. The recombinant
vector is then introduced into host cells, where the gene is transcribed and translated
into protein.

CRISPR-Cas9: CRISPR-Cas9 is a genome editing technology that uses a guide RNA

(gRNA) to direct the Cas9 nuclease to specific DNA sequences, where it induces
double-strand breaks (DSBs) that can be repaired by cellular mechanisms. The
principle of CRISPR-Cas9 revolves around the ability of the gRNA to guide the Cas9
protein to the target DNA sequence, resulting in precise DNA cleavage.
Methodologically, the gRNA is designed to be complementary to the target DNA
sequence and forms a complex with the Cas9 protein. The gRNA-Cas9 complex is
then introduced into cells, where it binds to the target DNA sequence and induces
DSBs. The cellular repair machinery then either repairs the DSBs through non-
homologous end joining (NHEJ) or homology-directed repair (HDR), resulting in
gene editing.

Fig. 2 Using CRISPR to edit genes

RNA Interference (RNAi): RNA interference (RNAi) is a mechanism for gene
silencing in which small RNA molecules, such as siRNAs or miRNAs, bind to
12
complementary mRNA molecules and induce their degradation or translational
inhibition. The principle of RNAi involves the sequence-specific recognition of target
mRNA molecules by small RNA molecules, leading to their degradation or
translational repression. Methodologically, double-stranded RNA (dsRNA)
molecules that are complementary to the target gene are introduced into cells. These
dsRNA molecules are processed into siRNAs or miRNAs, which guide the RNA-
induced silencing complex (RISC) to the target mRNA. The RISC cleaves the
mRNA, leading to its degradation and silencing of the gene.

IV. Applications of Genetic Modification in Agriculture

A. Enhancement of Livestock Productivity and Quality
Livestock farming plays a crucial role in meeting global demand for meat, milk, and
other animal products. However, challenges such as population growth,
environmental concerns, and the need for sustainable food production have prompted
the exploration of innovative approaches to enhance livestock productivity and
quality. Genetic engineering has emerged as a promising tool to address these
challenges by improving traits such as growth rate, disease resistance, and nutrient
composition. This essay explores how genetic engineering techniques can be used to
enhance livestock productivity and quality, benefiting both producers and consumers.
Genetic engineering offers the potential to develop livestock breeds with enhanced
resistance to common diseases. By identifying and introducing genes associated with
disease resistance, such as those encoding for antimicrobial peptides or immune
system regulators, animals can be better equipped to fend off pathogens. This
approach reduces the reliance on antibiotics and other medications, promoting animal
welfare and reducing the risk of antimicrobial resistance.
Genetic engineering can accelerate livestock growth rates through the manipulation
of genes involved in growth and development pathways. By introducing genes
associated with increased muscle mass, improved feed conversion efficiency, or
reduced fat deposition, animals can reach market weight more quickly and efficiently.
Faster growth rates translate to reduced production costs for farmers and an increased
supply of high-quality meat for consumers.
Genetic engineering enables the enhancement of nutritional quality in livestock
products, such as meat and milk. Genes encoding for beneficial nutrients, vitamins, or
13
omega-3 fatty acids can be introduced into livestock breeds to enrich their products.
This approach provides consumers with healthier and more nutritious animal
products, contributing to overall human health and well-being.
Genetic engineering can help mitigate the environmental impact of livestock farming
by reducing resource inputs and emissions. Animals with improved feed efficiency
require less feed for the same level of production, resulting in reduced land use, water
consumption, and greenhouse gas emissions. Additionally, genetically engineered
traits such as methane-reducing microbes in the rumen can help curb methane
emissions from livestock, a significant contributor to climate change.
Despite the potential benefits of genetic engineering in livestock farming, consumer
acceptance and regulatory approval remain key challenges. Transparent
communication, labeling, and rigorous safety assessments are essential to address
consumer concerns and ensure the responsible use of genetic engineering
technologies. Regulatory frameworks must be developed to assess the safety and
efficacy of genetically engineered livestock breeds while balancing innovation with
ethical and environmental considerations.
Genetic engineering holds immense potential to enhance livestock productivity and
quality, addressing key challenges facing the agricultural sector. By developing
livestock breeds with improved disease resistance, growth rates, and nutritional
quality, genetic engineering can contribute to sustainable food production, animal
welfare, and environmental conservation. However, addressing consumer concerns
and navigating regulatory frameworks are crucial for the successful adoption of
genetically engineered livestock breeds. With careful consideration of ethical,
environmental, and safety implications, genetic engineering can revolutionize
livestock farming and pave the way for a more sustainable and resilient food system.
B. Disease Resistance in Animals

