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STUDY GUIDE FOR MODULE NO. 12

GENETICALLY MODIFIED ORGANISMS AND GENE THERAPY

MODULE OVERVIEW

This section discusses moral and ethical issues concerning Genetically Modified Organisms (GMOs)
and their impacts on society. It also discusses forms and applications of Gene Therapy.

MODULE LEARNING OBJECTIVES

At the end of this Module, you should be able to:

1. Discuss the ethics and implications of GMOs and potential future impacts
2. Describe gene therapy and its various forms
3. Assess the potential benefits and detriments to global health of GMOs and gene therapy

GENETICALLY MODIFIED ORGANISMS (GMOs)

Biotechnology

According to Bragdon in the module released by Biodiversity International entitled “Law and policy of
relevance to the management of plant genetic resources”, biotechnology uses biological systems, living
organisms, or derivatives thereof, to make or modify products or processes for specific use. Biotechnology
includes such early practices as selective breeding of farm animals and using microorganisms to make wine
and cheese. Today, biotechnology also encompasses genetic engineering, the direct manipulation of genes
for practical purposes. Genetic engineering has launched a revolution in biotechnology, greatly expanding the
scope of its potential applications. Tools from the DNA toolbox are now applied in ways that affect everything
from agriculture to criminal law to medical research. Modern biotechnology gives scientists molecular tools for
obtaining a better understanding of the structure and function of genes in living organisms. Modern
biotechnology has aimed to develop new precision tools and diagnostics; speed up breeding gains and
efficiency; develop pest- and disease-resistant crops; combat salinity, drought, and problems of agriculture;
enhance the nutritional quality of food; increase crop varieties and choice; reduce input and production costs;
and increase profits.

Genetically Modified Organisms

A genetically modified organism (GMO) is one that has acquired by artificial means (through
recombinant DNA methods, gene modification, or transgenic technology) one or more genes from another
species or even from another variety of the same species. The majority of the GM organisms that contribute
to our food supply are crop plants. GM crops are widespread in the United States, Argentina, and Brazil;
together these countries account for over 80% of the world’s acreage devoted to such crops.

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Most methods for cloning pieces of DNA in the laboratory share certain general features. One
common approach uses bacteria, most often Escherichia coli. E. coli chromosome is a large circular molecule
of DNA. In addition, E. coli and many other bacteria have plasmids, small circular DNA molecules that
replicate separately from the bacterial chromosome. A plasmid has only a small number of genes; these
genes may be useful when the bacterium is in a particular environment but may not be required for survival or
reproduction under most conditions.

To clone pieces of DNA in the laboratory, researchers first obtain a plasmid and insert DNA from
another source (“foreign” DNA) into it. The resulting plasmid is now a recombinant DNA molecule. The
plasmid is then returned to a bacterial cell, producing a recombinant bacterium. This single cell reproduces
through repeated cell divisions to form a clone of cells, a population of genetically identical cells. Because the
dividing bacteria replicate the recombinant plasmid and pass it on to their descendants, the foreign DNA and
any genes it carries are cloned at the same time. The production of multiple copies of a single gene is called
gene cloning.

Roles of GMOs

I. Food and Agricultural products

1. Pest resistance (e.g., Bt corn, where corn has been modified with gene from Bacillus thuringensis
which is toxic to corn borers)
2. Virus resistance (e.g., rainbow papaya, where protein from papaya ringspot virus was introduced to
papaya)
3. Herbicide tolerance (e.g., Roundup Ready soybean, where the herbicide glyphosphate was
introduced to soybeans)
4. Fortification (e.g., Golden Rice, where beta-carotene was introduced to rice which fortified it with
vitamin A)
5. Cosmetic preservation (e.g., Arctic apple, where the apple does not brown easily)
6. Increase growth rate (e.g., AquAdvantage salmon, where genes from ocean pout was introduced to
Pacific Chinook salmon to make them grow faster)

