I. BOON OR BANE?

GMO’s IN DETAIL

A. Definition
The Online Encyclopedia Britannica defines GMO is “an organism whose genome has been
engineered in the laboratory in order to favor the expression of desired physiological traits or the
production of desired biological products”. In traditional livestock production and crop farming,
it has long been the method to breed select species in order to produce offspring with desirable
qualities. Furthermore, Britannica Encylopedia provides that “in genetic modification, however,
recombinant genetic technologies are employed to produce organisms whose genomes have been
precisely altered at the molecular level, usually by the inclusion of genes from unrelated species
of organisms that code for traits that would not be obtained easily through conventional selective
breeding”1.
The first GMO crops were developed to give resistance against certain pests, diseases,
weather conditions, decay or chemicaly treated herbicides. The second generation of GMO
crops aimed to improve the quality, often by modiying the crop’s nutrient profile. Third
generation GMO crops were for non-food like the production of pharmaceutical agents, biofuels,
and other industrially useful components.2
There are three main objectives to agricultural advancement thru genetic engineering
technology; increased production, improved conditions for farmers and sustainability. GM crops
help by improving harvests through mitigating insect pressure, topping up nutrient value and
tolerance to various abiotic stresses (Qaim 2016).3
Most currently available genes used to engineer insect resistance come from the Bacillus
thuringiensis bacterium and code for delta endotoxins. A few use the genes that encode for
vegetative insecticidal proteins (Fleischer, et al 2014).4
Golden rice is the most prominent GM crop that is aimed at boosting the nutrient value. It has
been modified with genes that biosynthesize beta-carotene, a precursor of vitamin A, in the
edible parts of rice (Ye, et al 2000).5
B. International Regulations
In most countries, the use of GMO’s is government regulated. In 1975, the first regulatory
framework regarding genetic engineering started in Asilomar California. The Asilomar meeting

1
Britannica.com, https://www.britannica.com/science/genetically-modified-organism/GMOs-in-medicine-and-
research (last accessed 1 Oct 2019)
2
Qaim M (29 April 2016), "Introduction", Genetically Modified Crops and Agricultural Development. Springer. pp.
1–10. ISBN 9781137405722.
3
Id.
4
Fleischer, Shelby & Hutchison, William & Naranjo, Steven. (2014). Sustainable Management of Insect-Resistant
Crops, https://www.researchgate.net/publication/278659933_Sustainable_Management_of_Insect-
Resistant_Crops (last accessed 1 Oct 2019)
5
Ye X, Al-Babili S, Klöti A, Zhang J, Lucca P, Beyer P, Potrykus I (14 January 2000) Engineering the provitamin A
(beta-carotene) biosynthetic pathway into (carotenoid-free) rice endosperm, Science (New York, N.Y.),
https://www.ncbi.nlm.nih.gov/pubmed/10634784 (last accessed 1 Oct 2019)
introduced a number of guidelines concering the cautious application of recombinant technology
and any of its byproducts (Berg, et al 1975).6
The most well-known regulatory policy to date is the Cartagena Protocol on Biosafety. It is
an international treaty governing the transfer, handling and use of GMO’s. The Protocol was
adopted on 29 January 2000 and later on put into force on 11 September 2003. It was signed by
one hundred and fifty-seven countries and many apply it as a reference point for their own
regulations.
There are nuances in the regulation for the usage of GMOs between countries, with some of
the most marked differences occurring between the US and Europe (Gaskell, et al 1999).7 In
2016, thirty eight countries officially prohibit the cultivation of GMOs and nine (Algeria,
Bhutan, Kenya, Kyrgyzstan, Madagascar, Peru, Russia, Venezuela and Zimbabwe) ban their
importation.8
One of the basic matters concerning regulators is whether GM products should be labeled.
The European Commission mandates that labeling and traceability are compulsory to allow for
informed choice and to avoid false advertising. In Canada and the US, labeling of food with GM
content is voluntary (Sheldon 2002).9
C. Controversies
There is controversy about GMO’s, especially over their release outside laboratory
environments. The dispute involves consumers, suppliers, biotechnology firms, government
regulators, NGOs, and the scientific community. Many of these concerns relate to GM crops and
whether the food they produce is safe and what impact they will have on the environment. Such
issues have contributed in some countries to lawsuits, international trade disputes, and
demonstrations, as well as stringent control of export goods.10
According to the World Health Organization, “most concerns are about the effects of GMOs
on health and the environment”. These include “whether they can cause an allergic reaction,
whether transgenes can be transferred to human cells and whether genes that are not approved
for human consumption can cross into the food supply.”11 It is tested for animal toxicity and
allergicity before food is released. The legal and regulatory status of GM foods varies from
country to country, with some nations banning or restricting them and others allowing them to be

