GENETIC MODIFICATION TECHNOLOGY AND ITS IMPACT ON FOOD SAFETY REGULATORY VIEW

SYED REHAN AHMAD [Include, complete mailing address, telephone, and e-mail address]

Abstract: the paper highlights food safety of GM foods and its associated technology using a regulatory framework, in order to understand the implications of regulations over the use of GM foods. The paper also shows how GMOs are derived and how it is implanted into plants to create a more sustainable world food balance. It is also further explained how the US and EU members states along with Canada are responding to meet the challenges associated with GMOs. Some fragments of the individual countries framework has been mentioned and how they are adopting new and better measures to ensure the sustainability as well as the safety of the GMO foods. Nonetheless, in the end it is the consumer who has to have the choice to decide whether GMOs are going to be accepted or disapproved in the light of R&D, safety Regulatory measures by responsible agencies and accurate consumer information. Keywords: GM foods, regulatory, sustainability, technology, implanted Introduction: The emergence of GMOs has come with the demand for more food for the multiply growing population and its associated problems to create a sustainable supply of food thus solving the problem of world hunger. Traditional food supplies have become insufficient to address this need which is why technology has been called to rescue the hungry world thus promising a sustainable supply and somewhat claims a healthier and better version of the traditionally natural foods. Genetically modified foods, are also better known as transgenic crops. The following paper will focus on the safety of modified foods and how they should be regulated. Historically plant breeding has been around for eons, but by the development of the so called recombinant DNA techniques has opened the doors to plant breeding using the genes of soil bacteria or a virus etc. and inserting them into the plant genomes, thus altering the natural state of the plant hitherto making it more resistant to survive and bloom in the worst of conditions. Transgenic plants are usually made up of a genetic marker (antibiotic or herbicide

resistance) and a well-characterized gene. The coding region of the gene is usually fused to a promoter, most commonly used is the 35S promoter from cauliflower mosaic virus (CMV), in order to promote higher expression levels. (Snow et. al, 1997) The gene transfer in plants is usually done via an Agrobacterium tumefaciens, found in fertile soils. The transfer-DNA (TDNA) vector is made by inserting the desired gene fragment in between specific 25bp repeat domains in the bacterium. The vector is then inserted into the Agrobacterium and "the virulence gene products of Agrobacterium actively recognize, excise, transport, and integrate the T-DNA region into the host plant genomes. (Conner et. al, 1999)

In contrast the benefit to applying GM technology to foods is hence yield. On average, farmers in developed countries experienced increase in yield of 6% and in underdeveloped countries of 29%. Tillage was decreased by 2558% on herbicide resistant soybeans, insecticide applications on Bt crops were reduced by 1476% and 72% of farmers worldwide experienced positive economic results. (Carpenter, Janet E 2010) However in the midst of such frenzy and excitement and promises GMOs have not become as popular are it should have been. The methods employed to develop GMO based foods and the risks associated with it are still shrouded in controversies, whether GM foods are safer to consume or is it going to possess a threat to world economies in terms of exploitation by only a few large corporations. For this world governments are seeking to develop a framework as to how to assess the safety, sustainability and viability of this technology. The main issue is the dispute over the relative advantages

Adoption of genetically-engineered crops in the United States

and disadvantages of GM foods and its use in production. The main players in this dispute are large corporations, biotechnology companies, government regulators, and scientists. The United States shows more acceptance and openness to this technology as compared to Europe. GM based crops are widely grown and less controversial in the United States than any other country in the world. Therefore the main political issue here with GM foods is safety in consuming it. Some studies conducted by the European Commission Directorate-General for Research and Innovation 2010 have stated that The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of more than 25 years of research, and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies. (A decade of EU-funded GMO research, 2001-2010). But amidst these claims many EU countries have banned the use of GM crops altogether. Herein lies the main crux in how to regulate GM foods and make it acceptable enough by creating a framework so that countries may benefit from such a beneficial technology.