II. Non-Food crops and microorganisms

1. Flower production (e.g., Blue Rose, where 31,51-hydroxylase gene was introduced)
2. Paper production (e.g., poplar trees, where genes that code for ferulic acid was inserted to modify
lignin structure)
3. Pharmaceutical production (e.g., periwinkle plant, where bacterial genes was modified to enhance the
production of vinblastine that is used for cancer treatments such as Hodgkin’s lymphoma)
4. Bioremediation (e.g., Nicotiana glauca or shruc tobacco, where it was modified with phytochelatin
TaPCSI1 to help it accumulate high levels of zinc, lead, cadmium, nickel, and boron and produce high
biomass)
5. Enzyme and drug production (e.g., cyclomaltodextrin, which is used as a food flavor enhancer that
was produced by Bacillus modified by Thermoanaerobacter)

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6. Diagnosis and treatment of diseases (e.g., Humulin, genetically engineered insulin for Type I diabetes
patients developed by National Medical Center and Genentech Biotechnology Company)

Benefits of GMOs

1. Higher efficiency in farming

2. Increase in harvest
3. Control in fertility
4. Increase in food processing
5. Improvement of characteristics
6. Nutritional and pharmaceutical enhancement
7. Reduction in the use of fertilizers and pesticides

Potential Risks of GMOs

1. There are inadequate studies on the effects of GMOs to humans and the environment
2. Genetic engineering promotes mutation with unknown long-term effects.
3. GMOs consumed by humans might cause or create allergic reactions, gene mutations, antibiotic
resistance, and change in the balance of microorganisms in the digestive system.
4. GMOs might also have change in nutritive value of the food or might produce toxins
5. There is a risk that the modified gene might be transferred from the GMO to its wild relative or other
organisms.
6. There is a risk of new pest or weed resistance. Alteration of agricultural practices for GMOs might
also cause this.
7. There is a risk that the modified gene may be transferred to viral and bacterial genes, which may
cause new diseases. Genetically-modified bacteria and viruses might also be more resistant to
treatment.
8. Introduction of GMOs to the environment might cause competition or interference.
9. There is a potential that GMOs might become pests or post threats to the environment.
10. There is a risk in interfering with natural biochemical processes.
11. There is a risk that the modified genes might persist after its harvest and might cause negative
effects.
12. There are ethical issues regarding GMOs, such as man “playing God” and violation of nature.
13. Because GMOs are novel life forms, biotechnology companies patent their processes and products
which restrict their use, enabling them to sue farmers whose field has been contaminated with these
organisms, even by natural processes.
14. There is worry of creating biases and giving much power to those who hold genetic information (e.g.,
issues on the Human Genome Project)

Golden Rice is one of the more controversial GMOs that have been developed. To learn more about
this, you may read the following articles:

 Dubock, A. (2014). The politics of golden rice. GM Crops & Food, 5(3), 210-222.
http://www.goldenrice.org/PDFs/Dubock-Politics_of_GR-2014.pdf

 Duguet, A. et al. (2013). Ethics in Research with Vulnerable Populations and Emerging Countries:
The Golden Rice Case. Journal of International Law and Commercial Regulations, 38(4), 979-1013.
https://scholarship.law.unc.edu/cgi/viewcontent.cgi?referer=https://www.google.com/
&httpsredir=1&article=1978&context=ncilj

Initiatives on Safety from GMOs

1. Codex Alimentarius Commission (Codex). Created by the Food and Agricultural Organization
(FAO) and World Health Organization (WHO), this is an intergovernmental body that develops the
International Food Code. For GMOs, Codex developed the Codex Principles for the human risk
analysis of GM food products, such as pre-market assessments and effect evaluation.

2. Cartagena Protocol on Biosafety. This is an international environmental treaty that regulates the

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transboundary movements of Living Modified Organisms (LMOs). It requires exporters to seek

consent from importers before its first shipment of LMOs.

3. International Trade Agreement on labeling of GM food and food products. Exporters are
required for GM food products to be labeled and importers may accept or reject these products.

The Philippines and GMOs

GMO concern in the Philippines started in the 1990s, with the creation of National Committee on
Biosafety of the Philippines through Executive Order No. 430 of 1990. The NBCP developed guidelines on
the planned release of GMOs and potentially harmful exotic species in 1998.

In 2002, the Department of Agriculture (DA) released Administrative Order No. 8, the guideline for the
transportation and release to the environment of GM plants and plant products. This was also the same year
when GMO started and the same year when the Philippines became the first Asian country to approve
cultivation of GMOs (genetically-modified corn). From then until today, there are 70 GMO applications
approved by DA, 62 for food feed and processing and 8 for propagation.