6
Berg P, Baltimore D, Brenner S, Roblin RO, Singer MF (June 1975). "Summary statement of the Asilomar
conference on recombinant DNA molecules". Proceedings of the National Academy of Sciences of the United
States of America. 72 (6): 1981–4.
7
Gaskell G, Bauer MW, Durant J, Allum NC (July 1999). Worlds apart? The reception of genetically modified foods
in Europe and the U.S, https://www.ncbi.nlm.nih.gov/pubmed/10411496 (last accessed 11 Oct 2019)
8
Where are GMOs grown and banned?". GMO FAQ. 7 February 2016. Retrieved from
https://gmo.geneticliteracyproject.org/FAQ/where-are-gmos-grown-and-banned/ (last accessed 11 Oct 2019)
9
"The Regulation of Genetically Modified Foods". http://www.hc-sc.gc.ca/sr-sr/pubs/biotech/reg_gen_mod-
eng.php. Archived from the original on 10 June 2017. Retrieved 14 October 2019.
10
Ian M. Sheldon, Regulation of biotechnology: will we ever ‘freely’ trade GMOs?, European Review of Agricultural
Economics, Volume 29, Issue 1, 1 March 2002, Pages 155–176
11
"Q&A: genetically modified food". Retrieved from https://www.who.int/foodsafety/areas_work/food-
technology/faq-genetically-modified-food/en/. World Health Organization. (last accessed 14 Oct 2019)
regulated differently.12 Specific concerns include the blending of genetically modified and non-
genetically modified products in the food supply, the environmental impacts of GMOs, the
thoroughness of the regulatory process and the restructuring of food supply control in companies
producing and selling GMOs.13
D. International Frameworks
Discussion of the potential environmental or human health risks of GMOs has stimulated
attention to biosafety. Biosafety is associated with the safe use of GMOs and, more generally, the
introduction into natural or managed ecosystems of non-indigenous species (Koonin, et al
2001).14 Regulation on biosafety—the policies and procedures implemented to ensure the
environmentally safe use of modern biotechnology—are discussed extensively at various
national and international forums.
While international agreements and standards offer important guidance, they leave
substantial room for interpretation and flexibility for countries that adopt them. The
implementation of biosafety at the national level has proved to be a big challenge, especially in
developing countries, and as a result, the actual ability to function of the international regulatory
framework for biotechnology is still in stasis (Koonin et al., 2001).15
1. The Cartagena Protocol on Biosafety (CPB)
More than 130 governments reached agreement in January 2000 on the Cartagena Protocol
on Biosafety (CPB), which regulates the safe transfer, handling and use of Living Modified
Organisms (LMOs) from modern biotechnology. The Protocol's goal is to contribute to
guaranteeing an adequate level of protection in the field of safe delivery, handling and use of
living modified organisms resulting from modern biotechnology, which may adversely affect the
conservation and sustainable use of biological diversity, also taking into consideration risks to
human health and, in particular, transboundary movements.16 As of November 2011, the CPB
had been ratified or acceded to by 162 countries and was came into force on September 11,
2003.17
The two cornerstones of the CPB are Advance Informed Agreement (AIA) and the
Precautionary Approach. AIA enables an importing country to subject all first imports of LMOs

12
"Restrictions on Genetically Modified Organisms" 2015. Retrieved from
https://www.loc.gov/law/help/restrictions-on-gmos/Library of Congress. 9 June 2015 (last accessed 14 Oct 2019)
13
"Statement on Genetically Modified Organisms in the Environment and the Marketplace". Canadian Association
of Physicians for the Environment. October 2013. Retrieved from
https://web.archive.org/web/20140326015525/http://cape.ca/capes-position-statement-on-gmos/. Archived
from the original on March 26, 2014 (last accessed 15 Oct 2019)
14
OECD,. (2008). Novel Food and Feed Safety SET 1: Safety Assessment of Transgenic Organisms OECD Consensus
Documents Volumes 1 and 2: OECD Consensus Documents Volumes 1 and 2. Retrieved from
https://www.researchgate.net/publication/318393762_Novel_Food_and_Feed_Safety_SET_1_Safety_Assessment
_of_Transgenic_Organisms_OECD_Consensus_Documents_Volumes_1_and_2_OECD_Consensus_Documents_Vol
umes_1_and_2/citation/download. Last accessed 30 Oct 2019
15
Id.
16
Frequently Asked Questions (faqs) on the Cartagena Protocol Biosafety Unit., Retrieved from
https://bch.cbd.int/protocol/cpb_faq.shtml (last accessed 30 Nov 2019)
17
US Department of State Archive. Cartagena Protocol on Biosafety. Retrieved from https://2001-
2009.state.gov/g/oes/rls/fs/2004/28621.htm (last accessed 30 Nov 2019)
to risk assessment before taking a final decision on import. The Protocol provides details of the
entire notification, recognition and decision process.
The Precautionary Approach, as applied in Article 11 of the Protocol, asserts that “lack of
scientific certainty due to insufficient relevant scientific information and knowledge regarding
the extent of the potential adverse effects of a living modified organism on the conservation and
sustainable use of biological diversity in the party of import, taking also into account risks to
human health, shall not prevent that party from taking a decision, as appropriate, with regard to
the import of that living modified organism intended for direct use as food or feed, or for
processing, in order to avoid or minimize such potential adverse effects.” In simple terms, this
approach allows countries to block imports like, seeds of genetically modified plant varieties on
a precautionary basis even in the absence of sufficient scientific evidence of their harmfulness.
The Protocol established a Biosafety Clearing-House (BCH) to facilitate exchange of scientific,
technical, environmental and legal information on LMOs, and to assist parties to implement the
Protocol. Before a GM seed can be shipped for the first time, the importing country must give its
approval. If the seeds are permitted for importation, the exporter will attach documentations
specifying their identity and characteristics (Komen, 2012). 18