Enhancing disease resistance in animals through genetic engineering represents a

significant opportunity to mitigate the impact of infectious diseases on livestock
populations. By leveraging genetic modifications to bolster the animals' innate
immune defenses, researchers aim to create livestock breeds that are more resilient to
a wide range of pathogens. This approach involves introducing genes encoding for
antimicrobial peptides, immune system regulators, or other defense mechanisms into
14
the animal's genome. By enhancing innate immune responses, such as the production
of antimicrobial proteins or the activation of phagocytic cells, genetically engineered
animals can better fend off bacterial, viral, or parasitic infections. Moreover,
advancements in genomic selection and marker-assisted breeding allow for the
identification and selection of animals with naturally occurring genetic variations
associated with enhanced disease resistance. This selective breeding approach
leverages the genetic diversity within livestock populations to develop more robust
and resilient breeds over successive generations. The ultimate goal of enhancing
disease resistance in animals is to reduce the incidence and severity of infectious
diseases, leading to improved animal health, welfare, and productivity. Additionally,
by minimizing disease outbreaks, farmers can reduce the need for costly treatments,
such as antibiotics, and mitigate production losses associated with morbidity and
mortality. However, while genetic engineering holds promise for enhancing disease
resistance in animals, it also raises ethical, regulatory, and societal considerations that
must be carefully addressed. Transparency, stakeholder engagement, and responsible
oversight are essential to ensure the ethical use of genetic engineering technologies in
livestock farming, while rigorous safety assessments and regulatory approval
processes are necessary to mitigate potential risks. Overall, genetic engineering offers
a powerful tool to bolster disease resistance in animals, contributing to improved
animal welfare, sustainable farming practices, and global food security.
C. Environmental Impacts and Sustainability
Genetic modification in animals has paved the way for numerous biomedical
applications, offering potential solutions to various human health challenges. Here
are some of the key biomedical applications of genetic modification in animals:
Disease Modeling: Genetically modified animals serve as valuable models for
studying human diseases, allowing researchers to better understand disease
mechanisms, identify potential therapeutic targets, and test new drugs. For example,
mice engineered to mimic human genetic disorders such as cystic fibrosis,
Huntington's disease, and muscular dystrophy have provided insights into disease
pathology and facilitated the development of novel treatments.
Drug Development and Testing: Genetically modified animals play a crucial role in
preclinical drug development and testing. By introducing human disease-related
genes or pathways into animal models, researchers can assess the efficacy and safety
of potential drug candidates in vivo. This approach enables researchers to evaluate
drug metabolism, pharmacokinetics, and toxicity before advancing to clinical trials,
ultimately accelerating the drug discovery process.
Gene Therapy: Animals genetically modified to carry disease-causing mutations can
serve as recipients of gene therapy interventions aimed at correcting or mitigating
genetic disorders. Gene therapy approaches may involve introducing therapeutic
genes into target tissues or cells using viral vectors, nanoparticles, or other delivery
systems. Genetically modified animal models provide valuable preclinical data on the
safety and efficacy of gene therapy strategies, helping to guide the development of
treatments for human genetic diseases.