In 2004, the Philippines was classified by International Service for acquisition of agro-biotech
applications as one of the 14 biotech-mega countries which grow 50,000 hectares or more GMO crops
annually. In the same year, Senator Juan Flavier authored a bill on labeling of GM food and food products but
it did not pass. In 2012, Representative Teddy Casiño and other congressmen aimed for the same bill.

In 2005, the Negros Organic Island was established through a memorandum of agreement (MOA)
between Negros Occidental and Negros Oriental. This MOA bans the entry of GMOs to their provinces.

In 2010, the Organic Agriculture Act was issued, encouraging organic-agriculture rather than GMO-
related agriculture. Similar to the Negros provinces, Davao City passed the Organic Agriculture Ordinance in
2010, which prevented the field testing of Bt eggplant in UP Mindanao. Eventually, the Bt eggplant field
testing was put to an end through the Supreme Court in December 2015, nullifying Administrative Order No. 8
of DA.

In March 17, 2016, the DA, DENR, DOST, DOH, and DILG passed Joint Department Circular No. 1,
on rules and regulations for the research and development, handling and use, transboundary movement,
release in the environment, and management of GM plants and plant products using modern biotechnology.
This joint circular paves way to issuances for planting and importing GM crops in the country.

To learn more about issues concerning GMOs in the Philippines, you may read the article entitled SC
reverses ruling on Bt ‘talong’ tests (https://newsinfo.inquirer.net/800262/sc-reverses-ruling-on-bt-talong-tests).

GENE THERAPY

Gene therapy is a therapeutic technique that aims to transfer normal genes into a patient’s cells. In
theory, the normal genes will be transcribed and translated into functional gene products, which, in turn, will
bring about a normal phenotype.

Human gene therapy began in 1990 with the treatment of a young girl named Ashanti DeSilva, who
has a heritable disorder called severe combined immunodeficiency (SCID). Individuals with SCID have no
functional immune system and usually die from what would normally be minor infections. Ashanti has an
autosomal form of SCID caused by a mutation in the gene encoding the enzyme adenosine deaminase
(ADA). Her gene therapy began when clinicians isolated some of her white blood cells, called T cells. These
cells, which are key components of the immune system, were mixed with a retroviral vector carrying an
inserted copy of the normal ADA gene. The virus infected many of the T cells, and a normal copy of the ADA
gene was inserted into the genome of some T cells. After being mixed with the vector, the T cells were grown
in the laboratory and analyzed to make sure that the transferred ADA gene was expressed. Then a billion or
so genetically altered T cells were injected into Ashanti’s bloodstream. Some of these T cells migrated to her

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bone marrow and began dividing and producing daughter cells that also produce ADA. She now has ADA
protein expression in 25 to 30 percent of her T cells, which is enough to allow her to lead a normal life.

Although gene therapy was originally developed as a treatment for single-gene inherited diseases, the
technique was quickly adapted for the treatment of acquired diseases such as cancer, neurodegenerative
diseases, cardiovascular disease, and infectious diseases, such as HIV. Over a 10-year period, from 1990 to
1999, more than 4000 people underwent gene therapy for a variety of genetic disorders. These trials often
failed and thus led to a loss of confidence in gene therapy.

Hopes for gene therapy plummeted even further in September 1999 when teenager Jesse Gelsinger
died while undergoing gene therapy to treat a liver disease condition. His death was triggered by a massive
inflammatory response to the vector, a modified adenovirus, one of the viruses that cause colds and
respiratory infections. Within hours of his first treatment, a massive immune reaction surged through Jesse’s
body. He developed a high fever, his lungs filled with fluid, multiple organs shut down, and he died four days
later of acute respiratory failure.