A 2003 review in Trends in Biotechnology has identified seven main parts of a standard safety test. (Kok EJ, Kuiper HA October 2003)

1. Study of the introduced DNA and the new proteins or metabolites that it produces; 2. Analysis of the chemical composition of the relevant plant parts, measuring nutrients, anti-nutrients as well as any natural toxins or known allergens; 3. Assess the risk of gene transfer from the food to microorganisms in the human gut; 4. Study the possibility that any new components in the food might be allergens; 5. Estimate how much of a normal diet the food will make up; 6. Estimate any toxicological or nutritional problems revealed by this data; 7. Additional animal toxicity tests if there is the possibility that the food might pose a risk.

Some countries are viewing and assessing the sustainability and viability of GM foods and assessing as to how well a standard framework can be designed to develop, grow and market GMOs based foods. Contrasting therefore the GMO regulatory issues between the United States, Canada and Europe, we find that the US and EU have different views about how to assess GM food safety. Initially Europe and the United both adopted the same regulatory framework in the early years of GMOs R& D but quickly took turns in the opposite direction because the initial support of the scientific community for strict regulatory controls was undermined by growing awareness of biotechnology's commercial potential. In deciding on its regulatory approach to genetically-modified organisms (GMOs or GMs) the United States federal government faced two critical issues. One was whether the government already possessed sufficient legal authority to regulate biotechnology. . . A second issue was whether regulations should govern the process by which genetically-engineered products were produced rather than the products of biotechnology. (Diahanna Lynch, David Vogel, 2001). In the United States the EPA, USDA, and FDA are the three primary regulatory agencies for regulating biotechnology. In the 1980s, the application of existing statutes to biotechnology led to significant questions about overlapping authorities among these agencies, and whether these agencies would be effective enough not to cross each other jurisdictions hence weakening the framework, hence in response to such a concern, the Reagan Administration created a domestic policy council for regulating and overseeing biotechnological affairs, which also was responsible for drafting a framework as well. This draft is considered important to U.S. biotechnology policy, as it established the underlying principles for federal regulation of biotechnology and segregated the roles of individual agencies. Some key aspects among these are the following principles: (excerpts)

Existing statutes were adequate enough to provide agencies with the required authority to regulate biotechnology activities, though legislation could be involved as the technology advanced and matured. Safety assessments and other regulatory questions turned on the nature of the products, rather than on the manner in which they are produced. The outcome of this principle is that products derived from biotechnology would be subject to the same kind of review as it would be given to the same kind of products produced in other ways. A lead agency; appointed to overlook to cases in which more than one agency had jurisdiction over the same category of products. The FDA is the main regulatory agency of food articles; with authority on safety and labeling (though the US still does not have stringent labeling regulations yet) for almost all foods, food additives, and dietary supplements; the USDAs Food Safety and Inspection Service (FSIS) has safety inspection and approval authority for meat, poultry, and egg products etc. where does the EPA come under this framework? Well the EPA's role in food safety is to monitor the use of pesticide in plants and animals grown for food. In contrast to their US counterparts, The EU has taken a much more stringent step to regulate GM foods. The EU's Biotechnology Committee established the Biotechnology Regulations Interservice Committee (BRIC). This committee would act as the main platform for developing biotechnology regulations within the European Commission. Therefore GMOs must be authorized by (BRIC) and its associated directives before they enter the EU market, which applies to GMOs used in food to seeds for GM crops. In 2004, a newly revised legal system took came about in all EU Member States. These fundamental EU policies were designed to have

tight safety standards while having the freedom of choice for consumers and farmers alike. Some of these key framework policies with respect to GMO food safety are; based on a standard decision making process the EU members states that it is permissible to use GMO foods, but should be approved prior to use, hitherto approval is granted under stringent conditions.

Safety: this is one of the most crucial issues. The GMO product should be safe for use as well as safe for the environment. They must be testable as well, if not they will not be deemed authorized for use or consumption.