2. Nagoya - Kuala Lumpur Supplementary Protocol

At the fifth meeting of the Conference of the Parties serving as the meeting of the
Cartagena Protocol on Biosafety, held in Nagoya, Japan, on 15 October 2010, the Supplementary
Protocol on Liability and Redress was adopted, which was later on entered into force in March
2018. 19
The Supplementary Protocol, adopted as a supplementary agreement to the Cartagena
Protocol on Biosafety, aims to contribute to the conservation and sustainable use of biodiversity
by providing international liability and redress rules and procedures for living modified
organisms, as set out in Article 1. It also applies to damage caused by living modified organisms
that originate in a transboundary movement. Damage is further defined as “the adverse effect on
the conservation and sustainable use of biological diversity that is measurable or otherwise
observable and significant, taking also into account risks to human health.”20
In Article 4 of the Supplementary Protocol, a causal link must be established between the
damage and the living modified organism. States shall ensure the operator to act immediately in
the event of damage caused by living modified organisms originating in a transboundary
movement, as provided for in Article 5. The Protocal defines the ‘operator’ as ‘any person in
direct or indirect control of the living modified organism’. Furthermore, the Protical provides
that the operator must also take response measures where there is a sufficient likelihood that
damage will result if timely response measures are not taken. Competent authority may also take
action to respond, for example if the operator has failed to do so. The competent authority can, in
such cases, recover from the operator the expenses and costs of such measures.

18
John Komen (2012) The emerging international regulatory framework for biotechnology, GM Crops & Food,
https://www.researchgate.net/publication/221723494_The_emerging_international_regulatory_framework_for_
biotechnology (last accessed 30 Nov 2019)
19
About the Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress.The Biosafety Clearing-House
(BCH), https://bch.cbd.int/protocol/supplementary/about/ (last accessed 30 Nov 2019)
20
Id.
 The Supplementary Protocol defines ‘response measures’ as ‘reasonable actions to
prevent, minimize, contain, mitigate or otherwise avoid damage, as appropriate, or reasonable
actions to restore biological diversity’.21
In conjunction to imposing a provision for response measures, the Supplementary
Protocol also requires Parties to continue applying existing laws on civil liability or to create and
develop specific legislation on liability and redress for material or personal harm linked to the
conservation and sustainable use of biological diversity as defined in the Supplementary
Protocol.

3. The U.S. Coordinated Framework for the Regulation of Biotechnology

The Coordinated Biotechnology Regulation Framework, proposed by the White House Science
and Technology Policy in 1984 and finalized in 1986, sets out the basic federal policy for the
development and introduction of biotechnology-derived products.22 According to the
Framework, the three main Federal agencies responsible for regulating the safe use of genetically
engineered organisms are the US Animal and Plant Health Inspection Service (APHIS), the U.S.
Environmental Protection Agency (EPA), and the U.S. Department of Health and Human
Services' Food and Drug Administration (FDA). Under the Plant Protection Act23, USDA-
APHIS is responsible for regulatory oversight of modern biotechnology products that could pose
such a risk. USDA-APHIS therefore regulates organisms and products known or suspected to be
plant pests or pose a risk of plant pests, including those altered or produced by genetic
engineering, also known as "regulated articles." USDA-APHIS regulates the importation,
handling, interstate movement and release into the environment of regulated organisms that are

21
Id.
22
United States Regulatory Agencies Unified Biotechnology Website Archived 2012-11-17 at the Wayback
Machine web page contains only links to other .gov pages (last accessed Nov 4 2019)
23
The Plant Protection Act (“Act”) is a U.S. federal statute that was enacted on June 20, 2000 to prevent the
importation, exportation, and spread of pests injurious to plants and to provide for their control and eradication
and for the certification of plants.