In the aftermath of the tragedy, several government and scientific inquiries were conducted.
Investigators learned that clinical trial scientists had not reported other adverse reactions to gene therapy and
that some of the scientists were affiliated with private companies that could benefit financially from the trials.
They found that serious side effects seen in animal studies were not explained to patients during
informed-consent discussions, and that some clinical trials were proceeding too quickly in the face of data
suggesting a need for caution. The U.S. Food and Drug Administration (FDA) scrutinized gene therapy trials
across the country, halted a number of them, and shut down several gene therapy programs. Other research
groups voluntarily suspended their gene therapy studies. Tighter restrictions on clinical trial protocols were
imposed to correct some of the procedural problems that emerged from the Gelsinger case. Jesse’s death
had dealt a severe blow to the struggling field of gene therapy—a blow from which it was still reeling when a
second tragedy hit.

The outlook for gene therapy brightened in 2000, when a group of French researchers reported the
first large-scale success in gene therapy. Nine children with a fatal X-linked form of SCID developed functional
immune systems after being treated with a retroviral vector carrying a normal gene. Published reports of the
study were greeted with enthusiasm by the gene therapy community. But elation turned to despair in 2003,
when it became clear that 2 of the 10 children who had been cured of X-SCID had developed leukemia as a
direct result of their therapy, and one died as a result of the treatment. In two of the children, their cancer cells
contained the retroviral vector, inserted near or into a gene called LMO2. This insertion activated the LMO2
gene, causing uncontrolled white blood cell proliferation and development of leukemia. FDA immediately
halted 27 similar gene therapy clinical trials, and once again gene therapy underwent a profound
reassessment. In 2005, a third child in the French X-SCID study developed leukemia, likely as a result of gene
therapy.

To date, no human gene therapy product has been approved for sale. Critics of gene therapy
continue to berate research groups for undue haste, conflicts of interest, and sloppy clinical trial management,
and for promising much but delivering little. Most problems associated with gene therapy have been traced to
the vectors used to transfer therapeutic genes into cells.

Types of Gene Therapy

I. According to the way that healing genes are delivered and to which cells they are sent
1. Germline gene therapy alters the DNA of a gamete or fertilized ovum. As a result, all cells of the
individual have the change. Germline gene therapy is heritable—it passes to offspring.
2. Somatic gene therapy corrects only the cells that an illness affects. It is non-heritable; a recipient
does not pass the genetic correction to offspring.

II. According to invasiveness

1. Ex vivo gene therapy is when cells are altered outside the body and then infused.
2. In situ gene therapy is when the functional gene plus the DNA that delivers it (the vector) are
injected into a very localized and accessible body part.
3. In vivo gene therapy is when the gene and vector are introduced directly into the body.

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Stem Cell Gene Therapy

Bodies grow and heal thanks to cells that retain the ability to divide, generating both new cells like
themselves and cells that go on to specialize. Stem cells renew tissues so that as the body grows, or loses
cells to apoptosis, injury, and disease; other cells are produced that take their places.

A stem cell divides by mitosis to yield either two daughter cells that are stem cells like itself, or one
that is a stem cell and one that is a partially specialized progenitor cell. The characteristic of self-renewal is
what makes a stem cell a stem cell—its ability to continue the lineage of cells that can divide to give rise to
another cell like itself. Our more than 260 differentiated cell types develop from lineages of stem and
progenitor cells.

A fertilized ovum is the ultimate stem cell. It is totipotent, which means that it can give rise to every
cell type, including the cells of the membranes that support the embryo. Other stem cells and progenitor cells
are pluripotent: Their daughter cells have fewer possible fates. Some are multipotent: Their daughter cells
have only a few developmental “choices.”

As stem cell descendants specialize, they express some genes and ignore others. All cells, however,
synthesize proteins for basic “housekeeping” functions, such as energy acquisition and protein synthesis.

Many, if not all, of the organs in an adult human body have stem or progenitor cells. These cells can
divide when injury or illness occurs and generate new cells to replace damaged ones. Stem cells in the adult
may have been set aside in the embryo or fetus in particular organs as repositories of future healing.
Evidence suggests that some stem cells, such as those from bone marrow, can travel to and replace
damaged or dead cells elsewhere in the body, in response to signals that are released in injury or disease.
Because every cell contains all of an individual’s genetic material, any cell type, given appropriate signals, can
in theory become any other. This concept is the basis of much of stem cell technology.