Labeling: This is most important tool for GMO based products within the EU framework. This ensures the consumers freedom of choice, which is a requirement by EU law, which directs GMO food products to be accurately labeled so that the consumer is aware of its existence. Traceability: even if a product is not found to have traces of GMO, it must be still mentioned. This ensures that all key players must inform the consumer that GMO has been used in their products. This directive is declared in its own EU regulations (1830/2003). In Canada however the GMO scene adopts a much more neutral scene. (1)The government categorizes genetically modified products as "novel" products. This term covers products that have not been previously available for sale in Canada, or are produced by a new process, such as genetic engineering. There are five acts under which biotechnology products are regulated by the CFIA: the Feeds Act, Fertilizers Act, Seeds Act, Health of Animals Act and the Plant Protection Act. The CFIA regulates seeds, plants, animals, veterinary biologics, fertilizers and feeds, including those derived from biotechnology. The CFIA carries out safety assessments to evaluate new agricultural products for their efficacy and the safety of the worker/bystanders, animals and the environment... The safety assessment process is based upon principles

developed through international expert consultations carried out by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations, the Codex Alimentarius Commission and the Organisation for Economic Co-operation and Development (OECD).
(1)

The safety assessment of foods developed using genetic modification includes the following considerations:

how the food crop was developed, including the molecular biological data which characterizes the genetic change; composition of the novel food compared to non-modified counterpart foods; nutritional information for the novel food compared to non-modified counterparts; potential for new toxins; and Potential for causing allergic reaction.

The Canadian government is trying its best to ensure that these standards are maintained and assessed in due course by its regulatory agencies and to keep at par with other countries to ensure the safety of its consumers as well as be able to exploit GMO based foods. CONCLUSION The differences between the US and the EU regulatory policies are striking. The EU has issued eighteen licenses for biotechnology products, nine of which were for genetically-modified crops.
(2)

By contrast, the USDA has issued approvals for fifty genetically-modified crops, (3) while the

EPA has approved eight. (4)Nearly three-quarters of all genetically modified crops are grown in the United States; hardly any are grown in Europe. The EU and a number of Member States have enacted strict labeling requirements, while US labeling requirements are more modest, only requiring only the labels of products which differ from their non-genetically modified counterparts. However the future of GMOs still exists within more flexible but rigid policies that need to be addressed, should countries need to capitalize on the novel technology. Once regulations fully come into play and global standard framework has been established by then

only the doors of fully exploiting this unique technology could be seen. Till then we have to wait and see how responsible countries respond to this call. References A decade of EU-funded GMO research (2001-2010). Directorate-General for Research and Innovation. Biotechnologies Agriculture, Food. European Union. 2010. p. 16. Conner, Anthony and Jeanne M.E. Jacobs. Genetic engineering of crops as potential source of genetic hazard in the human diet. Mutation Research: Genetic Toxicology and Environmental Mutagenesis. Vol. 443, 1999. Pp. 223-234. Carpenter, Janet E (2010). Peer-reviewed surveys indicate positive impact of commercialized GM crops. Nature Biotechnology 28 (4): 31921. Diahanna Lynch, David Vogel (April 5, 2001), The Regulation of GMOs in Europe and the United States: A Case-Study of Contemporary European Regulatory Politics, Council on Foreign Relations Press Kok EJ, Kuiper HA (October 2003). Comparative safety assessment for biotech crops. Trends Biotechnol. 21 (10): 43944. Office of Science and Technology Policy. 1986. Coordinated Framework for Regulation of Biotechnology; Announcement of Policy and Notice for Public Comment. 51 Fed. Reg. 23302 (June 26, 1986) REGULATION (EC) No 1830/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 22 September 2003,concerning the traceability and labelling of genetically modified organisms and the traceability offood and feed products produced from genetically modified organisms and amending Directive 2001/18/EC Snow, Allison and Pedro Moran Palma. Commercialization of transgenic plants: potential ecological risks. BioScience. Vol. 47, Feb. 1997. Pp. 86-96.

Other References 1. http://www.hc-sc.gc.ca/fn-an/gmf-agm/fs-if/genetically-genetiquement-eng.php 2. CNN Headline News, June 24, 1999; and "Genetically Modified Food: Food for Thought," The Economist, June 19, 1999. 3. Marian Burros, "U.S. Plans Long-Term Studies on Safety of Genetically Altered Foods," The New York Times, July 14, 1999: A16.

4. Nikki Tait, "EPA Sued over Genetic Crop Approval," Financial Times, February 19, 1999: 6.