15
Transplantation and Xenotransplantation: Genetic modification of animals holds
promise for overcoming the shortage of human organs available for transplantation.
By engineering pigs or other animals to express human-compatible cell surface
proteins and suppress immune rejection responses, researchers aim to generate donor
animals whose organs can be transplanted into humans without triggering an immune
response. This approach, known as xenotransplantation, has the potential to save
countless lives by providing a sustainable source of organs for transplantation.
Bioproduction of Therapeutic Proteins: Genetically modified animals, such as goats,
rabbits, and chickens, can be engineered to produce therapeutic proteins, antibodies,
or vaccines in their milk, eggs, or other bodily fluids. This approach, known as
biopharming, offers a cost-effective and scalable method for producing complex
biologics, particularly those that are difficult or expensive to produce using
traditional cell culture systems. Biopharming animals have been used to generate
therapeutic proteins for treating diseases such as hemophilia, cancer, and infectious
diseases.
Disease Surveillance and Control: Genetically modified animals can be engineered to
carry genetic markers that make them more susceptible to certain diseases or serve as
sentinels for environmental toxins or pathogens. These animals can be used for
disease surveillance and monitoring, providing early warning systems for emerging
infectious diseases or environmental hazards. Additionally, genetically modified
mosquitoes engineered to carry genes that interfere with pathogen transmission have
been proposed as a strategy for controlling vector-borne diseases such as malaria,
dengue fever, and Zika virus.
V. Biomedical Applications of Genetic Modification in Animals
A. Animal Models in Biomedical Research
Animal models are essential for several biomedical research fields such as cancer
biology and therapeutics, neuroscience, pharmacology and toxicology, neurobiology
of diseases, endocrinology, public health, palliative medicine, also, in studies in
human and animal biology, and for the discovery and testing of new drugs, vaccines,
and other biologicals (e.g., antibodies, hormones) whose validation requires
preclinical studies in animals [6,20]. Currently, these models address current research
priorities, considered as those imposing major global threats to human and animal
health. These include diseases that have afflicted humankind or increased
exponentially in recent years such as SARS-CoV-2, different types of cancer and
their therapy, cardiovascular diseases, metabolic and neurodegenerative disorders,
and experimental refinement of surgical techniques to treat these issues [21]. The
models may involve complete animals or only particular cells, tissues, organs, genes,
or other agents that reproduce pathological processes (Figure 1) [8,22]. Species
include rats, mice, guinea pigs, dogs, rabbits, birds, ruminants (cows, sheep), horses,
fish, frogs, monkeys, cats, reptiles, squid, crabs, bees, chimpanzees, hamsters, sea
slugs, pigs, nematodes (roundworm), fruit flies, and protozoans, among others [7].

16
Fig. 3 Classification of various animal models. The animals used in science can be divided into five
broad types. (a) The main ones are models in which animals are induced to present a pathology
similar to one that affects humans or other animals by administering drugs or other biologicals,
inflicting injuries, or subjecting them to stress or other environmental conditions. In contrast,
models based on spontaneous changes (b) include animals where the normal course of their life
predisposes them to develop a specific disease. (c) Genetically modified test subjects are animals
with knocking or knockout genes or proteins. In contrast to using healthy animals (e), negative
models (d) employ individuals who are not susceptible to certain diseases but serve to evaluate
susceptibility to a specific pathology. TBI: traumatic brain injury.
B. Ethical Considerations in Biomedical Applications
Ethical considerations loom large in the realm of biomedical applications, particularly
regarding genetic modification in animals. A multitude of ethical dimensions must be
carefully navigated, spanning animal welfare, human health and safety, informed
consent, social justice and equity, environmental impact, and long-term effects.
Striking a balance between scientific progress and ethical imperatives necessitates
transparent communication, robust adherence to ethical guidelines and regulatory
frameworks, and deliberate consideration of the potential risks and benefits inherent
in genetic modification technologies. Upholding ethical principles, such as respect for
animal welfare and human autonomy, requires ongoing dialogue and collaboration
among researchers, policymakers, and stakeholders to ensure that biomedical
applications remain grounded in ethical values and contribute positively to human
well-being while minimizing harm to animals and the environment. Ethical reflection
and consideration must be integral to every stage of biomedical research and
application, guiding decisions and actions toward responsible innovation and
equitable outcomes for all.
VI. Human Health and Safety Considerations
Safety evaluation of genetically modified animal products is crucial to ensure
consumer health and confidence. Rigorous testing protocols assess the safety of these
products, examining factors such as nutritional composition, allergenicity, and
potential toxicity. These evaluations typically involve comparing genetically
modified animal products to their conventional counterparts and assessing any
differences in composition or health impacts. By adhering to stringent safety