Stem Cell Sources

1. Embryonic stem (ES) cells are not actually cells from an embryo, but are created in a laboratory
dish using certain cells from a region of a very early embryo called an inner cell mass (ICM). Some
ICM cells, under certain conditions, become pluripotent and can self-renew—they are stem cells. The
ICM cells used to derive ES cells can come from two sources: “leftover” embryos from fertility clinics
that would otherwise be destroyed, and from nuclear transfer, in which a nucleus from a person’s
somatic cell is transferred to an egg cell that has had its own nucleus removed.

2. Induced pluripotent stem (iPS) cells are somatic cells that are “reprogrammed” to differentiate into
any of several cell types. This change may require a journey back through developmental time to an
ES cell-like state, then to specialize anew as a different, desired cell type. Or, cells can be
reprogrammed directly into another cell type. Deriving iPS cells does not require the use of any cells
from an embryo.

3. Adult or tissue-specific or somatic stem cells are found in the tissues of fetuses, embryos and
children, and not just in adult bodies. Adult stem cells self-renew, but most are multipotent, giving rise
to a few types of specialized daughter cells. Many potentially valuable adult stem cells are routinely
discarded as medical waste.

Stem Cell Applications

1. Drug discovery and development. Stem cell cultures supply the human cells that are affected in a
particular disease, which may be difficult or impossible to culture. Drugs are tested on these cells.
Using stem cells in drug development can minimize the need to experiment on animals and can weed
out drugs with adverse effects before they are tested on people.

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2. Observation for the earliest signs of a disease. Diseases may begin long before symptoms appear
in a person. Researchers are now observing the beginnings of hundreds of diseases—and
discovering new ways to treat them.

3. Implants and transplants for treatments. This approach is not new—the oldest such treatment, a
bone marrow transplant, has been around for more than half a century. Many other uses of adult stem
cells, delivered as implants, transplants, or simply infusions into the bloodstream, are being tested.

4. Reprogramming proteins directly into the body to stimulate stem cells in their natural niches.
Once we understand the signals, we might not need the cells. The applications of stem cells seem
limited only by our imaginations.

Gene Therapy Concerns

Scientific Concerns

1. Which cells should be treated, and how?

2. What proportion of the targeted cell population must be corrected to alleviate or halt progression of
symptoms?
3. Is overexpression of the therapeutic gene dangerous?
4. Is it dangerous if the altered gene enters cells other than the intended ones?
5. How long will the affected cell's function?
6. Will the immune system attack the introduced cells?
7. Is the targeted DNA sequence in more than one gene?
8. How can the activity of the transferred gene be controlled so that cells make appropriate amounts of
the gene product at the right time and in the right place?
9. How can we be sure that the insertion of the therapeutic gene does not harm some other necessary
cell function?
10. What is the proper route for gene delivery in different kinds of disorders? For example, what is the
best way to treat brain or muscle tissues?
11. What percentage of cells in an organ or tissue need to express a therapeutic gene to alleviate the
effects of a genetic disorder?
12. What amount of a therapeutic gene product must be produced to provide lasting improvement of the
condition, and how can sufficient production be ensured?
13. Will it be possible to use gene therapy to treat diseases that involve multiple genes?
14. Can expression of therapeutic genes be controlled in a patient?

Ethical Concerns

1. Does the participant in a gene therapy trial truly understand the risks?
2. If a gene therapy is effective, how will recipients be selected, assuming it is expensive at first?
3. Should rare or more common disorders be the focus of gene therapy research and clinical trials?
4. What effect should deaths among volunteers have on research efforts?
5. Should clinical trials be halted if the delivered gene enters the germline?
6. Is there a difference between the transplantation of genes into somatic cells and the transplantation of
organs?
7. Under what circumstances, if any, should we alter the genomes of human germ lines?
8. Would germline therapy inevitably lead to the practice of eugenics, a deliberate effort to control the
genetic makeup of human populations?
9. How can the “good” and the “bad” uses of gene therapy be distinguished?
10. Who decides which traits are normal and which constitute a disability and disorder?
11. Will the high costs of gene therapy make it available only to the wealthy?
12. Could the widespread use of gene therapy make society less accepting of people who are different?
13. Should people be allowed to use gene therapy to enhance basic human traits?
14. We have the technologies to test for genetic diseases for which there are no effective treatments.
Should we test people for these disorders?
15. With present genetic testing technologies, a negative result does not necessarily rule out future
development of a disease; nor does a positive result always mean that an individual will get the

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disease. How can we effectively communicate the results of testing and the actual risks to those being
tested?
16. What information should people have before deciding to have a genome scan or a genetic test for a
single disorder?
17. How can we protect the information revealed by such tests?
18. Since sharing of patient data through electronic medical records is a significant concern, what issues
of consent need to be considered?
19. How can we define and prevent genetic discrimination?

