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).1
A. 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 introduced a number of guidelines concerning the cautious application of recombinant
technology and any of its byproducts (Berg, et al 1975).2
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).3
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.4
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).5
B. 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.6
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

1
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)
2
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.
3
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)
4
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)
5
"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.
6
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
approved for human consumption can cross into the food supply.”7 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 regulated differently.8 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.9
C. 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).10 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).11

1. The Cartagena Protocol on Biosafety (CPB)

More than 130 governments reached agreement in January 2000 on the Cartagena

7
"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)
8
"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)
9
"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)
10
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_Assess
ment_of_Transgenic_Organisms_OECD_Consensus_Documents_Volumes_1_and_2_OECD_Consensus_Docum
ents_Volumes_1_and_2/citation/download. Last accessed 30 Oct 2019
11
Id.