17
standards and regulatory guidelines, researchers and regulatory agencies strive to
ensure that genetically modified animal products are safe for consumption.
Assessing allergenicity and toxicity is a fundamental aspect of evaluating the safety
of genetically modified animal products. Researchers conduct comprehensive
analyses to identify any potential allergens or toxic substances present in these
products. Testing methods may include in vitro assays, animal feeding studies, and
human clinical trials to assess allergic reactions and adverse health effects. By
thoroughly evaluating allergenicity and toxicity, researchers can identify and mitigate
potential risks associated with genetically modified animal products, ensuring
consumer safety and regulatory compliance.
Genetic modification in animals carries inherent risks of unintended consequences
and potential health implications. Researchers must carefully consider the genetic
modifications introduced into animals and assess the likelihood of unintended effects,
such as off-target gene edits or disruptions to biological pathways. Evaluating the
long-term health implications of these modifications is essential, as unforeseen health
risks may emerge over time. By conducting thorough risk assessments and
monitoring studies, researchers can identify and mitigate potential adverse effects,
safeguarding both animal welfare and human health.
Public perception and acceptance play a significant role in the adoption of genetically
modified animal products. Concerns about safety, ethics, and environmental impact
may influence consumer attitudes and purchasing decisions. Addressing public
concerns through transparent communication, education, and engagement is essential
to build trust and acceptance of genetically modified animal products. By fostering
open dialogue and providing accurate information about the safety and benefits of
these products, stakeholders can work towards promoting informed decision-making
and enhancing public confidence in genetically modified animal products.
VII. Ethical Considerations in Genetic Modification
Ethical frameworks provide a structured approach for evaluating the complex moral
dilemmas inherent in the genetic modification of animals. These frameworks, often
grounded in principles such as respect for autonomy, beneficence, non-maleficence,
and justice, guide researchers, policymakers, and stakeholders in making ethical
decisions. However, genetic modification presents unique ethical challenges, such as
balancing potential human benefits with animal welfare considerations, navigating
cultural and religious perspectives, and addressing uncertainties and unintended
consequences. Moral dilemmas may arise when ethical principles conflict, requiring
careful consideration and deliberation to determine the most ethically justifiable
course of action.
Balancing human benefits with animal welfare is a central ethical consideration in the
genetic modification of animals. While genetic modification has the potential to
improve human health, food security, and sustainability, it also raises concerns about
the well-being of the modified animals. Ethical frameworks guide stakeholders in
weighing the potential benefits and harms, considering factors such as animal
suffering, autonomy, and quality of life. Striking a balance between human benefits
and animal welfare requires careful ethical deliberation, transparent communication,
18
and robust regulatory oversight to ensure that genetic modification advances human
interests while respecting the intrinsic value and welfare of animals.
Cultural and religious perspectives influence attitudes and values surrounding the
genetic modification of animals. Different cultural and religious traditions may have
varying beliefs about the sanctity of life, the moral status of animals, and the
permissibility of genetic manipulation. Ethical frameworks must consider diverse
cultural and religious perspectives, recognizing the importance of cultural sensitivity,
pluralism, and respect for cultural and religious beliefs. Engaging with diverse
communities and stakeholders allows for meaningful dialogue and collaboration in
navigating ethical issues related to genetic modification, fostering mutual
understanding and respectful coexistence.
Stakeholder engagement is essential for ethical decision-making in the genetic
modification of animals. Meaningful engagement with stakeholders, including
researchers, policymakers, industry representatives, animal welfare advocates, and
the public, facilitates inclusive and participatory decision-making processes. Ethical
frameworks provide a common language and set of principles for stakeholders to
discuss and evaluate the ethical implications of genetic modification. By involving
stakeholders in ethical deliberations, soliciting diverse perspectives, and considering
stakeholder values and concerns, ethical decision-making processes become more
transparent, accountable, and responsive to societal needs and values.
VIII. International Regulations on Genetic Modification in Animals

Fig.4 Regulatory overlap of GM organisms by U.S. agencies.