To learn more about stem cells and gene therapy, you may watch the following videos:
 Irishstemcell. (2012, August 22). Science Friction: Stem Cell Research. Retrieved from
https://www.youtube.com/watch?v=mPy7NFkJ-TQ
 TED. (2009, February 17). The next species of human | Juan Enriquez. [Video file]. Retrieved from
https://www.youtube.com/watch?v=JNcLKbJs3xk
 TED. (2011, April 19). Susan Lim: Transplant cells, not organs. [Video file]. Retrieved from
https://www.youtube.com/watch?v=EU15c9hnftE

LEARNING ACTIVITY

Choose an issue that you feel is important in the area of genetically modified organisms and gene
therapy. Write a position paper regarding this issue, discussing your stance on your chosen issue. Your
paper should be 500 – 7000 words long. You will be graded according to the following criteria:

4 3 2 1
Depth of Content Demonstrates a Demonstrates a Demonstrates a Lacks
comprehensive comprehensive basic understanding of
understanding of understanding of understanding of the subject for
the subject for the subject for the subject for reflection.
reflection and work reflection. reflection.
can be used as an
example for others.
Originality and Work is insightful Work is insightful Work shows some Work is not
Insight and shows a high and shows insight and some original.
degree of imagination. degree of
imagination. imagination.
Style and Clarity Ideas are clearly Ideas are clearly Ideas show some Ideas are not
articulated and well articulated and well degree of clarity communicated
developed. developed. but are not well clearly nor are they
developed. well developed.
Organization and Writing is well- Writing is well- Writing has some Writing is
Grammar organized with no organized with few degree of unorganized and
spelling and spelling and organization with contains many
grammatical errors. grammatical errors. some spelling and spelling and
grammatical errors. grammatical errors.
Timeliness Completed work Completed work Completed work Completed work
was passed earlier was passed on the was passed the was passed more
than the deadline deadline given. day after the than a day after the
given. deadline given. deadline given.

SUMMARY

 Biotechnology uses biological systems, living organisms, or derivatives thereof, to make or modify
products or processes for specific use.
 Genetic engineering or the direct manipulation of genes for practical use has brought revolution in
biotechnology.
 Genetically modified organism (GMO) is acquired by artificial means (through recombinant DNA
methods, gene modification, or transgenic technology) one or more genes from another species or
even from another variety of the same species.

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 Benefits of GMOs are mostly for agriculture and medicine.

  Potential risks of GMOs are of human health, biodiversity, animal welfare and also ethical issues
such as violating the rule of nature.
 Gene therapy is a therapeutic technique that aims to transfer normal genes into a patient’s cells.
 Stem cells renew tissues so that as the body grows, or loses cells to apoptosis, injury, and disease.

REFERENCES

 MacNamara, D., Valverde, V., and Beleno, R. (2018). Science, Technology, and Society. pp. 96-104.
Quezon City: C&E Publishing.
 Serafica, J., et al. (2018) Science, technology and society. pp. 122-132. Quezon City: Rex Bookstore.
 Dubock, A. (2014). The politics of golden rice. GM Crops & Food, 5(3), 210-222.
 Duguet, A. et al. (2013). Ethics in Research with Vulnerable Populations and Emerging Countries:
The Golden Rice Case. Journal of International Law and Commercial Regulations, 38(4), 979-1013
 Silici, Laura. (2014). Agroecology What it is and what it has to offer. IIED Issue Paper.
 MacNamara, D., Valverde, V., and Beleno, R. (2018). Science, Technology, and Society. pp. 109-
114. Quezon City: C&E Publishing.
 Serafica, J., et al. (2018) Science, technology and society. pp. 165-169. Quezon City: Rex Bookstore.

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