International regulations on genetic modification in animals are characterized by a
diverse array of guidelines and frameworks aimed at ensuring the safety, ethical use,
and responsible oversight of genetically modified organisms (GMOs) worldwide.
Bodies such as the Codex Alimentarius Commission, the World Organization for
Animal Health (OIE), and the Convention on Biological Diversity (CBD) play
pivotal roles in setting international standards and protocols for the evaluation,
regulation, and trade of genetically modified animals. These standards encompass
various aspects, including risk assessment, environmental impact assessment, ethical
considerations, and post-market monitoring. Furthermore, international guidelines

19
and recommendations provided by organizations like the Organization for Economic
Co-operation and Development (OECD) and the United Nations Food and
Agriculture Organization (FAO) contribute to harmonizing regulatory approaches
across countries and regions. While international regulations provide a framework for
oversight, implementation, and enforcement remain the responsibility of individual
countries, which may adopt varying approaches based on their specific legal, cultural,
and socio-economic contexts. Collaboration and coordination among countries and
international organizations are essential to promote coherence, consistency, and
effectiveness in regulating genetic modification in animals on a global scale.
IX. Conclusion
Genetic modification in animals has the potential to enhance productivity, and
disease resistance, and serve as models for human diseases. However, it raises ethical
and environmental concerns. A genetically modified animal is one whose genetic
material has been altered by adding, changing, or removing certain DNA sequences
in a way that does not occur naturally. Genetic modification offers unparalleled
opportunities to enhance traits, address societal challenges, and drive innovation. GM
crops have revolutionized agriculture by conferring traits such as pest resistance,
disease tolerance, and increased nutritional value. GM organisms serve as
indispensable tools in scientific research, enabling investigations into gene function,
cellular processes, and organismal biology. The essay aims to provide a
comprehensive overview of genetic modification (GM) in animals, elucidating its
significance, applications, and ethical implications across various domains.

20
X. References
Perry Bradbury HACKETT. Regulatory issues for genetically modified
animals. Front. Agr. Sci. Eng., 2020, 7(2): 188‒203 https://doi.org/10.15302/J-FASE-
2019307
Akre, K. (2023, May 25). selective breeding. Encyclopedia Britannica.
https://www.britannica.com/science/selective-breeding
Khan, S., Ullah, M. W., Siddique, R., Nabi, G., Manan, S., Yousaf, M., & Hou, H.
(2016). Role of Recombinant DNA Technology to Improve Life. International
journal of genomics, 2016, 2405954. https://doi.org/10.1155/2016/2405954
Liangxue Lai, Jing X. Kang, Rongfeng Li, Jingdong Wang, William T. Witt, Hwan
Yul Yong, Yanhong Hao, et al. “Generation of Cloned Transgenic Pigs Rich in
Omega-3 Fatty Acids.” Nature Biotechnology 24 no. 4 (2006): 435–436.
Raylene Ramos Moura, Luciana Magalhães Melo, and Vicente José de Figueirêdo
Freitas. “Production of Recombinant Proteins in Milk of Transgenic and Non-
TransgenicGoats.” Brazilian Archives of Biology and Technology 54 no. 5 (2011):
927–938.
William S.M. Wold and Karoly Toth. “Adenovirus Vectors for Gene
Therapy, Vaccination and Cancer Gene Therapy.” Current Gene Therapy13 no. 6
(2013): 421.
Domínguez-Oliva, A., Hernández-Ávalos, I., Martínez-Burnes, J., Olmos-Hernández,
A., Verduzco-Mendoza, A., & Mota-Rojas, D. (2023). The Importance of Animal
Models in Biomedical Research: Current Insights and Applications. Animals: an open
access journal from MDPI, 13(7), 1223. https://doi.org/10.3390/ani13071223

21